Compound preparations for both humans and animals have existed for years. See United States v. Bader, slip opinion, *2-3, n.1 (Colo. July 23, 2009) Compound preparations accounts for some 30 million prescriptions a year in the United States and are a huge money-making business. Compounding is the only source for some medications. Today, compounding of drugs is “a traditional component of the practice of pharmacy, and is taught as part of the standard curriculum at most pharmacy schools.” Thompson v. W. States Med. Ctr., 535 U.S. 357, 361 (2002)(internal citations omitted).
Despite the long history and tradition of compound drugs, the Federal Drug Administration (FDA) does not have a formal definition of compounded drugs in its regulations. Instead, Congress defined what is not compounding in the Food and Drug Administration Modernization Act of 1997, which amended 21 U.S.C. § 353A, as follows:
The ability to customize preparation of a medicine that is not available from major drug makers is necessary for obvious reasons. The issue is when does this customize preparation of a medicine cross over from mere compounding and become manufacturing of a drug. This area of law is opaque and fluctuating and in much need of more developed laws, rules, regulations and especially guidance to those who prescribe and prepare compound drugs.