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Food and Drug Administration and Compliance Issues
The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:
The FDA issued Yale School of Public Health an emergency use authorization (EUA) for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19. This molecular test is for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider. SalivaDirect does not require any special type of swab or collection device – a saliva sample can be collected in any sterile container. It is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past.
As part of the FDA’s effort to protect consumers, the agency issued a joint warningletter with the Federal Trade Commission to SilveryGuy, a company that participates in the Amazon Associates program, for selling fraudulent COVID-19 related products. As an Amazon associate, the company earns commissions by promoting the sale of Colloidal Silver products on the company’s website, with misleading claims that the product can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. Currently, there are no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
To date, the FDA has currently authorized 214 tests under EUAs; these include 175 molecular tests, 37 antibody tests, and 2 antigen tests.