Update: as discussed in our April 27 alert, the U.S. Food & Drug Administration (FDA) loosened restrictions to allow outsourcing facilities and compounding pharmacies to compound FDA-approved drugs.
As states brace themselves for an increasing number of novel coronavirus (COVID-19) cases, some pharmacy boards have relaxed regulations to ease burdens on pharmacy practitioners. Several states have declared a state of emergency, which permits state boards of pharmacy to waive multiple administrative and licensure requirements and publish additional guidance for pharmacies in their respective states. Such guidance addresses certain prescribing requirements for telemedicine, permit renewal, vaccination, remote supervision and processing, compounding, staffing ratios and emergency refills.
While each state has taken a different approach, the general trend is to provide increased flexibility for practitioners and facilities to allow pharmacists and facilities to respond more quickly to the crisis. To illustrate some examples of ongoing pharmacy board efforts, this article provides a brief overview of responses taken thus far by three states – California, Texas and Virginia.
California – In response to the pandemic, the California State Board of Pharmacy issued a series of continually updated pharmacy law waivers, which are effective for up to 30 days from the date of issuance. Such waivers include extensions on inventory reconciliation reports for pharmacies and clinics (extended to six months, from the usual three months). Additionally, the California Board will temporarily allow the use of mobile pharmacies or clinics to ensure patient continuity of care. Other allowances include waivers of compounding license renewal requirements as well as increasing staffing ratio requirements. The California Board also made it possible for pharmacies to receive dangerous drugs and dangerous devices from out-of-state providers on a limited basis and under certain express conditions.
Texas – The Texas State Board of Pharmacy has issued ongoing similar rule waivers and emergency procedure regulations to assist consumers and pharmacy professionals during the pandemic. Certain licensing requirements are temporarily suspended for pharmacy professionals, including some continuing education requirements and requirements that pharmacists pay weekly visits to ambulatory surgical centers and free-standing emergency medical care facilities. Some further requirements that are temporarily suspended include annual inventory notarization requirements and inspection requirements. In addition, the Texas Board permitted a workaround for requirements for in-person consultations by instead authorizing telephonic patient contact. Texas is piloting a program for automated systems to allow for remote automated dispensing of medication. Note, however, that such remote dispensing programs are not permitted in many states. For example, New York recently issued an advisory notice warning pharmacies that, despite the ongoing pandemic, automated dispensing machines continue to be a violation of New York law.
Virginia – Virginia’s Board of Pharmacy has issued emergency provisions for the duration of the declared state of emergency, including several authorizations not expressly waived in California or Texas. Such provisions give pharmacists flexibility in discretionary dispensing of early refills and refills without authorization of Schedule II-VI drugs in limited circumstances. Pharmacies are also permitted to receive assistance from pharmacists and pharmacy technicians licensed in other states with proper verification and notification to the Virginia Board. Other states are taking measures to allow expedited temporary licenses for out-of-state practitioners, including the governor of Pennsylvania, who recently suspended several “administrative requirements” for out-of-state practitioners, thus ensuring a smoother transition for practitioners wishing to assist patients outside their home states.
This summary is not an exhaustive list of the steps states have taken to ease requirements for pharmacy practitioners and facilities but illustrates different approaches states are taking to fight this pandemic.
McGuireWoods has a dedicated team of lawyers that will continue to monitor state and federal responses to COVID-19. Please contact the authors of this alert with any questions and for additional guidance on how other COVID-19 considerations may impact particular requirements for pharmacies in your state(s). McGuireWoods has published additional thought leadership related to how companies across various industries can address crucial COVID-19-related business and legal issues.