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Tuesday, April 16, 2013

Federal Authority to Regulate the Compounding of Human Drugs

Andrew Nolan
Legislative Attorney

In light of the 2012 fungal meningitis outbreak, believed to have been caused by a contaminated compounded steroid injection, the regulation of human drug compounding has received significant attention. Drug compounding in its traditional form is the process of combining, mixing, or altering ingredients in order to create a medication for a particular patient. However, as illustrated by the entity that created the steroid medication linked with the meningitis outbreak, concerns have been raised about compounding pharmacies producing drugs on a larger scale. While drug compounding has historically been the focus of state governments through their regulation of pharmacies, questions have arisen regarding the extent the federal government can regulate the practice of compounding through the Food, Drug, and Cosmetic Act (FDCA).

Federal authority over compounding largely stems from the FDCA, enacted in 1938, and its subsequent amendments, including the Food and Drug Administration Modernization Act (FDAMA) of 1997, which added compounding specific provisions to the FDCA in section 503A. A First Amendment challenge to section 503A’s advertising provisions and a resulting Supreme Court decision has created a split amongst the federal courts regarding whether section 503A has any legal effect. The legal uncertainty regarding section 503A, coupled with section 503A’s basis in the FDCA’s “new drug,” “adulteration,” and “misbranding” provisions lends to an examination of the scope of federal authority under the base statute. Courts appear to agree that the federal government can regulate compounding activity that is akin to manufacturing, and courts have afforded deference to the FDA’s interpretation of when a compounder is acting like a manufacturer. However, uncertainty remains regarding the possible limits to the FDA’s power to regulate traditional compounding activities. This report will examine the FDA’s regulation of drug compounding and will discuss relevant legal authorities. The report will conclude by discussing potential limits to the FDA’s authority to regulate human drug compounding.

Date of Report: April 12, 2013
Number of Pages: 16
Order Number: R43038
Price: $29.95

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