Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic:
The FDA issued an Emergency Use Authorization (EUA) for infusion pumps and infusion pump accessories that, among other things, meet certain safety, performance, and labeling criteria, in response to concerns relating to the insufficient supply and availability of the devices for use by healthcare providers in the continuous infusion of medications, total parenteral nutrition, and/or other fluids into patients during the COVID-19 pandemic. This includes infusion pumps with remote monitoring or remote manual control features or administration sets and other accessories with increased length that help to maintain a safe physical distance between healthcare providers and patients with or suspected of having COVID-19 to reduce healthcare provider exposure. Infusion pumps and accessories that have been confirmed by FDA to meet the criteria will be added to the letter of authorization in Appendix A. A manufacturer may request the addition of any eligible infusion pump and/or infusion pump accessory to Appendix A by submitting a request to CDRH-COVID19-InfusionPumps@fda.hhs.gov, as outlined in the EUA.
Today, the FDA issued an update to its guidance for pharmacy compounders that experience shortages of the personal protective equipment (PPE) they typically use to compound human drugs that are intended or expected to be sterile. In the update, FDA has clarified that drugs can be compounded under the policy in a segregated compounding area that is not in a cleanroom, when specific beyond-use dates are utilized. FDA adopted this policy to help assure patient access to needed medicines and to reduce the risks of compounding when standard PPE are not available.
During the COVID-19 pandemic, the FDA has worked with more than 390 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
To date, the FDA has authorized 98 tests under EUAs, which include 85 molecular tests, 12 antibody tests, and 1 antigen test.