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California State Board of Pharmacy

All Pharmacy Law Waivers

In light of Governor Gavin Newsom’s declaration of emergency and the national declaration of emergency, and consistent with Business and Professions Code (BPC) section 4062, the California State Board of Pharmacy (Board) or the Board president through delegated authority has issued the following waivers.

The Board will make every effort to send a notice via a subscriber alert when the declaration of emergency has been lifted to signal the expiration of any waivers. The Board urges interested parties to sign up to receive subscriber alerts for the most up-to-date information.

Pharmacist Direct Supervision of Interns - Business and Professions Code section 4114

Waiver of the provision of Business and Professions Code section 4114(a) to allow for general supervision of an intern pharmacist at the discretion of the supervising pharmacist under the following conditions:

Effective: April 21, 2020

Expires: July 19, 2020

Reassessment/Revalidation/Re-evaluation Requirements for Sterile Compounding Staff Competencies – Title 16, California Code of Regulations, sections 1751.6(e)(2) and 1751.7(b) and (d)

This waiver extends the reassessment, revalidation, or re-evaluation requirements in Title 16 CCR sections 1751.6(e)(2) and 1751.7(b) and (d) for up to an additional 90 days with respect to semi-annual and annual reassessment, revalidation, or re-evaluation requirements for individuals involved in sterile compounding under the following conditions:

  1. The pharmacist-in-charge makes a determination that such a suspension in the reassessment, revalidation, or re-evaluation frequency is necessary and appropriate, balancing site-specific limitations and current staff competencies.
  2. The pharmacist-in-charge ensures only properly trained persons are allowed to perform compounding.
  3. Documentation is maintained identifying when reassessments, revalidations, or re-evaluations pursuant to this waiver were extended for each staff member involved in sterile compounding. Such documentation must be maintained for three years from the date of making.

Effective: April 15, 2020

Expires: July 13, 2020

Prelicensure Inspection at Proposed Location of an Automated Drug Delivery System (ADDS) - Business and Professions Code sections 4119.11(a)(9) and BPC 4427.2(e)

A California licensed pharmacy applying for an ADDS license for a proposed location or relocation of an ADDS will not be subject to the required prelicensure inspection at the proposed location provided the pharmacy submits the following:

  1. A description of the proposed ADDS location with pictures, video and/or a floor plan with the surrounding areas labeled and how the ADDS is secured.
  2. A copy of the pharmacy’s policies and procedures to operate the ADDS regarding security, safety, accuracy, accountability, patient confidentiality, maintenance, maintaining the quality, potency and purity of the dangerous drugs and devices, restocking, record keeping and quality assurance.
  3. Proof of training or plans for training pharmacy staff and personnel at the pharmacy applying for the proposed ADDS location on the policies and procedures.
  4. A statement that a copy of the policies and procedures will be maintained as required by BPC section 4427.3(c).

If the ADDS is an Automated Patient Dispensing System (APDS), the pharmacy must also provide the following with its application (see BCP section 4427.6):

  1. Policies and procedures that include all of the following: criteria used to determine which drugs are placed in the APDS; methods of ensuring patients are aware that consultation is available; a description of assignments of responsibility; training on using the APDS; plans for orienting participating patients; plans for ensuring delivery of drugs when the APDS is disabled or malfunctioning; and plans for handling of complaints, errors, omissions and other incidents with the use of the APDS.
  2. A statement explaining how a written consent from participating patients is obtained and what means are used to identify the patient or patient’s agent before releasing the drug.
  3. A statement confirming the APDS has a two-way audio and video for consultation; records are maintained for all transactions; child resistant containers are used; drug warning labels are used for drugs causing risk of overdose, addiction, impairment while operating a vehicle, and risk if alcohol is consumed; a sign is prominently posted on the APDS with the pharmacy’s name, address and phone number; the prescription label meets the patient-centered labeling requirements; and translation and interpretive services are available.

Effective: April 13, 2020

Expiration: July 11, 2020

Certification in Basic Life Support - Business and Professions Code section 4052.8(b)(2)

Waiver of Business and Professions Code section 4052.8(b)(2), requiring certification in basic life support (BLS) in order to initiate and administer immunizations, under the following conditions:

  1. The pharmacist held a BLS certification that expired on or after March 15, 2020.

Effective:  April 6, 2020

Expiration:  July 4, 2020

Restoration of Retired or Canceled Pharmacist License – BPC section 4200.5(d), Related to Retired Licensees; BPC section 4402(b), Related to Canceled Pharmacist Licenses; and BPC section 4403, Related to Payment of Fees for Reissuance or Renewal of License

To allow for the restoration of a previously retired or canceled pharmacist license for a maximum of six months or until the declaration of emergency is lifted, whichever is sooner, the Board waives the provisions of Business and Professions Code sections 4200.5(d), 4402(b), and 4403 under the following conditions:

  1. At the time of cancellation or transition to a retired status, the license was not subject to any disciplinary conditions or subject to any disciplinary proceeding.
  2. The license has been in such a status no longer than five years.
  3. The individual applies for restoration by completing the required form Application to Restore Your License located on the Board’s website under “COVID-19 Information.”

Upon processing of the application for restoring the license, the individual will receive email notification from the Board.

Effective: April 3, 2020

Expiration: July 1, 2020

Use of Sterile Disinfectant Agents – Title 16, California Code of Regulations, section 1751.4(d)(1)

Waiver of Title 16, California Code of Regulations, section 1751.4(d)(1) to allow for the use of a non-sterile alcohol-based disinfectant after cleaning on work table surfaces, carts, and counters under the following conditions:

  1. The pharmacist-in-charge has made a determination that the current and potential stock of sterile alcohol (sIPA) on hand is insufficient to maintain the requirements established in the regulation.
  2. The surface or equipment is NOT contained within an ISO Class 5 environment.
  3. Surface sampling schedule is reviewed for the possible need to increase the frequency of cleaning and disinfection.
  4. Documentation indicating the duration of time the pharmacy is operating under this waiver is maintained.

Effective: April 3, 2020

Expiration: July 1, 2020

Duty to Consult (Title 16, California Code of Regulations, section 1707.2(a))

If the pharmacist-in-charge makes the determination that oral consultation, as required under Title 16, California Code of Regulations, section 1707.2(a), places the public and/or personnel at risk for exposure to COVID-19, in-person oral consultation may be waived under the following conditions: 

  1. The patient or patient’s agent receives a verbal and prominently written notice of his or her right to request consultation by telephone.
  2. The written notice includes the telephone number to call and the hours of availability during which the patient may obtain oral consultation from a pharmacist who has ready access to the patient’s records.
  3. A pharmacist is readily available to speak to the patient or patient’s agent during any regular hours of operation, unless additional hours of availability are provided and a return call is scheduled to occur within that time in the same business day, if acceptable to the patient. The pharmacist must make two good faith attempts to contact the patient by telephone and document the attempts or consultation. Documentation shall include the name of patient or prescription number, date, time and identification of pharmacist who provided consultation.
  4. A pharmacist may provide oral consultation to the patient or patient’s agent prior to the sale or delivery of a prescription.
  5. The pharmacy has policies and procedures in place to ensure compliance with the requirements of this waiver prior to implementation. 
  6. A pharmacist may consult with patients or patients’ agents using telephone, video chat or other method as acceptable to the patient.
  7. If a pharmacist deems consultation is warranted in the exercise of his or her professional judgment or if there is an adverse drug therapy warning deemed necessary after the review as required by Title 16, California Code of Regulations, section 1707.3, consultation must occur prior to the patient or the patient’s agent receiving the prescription.
  8. Documentation required by this waiver shall be maintained and readily retrievable for one year following the end of the declared emergency.

Effective: April 1, 2020

Expiration: July 1, 2020

Use of PPE in Certain Compounding Aseptic Isolators or Compounding Aseptic Containment Isolators (Title 16, California Code of Regulations, section 1751.5)

Provisions of Title 16, California Code of Regulations, section 1751.5(a)(1)-(3) related to the requirement to don PPE garb (including masks, gowns, head, and shoe covers) when compounding in a compounding aseptic isolator or compounding aseptic containment isolator May be waived under the following conditions:

  1. The pharmacist-in-charge has made a determination that the current and potential stock of PPE on hand is insufficient to maintain garbing requirements established in the regulation.
  2. The isolator manufacturer has provided written documentation based on validated environmental testing that any component(s) of PPE or personnel cleansing are not required. This documentation must be readily retrievable by the licensed location.
  3. A policy is developed that details the revised conditions for use of PPE for compounding pursuant to this waiver.
  4. Applicable pharmacy staff are trained on the policy and the training is documented prior to implementation.
  5. Master formulas are evaluated to determine if changes are necessary to the criteria for establishing beyond-use dating.
  6. Surface sampling schedule will be reviewed for the possible need to increase the frequency.
  7. Documentation indicating the duration of time the pharmacy is operating under the waiver approval is maintained.

Note:  This waiver not does extend to the requirements for the use of sterile gloves.

Effective: April 1, 2020

Expiration: July 1, 2020

Inventory Reconciliation Report of Controlled Substances (Title 16, California Code of Regulations, section 1715.65(c))

A pharmacy or clinic must complete the required inventory reconciliation report specified in Title 16, California Code of Regulations, section 1715.65(c) at least once every six months rather than every three months if determined to be necessary by the pharmacist-in-charge or professional director to ensure continuity of direct patient care activities that would otherwise be impacted.

Effective:  March 24, 2020

Expiration:  June 22, 2020

Sterile Compounding Renewal Requirements for Facilities Located Within a Hospital (BPC sections 4127.1(c) & (d) and 4127.15(b))

A sterile compounding pharmacy whose license expires on or before July 1, 2020, may have its license renewed without being subject to the renewal requirements in BPC sections 4127.1(c) and (d) and 4127.15(b) under the following conditions:

  1. The sterile compounding facility is located within a hospital or satellite location regulated by the California Department of Public Health and issued a General Acute Care Hospital License.
  2. The compounding facility complies with all other provisions of Pharmacy Law as applicable, unless otherwise waived by the Board during this declared emergency.

Effective: March 21, 2020, modified March 27, 2020

Prohibited Acts involving Dangerous Drugs or Devices (BPC sections 4169(a)(1) and 4161(b))

A California-licensed pharmacy may receive dangerous drugs and dangerous devices from an unlicensed pharmacy, wholesaler, or third-party logistics provider located in another state to alleviate a temporary shortage of a dangerous drug or device that could result in the denial of health care under the following conditions:

  1. The unlicensed location is appropriately licensed in its home state, and documentation of the license verification is maintained by the California pharmacy.
  2. The pharmacy maintains documentation of the temporary shortage of any dangerous drug or device received from any pharmacy, wholesaler, or third-party logistics provider not licensed in California.
  3. The pharmacy complies with all record-keeping requirements for each dangerous drug and device received from any pharmacy, wholesaler, or third-party logistics provider not licensed in California.
  4. All documentation and records required above shall be maintained and readily retrievable for three years following the end of the declared emergency.
  5. The dangerous drug or device was produced by an authorized FDA registered drug manufacturer.

Effective:  March 21, 2020

Expiration:  July 24, 2020, or until the emergency declaration is lifted, whichever is sooner.

Staffing Ratio of Pharmacists to Intern Pharmacists (BPC section 4114(b))

The ratio of pharmacists to intern pharmacists may increase to allow for one additional pharmacy intern for each supervising pharmacist under the following conditions:

  1. The pharmacy documents the need for the ratio modification due to the COVID-19 public health emergency. Examples of documentation may include, but are not limited to, an increased prescription volume or limitation on staff availability because of quarantine.
  2. The additional intern pharmacist meets one of the following criteria:
    1. Enrolled in a recognized school of pharmacy with an anticipated graduation date in 2020; or
    2. Graduated from a recognized school of pharmacy; or
    3. Is certified by the Foreign Pharmacy Graduate Equivalency Committee.
  3. The pharmacy maintains a readily retrievable record documenting the date(s) and time(s) when the ratio is increased pursuant to this waiver, the staff operating under the waiver, and justification of the need. Records must be maintained for one year following the end of the declared emergency.

Effective:  March 20, 2020

Expiration:  June 24, 2020, or until the emergency declaration is lifted, whichever is sooner.

Staffing Ratio of Pharmacists to Pharmacy Technicians (BPC sections 4115(f)(1) and 4127.15(c)(2); and Title 16, California Code of Regulations, section 1793.7)

The ratio of pharmacists to pharmacy technicians may increase to allow for one additional pharmacy technician for each supervising pharmacist under the following conditions:

  1. The pharmacy documents the need for the ratio modification due to the COVID-19 public health emergency. Examples of documentation may include, but are not limited to, an increased prescription volume, limitation on staff availability because of quarantine.
  2. The supervising pharmacist, exercising their professional judgment, may refuse to supervise the additional pharmacy technician and provide the pharmacist-in-charge of their determination. When making such a determination, the supervising pharmacist must specify the circumstances of concern with respect to the pharmacy and patient care implications. Under such circumstances, the ratio may not increase.

The pharmacy must maintain a readily retrievable record, documenting the date(s) and time(s) when the ratio is increased pursuant to this waiver and the staff operating under the waiver, and justification of the need. Records must be maintained for one year following the end of the declared emergency.

Effective:  March 19, 2020

Expiration:  June 24, 2020, or until the emergency declaration is lifted, whichever is sooner.

Remote Processing (BPC section 4071.1(a))

For the purposes of this waiver, "remote processing" means the entering of an order or prescription into a computer from outside of the pharmacy or hospital for a licensed pharmacy as defined in Business and Professions Code (BPC) sections 4029 and 4037.

In addition to the provisions of BPC section 4071.1(a), pharmacists performing remote processing may also receive, interpret, evaluate, clarify, and approve medication orders and prescriptions, including medication orders and prescriptions for controlled substances classified in Schedule II, III, IV or V. Under this waiver, remote processing may also include order entry, other data entry, performing prospective drug utilization review, interpreting clinical data, insurance processing, performing therapeutic interventions, providing drug information services, and authorizing release of medication for administration. The waiver does not include the dispensing of a drug or final product verification by remote processing.

Further, this waiver expands the provisions of BPC section 4071.1(a) to allow for remote processing by pharmacy technicians and pharmacy interns to include nondiscretionary tasks, including prescription or order entry, other data entry, and insurance processing of prescriptions and medication orders for which supervision by a pharmacist is provided using remote supervision via technology that, at a minimum, ensures a pharmacist is (1) readily available to answer questions of a pharmacy intern or pharmacy technician; and (2) verify the work performed by the pharmacy intern or pharmacy technician.

Pharmacy and Pharmacist Remote Processing Waiver Conditions

Pharmacists are permitted to conduct remote processing as permitted by this waiver if in compliance with the following:

Pharmacy Intern and Pharmacy Technician Remote Processing Waiver Conditions

Pharmacy interns and pharmacy technicians are permitted to conduct nondiscretionary tasks related to remote processing as permitted by the waiver if in compliance with the following:

Effective:  March 18, 2020

Expiration:  June 24, 2020, or until the emergency declaration is lifted, whichever is sooner.

Signature Requirement for Receipt of Delivery of Drugs (BPC section 4059.5)

Waive the signature requirement for the receipt of the delivery of drugs as required in BPC 4059.5 under the following conditions:

Note: This waiver applies only to the signature requirement for the pharmacist accepting delivery.

Effective:  March 17, 2020

Expiration:  June 24, 2020, or until the emergency declaration is lifted, whichever is sooner.

Prescriber Dispensing Medication to Emergency Room Patient (BPC sections 4068(a)(1), 4068(a)(5), and 4068(a)(6))

Waive provisions related to the prohibition against a prescriber to dispensing medications to an emergency room patient if the medication dispensed is a short-acting, beta-agonist inhalation product.

Effective:  March 27, 2020

Expiration:  June 24, 2020, or until the emergency declaration is lifted, whichever is sooner.

Requirement for Consulting Pharmacist to Make Quarterly Visits to Clinic (BPC sections 4182(a) & (b)/BPC 4192(a) & (b))

Waive the requirement for a consulting pharmacist to perform quarterly visits to a clinic under the following conditions:

Effective:  March 17, 2020

Expiration:  June 24, 2020, or until the emergency declaration is lifted, whichever is sooner.

USP <797> Requirements Related to Use of Personal Protective Equipment (BPC section 4126.8)

Waive USP <797> requirements related to the use of personal protective equipment (PPE) as related to Business and Professions Code section 4126.8, in that a PPE mask and gown may be reused by staff performing sterile compounding under the following conditions:

Effective:  March 17, 2020

Expiration:  July 24, 2020

Use of Alcohol Sanitizer before Donning Sterile Gloves (Title 16, California Code of Regulations, section 1751.5(a)(5))

Waive Title 16, California Code of Regulations, section 1751.5(a)(5) to allow for hand cleaning with the use of non-persistent activity alcohol sanitizer prior to donning sterile gloves.

Effective:  March 17, 2020

Expiration:  July 24, 2020

Intern Pharmacist Licenses (BPC section 4208)

The Board will automatically extend any intern pharmacist license with an expiration date on or before July 1, 2020, for an additional six months, if the intern pharmacist license is current and in good standing.

To verify your intern pharmacist license is extended, please visit the Board’s website at www.pharmacy.ca.gov and select License Search under “Quick Hits” on the homepage.