COVID-19 – FREQUENTLY ASKED QUESTIONS
Are pharmacies still required to get the patient’s signature when picking up or delivering medications to the patient due to the risk of spreading the COVID-19 virus?
Please review Board regulation, Title 16, CCR section 1713, Receipt and Delivery of Prescriptions and Prescription Medication. Current pharmacy law does NOT require the patient to sign for picking up or the delivery of a prescription. But there may be insurance or pharmacy policies that require this information. You may wish to contact your insurance administrator or consult your pharmacy’s policies about waiving this provision.
Is a pharmacy allowed to compound hand sanitizer because the products are no longer readily available?
The Board does not have jurisdiction over over-the-counter (OTC) products such as hand sanitizers. The Food and Drug Administration (FDA) has recently published guidance on compounding hand sanitizer. Please consult the FDA guidance, “Policy for Compounding of Certain Alcohol-Based Hand Sanitizers Products During the Public Health Emergency.”
Can my pharmacy compound hydroxychloroquine and chloroquine if we can get the ingredients?
Please see Board regulation, Title 16, CCR 1735.2, Compounding Limitations and Requirements. In particular, section 1735.2(d)(3) prohibits the compounding of a drug preparation that is a copy or essentially a copy of a commercially available drug UNLESS that drug product appears on the ASHP or FDA lists of drugs that are in short supply at the time of compounding and dispensing.
Are there any changes in telehealth/telemedicine laws regarding controlled substance prescriptions due to the COVID-19 emergency?
Please see the Drug Enforcement Administration (DEA) website and contact the Medical Board of California for complete details and updates regarding telehealth/telemedicine.
The DEA, in consultation with the Department of Health and Human Services (HHS), announced that as of January 31, 2020, it will allow DEA registered practitioners to begin issuing prescriptions for controlled substances to a patient for whom they have not conducted an in-person medical evaluation. DEA-registered practitioners may continue this telemedicine practice for as long as the designation of the public health emergency is in effect provided all of the following conditions are met:
- The prescription is issued for a legitimate medical purpose.
- The telemedicine communication is conducted using an audio-visual, real time, two-way interactive communication system.
- The practitioner is acting in accordance with applicable federal and state laws.
- In addition to the above federal requirements, the Medical Board of California requires a physician to be licensed in the state of California (see BPC section 2290.5) but does not require the patient to have an in-person contact with the prescriber.
Do I need to notify the Board of Pharmacy if I want to temporarily change my pharmacy hours due to the COVID-19 crisis? What if I want to temporarily close the pharmacy?
There is no requirement to notify the Board when a pharmacy changes its hours. But see BPC section 4312, Voiding a Permit, if the pharmacy wants to TEMPORARILY close. This section requires a pharmacy to engage “in the ordinary activity for which the license was issued for at least one day each calendar week during any 120-day period.” If it does not, the Board may review the circumstances of closure before cancelling the license. If the pharmacy wants to PERMANENTLY close, Title 16 CCR section 1708.2, Discontinuance of Business, requires the pharmacy to notify the Board PRIOR to selling/transferring the dangerous drug inventory. Additionally, BPC section 4333 requires all prescription and other records be moved to and maintained at a Board-licensed facility for at least three years.
You must submit a request if you need a waiver to temporarily close your pharmacy. Send your request to email@example.com.
Can a pharmacy refill a prescription without the prescriber’s authorization during the COVID-19 crisis? What about a controlled substance or Schedule II prescription?
BPC section 4064 allows a pharmacist to refill a dangerous drug or device prescription without the prescriber’s authorization if the prescriber is unavailable to authorize the refill AND if, in the pharmacist’s professional judgment, failure to refill the prescription might interrupt the patient’s ongoing care and have an adverse effect on the patient’s well-being. The pharmacist must:
- Make a reasonable effort to contact the prescriber PRIOR to refilling the prescription and make an appropriate record, including the basis for proceeding.
- Inform the patient the prescription was refilled pursuant to this section.
- Inform the prescriber within a reasonable time that the refill was provided.
The prescriber does not incur any liability as a result of refilling a prescription pursuant to this section.
HSC section 11200(c) prohibits a prescription for Schedule II substance being refilled.
HSC section 11201 allows a pharmacist to refill a prescription for a controlled substance (other than Schedule II) if the prescriber is unavailable to authorize the refill AND if, in the pharmacist’s professional judgment, failure to refill the prescription might present an immediate hazard to the patient’s health and welfare or might result in intense suffering. The pharmacist shall:
- Make every reasonable effort to contact the prescriber prior to refilling a prescription pursuant to this section.
- Refill only a reasonable amount sufficient to maintain the patient until the prescriber can be contacted.
- Note on the reverse side of the prescription the date and quantity of the refill and that the prescriber was not available and the basis for his or her judgment to refill the prescription without the prescriber’s authorization.
- Inform the patient that the prescription was refilled without the prescriber’s authorization, indicating that the prescriber was not available and that, in the pharmacist’s professional judgment, failure to provide the drug might result in an immediate hazard to the patient’s health and welfare or might result in intense suffering.
- Inform the prescriber within a reasonable period of time.
The prescriber shall not incur any liability resulting from refilling a prescription pursuant to this section.
How can I apply for a waiver of Pharmacy Law, and how long is the waiver effective?
Pursuant to BPC section 4062, during a declared federal, state or local emergency, the Board has the ability to waive provisions of Pharmacy Law. Under the Board’s policy, waivers granted by the Board’s president are limited to 90 days. For information on how to request a waiver for any provision of Pharmacy Law, please go to the Board’s website, www.pharmacy.ca.gov, and click on How to Request a Pharmacy Law Waiver in the COVID-19 Information box.
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