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.
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 firstname.lastname@example.org.
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.
My pharmacy is having trouble findings certain drugs at my regular wholesaler due to the COVID-19 emergency, but the hospital down the street has the drug available. Can my pharmacy purchase this drug from the hospital during this emergency?
Yes. Although Business and Professions Code section 4380 in general prohibits the resale of drugs acquired at preferentially low prices (or bid price merchandise) permitted under federal law because of the Nonprofit Institutions Act (15 U.S.C. section 13c), there is an exception for the “occasional emergency situation” where no other drug sources are readily available in the community to meet the emergency need.
Is there a limit on the amount of a controlled substance that can be prescribed on a prescription? Is there a limit on the amount of a controlled substance that can be dispensed to the patient?
Federal and California pharmacy laws are silent on the amount of a controlled substance that can be prescribed. If the prescription is uncertain, erroneous or irregular, California Code of Regulations, title 16, section 1761(a) requires the pharmacist contact the prescriber to obtain the information needed to validate the prescription. But CCR section 1761(b) prohibits a pharmacist from dispensing a controlled substance that was not prescribed for a legitimate medication purpose even if validated by the prescriber.
Although there is no quantity limit on the original controlled substance prescription dispensed, Health and Safety Code section 11200 limits the quantity of a controlled substance dispensed as a refill for Schedule III or IV drugs to a 120-day supply. Furthermore, all controlled substance prescriptions must be filled and refilled within six months of the date written. Schedule III and IV drugs cannot be refilled more than five times. No prescription for Schedule II drugs can be refilled.
I have several out-of-state patients and students who have sheltered in place or been quarantined in California due to COVID-19. Is the pharmacy able to fill their out-of-state Schedule II prescriptions?
Please refer to the article “Q&A: Out-of-state e-scripts for Schedule II medications” on page 16 of the July 2018 issue of The Script and Health and Safety Code (HSC) section 11164.1(a)(1) on filling out-of-state Schedule II prescriptions.
Here are some other suggestions to take care of patients who come from out-of-state with prescriptions issued by out-of-state prescribers:
- Have the patient go to urgent care or a California prescriber to obtain a new Schedule II prescription.
- Contact the out-of-state prescriber for an alternative non-Schedule II controlled substance medication, which can be filled by the California pharmacy per HSC section 11164.1(b) and 16 CCR section 1717.
Many patients are requesting their controlled substances refills early due to the COVID-19 emergency. How early can I fill these controlled substances prescriptions?
The pharmacist should use professional judgment, exercise corresponding responsibility, and review the patient’s CURES Report. If warranted, the pharmacist should contact the prescriber to advise the prescriber of the patient’s request for an early refill and discuss if an early refill is appropriate and/or legitimate in this situation. Only then can the pharmacist determine whether and when the prescription should be refilled. See HSC section 11153 and 16 CCR section 1761 for complete law. The pharmacy may also wish to contact the insurance company regarding payment guidelines for early refills.
Due to COVID-19 pandemic, does the Board require my pharmacy staff to wear personal protective equipment (PPE) while working in the pharmacy? Can the pharmacy require the customers to wear PPE?
On June 18, 2020, Governor Newsom announced that Californians are now required to wear face coverings in public spaces – particularly indoors or when physical distancing is not possible.
The California Department of Public Health has released guidance requiring the use of face coverings in high-risk situations as follows:
- Inside or in line to enter any indoor public space.
- Obtaining services from the health care sector in settings including but not limited to a hospital, pharmacy, medical clinic, laboratory, physician or dental office, veterinary clinic, or blood bank.
- Waiting for or riding on public transportation or paratransit or while in a taxi, private car service, or ride-sharing vehicle.
- Engaged in work, whether at the workplace or performing work off-site, when:
- Interacting in person with any member of the public;
- Working in any space visited by members of the public, regardless of whether anyone from the public is present at the time;
- Working in any space where food is prepared or packaged for sale or distribution to others;
- Working in or walking through common areas, such as hallways, stairways, elevators, and parking facilities;
- In any room or enclosed area where other people (except for members of the person’s own household or residence) are present when unable to physically distance.
- Driving or operating any public transportation or paratransit vehicle, taxi, or private car service or ride-sharing vehicle when passengers are present. When no passengers are present, face coverings are strongly recommended.
- While outdoors in public spaces when maintaining a physical distance of 6 feet from persons who are not members of the same household or residence is not feasible.
Additionally, in May 2020, the California Department of Public Health published COVID-19 Guidance for Pharmacies and Pharmacy Staff. See www.cdph.ca.gov for complete details. Some of the recommendations:
For pharmacy staff:
- Ensure staff engage in frequent hand hygiene (i.e., routinely washing hands with soap and water for at least 20 seconds), and avoid touching eyes, nose, and mouth.
- Ensure staff self-monitors for illness (fever, cough, shortness of breath). Staff with flu-like symptoms should stay at home or should go home.
- Staff should wear facemasks or cloth face covering while in the pharmacy.
- Encourage prescribers to submit telephone or electronic prescriptions.
- Avoid touching items handled by customers such as insurance or credit cards, and wash hands or use hand sanitizer if these items are touched.
- Minimize physical contact with customers. As much as possible, maintain a 6-foot distance.
- Point-of-care services (e.g., immunizations, blood pressure measurements) should be avoided if a patient has respiratory symptoms, or if the service is not urgent for a patient who is asymptomatic. If point-of-care service is provided, the pharmacy staff should wear proper PPE and practice hand hygiene.
Can a California pharmacist provide COVID-19 testing? What about an advanced practice pharmacist?
Effective May 12, 2020, California Governor Gavin Newsom signed Executive Order N-39-20 allowing pharmacists to participate in COVID-19 testing. Guidance for pharmacists ordering and collecting specimens for COVID-19 tests is posted in the COVID-19 Information box on the Board’s website.
The DCA and the Board encourage pharmacists to contact their partner laboratories to obtain information about reporting requirements, specimen handling, transportation requirements, and reimbursements.
Please sign up for subscriber alerts and monitor the Board’s website for regular updates and additional resources related to COVID-19, including:
For additional information about COVID-19, please also visit the following websites: