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Boards of Pharmacy Nationwide Respond to COVID-19 Pandemic

In response to the nationwide COVID-19 emergency, state boards of pharmacy across the country are authorizing waivers of specific provisions of pharmacy laws and implementing policies to address potential staffing shortages and emergency dispensing of pharmaceuticals.  Below is a high-level overview of the various actions being taken by state boards of pharmacy.

State Pharmacy Law Waivers.  Many states have issued waivers of specific provisions of state pharmacy laws.  For example, the California Board of Pharmacy has issued numerous pharmacy law waivers including waivers that:

  • allow the use of a mobile pharmacy or clinic;
  • waive license renewal requirements for sterile compounding pharmacies located within hospitals;
  • permit increased staffing of intern pharmacists and pharmacy technicians that would otherwise be out of compliance with supervisory ratios;
  • allow pharmacists to perform remote processing if certain requirements are met;
  • waive the signature requirement for the receipt of the delivery of drugs;
  • permit prescribers to dispense medications to an emergency room patient if the medication is a short-acting or long-acting bronchodilator; and
  • waive the requirement for a consulting pharmacist to perform quarterly visits to a clinic under certain conditions.

Rather than issuing waivers, some state boards of pharmacy, including the New Jersey Board of Pharmacy, have implemented a process for pharmacies to request temporary waivers of specific regulations due to COVID-19-related issues.

Non-Resident Licensing.  Several states (e.g., Georgia, Ohio, Missouri, and Virginia) have implemented non-resident licensing waivers for pharmacists, pharmacy technicians, and pharmacies.  Under these waivers, state boards of pharmacy are permitting non-resident individuals and entities to provide pharmacy services if they are licensed in other states.  Other states, like Texas, are issuing emergency temporary licenses to pharmacists and pharmacy technicians licensed in other states. 

Emergency Dispensing of Drugs and Drug Refills.  Additionally, many state boards of pharmacy are allowing emergency dispensing of certain drugs and drug refills.  For example, the Virginia Board of Pharmacy issued provisions effective for the duration of the COVID-19 declared emergency that authorize pharmacists to dispense certain early refills based on their professional judgment.  Pharmacists may do the following:

  • dispense early refills for Schedules II, III-V, VI drugs if they document the reason for the early refill;
  • refill a Schedule VI drug without authorization from the prescriber if the pharmacist ascertains that the patient’s health would be in imminent danger without the benefits of the drug; and
  • dispense a Schedule II prescription upon receiving oral authorization from a prescriber.

Similarly, the Maryland Board of Pharmacy issued guidance noting that, during a state of emergency, pharmacists may refill prescriptions for which a refill has not been authorized if:

  1. the pharmacist is unable to obtain authorization from the prescriber;
  2. the refill is not for a controlled dangerous substance;
  3. the quantity dispensed does not exceed a 30-day supply or unit of use; and
  4. the pharmacist notifies the prescriber of the refill within seven days. 

Florida has a similar statute allowing pharmacists to dispense up to a 30-day supply of maintenance medication for chronic conditions under certain conditions.

Restrictions on the Use of Drugs for COVID-19.  A few states have placed restrictions on the use of hydroxychloroquine and chloroquine, which are both unproven treatments for COVID-19.  For example, the Ohio Board of Pharmacy issued an emergency rule prohibiting the dispensation of chloroquine or hydroxychloroquine unless the prescription bears a written diagnosis, and, if written for a COVID-19 diagnosis, the diagnosis has been confirmed by a positive test result.  Prescriptions for either presumptive positive patients or prophylactic use of chloroquine or hydroxychloroquine related to COVID-19 is strictly prohibited under the Ohio emergency rule.  Idaho has issued a similar temporary rule, and Nevada issued a guidance with similar restrictions on chloroquine and hydroxychloroquine.

Remote Order Verification.  State boards of pharmacy have taken different approaches towards remote order verification.  For example, the Alabama Board of Pharmacy issued certain provisions allowing institutional/hospital pharmacies to use remote order verification from a location outside the institutional facilities, but final verification and dispensing must still be done by a pharmacist on-site.  The Missouri Board of Pharmacy, on the other hand, has approved a broad waiver that allows remote final product verification if needed to provide disaster or emergency relief if:

  1. physical verification by a pharmacist cannot be promptly performed by the pharmacist;
  2. prompt dispensing is in the best interest of the patient’s health and safety;
  3. the technology used is sufficient to allow the pharmacist to properly and accurately inspect and verify the accuracy of the contents of the prescription or mediation order and the affixed label; and
  4. the pharmacy technician or intern pharmacist is supervised in compliance with regulatory requirements.

The Missouri Board of Pharmacy specified that the remote verification waiver is intended to address COVID-19-related pharmacy needs and is not intended to be a blanket waiver to accommodate normal pharmacy staffing issues.

Suspending Enforcement Action.  Lastly, some state boards of pharmacy have indicated that they do not intend to use their enforcement authority against pharmacies and pharmacists due to temporary non-compliance related to COVID-19.  For example, the Massachusetts Board of Registration in Pharmacy issued a FAQ in which it stated that it does not intend to take any enforcement action in the following situations:

  • pharmacies that are temporarily out of compliance with required supervisory ratios, provided that there is at least one pharmacist in the pharmacy;
  • pharmacists who continue to provide immunizations after their certifications have expired; and
  • sterile compounding pharmacies with expired certifications, provided that environmental monitoring for air and surface has been performed within the previous 30 days.

The Massachusetts Board of Registration in Pharmacy also indicated that more COVID-19-related guidance is forthcoming.

We anticipate boards of pharmacy will continue issuing guidance and waivers in response to the COVID-19 crisis. We will continue to monitor future developments and provide updates as appropriate.

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Author

Rachel E. Yount

Associate

Rachel Yount is a Mintz attorney who focuses her practice on health care industry transactions. Her clients include hospitals, health systems and plans, physician organizations, and pharmacy benefit managers.