State Pharmacy Boards Issue Waivers of Regulations in Response to the COVID-19 Pandemic

State Boards of Pharmacy are working with the Department of Health and Human Services (HHS) and their respective state Governor’s to identify pharmacy regulation and requirements that can be suspended to provide the flexibility needed to respond to the Coronavirus crisis. The patchwork of various State Board of Pharmacy waivers may significantly affect your pharmacy practice. Examples of these types of waivers which may benefit your pharmacy practice include:

  • Allowance and/or expansion of remote prescription processing
  • Pharmacists can perform non-dispensing activities outside of a licensed pharmacy and pharmacy staff can work from home
  • Requirements for direct supervision of pharmacy technicians
  • Mailing prescriptions permitted
  • Telehealth pharmacy services (e.g. patient counseling)
  • Out of state pharmacies permitted to practice in certain states for duration of emergency
  • Waiver of co-pays; loosened formularies
  • Waivers for signature requirement for the pharmacist accepting delivery of drugs
  • Waivers for <797> personnel protective equipment (PPE) requirements for compounding:

 

  • reuse permitted
  • not required for nonhazardous drug compounding
  • Emergency refill- early refills, pharmacist authorized refills (In some states insurers and PBMs are required to pay for these emergency refills – even though there were no refills remaining)
  • Adjustment of the dispensing quantity (e.g. from 30 day supply to 90 day supply)
  • Creation of a temporary or mobile pharmacy location (other than that listed in permit)
  • Dispensing allowed for drugs designated by CDC or NIH protocols to treat COVID-19
  • Deviations from pharmacy hours of operation and/or hours for pharmacist-in-charge
  • Pharmacies can limit service to delivery only or drive through service only
  • Waiver of manufacturer registration requirement for pharmacies compounding hand sanitizers
  • Health insurers and health care centers are encouraged to authorize payment to pharmacies for a ninety (90) day supply of maintenance prescription medications for individuals
  • Cross state practice as a pharmacist permitted; temporary reactivation of expired state licenses
  • Compounding of commercially available products and/or anticipatory compounding
  • Storage of excess inventory outside of the prescription department

On the Federal level, the DEA together with the HHS Secretary designated a telemedicine allowance for Schedule II-V controlled substances waiving the in-person medical evaluation requirement (under certain circumstances and in accordance with state laws). Other DEA Guidances have been issued for medication assisted treatment such as opioid treatment programs.

See https://www.deadiversion.usdoj.gov/coronavirus.html.

Additionally, FDA has released a Guidance permitting the temporary compounding of alcohol-based hand sanitizers by pharmacies. See https://www.fda.gov/media/136118/download.

How Frier Levitt Can Help?

Waivers are state specific and vary from jurisdiction-to-jurisdiction. Frier Levitt attorneys are available to assist pharmacies in navigating this patchwork of waivers and regulatory changes resulting from the COVID-19 crisis.

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