Do Compounding Pharmacies 'Live In Sin'? The FDA's Assertion Of Enforcement Authority Over Pharmacy Compounding, And Two Courts' Efforts To Bless The Practice.

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Do Compounding Pharmacies 'Live In Sin'? The FDA's Assertion Of Enforcement Authority Over Pharmacy Compounding, And Two Courts' Efforts To Bless The Practice.

Pharmacy compounding, as the Food and Drug Administration ("FDA") explains, "is an age-old practice in which pharmacists combine ... ingredients to create unique medications that meet specific needs of individual patients." The FDA has recognized that "pharmacy compounding is a vital service that helps many people."1 Congress expressly recognized and regulated the practice by adding s.503A to the Food, Drug, and Cosmetic Act. But the fundamental legal questions about compounding still have no definitive answer. Is pharmacy compounding even legal? The FDA's position is oddly ambiguous. The relevant FDA guidance document states that s.503A "is now invalid," and the Courts of Appeals are split on this point. The FDA warns that certain perceived abuses are subject to enforcement action, but the guidance document is pointedly silent regarding the legality of compounding as it is traditionally practiced. The FDA's implied position, and the stance it has taken in recent litigation, is that although even traditional forms of compounding are illegal, the FDA wil...

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