September 2003              return to newsletter contents page

FDA Issues New Guidance for Staff and Industry on Compounding of Drugs for Use in Animals

On July 3, 1996, FDA issued a CPG section 608.400 "Compounding of Drugs for Use in Animals,'' which provided guidance to FDA's field and headquarters staff with regard to the compounding of drugs for use in animals by veterinarians and pharmacists. It described the factors FDA intended to consider in exercising its enforcement discretion regarding the illegal compounding of drugs intended for use in animals. FDA is updating this CPG to ensure that its enforcement policy regarding the compounding of drugs intended for use in animals is  consistent, to the extent practicable, with its enforcement policy regarding the compounding of drugs intended

for use in humans. FDA issued the latter enforcement policy entitled ``Pharmacy Compounding Compliance Policy Guide'' that published in the Federal Register of  June 7, 2002 (67 FR 39409). 

FDA issued this CPG after the U.S. Supreme Court ruled that a statutory provision governing the compounding of; drugs intended for human use was unconstitutional. Because of that  court decision, FDA determined that it needed to issue guidance to the compounding industry on what types of compounding might be subject to enforcement action under current law. The guidance was based in part an earlier CPG. In addition to ensuring that its policies regarding the compounding of drugs intended for use in humans and animals are consistent, FDA is revising its previous animal drug compounding CPG to ensure it is consistent with the current animal drug compounding regulations, which are codified at 21 CFR part 530.

This compliance policy guidance is being issued as a level 1 guidance consistent with FDA's good guidance practices (GGPs) 
regulation in Sec. 10.115 (21 CFR 10.115). It is being implemented immediately without prior public comment, under Sec. 10.115(g)(2), 
because of the agency's urgent need to explain how, in light of the recent court decision and revised policy regarding drugs for human use, it intends to exercise its enforcement discretion regarding compounded drugs for animal use. However, under GGPs, FDA requests comments on the guidance and will revise the document, if appropriate. Comments will be considered by the agency in the development of future policy.

This compliance policy guidance represents the agency's current
thinking on the enforcement of the act with regard to drug products compounded for use in animals. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the applicable statutes and regulations.

Click here to retrieve a copy of the guidance.