In the wake of a hepatitis outbreak linked to a New England compounding pharmacy, Representative Edward Markey (D-Mass.) has released a staff report exploring “the nature of regulatory oversight and gaps in legal authority that led to one of the worst public health tragedies in recent U.S. history.” Titled, “Compounding Pharmacies, Compounding Risk,” the report details federal and state regulatory roles and concludes that while U.S. Food and Drug Administration (FDA) efforts to ensure the safety of compounded pharmaceuticals have been “challenged at every juncture by some members of the compounding pharmacy sector,” state pharmacy boards have not taken a consistent enforcement role.

According to the report, state regulators either do not or cannot “perform the same sort of safety-related oversight of compounding pharmacy practices that FDA has historically undertaken. But it is also clear that absent clear new statutory authority, FDA efforts will ultimately be constrained by gaps in regulatory oversight authority.” Markey said that the hepatitis outbreak “is clearly just the tip of an industry iceberg that has long needed reform and federal oversight. This tragedy demands the strongest response from Congress and federal and state authorities to ensure safeguards are in place to protect patients.” See Representative Ed Markey News Release, October 29, 2012.

Meanwhile, the Congressional Research Service (CRS) has updated its review of FDA 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 compliance guides of 1992 and 2002 outline the factors the agency will consider in exercising pharmacy-compounding enforcement discretion. 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 also 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.