The FDA has issued a guidance on its approach to regulating compounded drugs following court decisions that have invalidated the pharmacy compounding section 503A of the Food, Drug and Cosmetic Act.
The guidance does not affect the legitimate pharmacy compounding of reasonable quantities of human drugs on the receipt of valid prescriptions for individual patients. The document warns, however, that the FDA may seriously consider enforcement action if the scope and nature of a pharmacy's activities result in significant violations of rules protecting the integrity and labeling of pharmaceuticals.
Examples of potential violations include the following: excessive compounding of drugs in anticipation of receiving prescriptions; compounding drugs that were withdrawn or removed from the market for safety reasons; compounding finished drugs from bulk active ingredients that are not components of FDA-approved drugs; receiving, storing, or using drug components not guaranteed to meet official compendia requirements; using commercial scale manufacturing or . . . [Full Text of this Article]
