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 U.S. Department of Agriculture (USDA) and the FDA announced that the agencies signed a Memorandum of Understanding (MOU) to support the U.S. food and agriculture sector so that Americans can continue to have access to a safe and robust food supply. As a next step in carrying out Executive Order 13917, the MOU sets up a process to help prevent interruptions at FDA-regulated food facilities, including fruit and vegetable processing, in which the two agencies can make determinations about circumstances in which the USDA could exercise its authority under the Defense Production Act.
The FDA issued an Emergency Use Authorization (EUA) to Walter Reed National Military Medical Center for the COVID-19 Airway Management Isolation Chamber (“CAMIC”) to be used by healthcare providers within the U.S. Army and Military Health System as an extra layer of barrier protection, in addition to personal protective equipment, to prevent exposure to pathogenic biological airborne particulates during transport of patients, at the time of definitive airway management, or when performing medical procedures on such patients during the COVID-19 pandemic. The CAMIC system is a barrier device constructed by draping a large clear plastic bag over a box-like frame that is placed over the head, neck, and shoulders of the patient to isolate (i.e., capture and remove) airborne particulates.
The FDA and Federal Trade Commission (FTC) issued warningletters to two companies for promoting and participating in the sale of fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
The first company warned, Life Unlearned, LLC, participates in the Amazon Associates program. As an Amazon associate, the company earns commissions by promoting the sale of vitamin D products with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
The second company warned, SpiceTac, participates in the Amazon Associates program. As an Amazon associate, the company earns commissions by promoting the sale of vitamin C products with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
During the COVID-19 pandemic, the FDA has worked with more than 400 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 105 tests under EUAs, which include 92 molecular tests, 12 antibody tests, and 1 antigen test.