In the wake of a meningitis outbreak purportedly linked to a contaminated compounded steroid injection, the Congressional Research Service (CRS) has updated its look at the Food and Drug Administration’s (FDA’s) authority to regulate drug compounding. In its October 17, 2012, report, CRS examines FDA guidance documents on the issue, a 1997 amendment to the Federal Food, Drug, and Cosmetic Act (FFDCA) and conflicting decisions from the Fifth and Ninth Circuits to determine the extent of that authority in an era when pharmacies are no longer compounding drugs to create medication for an individual patient, but are instead producing drugs on a much larger scale.
FDA’s compliance guides of 1992 and 2002 outline the factors the agency will consider in exercising enforcement discretion as to pharmacy compounding. CRS notes that such guidance does not establish legally enforceable rights or responsibilities and does not legally bind the public or FDA. Congress addressed FDA’s role in the regulation of drug compounding as part of the FDA Modernization Act of 1997, generally exempting compounded drugs from FFDCA requirements on drug adulteration, misbranding, and new drug approval, if certain conditions are satisfied. “The compounded drug must comply with standards of an applicable U.S. Pharmacopoeia, or made from FDA-approved drug ingredients, meet certain manufacturing criteria, and the drug compounded must not be one that appears on a list of drugs or drug products that have been withdrawn or removed from the market because the product, or components of the product have been found to be unsafe or not effective.” The pharmacy also may not compound regularly or in inordinate amounts “any drug products that are essentially copies of a commercially available drug.”
The law included provisions on advertising, stating that drugs may be compounded and subject to the exemptions if they are based on a valid prescription that was not solicited and if the pharmacy, licensed pharmacists, or licensed physician does not advertise or promote the compounding of any particular drug. The advertising provisions and whether they are severable from the remainder of the statute were at issue before the Fifth and Ninth Circuits, and were found unconstitutional by the U.S. Supreme Court, which did not address the severability issue.
According to author Jennifer Staman, “the cases have created an interesting scenario of non-uniform enforcement throughout the U.S. In the Fifth Circuit, compounded drugs are specifically exempted from new-drug, adulteration, and misbranding requirements of the FFDCA if certain criteria are met; while in the Ninth Circuit (and, according to the FDA, the rest of the United States), compounded drugs are subject to these requirements, but the FDA may exercise discretion in taking action against an entity that violates these provisions.” The report may be purchased from CRS. See Health Legislation (a CRS blog), October 23, 2012.