Alerts

FDA and State Boards of Pharmacy React to Coronavirus – Update

Alerts / March 17, 2020

Here, we provide you with the first update to important actions in the life sciences sector that the Food and Drug Administration (FDA) and state boards of pharmacy are taking to address the pandemic so far. We will continue to keep you updated as new information becomes available. We have established a comprehensive online resource center to help answer legal questions about coronavirus disease 2019 (COVID-19).

Noteworthy to the life sciences sector is Attorney General Barr’s memo for all U.S. attorneys. Barr directs all U.S. attorneys to “prioritize the detection, investigation, and prosecution of all criminal conduct related to the current pandemic.” This conduct includes individuals and businesses selling fake cures for COVID-19.

FDA Actions

As mentioned previously, clinical trials are underway for a vaccine for COVID-19. As anticipated, the first experimental dose was administered on Monday, Mar. 16.

The FDA continues to focus on ensuring the availability of personal protective equipment for healthcare workers and providing ample diagnostic tests for COVID-19. FDA is utilizing its Emergency Use Authorization (EUA) authority to allow unapproved medical products or unapproved uses of approved medical products to be employed in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions. On Jan. 31, the secretary of Health and Human Services determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad. That declaration allows the FDA to issue EUAs. The FDA issued two additional EUAs for diagnostic tests since the first publication of this alert.

Furthering its focus on diagnostic tests, the FDA issued an updated policy for diagnostic tests for COVID-19 during the public health emergency. Commissioner Hahn remarked that “unprecedented policy set forth in today’s updated guidance, which addresses laboratories and commercial manufacturers, will help address these urgent public health concerns by helping to expand the number and variety of diagnostic tests, as well as available testing capabilities in health care settings, and reference and commercial laboratories.” The policy describes two pathways “for accelerating the development of certain laboratory tests for COVID-19 – one leading to an EUA submission to FDA, and the other not leading to an EUA submission when the test is developed under the authorities of the State in which the lab resides and the State takes responsibility for COVID-19 testing by laboratories in its State.” First, the FDA is allowing states and territories to authorize laboratories within their state or territory to develop their own COVID-19 tests and perform specimen testing without submitting validation to the FDA and without submitting an EUA. Second, the updated policy allows commercial manufacturers to distribute diagnostics for 15 business days while an EUA is being prepared for submission to the FDA. Commercial manufacturers of COVID-19 diagnostics may distribute their tests prior to receiving an EUA if the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s website. All diagnostic tests should be validated before use, and the FDA provides recommendations for minimum testing to ensure validity.

State Boards of Pharmacy

Previously, we noted the steps Florida, North Carolina, Ohio and Texas have taken regarding pharmacy practice during this public health emergency.

Alabama is the latest state to issue guidance for pharmacy practice. Like Ohio, the Alabama Board of Pharmacy is allowing remote order verification from a location outside the institutional facility. Final verification and dispensing must be done by a pharmacist on-site.

Virginia issued information on and provisions effective for the duration of the declared emergency. Pharmacists may exercise professional judgment regarding the dispensing of early refills for schedule VI drugs and must document the reason for the early refill. Additionally, pharmacists may dispense a one-time early refill of schedule II-V (only chronic conditions for schedule II) prescriptions and must document the reason for the early refill. Virginia also provided information on conserving sterile garb, compounding hand sanitizer, inpatient pharmacy labeling for dispensing to discharged patients, and the assistance of pharmacists and technicians licensed in other states.

Missouri provided information on pharmacy practice during the pandemic in a question and answer format. Topics addressed include remote work and reuse of sterile garb.

The California State Board of Pharmacy postponed meetings, canceled trainings and reposted the FDA’s policy for compounding hand sanitizer. Because California is in a statewide emergency, the board may waive provisions of the pharmacy law or regulations. The board is accepting and reviewing requests from licensees needing a waiver.

The Georgia Board of Pharmacy adopted an emergency policy and statement of interpretation for emergency prescription refills in response to COVID-19. The Georgia policy provides for up to a 30-day-supply emergency refill of noncontrolled substances. Pharmacists and technicians licensed in other states may apply for a temporary license in Georgia. The policy also provides provisions for temporary pharmacy facilities or mobile pharmacies.

Takeaways

Rapid response in the life sciences and pharmacy sector continues to occur at both the federal and state levels to address the threat of the new coronavirus. We expect to see continued activity in this space and will keep you updated as we become aware of developments.

Authorship Credit: Lindsay Holmes, Lee Rosebush and Marc Wagner

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