The Federal Food Drug & Cosmetic Act (FD&CA) gives FDA broad, wide and far-reaching regulatory powers. Prohibiting the compounding of medicines from bulk ingredients, however, is not one of them. The position that the FD&CA prohibits pharmacists from compounding animal drugs from bulk ingredients is simply incorrect.
A federal district court, the only court to review the issue, explicitly rejected the position that the FD&CA prohibits pharmacists from compounding animal drugs from bulk ingredients:
The undisputed evidence … shows that allowing the FDA to enjoin a pharmacist’s traditional, state-authorized practice of bulk compounding of animal drugs could destabilize the pharmacy profession and leave many animal patients without necessary medication. Such a result would be especially troublesome because the FDA’s longstanding policy has been to permit, and even promote, pharmacists’ compounding from bulk ingredients. The FDA cannot simply upset the expectations it helped to create through decades of inaction without explanation, especially where it asserted expansion of authority impacts the federal-state balance and potentially subjects many individuals and companies to criminal liability.
United States v. Franck’s Lab, Inc., et al. (816 F. Supp. 2d 1209 (M.D. Fl. 2011) (emphasis added)).
The FDA’s Historical Regulation and Enforcement of Compounding with Bulk Substances Further Questions the Implied FD&CA Prohibition
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