FDA Issues Compounding Guidance

By Walter F. Roche Jr.

Unsealed or loose ceiling tiles in production areas, using outdated disinfecting agents and visible microbial contamination: those were just some of the things seen by federal inspectors examining drug compounders across the country.
In a 12-page final guidance issued late last week, officials of the U.S. Food and Drug Administration, acknowledged that the agency does not inspect the vast majority of drug compounding operations.
The guidance, which is nearly identical to a proposed version issued two years ago, is yet another example of government efforts to avoid a repeat of the 2012 fungal meningitis outbreak which sickened hundreds and killed more than 100.
The outbreak was traced to a Massachusetts drug compounding company that had successfully evaded federal regulation as it shipped out thousands of vials of a spinal steroid laced with deadly fungus.
Compounding is preparation of a custom formulation of a medication to fit the unique need of a patient which cannot be met with commercially available products. The 12-page FDA document is intended to serve as a guide to drug compounders on what standards the FDA expects them to meet to avoid unsanitary condition.
The guidance acknowledges that the adverse events from contaminated compounded drugs are very likely under reported and a large number of drug compounders are subject only to state regulation.
"The agency is often not aware of these pharmacies, their conditions and practices and potential problems with the quality and safety of their products," the guidance states.
The guidance urges state regulators to "take appropriate action" when unsanitary conditions are identified. It also asks those state regulators to inform the FDA of their findings.
The guidance does urge drug compounders to take immediate action when unsanitary conditions are discovered. Dr. Michael Carome of Public Citizen, which has pushed repeatedly for tighter regulation of compounders, said the guidance should help drug compounders in meeting expected standards.
"The numerous detailed examples of insanitary conditions provided in the guidance should assist compounding facilities in preventing, identifying and remediating insanitary conditions," Carome said.
While he said Public Citizen generally supports the guidance, it does not support a footnote in which the agency gives what appears to be a blanket exemption to drugs compounded in a doctor's office.
The footnote states that the "FDA generally does not intend to take action ...against a physician who is compounding a drug product, repackaging an FDA-approved drug product, or who is mixing, diluting, or repackaging an FDA-licensed biological product, provided that such production by the physician occurs in the physician’s office for in-office administration, to his patients."
Carome said Public Citizen had urged the FDA to drop the footnote during the extended comment period.
Contact: wfrochejr999@gmail.com