On November 28, President Obama signed into law the Drug Quality and Security Act (formerly HR 3204) which strengthens the provisions of the Food, Drug, and Cosmetic Act relating to the safety of compounding pharmacies. The new law is important to physicians both as prescribers of compounding pharmaceuticals, and as potential passive investors in compounding pharmacies.
The Food and Drug Administration (FDA) immediately outlined plans to encourage large-scale compounding pharmacies to register with the agency and agree to increased federal regulations. The oversight comes in response to a fungal meningitis outbreak last year that killed 64 people and sickened more than 750 others across the country. The source of the outbreak was traced to tainted steroid injections mixed by the Framingham, Mass.-based New England Compounding Center.
A section of the new Drug Quality and Security Act allows large drug-compounding plants, which mix ingredients to make a custom blend of medicine, to register as “outsourcing facilities” and be subject to FDA oversight, including inspections and compliance with “current good manufacturing practices.”
“We will be encouraging healthcare providers and health networks to consider strongly purchasing compounded products from FDA-registered and regulated facilities,” FDA Commissioner Margaret Hamburg said, according to USA Today. “This will be a critical step they can take to better assure the health and safety of their patients.”
Outsourcing facilities will also be required to report specific information about the products they compound, including a list of all the products compounded during the previous six months, and details about the source of the active ingredient, as well a report known as adverse effects.
“We can say that it will be difficult for us to identify a compounding pharmacy that chose not to register as outsourcers and that try to hide out in the category of traditional compounders,” she says. “In those cases, we won’t be able to do proactive inspections of them. We’ll have to wait until we hear about them through either an adverse quality or report complaint.”
That has been a chief criticism of compounding pharmacy law. The federal government lacked the authority to regulate local compounding pharmacies, and state and local governments lacked the sophistication and budget to protect the public from unsafe manufacturing practices.
In fact currently, according to Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, the FDA doesn’t know for certain how many compounding pharmacies exist in the U.S., USA Today notes. She adds that the number could range from 700 businesses to 1,000 such businesses. Hopefully this new law will improve reliability and safety of compounding pharmaceuticals.