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Friday, April 13, 2012

What Is Considered a Compounded Drug?

When your child does not like the taste of the antibiotic the doctor prescribes and the pharmacist adds a flavor to the medication, the result is a compounded drug.  When a commercial drug is available only in tablet form for your pet, but a liquid version of the medication is needed, prepared and provided to you for your animal, the result is a compounded drug.

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:

``(f) Definition.--As used in this section, the term `compounding' does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling.''.


Case law defines compounding as "a process by which a pharmacist combines, mixes, or alters ingredients to create a medication tailored to the needs of an individual human or animal patient." United States v.Francks, Case No. 5:10-cv-147-Oc-32TBS, slip op., at *9 (M.D. Fla. 2011)(citing Thompson v. W. States Med. Ctr., 535 U.S. 357, 360-61 (2002); Med. Ctr. Pharm.v. Mukasey, 536 F.3d 383, 387 (5th Cir. 2008)).  See also Compounding Troubles, Trends Magazine (February 2012).  Another way of defining compounded drugs is that they are a customized preparation of a medicine in a way that is not available from major drug makers.  Compounded drugs are not the same thing as generic drugs. Generic drugs are approved by the Federal Drug Administration: compounded drugs are not.

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.

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