Regulatory Authority Over Compounding Pharmacies Resides with Boards of Pharmacy, Federal Judge Holds

September 23, 2011 9:34 AM Topics: Compounding

In the case of US v Franck's Lab, Inc, US District Court for the Middle District of Florida has ruled that FDA does not have jurisdictional authority over the compounding of medications by a licensed pharmacy as long as the pharmacy’s activities are not manufacturing. Judge Timothy Corrigan held that regulatory authority over compounding pharmacies rests with individual state boards of pharmacy. The case was brought against pharmacist Paul Franck by FDA, with the argument that the use of active pharmaceutical ingredients in compounding veterinary drugs for non food-producing animals was illegal. Judge Corrigan ruled, however, that the Federal Food, Drug, and Cosmetic Act of 1938 did not grant FDA authority over compounding pharmacies. Specifically, Corrigan held that FDA lacks the authority “to enjoin the long-standing, widespread, state-regulated practice of pharmacists filling a veterinarian’s prescription for a non food-producing animal by compounding from bulk substances.” Additional details are available in an International Academy of Compounding Pharmacists press release and in a Drug Store News article.