Frequently Asked Questions
or
Applicants
Applicants with a Criminal History
I have a criminal conviction. Am I eligible to obtain a license?
Applicants with a criminal conviction(s) are not automatically denied a license as there is nothing in pharmacy law that requires the Board of Pharmacy to deny an application based on a specific conviction. In reviewing applications for licensure, the board will consider prior convictions of the applicant, however.
Effective July 1, 2020, the board’s authority to deny an application based on certain criminal convictions was restricted. (Business and Professions Code Section 480). Specifically, the board cannot deny an application on the basis of an application if:
NOTE: The preceding seven-year limitation shall not apply in either of the following situations:
- The applicant was convicted of a serious felony, as defined in Section 1192.7 of the Penal Code,
- The applicant was convicted of a crime for which registration is required pursuant to paragraph (2) or (3) of subdivision (d) of Section 290 of the Penal Code.
Unless restricted, the board may deny an application for licensure if the applicant was convicted of a crime substantially related to the qualifications, functions or duties of the pharmacy profession. In assessing whether crimes are substantially related to the profession, the board uses the criteria set out in a board regulation (California Code of Regulations, title 16, Section 1770). The board will review applicants with a criminal history on a case-by-case basis and will consider evidence of rehabilitation using the criteria set out in Section 1769(b) of the board’s regulations and the board’s Disciplinary Guidelines, which currently includes:
- The nature and severity of the act(s) or offense(s).
- Evidence of any act(s) committed subsequent to the act(s) or crimes.
- The time that has elapsed since commission of the act(s) or crime(s).
- Whether the applicant has complied with any terms of parole, probation, restitution, or any other sanctions lawfully imposed against the applicant.
- Evidence, if any, of rehabilitation submitted by the applicant.
The board has proposed changes to both of these regulations to more specifically identify the criteria it uses. The proposed changes to these two regulations are on the board’s website at https://www.pharmacy.ca.gov/laws_regs/1769_1770_pt.pdf.
Revised August 2022
Does the California State Board of Pharmacy pre-screen potential applicants with criminal convictions before they apply?
No. A determination regarding an applicant’s eligibility to obtain a license will not be made prior to the submission of an application. Consequently, board staff will not provide opinions about whether an applicant’s specific criminal history will result in the approval or denial of an application.
Revised August 2022
My conviction occurred within the past seven years but it was later dismissed per Penal Code section 1203.4. Will the board still investigate my conviction?
Yes. The board may have to request court documents to assess and ensure that a conviction was dismissed pursuant to Penal Code sections 1203.4, 1203.4a, 1203.42 or a comparable dismissal or expungement. If the board determines that a conviction was dismissed pursuant to one of these sections or a comparable dismissal or expungement, the board cannot use the conviction as the basis for denying a license to the applicant.
Applicants are not required to disclose any conviction or provide any documentation regarding any prior convictions. Applicants may voluntarily provide a certified certificate of rehabilitation or proof of dismissal with their application.
Revised August 2022
I have a job offer that requires a license. Is there anything I can do to expedite the review process?
In order to be fair to all applicants, the board reviews each application in the order they are received. Applicants may, however, voluntarily provide the following documents to help expedite the review process. Providing the documents is completely voluntary and is not a factor in the board’s decision to approve or deny and application.
- A written explanation detailing the circumstances surrounding each conviction.
- A copy of the arrest/incident report(s) for each conviction.
- A certified copy of the court documentation for each conviction. Court documentation submitted should include, but is not limited to, the criminal complaint, court minutes, sentencing, and probation order.
- Current proof of compliance with probation may include, but is not limited to, participation in or completion of any drug and/or alcohol, anger management, domestic violence, or theft programs; payment of fees, fines or restitution; or completion of community service.
- Additional evidence of mitigation including, but not limited to: letters of recommendation, proof of employment or volunteer work, completion or enrollment in school or training programs, etc.
- A certified document showing the date an applicant was released from incarceration for a conviction, if any.
Revised August 2022
How will I know if my application was sent to the Criminal Conviction Unit?
The board will notify applicants by mail if their application has been forwarded to the Criminal Conviction Unit for additional review. If an applicants’ address of record changed since the application was submitted, please submit a change of address request at https://pharmacy.ca.gov/about/change_of_address.shtml.
Revised August 2022
How can I get in touch with the Criminal Conviction Unit about my application?
You may contact us for a status request if it has been at least 45 days since the date that the application was forwarded to the Criminal Conviction Unit and your license has not been issued.
Revised August 2022
Do I need to disclose past convictions or provide documentation related to my conviction(s)?
No. The board cannot require an applicant for licensure to disclose any information or documentation regarding the applicant’s criminal history. However, the board may request mitigating information from an applicant regarding the applicant’s criminal history for purposes of determining substantial relationship or evidence of rehabilitation. The applicant’s decision not to disclose any information is not be a factor in the board’s decision to grant or deny an application for licensure.
Revised August 2022
Consumers
Filing a Complaint
Is your complaint within the jurisdiction of the California State Board of Pharmacy?
The Board’s mission is to protect the health, safety, and welfare of Californians. This includes reviewing, evaluating, and resolving consumer complaints regarding licensees.
Complaints about pharmacist misconduct or prescription errors should be reported regardless of whether a patient is harmed. Other types of complaints are not within the Board’s jurisdiction – such as prescription drug prices, problems with over-the-counter medications, or insurance billing disputes. However, you may contact the Board for information about possible options to resolve your complaint.
Although the Board generally has no jurisdiction over drug prices, California law requires MediCal provider pharmacies to sell prescription drugs to Medicare recipients at Medi-Cal prices. You may file a complaint with the Board of Pharmacy if you believe a pharmacy is not charging you the correct price under this program.
The Board recommends comparing prices at several pharmacies to obtain the best prices for your drugs. Also, ask your doctor or pharmacist if a less expensive generic product is available.
The following are the most common complaints received that do NOT fall under the jurisdiction of the CA State Board of Pharmacy and the appropriate reporting agencies.
| Type of complaint: | Who to contact: |
|---|---|
| Assisted Living Facilities Board and Care Facilities |
CA Dept. of Social Services www.cdss.ca.gov (916) 651-8848 |
| Billing Issues with Health Plan and other billing issues | CA Dept. of Managed Healthcare www.dmhc.ca.gov 888-466-2219 |
| Customer Service Issues | Corporate Offices/Business Owner/Yelp |
| Discrimination | U.S. Dept. of Health & Human Services |
| Disability | CA Dept. of Justice, Disability Rights Bureau www.oag.ca.gov/civil/disability-rights 916-504-5800 |
| Over the Counter Medications (OTC) or Non-prescription Medications | CA Dept. of Public Health – Food & Drug Branch www.cdph.ca.gov 800-495-3232 |
| Medicare | CA Dept. of Health & Human Services www.cms.gov 800-633-4227 |
| Medi-Cal | CA Dept. of Health Care Services www.dhcs.ca.gov 888-452-8609 |
| Health Care Facilities Acute Care Hospitals Skilled Nursing Facilities Hospice Homecare |
CA Dept. of Public Health www.cdph.ca.gov 916-558-1784 |
| Physicians | Medical Board of CA www.mbc.ca.gov 800-633-2322 |
| Refunds | CA Dept. of Justice www.oag.ca.gov/consumers/general/refunds 916-210-6276 |
| Federal Veterans Affairs pharmacy/hospitals |
U.S. Dept. of Veterans Affairs www.va.gov 800-698-2411 |
| California Dept of Veterans Affairs Nursing facilities and Assisted Living Facilities |
California Dept. of Veterans Affairs (CalVet) www.calvet.ca.gov/contact 800-952-5626 |
You may refer to Business and Professions Code, Chapter 9, Sections 4057 for a detailed list of items not within Board of Pharmacy jurisdiction by clicking the Lawbook icon at the Board’s website, www.pharmacy.ca.gov.
The Board of Pharmacy’s jurisdiction includes dangerous drugs and dangerous devices described in Business and Professions Code, Chapter 9, Section 4006 and 4022.
Revised March 2026
What is pharmacist misconduct?
Any action by a licensed pharmacy or pharmacist that appears improper should be reported to the Board. Examples of misconduct include:
The pharmacist fails to counsel you about how to take a new prescription (or a prescription with changed instructions) and possible side effects.
A non-pharmacist employee is allowed to counsel you regarding your prescription.
The pharmacist is not present, and your prescription is filled by a non-pharmacist.
The pharmacist fails to maintain the confidentiality of your prescription.
The pharmacist appears unable to function safely (due to alcohol or drug abuse).
The pharmacy appears dirty, cluttered, or unsanitary.
Revised March 2026
What are prescription errors?
Examples of prescription errors include:
Incorrect information is entered on the label of the prescription container.
A prescription is dispensed with the wrong drug or wrong dosage.
A prescription is refilled without proper authorization from the prescribing physician.
A generic drug is substituted for a brand-name drug without informing the patient.
A prescription is filled with expired drugs.
Revised March 2026
How do I file a complaint?
You may submit a complaint online or download a complaint form at the Board’s website at www.pharmacy.ca.gov. (Forms are available in English and Spanish.) Mail the completed form to:
Board of Pharmacy
Attention: Complaint Unit 2720 Gateway Oaks Drive, Suite 100
Sacramento, CA 95833
To help the Board evaluate your complaint, provide as many details as possible. Include copies of any related documentation, such as prescriptions, invoices, or correspondence. If your complaint is about a dispensing error or a prescription container that is incorrectly labeled, keep the container and its contents for reference if possible.
Revised March 2026
What happens to my complaint?
The Board will notify you by letter when your complaint is received. After evaluating your complaint, the Board may advise the pharmacy of your concerns and ask for an explanation. In some instances, depending on the type of complaint, your name may be kept confidential.
The Board will take disciplinary action if its investigation reveals a violation of California pharmacy law. The action, based on the type and severity of violation, can range from an official warning and/or fine to suspension, probation, or revocation of license.
Revised March 2026
Will I be told the outcome of my complaint?
Yes. You will receive a written notice of the outcome and any action taken by the Board. Routine investigations may take about six months, while more complex cases requiring extensive investigation may take longer.
You also may write to the Board and request information regarding the complaint outcome. The Board will respond in writing with the following information:
The date the complaint was received.
A summary of the investigation.
The case outcome or type of discipline.
Formal disciplinary actions are matters of public record, as are licensee names, numbers, and addresses of record; original license date of issue; and current license status (active or inactive). You can check the license status of any pharmacy, pharmacist, or other business or person licensed by the Board of Pharmacy by clicking the License Search icon at the Board’s website, www.pharmacy.ca.gov.
Revised March 2026
Applicants
Becoming Licensed as a Pharmacist in California
The examination program will be comprised of two parts:
- Passing the North American Pharmacist Licensure Examination (or NAPLEX) which is prepared by the National Association of Boards of Pharmacy (NABP). For the score to be valid in California, this exam must be passed on or after January 1, 2004.
- Passing the California Pharmacist Jurisprudence Exam (CPJE). This exam is developed by the California State Board of Pharmacy. (Note: this exam is different than the Multistate Pharmacist Jurisprudence Examination Administered by NABP.)
Both of these examinations will be given via a computer, and will be available for qualified applicants to take the examination six days a week throughout the year.
The new exam structure replaces the board’s prior written examination that was given twice a year.
You will apply to the California Board of Pharmacy with the application posted at www.pharmacy.ca.gov. This is the first part in the application process where California will review your eligibility to take the pharmacist licensure examination. You are also required to apply through NABP for the NAPLEX.
The requirements to become eligible to take the licensure examination will remain the same. Specifically, to take the pharmacist licensure examination for California, you must:
- Be at least 18 years of age
- Be a graduate of a domestic school of pharmacy or be a graduate of a foreign school of pharmacy and have been certified by the Foreign Pharmacy Graduate Examination Committee (FPGEC)
- Have completed at least 150 semester hours of collegiate credit, 90 of which must be from a school of pharmacy
- Have earned at least a baccalaureate degree in a course of study devoted to pharmacy
- Have 1,500 hours of approved pharmaceutical experience as a registered intern or one year of experience as a licensed pharmacist in another state.
I passed the NAPLEX already and I am licensed in another state, how can I reciprocate my license?
California law does not allow for reciprocity. You are required, at least, to take and pass both the NAPLEX and CPJE.
Revised January 2010
Are the NAPLEX and CPJE computerized and multiple-choice examinations?
Yes
Revised January 2010
I graduated, but my transcripts won’t be available for another month. Can I take the NAPLEX prior to the board receiving my transcripts?
No, the board must receive your transcripts with the degree posted before the board will confirm your eligibility to NABP (which qualifies you to take the NAPLEX for California).
Revised January 2010
If I take the MPJE examination offered by the NABP, do I still have the take the California Jurisprudence Examination?
Yes. The MPJE examination offered by the NABP is a separate examination required by some states for licensure. It is not a requirement for licensure in California. Rather, applicants must pass the CPJE in addition to the NAPLEX to become licensed in California.
Revised January 2010
I am scheduled to take the NAPLEX examination for another state and would like to transfer my score to California. What are the procedures?
Score transfers are completed by the NABP. Please visit its Web site https://nabp.pharmacy/ for the specific requirements.
Revised January 2010
I took the NAPLEX examination in October 2003. Can I transfer this score?
No. To become licensed in California, you must take and pass the NAPLEX and the CPJE on or after January 1, 2004.
Revised January 2010
Does the California Specific Examination Content Outline posted on your Web site refer to the MPJE examination for California?
The content outline posted on the board’s Web site is for the CPJE. There is no MPJE examination required for applicants to become licensed in California. Rather an individual must pass the NAPLEX examination and the CPJE on or after January 1, 2004.
Revised January 2010
I heard that the NAPLEX examination changed after January 1, 2004, and is more difficult to pass. Is this true?
The NAPLEX examination is developed and administered by the NAPB. The board is not aware of any changes being made to this examination.
Revised January 2010
What do I need to do if I want to take the NAPLEX examination for California?
You must submit an examination application to the California Board of Pharmacy and satisfy all of the requirements. You must also submit a “Registration Bulletin” with the NABP to take the NAPLEX.
Revised January 2010
If I pass the NAPLEX examination but fail the California Pharmacist Jurisprudence Examination, do I need to retake both exams or just the CPJE?
You will need to retake the CPJE only.
Revised January 2010
Your Web site states that the CPJE is different from the MPJE. Does this mean that you don’t have to take an MPJE examination in California or is the CPJE taking the place of the MPJE?
The CPJE is required. This examination is different than the MPJE administered by the NABP.
Revised January 2010
I have already taken the exam for California three times in the old format. How many times do I get to take the NAPLEX and the CPJE before I must re-qualify with an additional 16 semester units?
You have a total of one time to take the CPJE and one time to take the NAPLEX.
Revised January 2010
Does the CPJE include clinical questions or just law questions like other states?
Please see the detailed content outline posted on the board’s Web site. There are sample questions available in the CPJE Handbook. There are additional sample test questions on the board’s Web site.
Revised January 2010
I am applying with NABP to take the NAPLEX with another state as my primary state and California as a score transfer. Do I need to apply to the board to take the CPJE?
Yes
Revised January 2010
How can I submit the $200 application fee to the board?
You may do this by personal check, money order or cashier’s check made payable to the “Board of Pharmacy.” Do not send cash.
Revised January 2010
What is the fee for the NAPLEX?
The NABP charges for the NAPLEX; this fee of $485 is paid directly to the NABP.
Revised January 2010
I took the board exam in June 2003. How do I submit an application to take the new exams? How long will the board keep my file? Is there a retake application I should use?
If you are applying within 2 years from your previous attempt, you may submit a retake application and fee, if required. If you are applying after 2 years from your previous attempt, you are required to submit a new application, supporting documents and fee, if required.
Revised January 2010
I had my Live Scan previously done and have not applied with the board yet. Do I have to have Live Scan redone?
If you had Live Scan done for the board within the past year, please submit with your application a copy of your Live Scan receipt. If the Live Scan was done more than a year ago, you are required to have Live Scan redone and submit a copy of the new receipt with your application. The board is able to follow up with the Department of Justice based on the receipt. If you had your Live Scan done for another agency (for example, employment or volunteer) you will need to have Live Scan done again as the results cannot be shared between agencies. You need to obtain both a state and federal background check.
Revised January 2010
I live outside of California. How do I do Live Scan?
If you live outside of California, you can come to California and have Live Scan done. However, if you are outside of California, you cannot do Live Scan as other states’ Live Scan systems are not connected to California’s Live Scan system. Instead, submit your fingerprints on fingerprint cards. We strongly recommend that you have your fingerprints professionally rolled on two fingerprint cards provided by the Board of Pharmacy. You also will need to submit with the fingerprint cards a processing fee of $49 made payable to the “Board of Pharmacy.” You may request the fingerprint cards at www.pharmacy.ca.gov.
Revised January 2010
I took and passed the NAPLEX after January 1, 2004. If NABP agrees to transfer my score, will the California board accept the score?
Yes, the board will accept a passing score on the NAPLEX provided the exam was passed on or after January 1, 2004.
Revised January 2010
I would like to take the NAPLEX as soon as I can. I have applied for the Authorization to Test (ATT) from another state and will transfer the score to California. I already have the ATT from the NAPLEX and am scheduled to take it for the other state. Can I use this ATT to make an appointment for the CJPE when it is available or do I have to submit another application to CA to verify my eligibility to test?
No, you can’t use the ATT from another state to take the CPJE. You will be required to apply with the California board and meet all application requirements to take CPJE.
Revised January 2010
Where are the test sites for NAPLEX and CPJE?
You need to use the candidate handbooks for this information. Both the NAPLEX and CPJE Handbooks are online at our Web site. Both exams will be available nationwide but at different test locations (different firms provide each exam).
Revised January 2010
Is it ok to send an application now for the NAPLEX and CPJE?
Yes, you may send your application to the board as well as the application to NABP for NAPLEX once you meet the requirements to take the exams. The application to be submitted to the board may be downloaded at www.pharmacy.ca.gov. Information pertaining to the application for NAPLEX may be found at https://nabp.pharmacy/. The board does not mail out either application.
Revised January 2010
Now that California is using the NAPLEX and the CPJE, is a pharmacist from Canada eligible to take the NAPLEX without applying through the board’s foreign graduate process?
All foreign graduates must first apply to the board as a foreign graduate in order to be scheduled for an exam for California. A United States social security number is still required before a license can be issued.
Revised January 2010
Applicants
CPJE and NAPLEX Passing Score
Section 4200(a)(6) of the Business and Professions Code (BPC) defines that the Board may issue a pharmacist license to an applicant who meets the following:
CPJE
- Has passed a version of the California Practice Standards and Jurisprudence Examination (CPJE) for Pharmacists that, at the time of application for licensure, was based on an occupational analysis that is either current or that was replaced by another occupational analysis no more than one year before the application for licensure and the applicant meets either of the following requirements:
NAPLEX
- Has passed the North American Pharmacist Licensure Examination (NAPLEX) on or after January 1, 2004, and holds an active pharmacist license in another state or territory of the United States.
- Has passed the North American Pharmacist Licensure Examination (NAPLEX) that, at the time of application for licensure, was based on an occupational analysis that is either current or that was replaced by another occupational analysis no more than one year before the application for licensure.
OR
Based on the changes to BPC section 4200, NAPLEX and CPJE results are evaluated each time an application is processed as well as at the time of licensure which may result in an applicant having to retake the CPJE and/or NAPLEX examination.
Please be advised the timeframe of an occupational analysis is approximately five years pursuant to BPC section 4200.3.
The current occupational analysis for CPJE went into effect 6/1/2022.
The current occupational analysis for the NAPLEX went into effect 5/1/2025.
I passed the NAPLEX prior to 4/30/2024, and I do not hold an active license in another state, will I be required to retake the NAPELX?
Yes, you will be required to retake the NAPLEX because you do not fall under the provisions of holding an active pharmacist license in another state and your passing NAPLEX score was outside the current occupational analysis.
Revised June 2025
I hold an inactive pharmacist license in another state.
You must hold a current active pharmacist license in another state for the Board to accept your passing NAPLEX score, if passed on or after January 1, 2004, pursuant to BPC 4200(a)(6)(A).
Revised June 2025
I passed the CPJE prior to June 1, 2022, but I have not passed the NAPLEX with my current application on file with the California Board. Will I be required to retake the CPJE?
Yes, you are required to retake the CPJE because your passing CPJE score is outside of the current occupational analysis for the CPJE.
Revised June 2025
Consumers
Why should I talk to my pharmacist?
Why do I need a consultation from my pharmacist?
California pharmacy regulations require pharmacies to maintain patient medication profiles and counsel patients regarding their prescription medication before dispensing. Consultation provides the pharmacist with the opportunity to educate patients who present new prescriptions and protect them from potential problems associated with a new medication by discussing possible side effects, contraindications and the importance of following directions. Consultation also provides the pharmacist one more opportunity to prevent dispensing errors by inspecting the medication container's contents to assure that the proper drug is dispensed.
Does the pharmacist have to talk to the patient about prescription medication?
The pharmacist is required to talk to you about all new prescription medications that have not been provided to you before. You should know the answers to at least the following questions before taking prescription medications:
- What is the name of the medicine and what is it supposed to do?
- How and when do I take it and for how long?
- What do I do if I forget to take my medicine?
- Are there any side effects, and what do I do if they occur?
- Is there any written information available about the medicine?
Can the pharmacist refuse to fill my prescription?
Yes, a pharmacist in his or her professional judgment may refuse to fill a prescription.
Can I return my prescription to the pharmacy?
No, the pharmacy is not required by law to take back prescriptions that have been dispensed.
Can the pharmacist give out my personal medical information?
California law places strict requirements on what information can be released. In most cases, the patient must approve release of any personal medical information.
Why does the pharmacy need my address, social security number, and date of birth?
This information is used to identify patients to avoid any error in dispensing medication to the wrong patient.
Is my prescription label supposed to look a certain way?
California law requires 4 elements on the label be in 12-point san serif font and occupy at least 50% of the label. These elements include:
- Name of the patient;
- Name of the drug and strength of the drug – name can mean a manufacturer’s trade name or the generic name with the name of the manufacturer;
- The directions for use of the drug; and,
- The condition or purpose for the drug being prescribed if it was indicated on the prescription.
What if my prescription doesn’t look like that?
You may file a complaint with the board. The board will research the issue and let you know if pharmacy law was violated. Information on filing a complaint can be found here.
I am more comfortable receiving instructions in my native language but I don’t think my pharmacist speaks my native language. Can I get an interpreter?
Yes. You have a right to interpreter services at your request with no cost to you.
If I don’t speak English, how can I ask for an interpreter?
The pharmacy is required to have an 8 ½ x 11 paper that says “Point to your language. Interpreter services will be provided to you upon request at no cost.” in the following languages: Arabic, Armenian, Cambodian, Cantonese, Farsi, Hmong, Korean, Mandarin, Russian, Spanish, Tagalog, and Vietnamese.
Do pharmacists have to have translated directions for use?
Effective 1/1/16, pharmacists have access to already translated directions for use in 5 languages from the board’s website: Chinese, Korean, Russian, Spanish and Vietnamese.
What should I ask my pharmacist about my medications?
- What is the name of the medicine and what is it supposed to do?
- How and when do I take it and for how long?
- What do I do if I forget to take my medicine?
- Are there any side effects, and what do I do if they occur?
- Is there any written information available about the medicine?
How do I take my pain medication effectively and safely and still get the pain relief I need?
If you are not getting pain relief or are having side effects that you cannot tolerate, call your doctor or pharmacist.
It is better to take your pain medication on a schedule if you are having constant pain. Do not wait until the pain is severe before taking your pain medication.
What are four common mistakes made with children's medication?
- Stopping too soon.
- Taking too little.
- Taking too much.
- Refusing to take the medicine.
What should parents know about their children's medication?
- What condition the medicine is for, and what it is supposed to do;
- How much to give;
- If there are any side effects and what to do if they occur; and
- What to do if a dose is missed.
Licensees
Automated Drug Delivery System (ADDS)
Section 1: Licensing
My pharmacy provides pharmacy services to a psychiatric health facility (PHF) and utilizes an Automated Unit Dose System (AUDS) at the nursing units. Are we exempt from licensure if the AUDS is used for administration only?
BPC section 4017.3(b) defines an “automated unit dose system” (AUDS) as an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions. BPC sections 4427.3 and 4427.65 provide the permissible locations at which AUDS can be located. These include a facility licensed by the State of California to provide pharmaceutical services. The exemptions from licensure of an ADDS are contained in BPC section 4427.2. Section 4427.2(i) exempts from licensure an AUDS operated by a licensed hospital pharmacy, as defined in BPC section 4029, and used solely to provide doses administered to patients while in a licensed general acute care hospital facility, as defined in subdivision (a) of section 1250 of the Health and Safety Code, to patients while in a licensed acute psychiatric hospital facility, as defined in subdivision (b) of section 1250 of the Health and Safety Code, or dispensed to patients pursuant to BPC section 4068 if the licensed hospital pharmacy owns or leases the AUDS and owns the dangerous drugs and devices in the AUDS. A psychiatric health facility does not meet the requirements for licensure exemption unless it is a licensed acute psychiatric hospital facility as detailed in section 4427.2(i). If a psychiatric health facility does not meet the licensure exemption criteria in BPC section 4427.2(i), it may use an AUDS, but that AUDS must be licensed with the Board, and it must follow all the other requirements for an ADDS.
NOTE: A psychiatric health facility, as defined in Health and Safety Code § 1250.2, is required to provide pharmaceutical services pursuant to Welfare and Institutions Code § 4080(e)(1)(J).
[Reference: Business and Professions Code (BPC) sections 4017.3, 4029, 4427.2 and 4427.65, Welfare and Institutions Code section 4080(e)(1)(J), Health and Safety Code sections 1250(a), 1250(b), 1250.2.]
Revised April 2026
My pharmacy provides pharmacy services to a county youth detention facility and utilizes an AUDS to administer medications to the youth inmates. Are we required to obtain licensure for the AUDS?
Yes. BPC sections 4427.3 and 4427.65(a)(2) provide that an AUDS can be located and operated in a jail, youth detention facility, or other correctional facility where drugs are administered within the facility under the authority of the medical director. However, the exemptions from the licensure requirements for an ADDS are contained in BPC section 4427.2(i) and AUDS in youth facilities are not exempt from licensure.
[Reference: BPC sections 4427.2(i), 4427.3, 4427.65(a)(2).]
Revised April 2026
We are a hospital with less than 100-beds and have a licensed drug room. When patients are discharged from the hospital, the physician sometimes writes an order for the patient to be discharged with a 72-hour supply which is taken from the ADDS. The physician will remove the drugs from the ADDS and dispense the drugs to the patient in a manner such that the drugs are properly labeled and meet the patient centered labeling requirements. Is the drug room exempt from licensing the ADDS located at the nursing station if the ADDS is primarily used to administer doses to patients in the hospital, but occasionally used for dispensing no more than a 72-hour supply of discharge medications to the patient?
No, the drug room is not exempt from licensing the ADDS under the circumstances described. The drug room would only be exempt from the ADDS licensing requirement if the drugs in the ADDS are used solely to provide doses administered to patients while in the licensed general acute care hospital. When drugs from the ADDS are used for dispensing under the provisions of BPC section 4056, not solely for administration, the exemption no longer applies.
[Reference: BPC sections 4427.2(i), 4056]
Revised April 2026
Can the facility start using the ADDS device as soon as the ADDS application is submitted or do I need to wait until the Board issues the ADDS permit?
The ADDS device cannot be used until the Board issues the ADDS permit.
[Reference: BPC sections 4427.1, 4427.2(a), 4119.11(a)(1), 4119.01(a)]
Revised April 2026
Is the hospital pharmacy required to license the AUDS in the emergency room if the AUDS is primarily used for the administration of doses to patients in the emergency room but is occasionally used to dispense drugs to a patient discharged from the emergency room?
BPC section 4427.2(i) provides an exemption from licensure for an AUDS that is used to dispense dangerous drugs to emergency room patients pursuant to BPC section 4068. Section 4068(a) authorizes a prescriber to dispense a dangerous drug, including a controlled substance, to an emergency room patient if specified requirements are met, including that the hospital pharmacy is closed and there is no pharmacist available in the hospital, and that the quantity of drugs dispensed is limited to that amount necessary to maintain uninterrupted therapy during the period when pharmacy services outside the hospital are not readily available or accessible, but shall not exceed a 72-hour supply. Section 4068(b) additionally authorizes a prescriber to dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge if certain conditions are satisfied, including that the drug is not a controlled substance, that the drug was administered from single patient use multidose packaging and can be self-administered by the patient, and that dispensing the unused portion of the drug is required to continue treatment of the patient. The AUDS must comply with all other requirements for an ADDS set forth in Article 25 of the Pharmacy Law.
[Reference: BPC sections 4017.3, 4068, 4427.2(i)]
Revised April 2026
I submitted my application for an ADDS and have completed the pre-licensure inspection. How will I know my application has been approved before I receive the physical license to be posted?
Once the application is approved, an email will be sent to the pharmacist-in-charge (PIC). The email will notify the pharmacy the application was approved and will include the ADDS license number, type of ADDS, the primary pharmacy license, the status, the name and address of the ADDS location, and expiration date. The Board requests that you print and attach a copy of the email to the location of the ADDS and replace it with the license when the physical license is received. Allow 4 to 6 weeks to receive the physical license in the mail at the pharmacy.
NOTE: To inquire about the status of your ADDS application, please email ADDS@dca.ca.gov.
Revised April 2026
My pharmacy uses an ADDS located in the pharmacy dispensing area to help with the dispensing of prescription drugs. The ADDS counts the number of tablets or capsules to be dispensed and labels the prescription container. Is an ADDS license required?
No. An ADDS license is not required for technology, installed within the secured licensed premises area of a pharmacy, used in the selecting, counting, packaging, and labeling of dangerous drugs.
[Reference: BPC section 4427.2(j)]
Revised April 2026
We are a licensed hospital pharmacy that oversees the AUDS at the nursing stations throughout the hospital. The drugs are used for administration only. The nurses will access the AUDS to remove drugs pursuant to a physician order. Are we required to license each AUDS?
No. An automated unit dose system (AUDS) operated by a licensed hospital pharmacy, as defined in BPC section 4029, and used solely to provide doses administered to patients while in a licensed general acute care hospital facility, as defined in subdivision (a) of section 1250 of the Health and Safety Code, or to patients while in a licensed acute psychiatric hospital facility, as defined in subdivision (b) of section 1250 of the Health and Safety Code, is exempt from the requirement of obtaining an ADDS license if the licensed hospital pharmacy owns or leases the AUDS and owns the dangerous drugs and dangerous devices in the AUDS. The licensed hospital pharmacy shall maintain a list of the locations of each AUDS it operates and shall make the list available to the Board upon request. In addition, the AUDS must comply with all other requirements for an ADDS set forth in Article 25 of the Pharmacy Law.
[Reference: BPC sections 4017.3 and 4427.2(i), Health and Safety Code sections 1250(a) and 1250(b)]
Revised April 2026
Section 2 Medication Error Reporting
A medication error was made, and a quality assurance review was completed related to the licensed ADDS. Do I have to report the medication error to the Board?
Yes, per 16 CCR section 1711(f), any quality assurance record related to the use of a licensed automated drug delivery system must be submitted to the Board within 30 days of completion of the quality assurance review. For purposes of section 1711, a “medication error” means any variation from a prescription or drug order not authorized by the prescriber, as described in CCR section 1716, but does not include any variation that is corrected prior to furnishing the drug to the patient or the patient’s agent or any variation allowed by law.
[References: 16 CCR sections 1711 and 1716]
Revised April 2026
A medication error was made, and a quality assurance review was completed related to an unlicensed ADDS, do I have to report the medication error to the Board?
Any facility with an unlicensed ADDS must report the quality assurance review to the Board at the time of annual renewal of the facility license.
Pursuant to Health and Safety Code section 1261.6 (g) if the ADDS utilizes removable pockets, cards, drawers, or similar technology, or unit of use, or single dose containers, and the facility, in conjunction with the pharmacy, has developed policies and procedures to ensure the removable pockets, cards, drawers, or unit of use or single dose containers are properly placed into the ADDS, then the facility and contracted personnel authorized by law to administer drugs may also restock the ADDS.
[Reference: CCR section 1711]
Revised April 2026
What information is required to be reported as part of an ADDS quality assurance review?
16 CCR section 1711(e) states that a record of the quality assurance review shall contain at least the following:
- The date, location, and participants in the quality assurance review;
- The pertinent data and other information relating to the medication error(s) reviewed and documentation of any patient contact required by subdivision (c) of section 1711;
- The findings and determinations generated by the quality assurance review; and
- Recommended changes to pharmacy policy, procedure, systems, or processes, if any.
[References: 16 CCR section 1711]
Revised April 2026
Where do I submit ADDS-related quality assurance records to the Board?
Pharmacies with a licensed ADDS may submit their ADDS-related quality assurance records either: 1) by mail to the address of the California State Board of Pharmacy at 2720 Gateway Oaks Drive, Suite 100, Sacramento, CA 95833; or 2) by email to ADDS@dca.ca.gov.
Any facility with an unlicensed ADDS must report the quality assurance review to the Board at the time of annual renewal of the facility license. Such reports may be submitted via email to ADDS@dca.ca.gov or included with the renewal application.
[Reference: 16 CCR section 1711(f).]
Revised April 2026
An ADDS that is used to select, count, package and label dangerous drugs occasionally misfills a prescription with a wrong tablet and/or wrong quantity, am I required to report this error to the Board under 16 CCR section 1711?
16 CCR section 1711(b) specifies that for purposes of section 1711, “medication error” does not include any variation that is corrected prior to furnishing the drug to the patient or patient’s agent. Accordingly, if the error is corrected prior to furnishing the drug to the patient or patient’s agent, this would not be considered a “medication error” for purposes of 16 CCR section 1711 and no report under section 1711(f) would be required.
[Reference: CCR section 1711]
Revised April 2026
Section 3 Automated Patient Dispensing System (APDS)
Our pharmacy offers an APDS to dispense to patients, what is required for patient consultation?
Drugs may only be dispensed from an APDS directly to a patient if certain specific requirements are met. Among other requirements, an APDS shall only be used for patients who have signed a written consent demonstrating their informed consent to receive prescription drugs and devices from an APDS and the APDS must have a means to identify each patient and only release the identified patient’s drugs and devices to the patient or the patient’s agent.
All prescribed drugs and devices dispensed to a patient from an APDS for the first time must be accompanied by a consultation conducted by a pharmacist licensed by the Board via a telecommunications link that has two-way audio and video. Further, the pharmacy must be able to provide an immediate consultation with a pharmacist, either in person or via telephone, upon the request of the patient.
[Reference: BPC sections 4119.11(d) and 4427.6(f); 16 CCR section 1713]
Revised April 2026
Can the pharmacist provide consultation via telephone for new prescriptions prior to placing the medication in the APDS?
No, all prescribed drugs and devices dispensed from the APDS for the first time shall be accompanied by a consultation conducted by a pharmacist licensed by the Board via a telecommunications link that has two-way audio and video.
[Reference: BPC sections 4119.11(d)(6) and 4427.6(f); 16 CCR section 1713]
Revised April 2026
Who can provide the consultation for patients using the APDS?
A pharmacist licensed by the board shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultation.
[Reference: BPC sections 4119.11(d)(4) and 4427.6(d)]
Revised April 2026
What drugs can be placed in the APDS?
The pharmacy shall develop, implement, and annually review written policies and procedures with respect to determining and applying inclusion criteria regarding which drugs and devices are appropriate for placement in the automated patient dispensing system and for which patients.
[Reference: BPC sections 4119.11(d)(1)(B) and 4427.6(a)(2); 16 CCR section 1713]
What shall a pharmacy do if a patient cannot use the APDS due to the drug not being in stock or the APDS is not in service?
The pharmacy must develop, implement, and annually review written policies and procedures orienting participating patients on the use of the APDS, notifying patients when expected prescription medications are not available in the APDS, ensuring that patient use of the APDS does not interfere with delivery of drugs and devices, and ensuring delivery of drugs and devices to patients expecting to receive them from the APDS in the event the APDS is disabled or malfunctions.
[Reference: BPC sections 4119.11(d)(1) and 4427.6(a); 16 CCR section 1713]
Revised April 2026
Is the use of an APDS located in a prescriber’s office limited to the patients of that prescriber?
Yes. Business and Professions Code section 4427.6 provides that an APDS must meet certain specific requirements. One of these requirements is that if an APDS is located and operated in a medical office or other location where patients are regularly seen for purposes of diagnosis and treatment, the APDS is only used to dispense dangerous drugs and dangerous devices to patients of the practice.
[Reference: BPC sections 4427.6(j) and 4119.11]
Revised April 2026
Section 4 Miscellaneous
Are drugs required to be restocked immediately into the ADDS?
Per BPC section 4427.4(f), if drugs are not immediately transferred into an ADDs upon arrival at the ADDS location, the drugs may be stored for no longer than 48 hours in a secured room within the ADDS location. Upon retrieval of these drugs from secured storage, an inventory must be taken to detect any losses or overages.
[Reference: BPC section 4427.4]
Revised April 2026
The pharmacy uses an ADDS device with an open-matrix design allowing the user to access multiple drugs, what are the requirements for the facility?
Facilities using automated drug delivery system with an open-matrix design shall contact the California Department of Public Health for a clear understanding of the requirements for such use.
[Reference: Health and Safety Code section 1261.6]
Revised April 2026
Is the pharmacy required to obtain a separate Drug Enforcement Administration (DEA) registration for each licensed ADDS if the device contains controlled substances?
Pharmacies should consult the federal regulations to ensure compliance with DEA requirements and contact the DEA for any necessary clarifications regarding federal rules regarding controlled substances. Cited below are some authorities from the DEA regarding ADDS.
[Reference: Code of Federal Regulations (CFR), title 21, section 1301.27, Pharmacist’s Manual DEA]
Revised April 2026
Licensees
Medication Error Reporting
What types of licensees are required to report medication errors under AB 1286?
A community pharmacy licensed pursuant to Article 7 of Chapter 9 of Division 2 of the Business and Professions Code (BPC) is required to report medication errors under AB 1286. For purposes of the measure, the term “community pharmacy” includes any pharmacy that dispenses medication to an outpatient, including both resident and nonresident pharmacies, but not including facilities of the California Department of Corrections and Rehabilitation.
[Reference: BPC 4113.1(a) and (c)]
Revised November 2025
What is considered a medication error for purposes of AB 1286 reporting?
For purposes of AB 1286 reporting, the term “medication error” includes any variation from a prescription drug order not authorized by the prescriber, including, but not limited to, errors involving the wrong drug, the wrong dose, the wrong patient, the wrong directions, the wrong preparation, or the wrong route of administration, but does not include any variation that is corrected prior to dispensing to the patient or patient’s agent or any variation allowed by law.
[Reference: BPC 4113.1(d)]
Revised November 2025
AB 1286 requires a community pharmacy to report medication errors to an entity approved by the Board. What is the name of the approved entity?
The Board approved the Institute for Safe Medication Practices (ISMP) as the entity to receive medication error reports from community pharmacies under BPC 4113.1.
[Reference: BPC 4113.1(a) and (b)]
Revised November 2025
When do community pharmacies have to start reporting medication errors under BPC 4113.1?
The Board has announced that medication errors occurring on or after September 1, 2025, must be reported under BPC 4113.1. The Board will use a variety of means to communicate any further updates to the implementation timeframe for BPC 4113.1 medication error reporting, including through the Board’s subscriber alert system and posting information on the California Medication Error Reporting (CAMER) page on its website.
Revised November 2025
How do I register with ISMP for medication error reporting?
A link to the ISMP registration portal can be found on the California Medication Error Reporting (CAMER) page on the Board’s website.
Revised November 2025
Is there a fee for medication error reporting under BPC 4113.1?
Per the contract between the Board and ISMP, ISMP will charge community pharmacies an initial registration fee of $70 for the first contract year, and a renewal fee of $47 per year for the second and third contract years.
Revised November 2025
I work in an outpatient hospital pharmacy. Am I required to report all medication errors to the Board-approved entity under the provisions of AB 1286?
It depends. AB 1286 generally requires a community pharmacy licensed by the Board to report, either directly or through a designated third party, all medication errors to an entity approved by the Board; however, subdivision (e) of BPC 4113.1 establishes a limited exemption from the reporting requirements, and specifies that an outpatient hospital pharmacy shall not be required to report a medication error that meets the requirements of an adverse event that has been reported to the State Department of Public Health pursuant to HSC 1279.1.
Revised November 2025
My hospital pharmacy holds an HSP license type but periodically dispenses outpatient prescriptions to discharge patients, emergency room patients or hospital employees. The volume of prescriptions dispensed to outpatients is within the limit set forth in California Code of Regulations, title 16, section 1710 and does not require us to have a separate PHY license type. Do I need to register the HSP with and report to ISMP?
No, it is the policy of the Board that if the hospital pharmacy dispensing volume to outpatients is within the limit set forth in California Code of Regulations, title 16, section 1710, the pharmacy is not required to report medication errors through the CAMER program. It is anticipated that the Board will pursue a regulatory change to document this policy.
Revised November 2025
My outpatient infusion center pharmacy holds a PHY license type. Do I need to register the PHY with and report to ISMP?
See questions #1, 7, and 8. If an infusion center pharmacy dispenses1 drugs to outpatients for administration2, and neither of the exemptions discussed in #7 or 8 apply, the pharmacy is required to report medication errors to CAMER.
Revised April 2026
I work at an infusion center pharmacy that is government owned with a PHE license. Additionally, our entity also has investigational drug pharmacies with a PHE license type. Are these pharmacies subject to CAMER reporting requirements?
If the facility meets the definition of a “community pharmacy” under BPC section 4113.1, the facility is required to report medication errors through the CAMER program. It is the responsibility of the pharmacist-in-charge to determine whether the facility is a “community pharmacy” as defined by BPC section 4113.1.
[Reference: BPC 4113.1]
Revised November 2025
If I am reporting medication errors to an entity approved by the Board, am I still required to complete a quality assurance review and report?
Yes. The Board’s quality assurance regulations remain in place and pharmacies are still required to comply with those regulations.
[Reference: 16 CCR 1711]
Revised November 2025
Are nonresident pharmacies required to report all medication errors to the Board- approved entity under the provisions of AB 1286?
Subdivision (f) of BPC 4113.1 (which was added by Assembly Bill 1503 (Berman, Chapter 196, Statutes of 2025), and which becomes effective on January 1, 2026) states that a pharmacy licensed pursuant to BPC 4112 shall only be required to report medication errors related to prescriptions dispensed to California residents.
[Reference: Stats. 2025, Ch. 196, Sec. 34 (AB 1503), effective January 1, 2026]
Revised November 2025
Licensees
Minimum Staffing Provisions
What minimum staffing requirements does AB 1286 establish?
Effective January 1, 2024, a chain community pharmacy subject to BPC 4113.5 is required to be staffed at all times during normal business hours (defined as 8:00 am to 7:00 pm) with at least one clerk or pharmacy technician fully dedicated to performing pharmacy-related services, unless any of the following conditions apply:
- The pharmacist on duty waives the requirement in writing during specified hours based on workload need.
- The pharmacy is open beyond normal business hours, which is before 8:00 am and after 7:00 pm, in which case the minimum staffing requirement does not apply during the hours before 8:00 am and after 7:00 pm.
- The pharmacy’s prescription volume per day on average is less than 75 prescriptions per day based on the average daily prescription volume for the past calendar year. However, if the pharmacist is also expected to provide additional pharmacy services such as immunizations, CLIA-waived tests, or any other ancillary services provided by law, this exemption does not apply.
In addition, where staffing of pharmacist hours within a chain community pharmacy does not overlap sufficiently, scheduled closures for lunch time for all pharmacy staff shall be established and publicly posted and included on the outgoing telephone message.
Note: Additional minimum staffing requirements are detailed under “Pharmacy Technician Expanded Duties” below.
[Reference: BPC 4113.6]
Revised November 2025
If a pharmacist is solely scheduled with an intern, does that meet the minimum staffing requirement established in BPC 4113.6(a)?
AB 1286 is silent about the impact to the minimum staff requirement when interns are present. As stated in the prior question, a pharmacist on duty may waive the BPC 4113.6(a) minimum staffing requirement during specified hours based on workload need.
[Reference: BPC 4113.6(a)]
Revised November 2025
Licensees
Revisions to Inventory Reconciliation
The revisions to California Code of Regulations (CCR), Title 16, section 1715.65, Inventory Reconciliation Reports of Controlled Substances took effect January 1, 2023.
Below are questions frequently asked regarding the revisions to CCR §1715.65.
General
With CCR §1715.65 revised, what inventory activities and inventory reconciliation reports are now required for controlled substances?
Effective January 1, 2023, every pharmacy and every clinic licensed under Business and Professions Code (BPC) §§ 4180 and 4190 must conduct inventory activities and prepare inventory reconciliation reports on the following ongoing basis:
- All federal Schedule II controlled substances, at least once every three months;
- For products containing the following substances in the following strengths per tablet, capsule, other unit, or specified volume, at least once every 12 months, the following controlled substances: alprazolam 1mg/unit, alprazolam 2mg/unit, tramadol 50mg/unit, and promethazine with codeine 6.25mg promethazine/10mg codeine/5mls drug product;
- For any controlled substances not listed above, an inventory reconciliation report must also be prepared when a controlled substance loss is identified, no later than three months after discovery of the reportable loss of the controlled substance in addition to the timely report of the loss as required;
- For any controlled substance not listed above, inventory activities must be performed at least once every two years from the performance of the last inventory activities.
CCR §§1715.65(a)(1), (a)(2), (a)(3)
However, if you are an inpatient hospital pharmacy, the inventory reconciliation for all federal Schedule II controlled substances, and alprazolam 1mg/unit, alprazolam 2mg/unit, tramadol 50mg/unit, and promethazine with codeine 6.25mg promethazine/10mg codeine/5mls drug product, must be performed quarterly. CCR §1715.65(a)(1), (a)(2), (a)(3)
Revised November 2023
While reviewing the pharmacy’s wholesale invoices, I noticed extra bottles of diazepam 5mg were being ordered when no prescriptions for diazepam 5mg was dispensed in the past 3 months. What time period am I required to audit to determine if there was any loss of diazepam 5mg and am I required to report any losses to the board?
Yes. When a controlled substance loss is identified, an inventory reconciliation report must be completed. The audit period must cover the period from the last physical count of the controlled substance before the loss was discovered through the date of discovery.
CCR §1715.65(a)(3)(A)
Losses of controlled substances must be reported no later than 30 days after the date of discovery in accordance with CCR 1715.6. If the cause of the losses is related to theft, diversion, or self-use the loss must be reported to the board within 14 days of discovery.
Controlled substance losses can be submitted online or mailed to the address of the board. CCR §1715.65(d), CCR §1715.6, BPC §4104(c)
Revised November 2023
With the new revisions for inventory reconciliation reports and inventory activities, what is now required to be in the report?
An inventory reconciliation report must include the following:
- A physical count, not an estimate, of all quantities of each federal controlled substance covered by the report that the pharmacy or clinic licensed by the board has in inventory, pursuant to BPC §§ 4180 or 4190. If an inpatient hospital pharmacy or licensed correctional pharmacy uses an ADDS to stock the controlled substances, the inventory in the ADDS may be accounted for by using a means other than a physical count.
- The individual(s) who performed the inventory must sign and date the inventory or the report.
- A review of all acquisitions and disposition of each federal controlled substance covered by the report since the last inventory reconciliation report covering that controlled substance.
- A comparison of the physical counts in inventory to all acquisitions and dispositions (since the last inventory reconciliation report) of each federal controlled substance covered by the report.
- Identification of all records used to compile the report, which must be maintained in the pharmacy or clinic.
- The identification of each individual involved in preparing the report.
- The possible causes of overages.
- Identify to the Board, in writing, the losses and known causes. Reportable losses defined in CCR §1715.6, must be reported to the board within 30 days of discovery, unless the cause of the loss is theft, diversion, or self-use in which case the board must be notified within 14 days of discovery.
- The inventory reconciliation report must be dated and signed by the PIC or the professional director of the clinic licensed pursuant to BPC §§4180 or 4190.
- The report and all records used to compile the report must be readily retrievable in the pharmacy or clinic for three years.
CCR §1715.65(c), (d), (e)
Revised November 2023
What type of “inventory activities” does the board require a pharmacy to perform for all other controlled substances that are not mandated to be physically counted quarterly or every 12 months?
“Inventory activities” are required for each controlled substances that is not already required to be physically counted quarterly or at least every twelve months. Inventory activities for these controlled substances must be performed at least once every two years from the performance of the last inventory activities. “Inventory activities” means inventory and all other functions sufficient to identify loss of controlled substances. The functions that are sufficient to identify loss outside of the inventory reconciliation process must be identified within the pharmacy’s policies and procedures.
CCR §1715.65(a)(1), (a)(2), (a)(3)(B)
Revised November 2023
Can I delegate a staff pharmacist to do the physical count and prepare the inventory reconciliation report for the pharmacy?
Yes. Any individual involved in preparing the report must be identified in the report. Any individuals who perform the physical count of each federal scheduled controlled substance must sign and date the inventory or the report.
“Inventory activities” are required for each controlled substances that is not already required to be physically counted quarterly or at least every twelve months. Inventory activities for these controlled substances must be performed at least once every two years from the performance of the last inventory activities. “Inventory activities” means inventory and all other functions sufficient to identify loss of controlled substances. The functions that are sufficient to identify loss outside of the inventory reconciliation process must be identified within the pharmacy’s policies and procedures.
The pharmacist-in-charge of a pharmacy or the consulting pharmacist for a clinic licensed by the board pursuant to BPC §§ 4180 or 4190, must review all inventory activities performed and inventory reconciliation reports prepared and establish and maintain secure methods to prevent losses of federal controlled substances, including written policies and procedures for performing the inventory activities and preparing the inventory reconciliation reports.
In addition, the inventory reconciliation report must be dated and signed by the pharmacist-in-charge or the professional director for a clinic licensed by the board pursuant to BPC §§ 4180 or 4190. An individual may use a digital or electronic signature or biometric identifier in lieu of a physical signature for this report if, in addition, the individual physically signs a printed statement confirming the accuracy of the inventory or report. The signature must be dated, and the signed and dated statement must be retained on file in the pharmacy or clinic for three years.
CCR §§1715.65(b), (e)(1), (e)(2)
Revised November 2023
How long is the pharmacy required to maintain its inventory reconciliation reports?
All inventory reconciliation reports, and all records used to compile the reports, are required to be readily retrievable in the pharmacy or clinic for three years.
CCR §1715.65(e)(2)
Revised November 2023
I am new PIC and this is my first time doing an inventory reconciliation report. What is required to be included in an inventory reconciliation report?
As a new PIC of a pharmacy, the PIC must complete an inventory reconciliation report for all federal Schedule II controlled substances, and alprazolam 1mg/unit, alprazolam 2mg/unit, tramadol 50mg/unit, and promethazine with codeine 6.25mg/10mg/5mls drug product within 30 days of becoming the PIC.
CCR §1715.65(f)
Revised November 2023
I am new PIC and this is my first time doing an inventory reconciliation report. What is required to be included in an inventory reconciliation report?
Whenever possible, the outgoing PIC should complete an inventory reconciliation report for all federal Schedule II controlled substances, and alprazolam 1mg/unit, alprazolam 2mg/unit, tramadol 50mg/unit, and promethazine with codeine 6.25mg/10mg/5mls drug product.
CCR §1715.65(f)
Whenever possible, it is also recommended (though not required) the outgoing PIC perform an inventory count of all controlled substances prior to their disassociation as the PIC.
Revised November 2023
Hospital Pharmacies and Drug Rooms
Are drug rooms required to complete an inventory reconciliation report?
Yes. Under 22 CCR §70263(a), hospitals having fewer than 100 licensed beds (informally referred to as drug rooms) are required to have a license pursuant to BPC 4029 and 4056, and must comply with CCR §1715.65.
Revised November 2023
Does a hospital pharmacy need to include the controlled substances stored in the automated drug delivery system (ADDS), if the controlled substances were already removed from the stock inside the hospital pharmacy’s narcotic locker?
Yes. The hospital pharmacy must account for all controlled substances subjected to inventory reconciliation stored inside the licensed pharmacy premise and stored in all the ADDS throughout the hospital, including locations listed on the general acute care hospital license, provided the ADDS were stocked by the hospital pharmacy.
However, if any inpatient hospital pharmacy, or licensed correctional pharmacy, uses an ADDS, only the inventory in the ADDS may be accounted for by using a means other than a physical count.
CCR §1715.65(h)
Revised November 2023
Are the controlled substance removed from the main hospital pharmacy inventory then transferred to the satellite pharmacies, nursing stations, surgical units, clinics, and other locations listed on the general acute care hospital license required to be included in the hospital pharmacy’s inventory reconciliation report?
Yes. The inventory reconciliation reports for an inpatient hospital pharmacy must include controlled substances stored within the pharmacy, within each pharmacy satellite location, and within each drug storage area in the hospital under the pharmacy’s control. A physical count of the controlled substances (all federal Schedule II controlled substances, and alprazolam 1mg/unit, alprazolam 2mg/unit, tramadol 50mg/unit, and promethazine with codeine 6.25mg promethazine/10mg codeine/5mls drug product) is required. If the inpatient hospital pharmacy uses an ADDS to stock the controlled substances, the inventory in the ADDS may be accounted for by using a means other than a physical count.
CCR §§1715.65(a), (g), (h)
Revised November 2023
For federal Schedule II controlled substances stored in an ADDS, are they required to be physically counted?
No. If the inpatient hospital pharmacy uses an ADDS to stock the controlled substances, the inventory in the ADDS may be accounted for by using a means other than a physical count.
CCR §1715.65(h)
Revised November 2023
The inpatient hospital pharmacy operates various ADDS throughout the hospital which includes controlled substances. We plan to generate audit reports through the ADDS report module. Are these reports sufficient to account for the controlled substance since the law allows the inpatient hospital pharmacy to use means other than physical counts for controlled substances stored in an ADDS?
It depends. Yes, the inpatient hospital pharmacy may use the ADDS audit report programs. However, when using these audit programs, the board recommends the pharmacy should also consider the following:
- A review of the records of acquisition for the controlled substances being audited.
- A review of the records of disposition for the controlled substances being audited, include expired drugs removed, drugs removed due to breakage, etc.
- Review of discrepancy reports and adjustments made for shortages and overages, including all discrepancy reports opened and closed, and unaccounted-for losses.
- The total loss of each controlled substance during the audit period, resulting from shortages, especially when the count is adjusted. If the total loss causes the aggregated amount to equal or exceed the thresholds listed in CCR §1715.6, the losses must be reported to the board.
- All shortages were investigated to determine the cause.
- When there is a shortage, the policies and procedures were reviewed to determine if any changes were needed to prevent the shortage from reoccurring.
CCR §§1715.65(b), (c), (h), 1715.6
Revised November 2023
Clinics licensed pursuant to BPC 4180 and 4190
Our surgical center maintains a perpetual inventory for controlled substances. Can we use the counts from the perpetual inventory for the inventory reconciliation report?
No. The surgical clinic is required to take a physical count, not an estimate, of all quantities of each federal controlled substance covered by the inventory reconciliation report. If the inpatient hospital pharmacy uses an ADDS to stock the controlled substances, the inventory in the ADDS may be accounted for by using a means other than a physical count.
CCR §§1715.65(c)(1), (h)
Revised November 2023
We are a surgical clinic that is listed on the general acute care license as an approved service. We do not have a separate clinic license pursuant to BPC 4180 or BPC 4190. The hospital pharmacy provides the medications for the surgical clinic used for administration only in an ADDS. Does the board require the surgical clinic to conduct a separate inventory reconciliation?
No. If the controlled substance in the ADDS is stocked by the inpatient hospital pharmacy, the controlled substances in the ADDS will need to be included in the inpatient hospital pharmacy inventory reconciliation report.
CCR §1715.65(a)
Revised November 2023
I am a consulting pharmacist at an ambulatory surgical center (ASC) that is not licensed with the board pursuant to BPC 4190. Based on the Capen decision in 2013, does an ASC that is not licensed with the board required to perform inventory reconciliation reports?
No. ASC who are not licensed by the board are not required to comply with CCR §1715.65, since it is not licensed as a pharmacy nor a clinic with the board. The controlled substance acquired for the ASC would be acquired by the licensed prescriber authorized to purchase controlled substances.
BPC §§4170, 4059(b)
Revised November 2023
At a surgical clinic licensed by the board, can a registered nurse perform the physical count of the federal Schedule II controlled substances?
Yes. CCR §1715.65 does not specify who is required to perform the physical count. However, any individual who performs the required inventory must be authorized to access controlled substances and sign and date the inventory or inventory reconciliation report.
CCR §§1715.65(c)(1), (e)(1)
Revised November 2023
Our surgical clinic verifies the inventory count twice each day. Are we required to do inventory reconciliation quarterly for the federal Schedule II controlled substances?
Yes. Every clinic licensed with the board must perform periodic inventory activities and prepare inventory reconciliation reports.
CCR § 1715.65(a)
Revised November 2023
Correctional Clinics – BPC §4187
Our pharmacy stocks federal Schedule II controlled substance in ADDS at each of the correctional clinics at the prison. Are we required to perform a physical count of these controlled substances in the ADDS for the inventory reconciliation?
No. If the correctional clinic, operated by the California Department of Corrections and Rehabilitation, uses an ADDS to stock the controlled substances, the controlled substance inventory in the ADDS may be accounted by using a means other than a physical count.
CCR §1715.65(h)
Revised November 2023
The county outpatient pharmacy operates ADDS at the county jail. Are we required to perform a physical count of the controlled substances in the ADDS for the inventory reconciliation and inventory activities?
Yes. A county jail is operated by the county where it is located and not by the California Department of Corrections and Rehabilitation. Therefore, every pharmacy licensed with the board must perform periodic inventory activities and prepare inventory reconciliation reports.
CCR § 1715.65(a)
Revised November 2023
Compounding Pharmacies
We have hydromorphone powder used for compounding. We are concerned, each time the powder is weighed, drug loss may occur with each transfer in and out of the bottle. Is the pharmacy required to physically count the powder by weighing out the powder by emptying the contents and recording the weight of the powder?
No. The board recommends that when the pharmacy receives a new bottle of a powder for a federal Schedule II controlled substance and when a physical count is required for the inventory reconciliation, the pharmacy records the weight of the bottle with the powder remaining in the bottle.
CCR §1715.65(c)(1)
Revised November 2023
Long Term Care (LTC) Pharmacies
We are a LTC pharmacy and provide the long-term care facilities with emergency kits stored in secured containers which contain federal Schedule II controlled substances. Are the federal Schedule II controlled substances in the emergency kits required to be physically counted for the inventory reconciliation?
Yes. A physical count is required.
CCR §1715.65(c)(1)
Revised November 2023
Our LTC pharmacy operates ADDS at various long term care facilities, and these ADDS include federal Schedule II controlled substances. Are the federal Schedule II controlled substances stored in the ADDS required to be physically counted for the inventory reconciliation?
Yes. Only inpatient hospital pharmacies and licensed correctional pharmacies that uses an ADDS may account for the inventory in the ADDS using means other than a physical count.
CCR §§1715.65(c)(1), (h)
Revised November 2023
Licensees
Staffing Decisions
I am the pharmacist-in-charge (PIC) of a pharmacy. What changes does AB 1286 make as far as my ability to make staffing decisions?
AB 1286 amended BPC section 4113 to explicitly provide that the PIC “may” make staffing decisions to ensure sufficient personnel are present in the pharmacy to prevent fatigue, distraction, or other conditions that may interfere with a pharmacist’s ability to practice competently and safely. Assembly Bill 1503 (Berman, Chapter 196, Statutes of 2025) further amended section 4113 to state that the PIC “shall” (instead of “may”) make staffing decisions. This change becomes effective on January 1, 2026. The Board recommends that the PIC document their efforts to ensure sufficient staff are present.
Note: These provisions do not apply to facilities of the Department of Corrections and Rehabilitation.
[Reference: BPC 4113(c)(2); see also Stats. 2025, Ch. 196, Sec. 33 (AB 1503), effective January 1, 2026]
Revised November 2025
I am the pharmacist on duty and the PIC is not available. Do I have the authority to adjust staffing?
Effective January 1, 2024, if the PIC is not available, a pharmacist on duty may adjust staffing according to workload if needed. The Board recommends that the pharmacist on duty document their efforts to adjust staffing.
Note: These provisions do not apply to facilities of the Department of Corrections and Rehabilitation.
[Reference: BPC 4113(c)(2)]
Revised November 2025
Licensees
Unsafe Pharmacy Conditions
I am concerned that the working conditions of the pharmacy are harmful. What should I do?
AB 1286 added new subdivision (d) to BPC section 4113, pursuant to which the pharmacist-in-charge or pharmacist on duty is required to immediately notify store management of any conditions that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff. Assembly Bill 1503 (Berman, Chapter 196, Statutes of 2025) further amended subdivision (d) to state that the PIC or pharmacist on duty shall immediately notify store management “or the building owner or a similar entity” of any such conditions. This change becomes effective on January 1, 2026.
Conditions that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff may include, but are not limited to, any of the following:
- Workplace safety and health hazards that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff.
- Sustained temperatures that could impact ambient temperature drug stability according to manufacturer data on acceptable drug storage conditions.
- Vermin infestation that poses a risk to the safety or efficacy of medicine.
The Board recommends that the PIC or pharmacist on duty document any such notification made by them to store management or the building owner or a similar entity. The Board also recommends that pharmacies establish policies and procedures for the notification process to ensure reporting personnel and store management (or the building owner or a similar entity) have a common understanding of the process to be used.
[Reference: BPC 4113(d); see also Stats. 2025, Ch. 196, Sec. 33 (AB 1503), effective January 1, 2026]
Revised November 2025
Is store management required to take action based on my report?
Yes. Effective January 1, 2024, store management is required to take immediate and reasonable steps to address and resolve the conditions that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff. The pharmacy owner may also close a pharmacy to mitigate against a perceived immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff.
[Reference: BPC 4113(d)]
Revised November 2025
I made a report, but the conditions remain. What should I do?
Effective January 1, 2024, the law states that if the conditions are not resolved within 24 hours, the PIC or pharmacist on duty shall ensure the Board is timely notified.
[Reference: BPC 4113(d)]
Revised November 2025
How do I make a report to the Board?
The Board has established a dedicated email for such reporting: PharmacyAlert@dca.ca.gov. The Board requests that the following information be provided with the notification:
- Name and license number of pharmacy,
- Name and contact information for reporting party,
- Name and contact information for store management that received the initial notification,
- Copy of the notification provided to store management,
- Documentation of the conditions including photographs, temperature logs, etc.
[Reference: BPC 4113(d)]
Revised November 2025
Do these requirements apply to all pharmacies?
No, facilities of the Department of Corrections and Rehabilitation are exempt from these requirements.
[Reference: BPC 4113(d)(6)]
Revised November 2025
Licensees
Pharmaceutical and Sharps Waste Stewardship Programs
Senate Bill 212 (Jackson, Chap. 1004, Statutes of 2018) was signed by Governor Newsom on September 30, 2018. This bill was codified in the California Public Resources Code, Chapter 2, sections 42030-42036.4. This bill leveraged existing law regarding drug-take back provisions established under pharmacy law and federal law and medical waste management provisions administered by the California Department of Public Health to create a new stewardship program to ensure that a “covered entity” pays for the proper disposal of “covered products” shipped into California. This Board was given certain enumerated responsibilities under the bill. The bill requires the following with respect to the Board of Pharmacy:
- “Covered entities” had to report to the Board by April 1, 2021 a list of the “covered products” and a list of drugs or sharps that are not covered products that it sells or offers for sale in California. Pub. Resources Code section 42031(a)(1).
- By January 15 each year, a “covered entity” or the stewardship program to which it belongs must update its list of “covered products” and uncovered products with Board. Pub. Resources Code section 42031(a)(2).
- Retail pharmacies that sell a covered product under its own store label were required to notify the Board of the “covered entity” that supplied the retail pharmacy with its store label covered products. Pub. Resources Code section 42031(b).
- The Board must verify the information received from covered entities regarding its covered products and from retail pharmacies identifying the supplier of any store label covered products. Pub. Resources Code section 42031(c).
- The Board also must review proposed stewardship plans for compliance with pharmacy law and make a determination whether the plan complies with pharmacy law. Pub. Resources Code section 42032(b).
The Board has other authorized duties under this law. However, primary oversight over the implementation of this new program lies with the California Department of Resources Recycling and Recovery (CalRecycle), including final approval of stewardship plans and enforcement of these new provisions.
How does a covered entity submit a list of products?
You can email the list of covered and non-covered products to BOPStewardship@dca.ca.gov. The Board provides a template to facilitate the submission and its review. Pursuant to Public Resources Code (PRC) section 42031(a)(1), a covered entity must submit both a list of covered products, and a “a list and description of any drugs or sharps that are not covered products”, that is sells or offers for sale in California, to the Board. A covered entity is responsible for the accuracy and completeness of the list.
Reference: PRC 42031(a)(1)
Revised November 2023
How often shall a covered entity submit the list of products?
Public Resources Code section 42031(a)(2) specifies that a covered entity or a stewardship organization on behalf of a group of covered entities shall submit an updated list with highlighted changes to the Board on or before January 15 of each year or upon request.
Reference: PRC 42031(a)(2)
Revised November 2023
Are auto-injectors and pre-filled syringes “covered products”?
Yes. Pursuant to Public Resource Code section 42030 (g), “covered product” means a covered drug or home-generated sharps waste. Auto-injectors and prefilled syringes are “covered products” unless they meet the exclusion criteria set forth in PRC 42030(e)(2) or PRC 42030(I)(2).
Reference: PRC 42030(g)
Revised November 2023
Are intramuscular injection needles used by ultimate users at home “covered products”?
Yes. Intramuscular injection needles, such as the ones for testosterone injection, are used to penetrate skin for the delivery of medication. They are “home-generated sharps waste” pursuant to Health & Safety Code (HSC) Section 117671, and thus “covered products” pursuant to Public Resource Code section 42030 (g).
Reference: PRC 42030(g); HSC 117671
Revised November 2023
Can an ultimate user bring sharps waste to a pharmacy or deposit sharps waste into a drug take-back kiosk?
Pursuant to California Code of Regulations (CCR), tit. 16 section 1776.1(e), medical sharps and needles shall not be deposited into a drug take-back kiosk. Under Business and Professions Code (BPC) section 4146, a pharmacy is permitted but not required to accept sharps containers.
Please check https://www.calrecycle.ca.gov/epr/pharmasharps/sharps/ for more information about sharps waste stewardship.
Reference: CCR 1776.1(e); BPC 4146
Revised November 2023
Some drugs are only being used in clinical settings. Are they “covered drugs”?
Pursuant to Public Resource Code section 42030(e)(1), a “covered drug” means a drug sold, offered for sale, or dispensed in or into the State of California. Additionally, Business and Professions Code sections 4024 and 4016 defines “dispense” and “administer”, respectively.
Based on the relevant sections of the law, a drug that is SOLELY administered in clinical settings within the definition of BPC section 4016, and not offered, sold or dispensed to a patient in California, would not be considered a “covered drug”. Public Resources Code section 42031(a)(1) requires that “covered entities” submit a list of covered and uncovered products, and the Board prefers that potential covered entities submit to the Board a statement why its drugs should not be considered “covered drugs” based on any such statutory interpretation. The potential covered entity is responsible for the truthfulness of such statement.
Reference: PRC 42030(e)(1); BPC 4016, 4024
Revised November 2023
Are APIs (Active Pharmaceutical Ingredients) “covered drugs”?
APIs are not finished drugs, thus not “covered drugs” pursuant to Public Resource Code section 42030(e).
Reference: PRC 42030(e)
Revised November 2023
How do I know if I am a “covered entity”?
Please refer to Public Resource Code section 42030(f) for the definition of “covered entity”. Please contact CalRecycle at pharmasharpsenforcement@calrecycle.ca.gov for interpretive questions regarding a “covered entity”.
Reference: PRC 42030(f)
Revised November 2023
Where can I find the list of “covered products” and “covered entities”?
Pursuant to California Public Resource Code 42035(a)(1), on or before June 30, 2022, CalRecycle will post on its Internet Web site (https://www.calrecycle.ca.gov/epr/pharmasharps) a list of stewardship organizations, including entities with an approved stewardship plan, and covered entities, authorized collection sites, retail pharmacies, and retail pharmacy chains provided in the stewardship plans that are in compliance with this chapter. The law does not require posting of a list of “covered products”.
Reference: PRC 42035(a)(1)
Revised November 2023
Where can I find information regarding stewardship organizations and stewardship plans?
You can find information about potential stewardship organizations at https://www.calrecycle.ca.gov/epr/pharmasharps/coveredentities You can find information about Pharmaceutical Stewardship Plans at https://www.calrecycle.ca.gov/epr/pharmasharps/pharma/plan, and Home-Generated Sharps Waste Plans at https://www.calrecycle.ca.gov/epr/pharmasharps/sharps/plan.
Revised November 2023
What are the responsibilities of a wholesaler in compliance with SB212?
A wholesaler may be considered a “covered entity” per the tiered definition under Public Resource Code 42030(f). Wholesalers should coordinate with appropriate entities in their supply chains to determine how statutory and regulatory requirements will be met.
In addition, a wholesaler has the reporting responsibility pursuant to Public Resource Code 42035(c). A wholesaler shall determine if covered products are in compliance with the law, by verifying that the covered entities providing the covered products are in compliance with the law and shall notify CalRecycle if it determines that the covered entity is not listed on CalRecycle’s Internet Web site.
Reference: PRC 42030(f), Reference: PRC 42035(c)
Revised November 2023
How can a pharmacy participate in a stewardship plan for pharmaceutical or home- generated sharps waste?
A pharmacy can contact approved stewardship plan operators for participating in the program. Please check https://www.calrecycle.ca.gov/epr/pharmasharps/coveredentities/for approved stewardship plans and their contact information.
Revised November 2023
Are compounded medications “covered drugs”?
Compounded medications are exempted from section 505 of the Federal Food, Drug and Cosmetics Act (21 U. S.C. 355). Therefore, compounded medications are not “covered drugs” under the stewardship program.
Reference: PRC 42030(e)(1)
Revised November 2023
Can a covered entity include non-covered drugs to the covered drug list?
The intent of the SB212 is to ensure the safe disposal of pharmaceutical and home- generated sharps wastes. In the spirit of the law, the Board does not view it as a violation of law if a covered entity voluntarily elects non-covered drugs to be covered under a stewardship plan.
Reference: PRC 42030(e)(1)
Revised November 2023
Where can I get more information if needed?
You can find more information at CalRecycle’s web site: https://www.calrecycle.ca.gov/epr/pharmasharps. Questions regarding “covered drugs” or “covered products” should be directed to bopstewardship@dca.ca.gov. Questions regarding “covered entity” and other provision of SB212 should be directed to pharmasharpsenforcement@calrecycle.ca.gov
Revised November 2023
How do I know if an over-the-counter drug is a “covered drug”?
Public Resource Code 42030(e)(1)(B) states a drug marketed under an over-the-counter drug monograph is a “covered drug”. Pursuant to Public Resource Code 42030(e)(1)(A), non-prescription drugs (over-the counter drugs) marketed under NDA or ANDA pursuant to Section 505 of the Federal Food, Drug and Cosmetic Act or Section 351 of the Federal Public Health Service Act are also “covered drugs”. There are some exclusions pursuant to Public Resource Code 42030(e)(2)(C). Please note whether a product is a cosmetic or/and a drug under the law is determined by a product's intended use. Different laws and regulations apply to each type of product. The Board recommends potential covered entities examine their over-the-counter drugs for their intended uses and contact appropriate agents, including potentially a lawyer, for guidance of whether their particular product is a covered drug.
Reference: PRC 42030(e)(1)(A); 42030(e)(1)(B); 42030(e)(2)(C); FDA Is It a Cosmetic, or a Drug, or Both?
Revised November 2023
If a covered entity does not offer a drug for sale, could a drug still be considered a “covered” Drug”?
Yes. Pursuant to PRC 42030(e)(1), “covered drug” includes drugs that were sold, offered for sale or dispensed in the state of California. If the drug is no longer produced or no longer for sale, it could still be considered a “covered drug” under the law.
Revised November 2023
If a covered entity does not currently offer a “covered drug” for sale, does the covered entity still need to report the covered drug?
No. PRC 42031(a) states a covered entity shall provide a list of covered products and a list of any drugs of sharps that are not covered products, that it sells or offers for sale in the state to the Board. While a drug may still be covered, the covered entity does not need to report it if the drug is no longer for sale in the State of California.
Revised November 2023
Licensees
Pharmacy Technician Expanded Duties
In addition to the traditional tasks pharmacy technicians may perform pursuant to BPC 4115(a) (i.e., packaging, manipulative, repetitive, or other nondiscretionary tasks only while assisting, and while under the direct supervision and control of, a pharmacist), what are the expanded duties pharmacy technicians may now perform?
BPC 4115(b) was clarified by Assembly Bill 1503 (Berman, Chapter 196, Statutes of 2025). Under these updates, which become effective January 1, 2026, a certified pharmacy technician as defined in BPC 4202 may perform the following duties under specified conditions:
- Prepare and administer influenza and COVID-19 vaccines via injection or intranasally
- Prepare and administer epinephrine
- Perform specimen collection for tests that are classified as CLIA
- Initiate and receive prescription transfers and accept clarification on prescriptions
Initiate and receive prescription transfers and accept clarification on prescriptions
Revised November 2025
What are the specified conditions that must be met for a pharmacy technician to perform the expanded duties?
The law establishes several conditions, as follows:
- The duties are performed under the direct supervision and control of a pharmacist.
- The pharmacy has scheduled another pharmacy technician to assist the pharmacist by performing the tasks provided in BPC 4115(a) (i.e., packaging, manipulative, repetitive, or other nondiscretionary tasks).
- The pharmacy technician is certified pursuant to the provisions of BPC 4202(a)(4) and maintains the certification.
- Assembly Bill 1503 (Berman, Chapter 196, Statutes of 2025), which takes effect on January 1, 2026, clarifies the conditions for technicians performing administration of vaccines (or epinephrine):
- Prior to performing administration of vaccines, the pharmacy technician has successfully completed at least six hours of practical training approved by the Accreditation Council for Pharmacy Education that includes hands-on injection technique, the recognition and treatment of emergency reactions to vaccines, and an assessment of the pharmacy technician’s injection technique.
- The pharmacy technician is certified in basic life support.
[Reference: BPC 4115(b); see also Stats. 2025, Ch. 196, Sec. 36 (AB 1503), effective January 1, 2026]
Revised November 2025
Licensees
Unprofessional Conduct
As a pharmacist, I know I am responsible for using professional judgment when taking care of patients. I believe my employer has implemented a policy that undermines my professional judgment. Does AB 1286 address this?
Yes. Effective January 1, 2024, the unprofessional conduct code was amended to expand the list of specified actions that constitute unprofessional conduct to include actions or conduct that would subvert the efforts of a pharmacist or PIC to comply with laws and regulations, or exercise professional judgment.
[Reference: BPC 4301(v) and (w)]
Revised November 2025
If I believe the pharmacy is violating the law, how do I file a complaint with the Board?
A consumer or licensee may file a complaint with the Board online. Fill out the boxes on the form that apply to your complaint. The Board requests that documentation or other evidence that support your allegations be retained and provided to the Board if requested.
Revised November 2025
Can I file a complaint anonymously?
Yes. The Board welcomes and investigates complaints received, including anonymous complaints. However, anonymous complaints may limit the Board’s ability to investigate.
Revised November 2025
Is a chain community pharmacy required to post a notice for pharmacy personnel that provides information on how to file a complaint?
Subdivision (c) of BPC 4113.6 (which was added by Assembly Bill 1503 (Berman, Chapter 196, Statutes of 2025), and which becomes effective on January 1, 2026) provides that a chain community pharmacy is required to post, in a prominent place for pharmacy personnel, a notice that provides information on how to file a complaint with the Board.
[Reference: Stats. 2025, Ch. 196, Sec. 35 (AB 1503), effective January 1, 2026]
Revised November 2025
Licensees
Surgical Clinic Provisions
Under new requirements established by AB 1286, a surgical clinic is required to complete a Surgical Clinic Self-Assessment Form. Where can I find that form?
The Surgical Clinic Self-Assessment Form can be found here on the Board’s website.
[Reference: BPC 4192(b)]
Revised November 2025
It is my understanding that AB 1286 makes changes to the renewal requirements for surgical clinics. Please provide me with an explanation of the changes.
Effective January 1, 2024, as part of the renewal process for a surgical clinic, the consulting pharmacist must certify compliance with the quarterly inspections as required by BPC 4192. Further, as part of the renewal process of every odd-numbered year, the most recent self-assessment form completed as provided in BPC 4192 must be provided to the Board.
[Reference: BPC 4204(c)]
Revised November 2025
How does the consulting pharmacist certify compliance with the quarterly inspection requirements?
The renewal application form includes a statement that must be completed by the consulting pharmacist as part of the renewal process. As a reminder, the Board has a policy to accept digital signatures. The policy is available here.
[Reference: BPC 4192(b), 4204(c)]
Revised November 2025
How does the consulting pharmacist certify compliance with the quarterly inspection requirements?
A copy of the completed self-assessment form can be mailed along with the renewal application form and renewal fee to the Board’s office at 2720 Gateway Oaks Drive, Suite 100, Sacramento, CA 95833.
Alternatively, the self-assessment form may be emailed to surgicalclinicselfassessment@dca.ca.gov and the renewal application form and fee may be mailed to the Board’s office.
[Reference: BPC 4204(c)]
Revised November 2025
Licensees
Compounding Regulations
Title 16, California Code of Regulations (CCR), Sections 1735 et seq., 1736 et seq., 1737 et seq., and 1738 et seq.
Regulations Effective October 1, 2025
This information is intended solely to assist pharmacists and pharmacies with understanding the California regulations governing nonsterile compounding, sterile compounding, hazardous drugs, and radiopharmaceuticals that took effect on October 1, 2025. It is not nor is it a substitute for legal advice. References to specific sections of the regulations are provided to aid the users of this document. Licensees are strongly encouraged to read the regulations in their entirety to have full understanding of the requirements. Licensees are also reminded that the regulations are in addition to (not in replacement of) applicable state and federal law and USP standards, and are advised that this document only addresses the additional requirements that apply under the regulations. All references in this document to California Business and Professions Code (BPC) sections are in Division 2, Chapter 9. All references in this document to California Code of Regulations (CCR) sections are in Title 16. Licensees are also advised that this is a dynamic document, which may be updated periodically.
General Compounding
How do the previous California regulations addressing compounding correspond to the current compounding regulations that took effect on October 1, 2025?
| Type of Compounding | Previous CCR | Current CCR | USP Related Chapters |
|---|---|---|---|
| Nonsterile compounding | 1735 – 1735.8 | 1735 – 1735.15 | USP 795 |
| Sterile compounding | 1735 – 1735.8 and 1751 – 1751.10 | 1736 – 1736.21 | USP 797 |
| Handling of hazardous drugs | 1735 – 1735.8 and 1751 – 1751.10 | 1737 – 1737.17 | USP 800 |
| Radiopharmaceutical- preparation, compounding, dispensing and repackaging | 1708.3 – 1708.5, 1735 – 1735.8, and 1751 – 1751.10 | 1738 – 1738.14 | USP 825 |
Revised January 2026
Can a facility have more than one designated person (DP) and does the DP need to be a pharmacist?
For nonsterile and sterile compounding, “designated person(s)” means one or more individuals assigned by the pharmacist-in-charge (PIC) to be responsible and accountable for the performance and operation of the facility and personnel as related to the preparation of the compounded nonsterile preparations (CNSPs)/ compounded sterile preparations (CSPs), as applicable. Nothing in this definition allows for a designated person to exceed the scope of their issued license. When the designated person is not a pharmacist, the PIC must review all practices related to the operations of the facility that require the professional judgment of a pharmacist. Nothing in this definition prohibits the PIC from also serving as the designated person.
For hazardous drugs (HDs), in a pharmacy, the “designated person(s)” must be approved by the PIC to be responsible and accountable for the performance and operation of the facility and personnel as related to the handling of HDs. The designated person(s) shall not exceed the scope of their issued license. When a designated person is not a pharmacist, the PIC must review all practices related to the operations of the facility that require the judgment of a pharmacist.
For radiopharmaceuticals, “designated person” means a pharmacist identified as assigned, responsible, and accountable for the performance and operation of the radiopharmaceutical processing facility and for personnel who prepare, compound, dispense, and repackage radiopharmaceuticals. Nothing in this definition prohibits the PIC from also serving as the designated person.
[Reference: CCR 1735(b), 1736(c), 1737.2(a)(1), 1738(c)]
Revised January 2026
When can a facility compound a drug in shortage?
For nonsterile compounding: A facility may compound a drug in shortage when the drug product appears in an American Society of Health-System Pharmacists (ASHP) Drug Shortages List or FDA Drug Shortages Database of drugs that are in short supply at the time of compounding or within 60 days of the end of the shortage, or in a health care facility licensed pursuant to Health and Safety Code Section 1250 where the drug product cannot be obtained from the manufacturer or wholesaler and documentation is maintained.
For sterile compounding: A facility may compound a drug in shortage when that drug product appears in an ASHP Drug Shortages List or FDA Drug Shortages Database of drugs that are in short supply at the time of compounding and at the time of dispensing, or in a health care facility licensed pursuant to Health and Safety Code Section 1250 where the drug product cannot be obtained from the manufacturer or wholesaler and documentation is maintained.
[Reference: CCR 1735.1(e)(1)(A), 1736.1(e)(1)(A)]
Revised January 2026
Is an audit trail required if I make a change on any of my compounding records?
For nonsterile compounding, sterile compounding, and the processing of radiopharmaceuticals, the regulations require that records be created and maintained in a manner to provide an audit trail for revisions and updates of each record document. Prior versions of each record must be maintained for at least three years from the date the record was created, modified, or relied on, in a readily retrievable format and include the changes to the document, identification of the individual who made each change, and the date of each change.
[Reference: CCR 1735.14(b), 1736.20(b), 1738.9(d)]
Revised January 2026
Where can I submit licensing questions to the Board?
Questions regarding your compounding license, license renewal, or general licensing questions can be submitted to Compounding.Pharmacy@dca.ca.gov.
Revised January 2026
How do the regulations define “essentially a copy” of a commercially available drug product for purposes of nonsterile or sterile compounding?
Under the regulations, “essentially a copy” of a commercially available drug product means a preparation that includes the same active pharmaceutical ingredient(s) (API(s)) as the commercially available drug product, except that it does not include any preparation in which there has been a change made for an identified individual patient that produces for that patient a clinically significant difference, as verified and documented by the pharmacist, between that compounded preparation and the comparable commercially available drug product.
[Reference: CCR 1735(d), 1736(e)]
Revised January 2026
What is required before a trainer is allowed to provide training to other pharmacy staff performing nonsterile or sterile compounding duties?
Any person assigned to provide the training specified in section 1735.2 (applicable to nonsterile compounding) or section 1736.2 (applicable to sterile compounding) shall have demonstrated competency in the skills in which the person will provide training or observe and measure competency described in the facility’s standard operating procedures (SOPs).
[Reference: CCR 1735.2(c), 1736.2(e)]
Revised January 2026
As the designated person, how do I document a garbing accommodation?
For nonsterile or sterile compounding, any garbing accommodations provided by the designated person shall be documented, and the documentation shall include the name of the individual granted the accommodation, date granted and description of the reasons for granting the accommodation.
[Reference: CCR 1735.3(f), 1736.3(e)]
Revised January 2026
Does the compounding record (CR) need to be one document?
For nonsterile or sterile compounding, a CR shall, upon request, be produced as a single document.
[Reference: CCR 1735.7(c), 1736.11(c)]
Revised January 2026
Are a facility’s SOPs required to address the handling of temperature sensitive Compounded Non-sterile Preparations (CNSPs)/ Compounded Sterile Preparations (CSPs)?
The facility’s SOPs for nonsterile compounding must describe the validated processes for storage, for shipping containers (as applicable), and for transportation of temperature sensitive CNSPs (as applicable) to preserve quality standards for integrity, quality and labeled strength. For sterile compounding, there must be written procedures for qualification of storage, shipping containers and transportation of temperature sensitive CSPs to preserve quality standards for integrity, quality, and labeled strength.
[Reference: CCR 1735.11(a)(2)(D), 1736.17(g)]
Revised January 2026
Nonsterile Compounding
If the pharmacist does not follow the manufacturer’s instructions when reconstituting a commercially available drug product, is this considered compounding?
Yes, reconstitution of a conventionally manufactured drug product that is not done in accordance with the FDA approved directions is
[Reference: CCR 1735.1(b)]
Revised January 2026
How much CNSP can a pharmacy compound in advance and store in the pharmacy prior to receiving a patient-specific prescription for the CNSP?
A limited quantity of a CNSP may be prepared and stored in advance of receipt of a patient specific prescription document where it is necessary, and solely in such quantity to ensure continuity of care of individual patients based on a documented history of prescriptions for those patient populations.
[Reference: CCR 1735.1(c)]
Revised January 2026
How much CNSP can a pharmacy furnish to a veterinary office for use by the veterinarian?
A reasonable quantity of CNSP may be furnished to a veterinary office for use by the veterinarian that is sufficient:
- for administration or application to veterinary patients solely in the veterinarian’s office.
- for furnishing of no more than a 14-day supply, for an individual patient, as fairly estimated by the prescriber and documented on the purchase order or other documentation submitted to the pharmacy prior to furnishing.
[Reference: CCR 1735.1(d)]
Revised January 2026
Do gloves need to be wiped or changed when performing nonsterile compounding?
Gloves must be wiped or replaced before beginning a CNSP that contains different components.
[Reference: CCR 1735.3(d)]
Revised January 2026
How long is the pharmacy required to maintain the source referenced to support the assigned beyond-use date (BUD)?
If a source is referenced to support an assigned BUD, the source referenced must be readily retrievable at the time of compounding and must be maintained for three (3) years from the date each CNSP is dispensed.
[Reference: CCR 1735.7(a)(1)]
Revised January 2026
If the names of the compounding facility and the dispensing facility is different, are they both required to be included on a CNSP’s label?
Yes, a CSNP’s label shall include the name of the compounding facility and the name of the dispensing facility, if different.
[Reference: CCR 1735.9(a)(2)]
Revised January 2026
Can a facility use antimicrobial effectiveness testing provided by a current FDA-registered drug establishment or an outsourcing facility?
Yes, if the testing is compliant with USP Chapter 51, Antimicrobial Effectiveness Testing. If such testing is used, or if relying upon current published peer-reviewed literature sources, the reference or test in its entirety shall be readily retrievable in accordance with Business and Professions Code section 4081 for three years from the last date the CNSP was dispensed.
[Reference: CCR 1735.10(c)]
Revised January 2026
Prior to compounding, must the facility’s SOPs for nonsterile compounding include how the facility selected the ingredients for each CNSP?
Yes, the facility’s SOPs for nonsterile compounding must include the methods a pharmacist will use to determine and approve the ingredients and the compounding process for each preparation before compounding begins.
[Reference: CCR 1735.11(a)(2)(C)]
Revised January 2026
What do the regulations say about adding flavoring?
Under the regulations, a facility that limits its compounding to combining a flavoring agent with a prescribed FDA approved drug in an oral liquid dosage form at the request of a prescriber, patient, or patient’s agent is exempt from certain sections of the regulations, as specified in subdivision (i) of section 1735.1. However, for such facilities, section 1735.15 requires, among other things, that the pharmacist adding the flavoring agent must document the compounding in the prescription or compounding record.
A facility that performs any other form of nonsterile compounding at any time does not qualify for the exemption described above.
Licensees are advised to read the regulations referenced below in their entirety for a full understanding of the requirements regarding adding flavoring agents.
[Reference: CCR 1735.1(i), 1735.15]
Revised January 2026
Sterile Compounding
When can a pharmacy compound for immediate administration or immediate use?
Except as described in the two bullet points below, compounded sterile preparations (CSPs) for direct and immediate administration as provided in USP Chapter 797 shall only be compounded in those limited situations where the failure to administer such CSP could result in loss of life or intense suffering of an identifiable patient.
- If the sterile compounding equipment or environment fail(s) to meet any required specification, after attempts to remediate pursuant to the facility’s SOPs are unsuccessful, an immediate use CSP may be compounded without the requirement for there to be loss of life or intense suffering of an identifiable patient; however, this provision may only be used for 48 hours after such failure(s).
- If the sterile compounding equipment or environment fail(s) to meet any required specification in a critical access hospital, as defined in section 1395i-4(c)(2)(B) of title 42, United States Code, after attempts to remediate pursuant to the facility’s SOPs are unsuccessful, an immediate use CSP may be compounded without the requirement for there to be loss of life or intense suffering of an identifiable patient; however, this provision may only be used for 120 hours after such failure(s).
Licensees are advised to read the regulation in its entirety for a full understanding of the requirements that apply to immediate-use CSPs.
[Reference: CCR 1736.1(b)]
Revised January 2026
How much CSP can a pharmacy furnish to a veterinary office for use by the veterinarian?
A reasonable quantity of a CSP may be furnished to a veterinary office for use by the veterinarian that is sufficient:
- for administration or application to veterinary patients solely in the veterinarian’s office.
- for furnishing of not more than a 7-day supply for an individual patient, as fairly estimated by the prescriber and documented on the purchase order or other documentation submitted to the pharmacy prior to furnishing, with the exception of a topical ophthalmic where up to a 28-day supply may be furnished to the veterinarian’s office for an individual patient; provided that such topical ophthalmics shall be compliant with USP Chapter 797 section 14.5, Multiple-Dose CSPs.
[Reference: CCR 1736.1(d)]
Revised January 2026
Can garbing and hand hygiene competencies and aseptic manipulation competencies from one premises be used for another premises?
Yes, if all of the following conditions are met:
- The Standard Operating Procedures (SOPs) required by section 1736.17 related to compounding are identical.
- The Secondary Engineering Control (SEC) facility designs are sufficiently similar to accommodate the use of the same SOPs.
- The Primary Engineering Controls (PECs) are of the same type and sufficiently similar to accommodate the use of the same SOPs describing use and cleaning.
[Reference: CCR 1736.2(b)]
Revised January 2026
What happens if compounding personnel fail any part of aseptic manipulation training and competency evaluation?
Compounding personnel or persons with direct supervision and control of compounding personnel who fail any aspect of the aseptic manipulation ongoing training and competency evaluation shall not be involved in compounding of a CSP until after successfully passing training and competency in the deficient area(s) as detailed in the facility’s SOPs.
A person with only direct supervision and control of personnel who fails any aspect of the aseptic manipulation ongoing training and competency evaluation may continue to provide only direct supervision and control of personnel for no more than 30 days after a failure of any aspect while applicable aseptic manipulation ongoing training and competency evaluation results are pending.
[Reference: CCR 1736.2(d)]
Revised January 2026
If the pharmacy uses a Segregated Compounding Area (SCA), can a wall be considered part of the SCA?
Yes, as long as the wall is smooth, impervious, free from cracks and crevices, and non-shedding so it can be easily cleaned and disinfected and to minimize spaces in which microorganisms and other contaminants can accumulate.
[Reference: CCR 1736.4(b)]
Revised January 2026
If the pharmacy uses a Segregated Compounding Area (SCA), can a wall be considered part of the SCA?
Yes, as long as the wall is smooth, impervious, free from cracks and crevices, and non-shedding so it can be easily cleaned and disinfected and to minimize spaces in which microorganisms and other contaminants can accumulate.
[Reference: CCR 1736.4(b)]
Revised January 2026
Does the temperature in the designated compounding area, such as an SCA, need to be monitored?
The temperature shall be monitored in each room of the designated compounding area each day that compounding is performed, either manually or by a continuous recording device.
[Reference: CCR 1736.4(c)]
Revised January 2026
If on October 1, 2025, a pharmacy has an existing secondary engineering control that has a pass-through that is not an interlocking device, is the pharmacy required to install an interlocking device?
No, an existing secondary engineering control that has a pass-through that is not an interlocking device may continue to be used if the SOPs document that two doors may not be opened at the same time.
Where a pass-through is installed in a secondary engineering control After October 1, 2025, the doors must be interlocking.
[Reference: CCR 1736.4(d)]
Revised January 2026
What standards apply to the certification and testing of the pharmacy’s classified compounding areas?
In addition to the requirements of USP Chapter 797, testing and certification of all ISO classified areas shall be performed by a qualified technician in accordance with Controlled Environment Testing Association’s (CETA) Certification Guide for Sterile Compounding Facilities (CAG-003, Revised October 2022). The CETA standard(s) used to perform certification testing in all ISO classified areas shall be recorded on the report issued by the certifying technician in accordance with the Certification Guide for Sterile Compounding Facilities.
[Reference: CCR 1736.5]
Revised January 2026
What standards apply to environmental sampling?
In addition to the requirements of USP Chapter 797, environmental sampling shall be done in accordance with the Controlled Environment Testing Association’s Certification Application Guide USP <797> Viable Environmental Monitoring for Sterile Compounding Facilities (CAG-009, Revised September 2020).
[Reference: CCR 1736.6]
Revised January 2026
If the pharmacy is using an incubator, how should the incubator be maintained?
Incubators used by the facility shall be cleaned, maintained, calibrated, and operated in accordance with manufacturers’ specifications. For incubators without specific manufacturers’ specifications, cleaning shall take place at least every 30 days and calibration shall take place at least every 12 months. Temperatures must be monitored either manually or by a continuous recording device during incubation, and the results shall be reviewed and documented as described in the facility’s SOPs.
[Reference: CCR 1736.9(b)]
Revised January 2026
Can facilities compound with FDA Category 1 bulk drug substances?
If a component included in the published 503A Category 1 Bulk Drug Substances List is used, it must be found suitable for sterile drug preparations as provided in USP Chapter 797, Section 9.3 Components. The facility’s SOPs shall establish a process to determine the quality of the API, and the SOPs, which must comply with USP Chapter 1163, Quality Assurance in Pharmaceutical Compounding, must define both the methods by which the pharmacist compounding or supervising the compounding will ensure the quality of compounded drug preparations and the methods used to determine and approve components and the compounding process for each preparation before compounding begins.
Licensees are advised to read Article 4.6 (Sterile Compounding) of the regulations in its entirety for a full understanding of the requirements that apply to components used to compound CSPs.
[Reference: CCR 1736.9(f), 1736.17(a)]
Revised January 2026
Can a pharmacy compounding CSP from a nonsterile component send the CSP to another facility for sterilization (for example, by e-Beam radiation)?
Section 1736.10 of the regulations describes requirements, in addition to the requirements in USP Chapter 797, that apply to sterilization and depyrogenation. Subdivision (e) of section 1736.10 states that no compound of a CSP from nonsterile components shall be prepared when the licensed location cannot also sterilize the CSP as described in section 1736.10.
[Reference: CCR 1736.10(e)]
Revised January 2026
Is a USP Category 1 injectable CSP compounded from a nonsterile component required to be tested for endotoxins prior to dispensing?
Yes. A pharmacist performing or who has direct supervision and control of compounding personnel is responsible for ensuring injectable CSPs made from nonsterile components, regardless of the USP Category, are tested to ensure that they do not contain excessive bacterial endotoxins, as established in USP Chapter 85, Bacterial Endotoxins.
Results shall be reviewed and documented in the compounding record prior to furnishing.
[Reference: CCR 1736.12(c)]
Revised January 2026
Can a CNSP compounded following USP 795 be used as a stock solution to compound a CSP?
A compounded stock solution intended for use in a CSP must comply with all provisions of Article 4.6 (Sterile Compounding) of the regulations and USP Chapter 797 Category 1, Category 2, or Category 3.
[Reference: CCR 1736.16(a)]
Revised January 2026
Can a pharmacy obtain a CSP for use as a component from an outsourcing facility?
Yes, as long as the outsourcing facility is licensed in California.
NOTE: To verify if an outsourcing facility is licensed in California, go to: https://search.dca.ca.gov/?BD=7200&TP=180
[Reference: CCR 1736.16(b)]
Revised January 2026
Hazardous Drugs (HD)
Our facility compounds HD in a containment secondary engineering control (C-SEC) which has a pass-through without interlocking doors. Under the regulations that took effect on October 1, 2025, is our facility exempt from changing to interlocking doors since the facility has an existing sterile compounding license?
No, although the regulations provide a grace period to come into compliance. Where there is a pass-through in a C-SEC, the doors must be gasketed and interlocking by January 1, 2027.
[Reference: CCR 1737.5(c)]
Revised January 2026
Our facility installed a pass-through in our cleanroom, but it is not a HEPA purge type pass-through. Do the regulations that took effect on October 1, 2025, require that we replace and install a new pass-through?
On or after January 1, 2028, prior to installing a new pass-through, a facility must consider the use of a HEPA purge type pass-through. Documentation shall be maintained showing compliance with this requirement if such a pass-through is not used.
[Reference: CCR 1737.5(d)]
Revised January 2026
Continuing Education
Pharmacists
What are the Continuing Education (CE) requirements to renew my pharmacist (RPH) license?
RPH licensees are required to complete 30 CE hours during the two years preceding the application for renewal. This must include:
- At least two hours of participation in a Board-provided CE course in Law and Ethics. [Note: Currently, the Board offers two separate webinars: a Board-provided law webinar (1 hour) and a Board-provided ethics webinar (1 hour). RPH licensees must view both webinars to satisfy the 2-hour Law and Ethics CE requirement. Click here to access both courses.]
- At least one hour of participation in a cultural competency course.
[Reference: Business and Professions Code (BPC) section 4231; Title 16, California Code of Regulations (CCR) section 1732.5(a) – 1732.5(b).].
Approved June 2026
Are newly licensed pharmacists in California required to complete Continuing Education (CE) before their first renewal?
No, the Board does not require completion of CE for the first renewal of a pharmacist license.
[Reference: BPC section 4231.]
Revised June 2026
What are the specific requirements for the cultural competency Continuing Education (CE) course?
BPC section 4231 defines “cultural competency course” to mean a cultural competency and humility course that meets the following criteria:
- The course focuses on patients who identify as lesbian, gay, bisexual, transgender, gender nonconforming, or queer, or who question their sexual orientation or gender identity and expression.
- The course is approved from an accreditation agency approved by the Board.
- The course covers recognized health disparities faced by Black, Indigenous, and people of color.
- The course contains elements demonstrating how sexual identity is directly impacted through intersectionality.
[Reference: BPC section 4231.]
Revised June 2026
Are there any specific requirements for Continuing Education (CE) for pharmacists that prescribe Schedule II controlled substances?
Yes, pharmacists who prescribe any Schedule II controlled substances shall complete at least one hour of the required CE hours by participating in a Board approved CE course once every four years on the risks of addiction associated with the use of Schedule II drugs.
[Reference: BPC section 4232.5 and CCR section 1732.5; Health and Safety Code section 11055.]
Revised June 2026
If I completed more than 30 Continuing Education (CE) hours during my two-year renewal period, can my extra CE hours be “carried over” to my next renewal period?
No. CE must be completed during the two years preceding the application for renewal.
[Reference: BPC section 4231; CCR section 1732.5(a).]
Revised June 2026
Do I have to complete specialized Continuing Education (CE) if I furnish FDA-approved or authorized medications as part of preventative health care services that do not require a diagnosis (such as emergency contraception, hormonal contraception, smoking cessation, travel medications, and anti-viral or anti-infective medications), furnish medication used to reverse opioid overdose, or initiate and administer vaccines?
No. Under provisions in Assembly Bill 1503 (Berman, Chapter 196, Statutes of 2025), effective January 1, 2026, pharmacists who perform these functions are no longer subject to specialized CE requirements. The Board is pursuing a regulation change to update its CE regulations to formally remove those specialized CE requirements.
Revised June 2026
Board-Provided Continuing Education (CE)
How do I register for Board-provided Continuing Education (CE) programs and/or webinars?
Registration for Board-provided Continuing Education (CE) programs is conducted through PharmEd. Learn more about current trainings available on PharmEd.
Revised June 2026
Will Board-provided Continuing Education (CE) programs and/or webinars appear on my NABP CPE Activity Monitor Transcript?
No. Please contact the NABP to learn about options to upload CE into the NABP CPE system.
Revised June 2026
How do I access my certificate(s) of completion for Board-provided Continuing Education (CE) programs and/or webinars?
Licensees may access certificates of completion for Board-provided CE courses via their PharmEd account dashboard.
Revised June 2026
How do I claim Continuing Education (CE) credit for attending a Board or Committee meeting?
Licensees interested in claiming CE for attending a Board or Committee meeting should follow the instructions included on the meeting agenda.
[Reference: CCR sections 1732.2(d) – 1732.2(e).]
Revised June 2026
Renewal Process
Do I need to submit certificates of completion of Continuing Education (CE) with my license renewal application?
No. At the time of renewal, a pharmacist licensee renewing as active must simply enter on the renewal application the number of hours of CE successfully completed during the two years preceding the application for renewal.
[Reference: BPC section 4231; CCR section 1702 and 1732.5.]
Revised June 2026
Why has my license status been changed to “Continuing Education (CE) Inadequate – License Held”?
A pharmacist license status will change to “CE Inadequate – License Held” if a pharmacist fails to numerically declare on their renewal application the number of hours of CE successfully completed during the preceding two years.
[Reference: BPC section 4231; CCR section 1702 and 1732.5.]
Revised June 2026
How do I remedy a “Continuing Education (CE) Inadequate – License Held”?
To restore the license status back to “active”, download a new renewal application and complete it in its entirety. The completed renewal application may be submitted via mail, fax or online.
Upon review and approval of the amended renewal application, the “active” license status will be reflected on the Board’s website.
Note: To ensure an online inquiry is appropriately routed, select “Renewal of an Individual” as the reason for your inquiry.
Revised June 2026
Can the Board grant an extension if I cannot finish my Continuing Education (CE) on time?
No. Currently, there is no provision in pharmacy law that authorizes the Board to grant an extension for licensees to complete the required CE for renewal of their license.
Revised June 2026
Can I request an exemption from the Continuing Education (CE) requirements if I have an emergency or hardship?
Yes, pharmacists may seek exemption from the CE requirements for renewal on the grounds of emergency or hardship by applying to the Board in writing setting forth the reasons why such exemption should be granted. Exemptions may be granted for such reasons as illness or full-time enrollment in a health professional school.
[Reference: BPC section 4234 and CCR section 1732.6.]
Revised June 2026
How do I reactivate my pharmacist license if it has been inactivated due to failure to meet Continuing Education (CE) requirements?
A licensee with an inactive license issued pursuant to BPC section 4231 may obtain an active license by paying the renewal fees due and submitting satisfactory proof to the Board that the licensee has completed all CE renewal requirements.
[Reference: BPC section 4231(e).]
Revised June 2026
CE Audits
How long do I need to retain copies of Continuing Education (CE) certificates of completion?
Licensees shall retain their certificates of completion for four years following completion of a CE course to demonstrate compliance.
[Reference: CCR section 1732.5(e).]
Revised June 2026
How will I be notified that I have been selected for a Continuing Education (CE) audit?
The Board conducts CE audits to confirm whether licensees have completed their CE requirements. If a licensee has been selected for a CE audit, the Board will send a notification to the licensee’s address of record. Additionally, if available, the Board will send a notification to the licensee’s email address of record. As a reminder, licensees must notify the Board of any changes to their address of record within 30 days of the change.
Consistent with legal requirements, if, as part of an investigation or audit conducted by the Board, a licensee fails to provide documentation substantiating completion of required CE, the Board shall cancel the active license and issue an inactive license in its place.
[Reference: BPC sections 4100 and 4231(e).]
Revised June 2026
Continuing Education (CE) Providers
Does the Board maintain a list of recommended Continuing Education (CE) providers and/or courses?
No, the Board does not maintain such a list.
Revised June 2026
How can I determine if a Continuing Education (CE) provider and/or course is accepted by the Board?
CE courses must be relevant to the practice of pharmacy and, subject to certain exceptions (outlined in paragraphs 2-4 below), must be obtained from a provider who is recognized by one of the two accreditation agencies designated by the Board: the Accreditation Council for Pharmacy Education (ACPE) or the California Pharmacists Association (CPhA).
Additionally, coursework which meets the standard of relevance to pharmacy practice and has been approved for CE by the Medical Board of California, the California Board of Podiatric Medicine, the Dental Board of California, or the California Board of Registered Nursing shall, upon satisfactory completion, be considered approved CE for RPHs.
RPHs may also earn CE credit for completing certain Board-provided training courses. Click here to access current mandatory and elective Board-provided training webinars.
Finally, individuals may petition the Board to allow CE credit for specific coursework which is not offered by an accredited provider but meets the standard of relevance to pharmacy practice.
[Reference: BPC section 4232; CCR sections 1732, 1732.05(a), 1732.1, 1732.2, and 1732.3(e).]
Revised June 2026
What coursework meets the standard of relevance to pharmacy practice?
Continuing Education (CE) courses shall be relevant to the practice of pharmacy as provided in CCR section 1732.3 and BPC section 4232 and related to one or more of the following topics:
- the scientific knowledge or technical skills required for the practice of pharmacy
- direct and/or indirect patient care
- the management and operation of a pharmacy practice.
The subject matter shall be pertinent to the socioeconomic and legal aspects of health care, the properties and actions of drugs and dosage forms and the etiology, and characteristics and therapeutics of the disease state. The subject matter of the courses may include, but shall not be limited to, the following:
- pharmacology
- biochemistry
- physiology
- pharmaceutical chemistry
- pharmacy administration
- pharmacy jurisprudence
- public health and communicable diseases
- professional practice management
- anatomy
- histology
- and any other subject matter as represented in curricula of accredited colleges of pharmacy
[Reference: BPC section 4232; CCR sections 1732.1(b), 1732.2, and 1732.3(e).]
Revised June 2026
What information needs to be included on a certificate of completion of Continuing Education (CE)?
Certificates of completion must contain the name of the enrollee, name and number of the course provider, title of the course, number of completed hours, date of completion, expiration date of the coursework, course number, if applicable, and the name of the accrediting agency.
[Reference: CCR section 1732.1(c).]
Revised June 2026
Continuing Education
Pharmacy Technicians
What are the Continuing Education (CE) requirements to renew my pharmacy technician (TCH) license?
Effective January 1, 2024, TCH licensees must successfully complete at least one hour of participation in a cultural competency course each renewal period (i.e., every two years) (see Business and Professions Code section 4202(d)). Please note, all CE must be completed prior to signing and submitting your renewal application.
The term “cultural competency course” means a cultural competency and humility course that meets the following criteria, as outlined in Business and Professions Code section 4231(a):
- The course focuses on patients who identify as lesbian, gay, bisexual, transgender, gender nonconforming, or queer, or who question their sexual orientation or gender identity and expression.
- The course is approved from an accreditation agency approved by the Board.
- The course covers recognized health disparities faced by Black, Indigenous, and people of color.
- The course contains elements demonstrating how sexual identity is directly impacted through intersectionality.
Approved April 2024
Does the California State Board of Pharmacy (Board) have a list of recommended Continuing Education (CE) providers and/or courses?
No. The Board does not maintain a list of Continuing Education providers/courses and does not endorse or recommend any specific provider or course. The Board recommends that, prior to registering for any cultural competency course, licensees confirm compliance with the course provider to ensure the course meets the requirements set forth in Business and Professions Code section 4231(a).
Approved April 2024
Do I need to submit proof of completion of Continuing Education with my license renewal application?
You do not need to submit proof of completion of Continuing Education with your renewal application. If you are randomly selected for an audit of your CE compliance, the Board will send a letter to your address of record requesting proof of successful completion of Continuing Education.
Approved April 2024
Why has my license status been changed to “Continuing Education Inadequate – License Held” even though I completed my Continuing Education?
Your license status has been changed to “Continuing Education Inadequate – License Held” because you failed to answer the continuing education question on your renewal application.
In order to change your license status back to “active”, you will need to download a new renewal application and complete it in its entirety: https://pharmacy.ca.gov/licensees/personal/tch.shtml.
Please email your completed renewal application so we may resolve this for you. Once Board staff has reviewed your amended renewal application, your updated license status will be reflected on the Board’s website.
Approved April 2024
Can the Board issue an extension if I cannot finish my Continuing Education on time?
No. Currently, there is no provision in pharmacy law for the Board to grant any Pharmacy Technician licensee an extension to complete the required Continuing Education for renewal of their license.
Approved April 2024
Can the Board issue an exemption from completion of the cultural competency Continuing Education (CE) renewal requirement for a Pharmacy Technician license?
No. Currently, there is no provision in pharmacy law for the Board to grant a Pharmacy Technician licensee an exemption from completion of the required Continuing Education for renewal of their license.
Approved April 2024
Aside from the cultural competency Continuing Education (CE) requirement, are there any other Continuing Education requirements for pharmacy technicians to renew their Board-issued license?
No. However, if you hold a CPhT certificate, you may wish to contact the issuing organization (PTCB or NHA) directly regarding their Continuing Education requirements. The Board is not associated with PTCB or NHA.
Approved April 2024
Should you have any further questions, please send us a message via our contact us page.
Licensees
Digital Records
Is a pharmacy allowed to digitize paper records?
Yes, Business and Professions Code section 4105 states that paper records may be converted into a digital format. The section further provides that digitized records must be maintained in a noneditable format.
Approved April 2026
Does the Board require certification that digitized records have not been altered?
Pursuant to Business and Professions Code section 4105, the Board may require certification that digitized documents have not been altered.
Approved April 2026
Will other regulators accept digitized records?
A pharmacy will need to consult with other regulators and payors to confirm if they will similarly allow for digitized records.
Approved April 2026
How long is a pharmacy required to retain digitized records?
All records required to be maintained pursuant to Chapter 9 of Division 2 of the Business and Professions Code, regardless of form (i.e., paper or digital/electronic), shall be retained for at least three years from the date of making. (See Bus. & Prof. Code §§ 4081, 4105, and 4333.)
Approved April 2026
Licensees
Electronic Data Transmission Prescriptions (E-Prescriptions)
Licensees of the California State Board of Pharmacy are subject to the e-prescribing requirements established by Assembly Bill (AB) 2789 (Wood, 2018). All prescriptions issued by a licensed healthcare practitioner to a California pharmacy must be submitted electronically. In addition, all California pharmacies must have the capability to receive prescriptions electronically.
Does the pharmacy need to have the capability of receiving electronic data transmission prescriptions from all prescribers?
Under California Business and Professions Code (BPC) section 688(b), a pharmacy must have the capability to receive an electronic data transmission prescription on behalf of a patient from a health care practitioner authorized to issue a prescription pursuant to BPC section 4040.
Reference: BPC 688(a), 688(b), 4040
Revised September 2021
Does BPC section 688(b) apply to both non-controlled and controlled substances?
BPC section 688(b) applies to both non-controlled and controlled substances with regard to a pharmacy’s capability to receive electronic data transmission prescriptions. However, under BPC section 688(c), a prescription for a controlled substance, as defined by BPC 4021, the electronic data transmission prescription must comply with Parts 1300, 1304, 1306, and 1311 of Title 21 of the Code of Federal Regulations (CFR). Note: The Board of Pharmacy recommends practitioners contact their respective regulatory boards for guidance on their requirements for issuing a prescription.
Reference: BPC 688(a) 688(b), 688(c), 4021; 21 CFR 1300, 1304, 1306, 1311
Revised September 2021
May a pharmacy dispense a prescription medication if it receives a prescription that is not transmitted to the pharmacy as an electronic data transmission prescription?
BPC section 688(i) states that a pharmacist who receives a written, oral, or faxed prescription is not required to verify that the prescription properly falls under one of the exceptions in subdivision (e). Pharmacists may continue to dispense medications from legally valid written, oral, or faxed prescriptions pursuant to this division.
Reference: BPC 688(i)
Revised September 2021
Can an unfilled non-controlled electronic data transmission prescription received by a pharmacy be transferred or forwarded to another pharmacy?
BPC section 688(g) states a pharmacy that receives an electronic data transmission prescription from a prescribing health care practitioner who has issued the prescription but has not dispensed the medication to the patient must, at the request of the patient or a person authorized to make a request on behalf of the patient, immediately transfer or forward the electronic data transmission prescription to an alternative pharmacy designated by the requester.
Reference: BPC 688(g)
Revised September 2021
Can an unfilled Schedule II-V controlled substance electronic data transmission prescription received by a pharmacy be transferred or forwarded to another pharmacy?
BPC section 688(g) states a pharmacy that receives an electronic data transmission prescription from a prescribing health care practitioner who has issued the prescription but has not dispensed the medication to the patient must, at the request of the patient or a person authorized to make a request on behalf of the patient, immediately transfer or forward the electronic data transmission prescription to an alternative pharmacy designated by the requester.
Reference: BPC 688(g)
The Board of Pharmacy would strongly encourage licensees to contact their local DEA office for confirmation of DEA’s policy and the federal requirements related to the forwarding of an unfilled controlled substances prescription.
Revised September 2021
What are the record-keeping requirements for a pharmacy that transfers or forwards electronic data transmission prescriptions? What are the record-keeping requirements for a pharmacy that receives a transfer or forward of electronic data transmission prescriptions?
Record-keeping must comply with California Code of Regulations (CCR) section 1717(e) and 21 CFR 1306.25, if applicable
Revised September 2021
If a licensed non-resident pharmacy is located outside of California and services a patient in California, is an electronic data transmission prescription required?
BPC section 688(b) states a pharmacy, pharmacist, or other practitioner authorized under California law to dispense or furnish a prescription pursuant to section 4040 must have the capability to receive an electronic data transmission prescription on behalf of a patient. Depending on the scenario, the pharmacy would not need to question a non-electronic data transmission prescription under BPC section 688(i).
Reference: BPC 688(b), 688(i)
Revised September 2021
How does BPC section 688 apply to out-of-state telemedicine doctors or telephonic/faxed prescriptions from out-of-state?
BPC section 688(a) states a health care practitioner authorized to issue a prescription pursuant to section 4040 must have the capability to issue an electronic data transmission prescription, as defined under section 4040 on behalf of a patient and to transmit that electronic data transmission prescription to a pharmacy selected by the patient. Depending on the scenario, the pharmacy would not need to question a non-electronic data transmission prescription under BPC section 688(i). Note: The Board of Pharmacy recommends practitioners contact their respective regulatory boards for guidance on their requirements for issuing a prescription.
Reference: BPC 688(a), 688(i)
Revised September 2021
BPC section 688(e)(1) contains an exception to the law referencing California Health and Safety Code (HSC) section 11159.2, which discusses controlled substance prescriptions issued to terminally ill patients. Does HSC 11167.5 remain effective for those that practice in the applicable hospice and long-term care settings?
Is there an instance when an electronic data transmission prescription must be printed?
Under certain circumstances as outlined in Health and Safety Code (HSC) section 11167.5, there may be instances where a long-term care or hospice care pharmacy may need to print the electronic transmission prescription. Additionally, BPC section 688(e)(4)(A)(B) references instances when a prescription must be electronically issued but does not require electronic transmission and may be provided directly to the patient. Controlled substance prescriptions provided directly to the patient also must comply with federal law. Depending on the scenario, the pharmacy would not need to question a non-electronic data transmission prescription under BPC section 688(i).
Reference: HSC 11167.5; BPC 688(e)(4)(A)(B), 688(i)
Revised September 2021
Does the hospital retail pharmacy have the option to only receive electronic data transmission prescription from its own hospital health care practitioners, but not from any other health care practitioner?
BPC section 688(a) is inclusive of all health care practitioners authorized to issue a prescription pursuant to BPC section 4040. As indicated in BPC section 688(b), a pharmacy must have the capability to receive an electronic data transmission prescription on behalf of a patient from all types of health care practitioners pursuant to BPC section 4040. BPC section 688(e)(7) provides a potential exemption if the health care practitioner and the dispenser are the same entity.
Reference: BPC 688(a), 688(b), 688(e)(7)
Revised September 2021
Is posting a prescription in a health care provider’s system accessible by pharmacists in their system considered transmission?
Under BPC section 688(e)(7), if the prescribing health care practitioner and dispenser are the same entity, electronic transmission prescriptions are not required. Based on the Board’s understanding of the scenario posed, “posting” of the prescription in an electronic medical record for dispensing by a pharmacy of the same entity meets the intent of California law. Controlled substance prescriptions must also comply with federal law.
Reference: BPC 688(a)(d)(e)(7)
Revised September 2021
Under BPC 688(e)(7), what does “same entity” mean? Same location or just same health care system?
As described in BPC 688(e)(7), “same entity” refers to the same health care system which may or may not be the same physical location.
Reference: BPC 688(e)(7)
Revised September 2021
For prescribers working under exempted medical practices described in BPC 688(e), do they still need to comply with BPC 688(a) and have the capability of issuing and transmitting an electronic data transmission prescription?
BPC section 688(d) would not be applicable to a health care practitioner prescribing a prescription pursuant to subdivision (e). However, the health care practitioner must have the capability to issue and transmit an electronic data transmission prescription as defined under BPC section 4040 and BPC section 688(a). Note: The California State Board of Pharmacy recommends practitioners contact their respective regulatory boards for guidance on their requirements for issuing a prescription.
Reference: BPC 688(a), 688(d), 688(e), 4040
Revised September 2021
Does an e-mail qualify as “an electronic data transmission prescription,” or does the prescription need to come from an electronic prescribing platform?
BPC section 4040(c) describes an “electronic data transmission prescription” as any prescription order other than an electronic image prescription that is electronically transmitted from a licensed prescriber to a pharmacy. An email could potentially qualify as an electronic data transmission prescription for noncontrolled substances; however, this does not appear to meet the spirit of the law. However, under BPC section 688(c), a prescription for a controlled substance as defined by BPC section 4021, the electronic data transmission prescription must comply with Parts 1300, 1304, 1306, and 1311 of Title 21 of the Code of Federal Regulations (CFR).
Note: The Board of Pharmacy recommends practitioners contact their respective regulatory boards for guidance on their requirements for issuing a prescription.
Reference: BPC 4040(c), 4021, 688(c); 21 CFR 1300, 1304, 1306, 1311
Revised September 2021
If after speaking with the prescriber/agent a modification is made, would the electronic data transmission prescription be voided, and does the prescription need to be rewritten as a telephone prescription?
BPC section 688 does not address the modification of an electronic data transmission prescription. For a noncontrolled and Schedule III-V prescription, a pharmacy may reduce the oral prescription to writing as described in BPC section 4070(a) and HSC section 11164(b). Note: DEA registrants also must comply with federal law regarding controlled substances.
Reference: BPC 688, 4070(a); HSC 11164(b)
Revised September 2021
Does a pharmacist have a responsibility to report prescribers who are not complying with BPC section 688?
The law does not require pharmacists to notify the respective regulatory agency of issues of non-compliance, but they may choose to do so.
Reference: BPC 688(j)
Revised September 2021
Do health care practitioners, pharmacists, or pharmacies, when providing health care services to an inmate, individual on parole, or youth under the jurisdiction of the Department of Corrections and Rehabilitation, need to comply with BPC section 688?
BPC section 688(k) indicates this section must not apply in the scenario described. However, if an inmate, individual on parole, or youth is not under the jurisdiction of the Department of Corrections and Rehabilitation, BPC section 688 would apply.
Reference: BPC 688(k)
Revised September 2021
Ask an Inspector
Pharmacist and Technician / Intern Duties and Identification
Does a pharmacist have to perform a final verification by physically inspecting the patient’s medication if it was filled by a pharmacy technician or an intern?
There are multiple provisions of law that address this question, and the answer varies based on various factors. Relevant legal references include:
- With respect to interns, section 1726 of title 16 of the California Code of Regulations states that a pharmacist supervising an intern shall be responsible for all professional activities performed by the intern under his or her supervision.
- With respect to pharmacy technicians, section 1793.7 of title 16 of the California Code of Regulations states that any function performed by a pharmacy technician in connection with dispensing of a prescription, including repackaging from bulk, must be verified and documented in writing by a pharmacist. Except for certain situations outlined in the regulation, the pharmacist shall indicate verification of the prescription by initialing the prescription label before the medication is provided to the patient. (See also Business and Professions Code section 4115.5(b)(3) for similar provisions with respect to pharmacy technician trainees.)
- Pursuant to section 1712 of title 16 of the California Code of Regulations, section 1793.7’s requirement for the pharmacist to initial the prescription label can be satisfied by recording the identity of the reviewing pharmacist in a computer system by a secure means. The computer used to record the reviewing pharmacist's identity shall not permit such a record to be altered after it is made, and the record of the reviewing pharmacist's identity made in the computer system must be immediately retrievable in the pharmacy.
Revised June 2025
What is the pharmacist to intern pharmacist ratio?
Business and Professions Code section 4114(b) provides that a pharmacist may not supervise more than two interns at one time.
Revised June 2025
What is the pharmacist to pharmacy technician ratio in a community pharmacy?
Business and Professions Code section 4115(g) specifies as follows:
- A pharmacy with only one pharmacist shall have no more than one pharmacy technician performing the tasks specified in subdivision (a) of Business and Professions Code section 4115 (i.e., packaging, manipulative, repetitive, or other nondiscretionary tasks).
- A pharmacy with only one pharmacist shall have no more than one pharmacy technician performing the tasks specified in subdivision (b) of Business and Professions Code section 4115 (these include preparation and administration of certain vaccines and/or epinephrine, performing specimen collection for CLIA-waived tests, receiving prescription transfers, and accepting clarification on prescriptions, subject to specified conditions). If a pharmacy technician is performing the tasks specified in subdivision (b), a second pharmacy technician shall be assisting a pharmacist with performing tasks specified in subdivision (a).
- The ratio of pharmacy technicians increases for each additional pharmacist to a ratio not to exceed 2 technicians to 1 pharmacist for pharmacy technicians performing the tasks specified in subdivision (a).
- A pharmacist scheduled to supervise a second pharmacy technician may refuse to supervise a second pharmacy technician if the pharmacist determines, in the exercise of their professional judgment, that permitting the second pharmacy technician to be on duty would interfere with the effective performance of the pharmacist’s responsibilities under Pharmacy Law. (See paragraph (3) of subdivision (g) of Business and Professions Code section 4115 for specific conditions that apply in such situations.)
Revised June 2025
Are technicians and pharmacists required to wear identification?
Yes. According to California Code of Regulations, title 16, section 1793.7(c), a pharmacy technician must wear identification clearly identifying him or her as a pharmacy technician. In addition, Business and Professions Code section 680(a) states, in pertinent part: “Except as otherwise provided in this section, a health care practitioner [which includes a pharmacist; see section 680(c)] shall disclose, while working, his or her name and practitioner's license status, as granted by this state, on a name tag in at least 18-point type. A health care practitioner in a practice or an office, whose license is prominently displayed, may opt to not wear a name tag.”
Example: If your name is John Doe, the following formats are acceptable:
John Doe, RPh
PharmacistJohn Doe
PharmacistJ. Doe
PharmacistJohn D.
PharmacistJohnny
PharmacistJohn
Pharmacist
Revised June 2025
Ask an Inspector
Hypodermic Needles and Syringes (Over-The-Counter Sales)
Is it possible to purchase pen needles over-the-counter in California?
Yes, but with a few restrictions and requirements. Please see Business and Professions Code sections 4144.5, 4145.5, and 4146 for the complete requirements.
A pharmacist or physician MAY (but is not mandated to) furnish hypodermic needles and syringes for human use without a prescription, if the furnisher has previously been provided with a prescription or other proof of legitimate medical need requiring a hypodermic needle or syringe to administer a medicine or treatment.
Additionally, until January 1, 2026, as a public health measure, the pharmacist or physician MAY (but is not mandated to), without a prescription, furnish hypodermic needles and syringes for human use to a person 18 years or older solely for personal use. A pharmacy that furnishes nonprescription hypodermic needles and syringes must counsel the consumer on the safe disposal of syringes or needles and provide the consumer with one or more of the following disposal options:
- Onsite disposal that meets applicable state and federal standards for collection and disposal of medical sharps waste.
- Mail-back sharps containers authorized by the USPS that meet applicable state and federal requirements for the transport of medical sharps waste, with tracking forms to verify destruction at a certified disposal facility.
- A sharps container that meets applicable state and federal standards for collection and disposal of medical sharps waste.
Until January 1, 2026, the pharmacy must also provide written information or verbal counseling to the consumer at the time of furnishing or sale of nonprescription hypodermic needles or syringes on how to (1) access to drug treatment, (2) access testing and treatment for HIV and hepatitis C, and (3) safely dispose of sharps waste.
A pharmacy may accept the return of needles and syringes from the public if contained in a sharps container, as defined in section 117750 of the Health and Safety Code.
Business and Professions Code section 4144.5 allows a pharmacy to sell hypodermic needles and syringes without a prescription for uses that the Board determines are industrial. In addition, Business and Professions Code section 4145.5(c) allows a pharmacist to furnish hypodermic needles and syringes without a prescription for use on animals.
Revised June 2025
Ask an Inspector
Controlled Substances: Prescribing, Filling, and Refilling
Can a Schedule II controlled substance prescription be refilled?
Health & Safety Code section 11200(c) prohibits the refilling of a prescription for a Schedule II controlled substance. (Also see 21 U.S.C. 829(a).) However, pursuant to Business and Professions Code section 4052.10, a pharmacist may partially fill a Schedule II controlled substance prescription as requested by the patient or prescriber. If a pharmacist dispenses a partial fill on a prescription under section 4052.10, the pharmacy must retain the original prescription, with a notation of how much of the prescription has been filled, until the prescription has been fully dispensed. The total quantity dispensed shall not exceed the total quantity prescribed. The full prescription shall be dispensed not more than 30 days after the date on which the prescriptions was written. See Business and Professions Code section 4052.10 for complete requirements regarding partial fills of Schedule II controlled substance prescriptions; see also 21 U.S.C. 829(f) and 21 CFR 1306.13.
Revised June 2025
How long is a controlled substance prescription valid?
Health & Safety Code section 11200(a) specifies that no person shall dispense or refill a controlled substance prescription more than six months after the date thereof. See also Health & Safety Code section 11166, providing: “No person shall fill a prescription for a controlled substance after six months has elapsed from the date written on the prescription by the prescriber.”
Revised June 2025
How many times can a Schedule III or IV controlled substance prescription be filled?
Health & Safety Code section 11200(b) specifies that no prescription for a Schedule III or IV controlled substance may be refilled more than five times. Further, this section also creates a limit of a 120-day total supply for refills of a Schedule III or IV controlled substance prescription.
Example: A prescription is written for temazepam 15mg QHS (a Schedule IV controlled substance), quantity #30 with 5 refills. The prescription is dispensed on 7/1/2016 for a quantity of 30. The pharmacy refills the prescription on 8/1/2016, 9/1/2016, 10/1/2016, and 11/1/2016, a 30-day supply for each refill and a total of a 120-day supply between the four refills. Although the prescriber wrote for 5 refills, the pharmacy cannot dispense the remaining refill because the 120-day limit was reached after dispensing the refill on 11/1/2016. A new prescription is required for any additional dispenses.
Revised June 2025
Where is the law that establishes the requirement for a pharmacist to exercise corresponding responsibility?
Health & Safety Code section 11153(a) states that a prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. Health & Safety Code section 11153(a) further provides that the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. In addition, subdivision (b) of section 1761 of title 16 of the California Code of Regulations states: “Even after conferring with the prescriber, a pharmacist shall not compound or dispense a controlled substance prescription where the pharmacist knows or has objective reason to know that said prescription was not issued for a legitimate medical purpose.”
NOTE: Additional information about corresponding responsibility can be found using the following link - - http://www.pharmacy.ca.gov/publications/corresponding_responsibility.pdf. Information on the Board’s precedential decision on corresponding responsibility can be found at http://www.pharmacy.ca.gov/enforcement/precedential.shtml. The DEA Pharmacist’s Manual, available at https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-046R1)(EODEA154R1)_Pharmacist's_Manual_DEA.pdf, includes an overview of a pharmacist’s duty of corresponding responsibility under federal law.
Revised June 2025
Ask an Inspector
CURES Requirements
Am I required to apply for registration to California’s prescription drug monitoring program, CURES?
Health & Safety Code section 11165.1(a)(1)(A)(ii) requires that a pharmacist shall, upon licensure, submit an application to the California Department of Justice to obtain approval to electronically access the CURES system. The California Department of Justice website to register for CURES is: https://cures.doj.ca.gov/register/pre-registration
Revised June 2025
How often does a pharmacy need to report controlled substances dispensing information to CURES?
Health & Safety Code Section 11165(d) specifies that a dispensing pharmacy must report information to the Department of Justice as soon as reasonably possible, but not more than one working day after the controlled substance is dispensed.
Revised June 2025
Ask an Inspector
Public Resources and Consumer Information
How do I get on the Board’s email distribution list?
You may sign up for the Board’s email distribution list by visiting the following website and signing up: https://www.pharmacy.ca.gov/webapplications/apps/subscribe/index.shtml
Revised June 2025
Where can I find prescription drug take back locations?
Go to the Board’s website, www.pharmacy.ca.gov; click on the “Consumers” menu, then select “Information for Consumers”; and click on “Drug Takeback Search and Information.”
Revised June 2025
Ask an Inspector
Remote Verification and Shared Electronic Files
Can a Board-licensed pharmacy or pharmacist remotely verify medication chart orders?
There are two provisions in the law that allow for remote verification of chart orders.
Business & Professions Code section 4071.1(d)(1) states that a pharmacist located and licensed in California may, on behalf of a health care facility licensed pursuant to Chapter 2 (commencing with section 1250) of Division 2 of the Health and Safety Code, from a location outside of the facility, verify medication chart orders for appropriateness before administration consistent with federal requirements, as established in the health care facility’s policies and procedures.
In addition, a pharmacy can process prescriptions for another pharmacy sharing a common electronic file pursuant to section 1717.1 of title 16 of the California Code of Regulations.
For dangerous drugs other than controlled substances: Two or more pharmacies may establish and use a common electronic file to maintain required dispensing information. Pharmacies using such a common file are not required to transfer prescriptions or information for dispensing purposes between or among pharmacies participating in the same common prescription file.
For controlled substances: To the extent permitted by federal law, two or more pharmacies may establish and use a common electronic file of prescriptions and dispensing information.
(Refer to section 1717.1 of title 16 of the California Code of Regulations for complete requirements.)
Revised June 2025
Ask an Inspector
Medication Guides and Patient Labeling
Can a QR Code be provided to the patient, instead of the medication guide in paper format?
According to FDA’s Patient Labeling Resources for Industry, available at https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/patient-labelingresources#medication-guides (accessed May 21, 2025): The medication guide shall be dispensed to the patient (or to the patient’s agent) in paper form when the product is dispensed; however, the patient may also request electronic delivery of the Medication Guide in lieu of the printed form.
Revised June 2025
Ask an Inspector
Community Pharmacy Staffing Requirements
What are the staffing requirements in a retail chain community pharmacy?
Business and Professions Code section 4113.5(a) states that a community pharmacy shall not require a pharmacist employee to engage in the practice of pharmacy at any time the pharmacy is open to the public, unless either another employee of the pharmacy or, if the pharmacy is located within another establishment, an employee of the establishment within which the pharmacy is located, is made available to assist the pharmacist at all times. See section 1714.3 of title 16 of the California Code of Regulations for additional requirements that apply to community pharmacies that are required to comply with Business and Professions Code section 4113.5.
Business and Professions Code section 4113.6(a) states that a chain community pharmacy subject to Business and Professions Code section 4113.5 shall be staffed at all times with at least one clerk or pharmacy technician fully dedicated to performing pharmacy-related services. Business and Professions Code section 4113.6(a) further states that the Board shall not take action against a pharmacy for violation of Business and Professions Code section 4113.6 if any of the following conditions apply:
- The pharmacist on duty waives the requirement in writing during specified hours based on workload need.
- The pharmacy is open beyond normal business hours, which is before 8:00 a.m. and after 7:00 p.m. During the hours before 8:00 a.m. and after 7:00 p.m., the requirement shall not apply.
- The pharmacy’s prescription volume per day on average is less than 75 prescriptions per day based on the average daily prescription volume for the past calendar year. However, if the pharmacist is also expected to provide additional pharmacy services such as immunizations, tests classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988, or any other ancillary services provided by law, paragraph (3) does not apply.
In addition, per Business and Professions Code section 4113.6(b), where staffing of pharmacist hours within a chain community pharmacy does not overlap sufficiently, scheduled closures for lunch time for all pharmacy staff shall be established and publicly posted and included on the outgoing telephone message.
If you believe a pharmacy is in violation of community pharmacy staffing requirements, you can notify the Board by filing a complaint here. The Board requests the following information be provided:
- Name and license number of pharmacy
- Information about how the pharmacy is non-compliant with staffing requirements.
Revised June 2025
Ask an Inspector
Recordkeeping Requirements
Is a retail pharmacy required to keep the physical prescriptions, or can the prescriptions be scanned and kept electronically?
Business & Professions Code section 4105(a) states all records or other documentation of the acquisition and disposition of dangerous drugs and dangerous devices by any entity licensed by the Board shall be retained on the licensed premises in a readily retrievable form. Business and Professions Code section 4105(d)(1) states any records that are maintained electronically shall be maintained so that the pharmacist-in-charge, or the pharmacist on duty if the pharmacist-in-charge is not on duty, shall, at all times during which the licensed premises are open for business, be able to produce a hardcopy and electronic copy of all records of acquisition or disposition or other drug or dispensing-related records maintained electronically. Business and Professions Code section 4105(c) states that the records required by section 4105 shall be retained on the licensed premises for a period of three years from the date of making.
Revised June 2025
Licensees
Mobile Units
What is the difference between a mobile unit and a mobile pharmacy?
A mobile unit is operated as an extension of a pharmacy license held by the county, city and county, or special hospital authority to provide prescription medication within its jurisdiction to individuals without fixed addresses, individuals living in county-owned or city-and-county-owned or operated housing facilities, and those enrolled in Medi-Cal plans operated by the county or a city and county, a health district, or a joint powers authority pursuant to Chapter 7 (commencing with Section 14000) or Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code.
In contrast, a mobile pharmacy is used temporarily when a pharmacy is destroyed or damaged, and the mobile pharmacy is necessary to protect the health and safety of the public, under specified conditions. The Board must approve the temporary use of a mobile pharmacy and the pharmacy operating the mobile pharmacy must provide the Board with records of the destruction of, or damage to, the pharmacy and an expected restoration date of the permanent pharmacy.
A mobile pharmacy can also be employed during a declared federal, state, or local emergency in order to ensure the continuity of patient care, under specified conditions, including that the mobile pharmacy is located within the declared emergency area or affected areas.
(BPC 4062(c), BPC 4110(c), BPC 4110.5)
Revised January 2024
How many mobile units may a county, city and county, or special hospital authority operate?
A county, city and county, or special hospital authority may operate one or more mobile units. The pharmacist-in-charge shall determine the number of mobile units that are appropriate for a particular pharmacy license.
(BPC 4110.5)
Revised January 2024
What “special hospital authority” can operate a mobile unit?
The special hospital authorities that may operate a mobile unit are the Alameda Health System Hospital Authority described in Chapter 5 (commencing with Section 101850) of Part 4 of Division 101 of the Health and Safety Code, and the Kern County Hospital Authority described in Chapter 5.5 (commencing with Section 101852) of Part 4 of Division 101 of the Health and Safety Code.
(BPC 4110.5, HSC 101850, HSC 101852)
Revised January 2024
How can a county, city and county, or special hospital authority notify the Board of their intent to operate a mobile unit?
A county, city and county, or special hospital authority shall notify the Board of its intention to operate a mobile unit as soon as possible, and no later than five business days after commencing operation of a mobile unit. To assist with notification requirements, the Board has developed a form that can be accessed here.
(BPC 4110.5(f))
Revised January 2024
I am an independent retail pharmacy and would like to service my community by helping the homeless by providing better access in obtaining their medications. Can I operate a mobile unit?
No, only a county, city and county, or special hospital authority described in Chapter 5 (commencing with section 101850) or Chapter 5.5 (commencing with section 101852) of Part 4 of Division 101 of the Health and Safety Code may operate a mobile unit to provide prescription medications.
(BPC 4110.5)
Revised January 2024
Can a clinic licensed by the Board pursuant to BPC 4180 qualify to operate a mobile unit?
No, a mobile unit can only be operated as an extension of a pharmacy license held by a county, city and county, or special hospital authority.
(BPC 4110.5)
Revised January 2024
Our county operates a mobile unit. At the end of the day, can we park the mobile unit in a secured garage located where the pharmacy operating the mobile unit is located? Can we leave the drugs in the mobile unit if the garage has a security gate only accessible with a key fob by authorized personnel, the garage is well lit, and there is a security guard that patrols the area?
No, dangerous drugs must not be left in the mobile unit during the hours that the mobile unit is not in operation. The dangerous drugs must be returned to the licensed pharmacy.
(BPC 4110.5(e))
Revised January 2024
At the end of the operational day, where can the mobile unit be parked?
Pharmacy law does not specify where the mobile unit is required to be parked. However, during the hours that the mobile unit is not in operation, dangerous drugs cannot be left in the mobile unit. Therefore, the Board recommends the mobile unit be parked at or close to the address of the licensed pharmacy since drugs are required to be stored and secured at the licensed pharmacy operating the mobile unit.
(BPC 4110.5, 16 CCR 1714(b) and (d))
Revised January 2024
If a county, city and county, or special hospital authority plans to discontinue the use of a mobile unit, how should the Board be notified?
Notice of intention to discontinue operation of a mobile unit must be given to the Board ,as soon as possible, and at least one business day before discontinuing operation of a mobile unit.-To assist with notification requirements, the Board has development a form that can be accessed here.
(BPC 4110.5(f))
Revised January 2024
Does the mobile unit require the Notice to Consumer poster to be posted in public view?
Yes. The mobile unit operates as an extension of a pharmacy license held by the county, city and county, or special hospital authority. Pharmacy law requires every pharmacy to place the Notice to Consumer poster in a conspicuous place, physically access to a prescription drug consumer, so that the consumer can easily read it. The mobile unit must use the standardized poster provided or made available by the Board, unless the pharmacy has received prior approval of another format or display methodology from the Board. The mobile unit can also display the notice on a video screen located in a place conspicuous to and readable by consumers, subject to specified conditions.
(BPC 4110.5, 16 CCR 1707.6)
Revised January 2024
Is the mobile unit required to have hot and cold running water?
Yes. The mobile unit operates as an extension of a pharmacy license held by the county, city and county, or special hospital authority. Therefore, the mobile unit must be equipped with a sink with hot and cold running water for pharmaceutical purposes.
(BPC 4110.5, 16 CCR 1714(c))
Revised January 2024
Who can possess the keys to the mobile unit?
The mobile unit operates as an extension of a pharmacy license held by the county, city and county, or special hospital authority. When drugs are stored in the mobile unit, the key to the mobile unit is restricted to a pharmacist. The pharmacy owner (the county, city and county, or the special hospital authority) may possess a key to the mobile unit that is maintained in a tamper evident container for the purpose of 1) delivering the key to a pharmacist or 2) providing access in case of emergency, including fire, flood, or earthquake. The signature of the pharmacist-in-charge must be present in such a way that the pharmacist may readily determine whether the key was removed from the container.
(BPC 4110.5, 16 CCR 1714(d) and (e))
Revised January 2024
Can a county pharmacy operate a mobile unit to assist the county’s methadone program to dispense methadone to better serve the homeless population?
No. Methadone is classified as a Schedule II controlled substance and a mobile unit cannot carry or dispense controlled substances, except Schedule III, Schedule IV, or Schedule V controlled substances approved by the United States Food and Drug Administration (FDA) for the treatment of opioid use disorder.
(BPC 4110.5(d), HSC 11055(c)(14))
Revised January 2024
What are the staffing limitations for a mobile unit?
A mobile unit operates as an extension of a pharmacy license held by the county, city and county, or special hospital authority. Therefore, if the pharmacy operating the mobile unit has a community pharmacy license (PHY or PHE) and only one pharmacist, it must have no more than one pharmacy technician performing the tasks specified in BPC 4115(a). The ratio of pharmacy technicians performing the tasks specified in BPC 4115(a) to any additional pharmacist shall not exceed 2:1, except that this ratio shall not apply to personnel performing clerical functions pursuant to BPC 4116 or 4117.
(BPC 4110.5, BPC 4115(f)(1))
Revised January 2024
Can a pharmacist working on a mobile unit provide vaccine administration?
Yes. In addition to dispensing prescriptions, the pharmacist may perform activities consistent with Article 3 (commencing with section 4050) of the Business and Professions Code.
(BPC 4110.5(b), BPC 4050-4068)
Revised January 2024
During the temporary absence of a pharmacist for their duty free breaks and meal periods, can the pharmacist leave the mobile unit, leaving ancillary staff in the mobile unit?
The decision to keep the mobile unit open during the temporary absence of the pharmacist for their duty fee breaks and meal periods resides with the pharmacist working in the mobile unit. The pharmacist may leave the mobile unit temporarily for breaks and meal periods without closing the mobile unit and removing ancillary staff if the pharmacist reasonably believes that the security of the dangerous drugs and devices will be maintained in the pharmacist’s absence.
If the mobile unit remains open during any temporary absence of the pharmacist, no prescription medications may be provided to a patient or patient’s agent unless the prescription medication is a refill medication that the pharmacist has checked, released for furnishing to the patient and was determined not to require the consultation of a pharmacist.
During the temporary absence of the pharmacist, an intern pharmacist may not perform any discretionary duties nor otherwise act as a pharmacist. However, the intern pharmacist may perform non-discretionary tasks. Other ancillary staff may also continue to perform the non-discretionary duties authorized to them by Pharmacy Law.
(BPC 4110.5(a), 16 CCR 1714.1, 16 CCR 1793.2)
Revised January 2024
Our mobile unit has very limited storage space. Where can a mobile unit store its records?
All records required by BPC 4081 and 4105 may be temporarily stored in the mobile unit while it is in operation. At the end of the day, when the mobile unit is not in operation, all records required by BPC 4081 and 4105 must be transferred and maintained on the licensed pharmacy premises that is operating the mobile unit.
(BPC 4110.5, BPC 4081, BPC 4105)
Revised January 2024
Are the prescription labels dispensed by the mobile unit required to have patient-centered labeling?
Yes, all prescription medication dispensed by the mobile unit must comply with all labeling requirements applicable to a California licensed pharmacy, including all the requirements for patient-centered labeling.
(BPC 4076, BPC 4076.5, 16 CCR 1707.5)
Revised January 2024
Are pharmacists required to provide consultation for new prescriptions dispensed from the mobile unit?
Yes. The mobile unit is an extension of a pharmacy license held by a county, city and county, or special hospital authority. Therefore, the duty to consult applies to pharmacists working in mobile units in the same manner as it applies to pharmacists working in any other pharmacy.
(BPC 4110.5, 16 CCR 1707.2)
Revised January 2024
If a physician is practicing in the mobile unit, writes a new prescription for the patient and consults the patient on how to take the new medication, is the pharmacist also required to provide consultation to the patient when the mobile unit dispenses the new prescription to the patient?
Yes, the pharmacist is still responsible to provide patient consultation pursuant to 16 CCR 1707.2.
(BPC 4110.5, 16 CCR 1707.2)
Revised January 2024
Does a Board inspector have the authority to inspect a mobile unit?
Yes. Inspectors employed by the Board (or by the Division of Investigation of the Department of Consumer Affairs) may inspect during business hours all pharmacies or places where drugs or devices are compounded, prepared, furnished, dispensed, or stored.
(BPC 4008)
Revised January 2024
When the mobile unit is in use, what operational standards and security measures apply to the mobile unit?
The mobile unit is operated as an extension of a pharmacy license held by the county, city and county, or special hospital authority. Therefore, the mobile unit is required to maintain its facilities, space, fixtures, and equipment so that drugs are safely and properly prepared, maintained, secured, and distributed. Further, the mobile unit and fixtures and equipment must be maintained in a clean and orderly condition, and the mobile unit must be dry, well-ventilated, free from rodents and insects, and properly lighted.
Each pharmacist while on duty in the mobile unit is responsible for the security of prescription drugs in the mobile unit, including provisions for effective control against theft or diversion of dangerous drugs and devices, and records for such drugs and devices.
(16 CCR 1714)
Revised January 2024
Can the mobile unit carry and dispense controlled substances?
Mobile units can only carry and dispense Schedule III, Schedule IV, or Schedule V controlled substances approved by the FDA for the treatment of opioid use disorder.
(BPC 4110.5(d))
Revised January 2024
How much buprenorphine, a Schedule III controlled substance approved by the FDA for the treatment of opioid use disorder, can be carried and stored on the mobile unit?
Any Schedule III, Schedule IV, or Schedule V controlled substance approved by the FDA for the treatment of opioid use disorder shall be carried in reasonable quantities based on prescription volume and stored securely in the mobile pharmacy unit.
(BPC 4110.5(d)(2))
Revised January 2024
Can the mobile unit carry and dispense naltrexone?
Yes. Naltrexone is not a federally scheduled controlled substance. Currently, there is no prohibition, against a mobile unit carrying or dispensing this drug.
(BPC 4110.5)
Revised January 2024
Does the mobile unit have to report the controlled substances dispensed for the treatment of opioid use disorder to CURES?
Yes.
(HSC 11165 (d))
Revised January 2024
Licensees
Patient Specific Prescriptions Dispensed by a California Licensed Outsourcing Facility within or into California
A statute effective January 1, 2022, allows for California licensed outsourcing facilities to dispense patient specific prescriptions. To qualify, an outsourcing facility must: 1) be licensed with the federal Food and Drug Administration as an outsourcing facility; 2) be licensed with the Board of Pharmacy in the State of California as a resident or nonresident outsourcing facility; and 3) comply with same requirements of a pharmacy when dispensing patient-specific prescriptions. The purpose of these FAQs is to generally describe the requirements under California law governing patient-specific dispensing by licensed outsourcing facilities. For a full understanding of the requirements, please read the cited sections of California Pharmacy Law.
A California licensed outsourcing facility, when dispensing patient-specific prescriptions in or into California, will need to comply with California law governing the dispensing of patientspecific prescriptions that a pharmacy would have to comply with including, but not limited to, the duty to provide consultation, requirements regarding prior review of drug therapy and labeling of prescriptions and other miscellaneous requirements.
References to BPC refers to California’s Business and Professions Code, references to HSC refers to California’s Health and Safety Code, references to CCR refers to sections of Title 16 of the California Code of Regulations, and references to CFR refers to sections of Title 21 of the Code of Federal Regulations. Additionally, the provisions of law can be found on the Board’s website.
Is patient consultation required?
Yes, under specified conditions including:
- upon request;
- whenever the pharmacist deems it warranted in the exercise of their professional judgment;
- whenever the prescription drug has not previously been dispensed to a patient;
- whenever a prescription drug not previously dispensed to a patient in the same dosage form, strength or with the same written directions, is dispensed.
Note: The pharmacist must review a patient’s drug therapy and medication record prior to consultation. Further, consultation must be performed in a manner suitable for patient confidentiality (Civil Code 56.10, CCR 1714(a), 1764)).
Reference: CCR sections 1707.2 & 1707.3
Revised January 2022
What is the required information on the prescription document?
BPC sections 4040 and 4070 detail the required information on the prescription.
Revised January 2022
How can I receive a prescription?
- Effective January 1, 2022, most prescriptions must be sent and received electronically subject to certain exemptions. The Board has FAQs available that provide further information on those requirements.
- Prescriptions that are orally transmitted can only be received and reduced to writing by a pharmacist or a pharmacist intern, working under the direct supervision of a pharmacist.
- A faxed or electronically submitted prescription must be received only from a prescriber’s office unless otherwise provided in the law.
Note: Records must include identification of the pharmacist and be retained for a period of three years.
Reference: BPC 688, 4040, 4070, 4071 and CCR 1712, 1717
Revised January 2022
Can we accept written prescriptions for a controlled substance for a California patient?
Yes, under specified conditions. The prescriptions must be comply with Division 10, Chapter 4 of the HSC. [Add link]. Prescriptions must be on forms with certain security features as specified in this chapter. Also, California law imposes a duty of corresponding responsibility on pharmacists who dispense a controlled substance that it is issued for a legitimate medical purpose.
Note: Controlled substances prescriptions are valid for a limited period of time and have additional requirements if e-prescribed.
Reference: HSC sections 11153, 11159.2, 11159.3, 11162.1, HSC 11164(a), 11166, 21 CFR 1306.08, 1306.11, 1311.100
Revised January 2022
Do we have to follow California requirements for the prescription label?
Yes. Requirements for prescription labeling are established in provisions of state and federal law described below.
- The prescription label must contain all the required information established in BPC section 4076, the prescription label must be formatted in accordance with patientcentered labeling requirements. Also, the expiration date of a drug’s effectiveness must be accurately identified on the label. (Reference: BPC 4076 and CCR 1707.5.)
- The trade name or generic name and manufacturer of the prescription drug must be accurately identified on the label and prescription record and includes the statement “generic for _____” where the brand name is inserted, and the name of the manufacturer. In the professional judgment of the pharmacist, if the brand name is no longer widely used, the label may list only the generic name of the drug and the manufacturer’s name may be listed outside the patient-centered area. (Reference: BPC 4076, CCR 1717[b][2], CCR 1707.5[a][1][B])
- The federal warning label prohibiting transfer of controlled substances must be on the prescription container. (Reference: 21 CFR section 290.5)
- If the prescription is filled by a pharmacy technician or a pharmacy technician trainee, before dispensing, the prescription must be checked for accuracy by a pharmacist and that pharmacist must initials the prescription label or records by their identity as the reviewing pharmacist in a computer system by a secure means. (Reference: BPC 4115, 4115.5, CCR 1793.7, CCR 1712)
- Prescriptions must be dispensed in a new and child-resistant container, or senior-adult ease-of-opening tested container, or in a non-complying package only pursuant to the prescriber or when requested by the purchaser. (Reference: 15 USC section 1473[b], 16 CFR section 1700.15, CCR section 1717)
- The label must include a physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules. (Reference: BPC 4076)
(BPC 4110.5)
Revised January 2022
Are there are other requirements for patient specific prescriptions?
Yes
- Patient package inserts must be dispensed with all estrogen medications. (Reference: 21 CFR section 310.515)
- The pharmacy must provide patients with Black Box Warning Information in conformance with 21 CFR section 201.57[c].
- Medication guides must be provided on required medications. (Reference: 21 CFR, Part 208, Section 208.24[e])
- The drug container must contain a written label indicating that the drug may impair a person’s ability to operate a vehicle or vessel. The label may be printed on an auxiliary label affixed to the prescription container. (Reference: BPC 4074, 4076.7, and CCR 1744)
- The written label on the drug container must alert the patient about possible potentiating effects when taken in combination with alcohol. The label may be printed on an auxiliary label affixed to the prescription container. (Reference: BPC 4074, CCR 1744)
- Whenever an opioid prescription drug is dispensed to patient for outpatient use, the label or container must contain a flag or other notification on the container, with a notice that states, “Caution: Opioid. Risk of overdose and addiction.” (Reference: BPC 4076.7)
- No drug preparation may be compounded prior to receipt by the outsourcing facility of a valid prescription for an individual patient where the prescriber has approved use of a compounded drug preparation either orally or in writing. Where approval is given orally by the prescriber, that approval shall be noted on the prescription prior to compounding. There are two exceptions to this prohibition of prior compounding of a drug preparation of: 1) a limited quantity to ensure continuity of care for an identified population of patients of the outsourcing facility based on a documented history of prescriptions for that patient population; and 2) a reasonable quantity that may be compounded for prescriber office use as authorized by BPC section 4052(a)(1). (Reference: CCR 1735.2).
Revised January 2022
Is there a limit on the days’ supply or quantity of a non-controlled medication we can send pursuant to a patient specific prescription?
No, generally prescriptions for non-controlled substances can be filled for more than the prescription allows; however, there are several exceptions. Please see the referenced law section for more information about the specific provisions conditions.
Reference: BPC 4064.5
Revised January 2022
Is there a limit on the day’s supply or quantity that can be dispensed for a controlled substance?
Yes, there are limits. Requirements vary based on the schedule.
Reference: HSC 11200
Revised January 2022
We have an auto ship option; can we use this for patient specific prescriptions?
- Refill authorization from the prescriber must be obtained before refilling a prescription (BPC section 4063) and refills must be documented. (Reference: CCR 1717).
- Refills for Schedule II controlled substances are prohibited. (Reference: HSC 11200)
- Refills for Schedule III and IV controlled substance prescriptions are limited to a maximum of 5 times within 6 months, and all refills taken together may not exceed a 120-day supply. (Reference: HSC 11200)
Note: Effective July 1, 2022, Board regulations established parameters for automatic refill programs generally related to obtaining informed patient consent to enroll in such programs and how to withdraw from such programs.
Revised January 2022
Are there required actions that must be done in the event of a medication error?
Yes, a quality assurance process is necessary to meet the requirements of California Law.
Reference: BPC 4125, CCR 1711
Revised January 2022
Is there a requirement to exercise corresponding responsibility before dispensing a controlled substance?
Yes, a pharmacist must fulfill their corresponding responsibility.
Note: The Board has issued a precedential decision on this point, the Pacifica Pharmacy matter, which can be found on the Board’s website in addition to educational information and a video on corresponding responsibility.
Reference: HSC 11153, CCR 1761
Revised January 2022
Do we need to report our controlled substance prescription dispensing to the California Department of Justice?
Yes, schedule II-V controlled substances must be reported to the CURES system.
Note: The Board has information on the CURES system on its website, including how to register for access to the CURES system.
Reference: HSC 11165, 21 CFR 1308.12, 1308.13, 1308.14, 11308.15
Revised January 2022
Can we advertise our products directly to consumers?
Yes. There is no express prohibition against advertising per se. See Business and Professions Code section 17500.1. However, false and misleading advertising by any licensee of the Board could constitute violations of BPC sections 17500, 651 and 4301. Also, California law regulates different arrangements including rebates and referrals and you should consult California law, including but not limited to, BPC sections 650 through 657 in structuring arrangements to ensure compliance with California law.
Reference: BPC 650, 4301, 17500 and CCR 1766
Revised January 2022
Is there any other information guides to assist us with the requirements under California law?
Yes. The Board of Pharmacy has adopted self-assessment forms to assist pharmacists in maintaining compliance with Pharmacy Law. Review of the form may provide additional information and guidance on requirements for dispensing prescriptions to California patients.
Revised January 2022
Licensees
License Renewal Applications: Reporting Criminal Convictions/Disciplinary Action
I have a criminal conviction. Do I have to report it on my renewal application?
Yes, if it occurred during your last renewal. For the purposes of completing the renewal application, a criminal conviction means a plea or verdict of guilty or a conviction following a plea of nolo contendere. This includes misdemeanors and felonies.
Do I have to report a criminal conviction that occurred outside of California?
Yes. Criminal convictions in another state or in United States District Court must be reported if they occurred during your last renewal period.
My criminal conviction did not involve drugs or alcohol. Do I still have to report it on my renewal?
Yes.
What documents should I provide if I report a criminal conviction on my renewal application?
A written statement, arrest report, court documents, and proof of compliance with courtordered probation.
Do I have to report a citation issued for a traffic infraction?
Traffic infractions not involving alcohol, dangerous drugs, or controlled substances do not need to be reported.
I have a criminal conviction. The Board of Pharmacy is already aware of the conviction and issued a citation and fine or Letter of Admonishment. Do I still have to report the conviction on my renewal application?
Yes. If you renew by mail, please provide a copy of the citation/fine letter or Letter of Admonishment in addition to the renewal application. If you no longer have this documentation, please provide a written statement including the conviction date, court location, and conviction charges.
I reported a criminal conviction and provided supporting documents with my renewal application. Then I received a letter from the Department of Consumer Affairs requesting the same documentation. Do I have to provide the documentation twice?
The Department of Consumer Affairs automatically sends a letter to licensees who mark ”Yes” to the criminal conviction question on their online renewal application. You may disregard this notice if you have already provided the requested documents to the board.
I have a pending criminal conviction case. Do I have to report it to the board on my renewal application?
No. You may voluntarily report this information to the board, but it is not required. Please contact enfappreview@dca.ca.gov if you have further questions.
My driver’s license was suspended. Is this considered formal discipline against a license?
No. Suspension against a driver’s license does not need to be reported on a renewal application.
Why do I have to provide documentation for a criminal conviction?
The California Board of Pharmacy is a consumer protection agency that is mandated to conduct investigations on all licensees with criminal history pursuant to Business and Professions Code section 4301.
What does the board define as “formal disciplinary action”?
For the purposes of a renewal application, “formal disciplinary action” means an adverse action that resulted in a restriction or penalty being placed on the license, such as revocation, suspension, probation or public reprimand or reproval.
My license was formally disciplined by the California State Board of Pharmacy. Do I have to report this on my renewal?
Yes. If your license was placed on probation or issued a letter of public reprimand or reproval, please provide your administrative case number along with your renewal application.
I was issued a citation and fine by the California State Board of Pharmacy for a non-criminal conviction related issue. Do I have to report this on my renewal?
No. If the citation and fine was issued for a non-criminal matter, it does not need to be reported on the renewal application.
Another state board of pharmacy took action against a license I have in another state. Do I have to report this on my renewal application?
If formal disciplinary action was taken against your professional license in another state, it must be reported on your renewal application.
What documents should I provide if I need to report discipline by another state or federal agency on my renewal application?
Please provide the charging document (ex: Accusation, Complaint, etc.) and any final documents showing the case outcome (ex: Settlement Agreement, Consent Order, etc.).
Who can I contact if I have questions about my renewal application?
For questions regarding reporting criminal convictions or formal disciplinary action on a renewal application, please contact enfappreview@dca.ca.gov. For general questions regarding renewals, please contact renewalstatus@dca.ca.gov.
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