Compounding Animal Drugs From Bulk Ingredients: Not Prohibited By Federal Food Drug And Cosmetic Act, Affirmed As Recently As 2011

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

1938

For approximately the first 50 years after the enactment of the FD&CA in 1938, the FDA generally left regulation of compounding to the states.

1988

United States v. 9/1 Kg. Containers (854 F.2d 173 (7th Cir. 1988)) held that bulk ingredients suppliers could not sell to veterinarians except for specific circumstances. The case did not mention selling to pharmacists and courts have distinguished 9/1 Kg. Containers as being inapplicable to pharmacists.

1989

United States v. Algon Chemical, Inc., (879 F.2d 1154 (3rd Cir. 1989)) held that bulk ingredients suppliers could not sell to veterinarians except for specific circumstances. The case did not mention selling to pharmacists and courts have distinguished Algon Chemical, Inc. as being inapplicable to pharmacists.

1992

The 1992 Compliance Policy Guide listed nine noninclusive activities that the FDA believed improperly crossed the line between "pharmacist" and "manufacturer." Compounding drugs from bulk substances was not among the nine prohibited practices.

1994

Animal...