The regulation of human drug compounding is getting the attention of Congress as a result of the 2012 fungal meningitis outbreak, believed to have been caused by a contaminated compounded steroid injection. A House Energy and Commerce subcommittee hearing on oversight by the Food and Drug Administration (FDA) of drug compounding was held on April 16, 2013, according to a story in ModernHealthcare, “GOP lawmakers balk at giving FDA more authority over compounding pharmacies.” According to the story, FDA Commissioner Margaret Hamburg asked a House subcommittee five months ago for legislation that requires all compounders to register with the agency. In addition, she called for uniform quality standards to abide by and mandatory reporting of adverse events to the FDA. Currently, section 503(a) of the Food, Drugs and Cosmetics Act exempts compounders from certain regulations that apply to other drug manufacturers.
A report prepared by the Congressional Research Service (CRS) on April 12, 2013, explained that 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, CRS said questions have arisen regarding the extent the federal government can regulate the practice of compounding through the Food, Drug, and Cosmetic Act (FDCA).
Courts appear to agree that the federal government can regulate compounding activity that is akin to manufacturing, the CRS report said, and courts have afforded deference to the FDA’s interpretation of when a compounder is acting like a manufacturer. CRS found, however, that uncertainty remains regarding the possible limits to the FDA’s power to regulate traditional compounding activities. The CRS report examined the FDA’s regulation of drug compounding and discussed relevant legal authorities. The report also discussed potential limits to the FDA’s authority to regulate human drug compounding.
Legislation that affects FDA authority over compounding activity, culminated in the Food and Drug Administration Modernization Act of 1997 (FDAMA) (P.L. 105-115), the CRS reported. A U.S. Supreme Court decision in 2003, Thompson v. Western States Medical Center invalidated the FDAMA’s advertising provisions on First Amendment grounds, and the federal circuit courts are split on whether the remaining provisions of the FDAMA are “severable” from the advertising provisions and remain in effect. For the states within the Ninth Circuit, the controlling precedent renders the remaining provisions of the FDAMA inoperable, but the opposite is true in the Fifth Circuit, the CRS report said. The legal effect of the FDAMA is unresolved in the rest of the country, according to CRS.
The limit to federal authority with respect to drug compounding remains uncertain, the CRS report said, although Congress could arguably expand the scope of the FDCA to reach traditional compounding. As a matter of policy, the FDA has generally declined to test the current limits of its authority to regulate compounding, preferring to defer to state governments with respect to the regulation of “traditional compounding.” As a result, absent further congressional action, the limits of the FDA’s authority to regulate all forms of compounding will likely continue to be unresolved, the CRS concluded.