Federal Programs

FDA Issues Final Guidance on Compounding

From NCPA:

Last week, the Food and Drug Administration released a final guidance addressing the repackaging of certain human drug products by pharmacies and outsourcing facilities. The agency outlined the situations where it does not intend to enforce certain federal regulations regarding the repackaging of drugs by state-licensed pharmacies, federal facilities, or registered outsourcing facilities. The guidance also clarifies FDA’s definition of repackaging to mean “the act of taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the drug.” While FDA says that repackaged drugs are “generally not exempt from any of the provisions of the [Food, Drug, and Cosmetic Act] FD&C Act related to the production of drugs,” the agency does not intend to enforce these provisions against state-licensed pharmacies, federal facilities, or outsourcing facilities as long as they meet the criteria set out in the guidance.