Regulating Compounding Pharmacies

A new law aims to fill the gaps in FDA inspection and enforcement of compounding pharmacies.

A resident in a university lab looks at a test tube.

Outraged over a 2012 fungal meningitis outbreak traced back to a Framingham, Mass.–based drug compounder that left 64 people dead and more than 700 sickened, Congress passed the Compounding Quality Act in November 27, 2013.

The law is designed to plug a regulatory gap that existed because drug compounding pharmacies have traditionally been regulated by the states, not the federal government, in many cases even when they grew bigger and crossed the line from “compounding” to “manufacturing.”

During the 1990s, however, some compounding drug makers moved into so-called nontraditional compounding, which involved manufacturing much larger batches of drugs that they would sell to hospitals and physicians’ offices, including the injectable steroid methylprednisolone acetate that led to the 2012 meningitis outbreak. The new law, which is part of HR 3204, the Drug Quality and Security Act (DQSA) of 2013, clarifies regulatory oversight over traditional compounders and sets up a voluntary category known as “outsourcing facilities” under a newly created section 503B of the Federal Food, Drug, and Cosmetics (FD&C) Act. This new category is aimed at bringing mostly larger compounding manufacturers squarely under the federal regulatory and enforcement fold.

The drug compounding community is now waiting for more detailed guidance later this summer or fall from the FDA on several questions that the law has left unresolved.