Excerpt from Health Affairs - May 1, 2014
The Drug Quality and Security Act is two-part legislation that became law in November 2013. One part of the law is commonly known as the Compounding Quality Act, an effort to give the FDA more of the unambiguous authority over the compounding drug industry that Representative Waxman had sought, making a distinction between traditional compounders who work at the neighborhood pharmacy and companies producing large quantities of compounded drugs without the need for a prescription. The other part of the law sets up a national prescription drug "track and trace" system designed to ensure a uniform nationwide standard that Congress was eager to pass before a tough new California law went into effect. Although essentially a separate piece of legislation, the DQSA's track-and-trace provisions provided a convenient, related, and quickly moving vehicle for the Compounding Quality Act to be enacted.
The Compounding Quality Act makes two major changes to current law: It re-enacts the compounding provisions from the Food and Drug Administration Modernization Act, with the unconstitutional advertising provisions removed, and sets up a voluntary category known as an "outsourcing facility" under section 503B. This new category allows compounders making sterile products--such as the steroid injections manufactured by NECC--to avoid the complex and time-consuming new drug approval requirements of the FD&C Act and to sell unlimited quantities of drugs on the FDA's drug shortage list without requiring a preexisting prescription anywhere in the country. In exchange for such flexibility, compounders must follow, among other things, formal and often expensive CGMPs, compound under the supervision of a licensed pharmacist or physician, and use only drugs from a bulk ingredients list. Companies registered as outsourcing facilities are also not allowed to compound copies of drugs already on the market unless they are on a drug shortage list and must follow new labeling requirements, report any adverse drug reactions to the FDA, be inspected by the FDA based on a set of risk factors, and pay the FDA an annual $15,000 fee.
Outbreak originating from Main Street Pharmacy in Newburn, Tennessee
Outbreak originating from New England Compounding Center in Framingham, Massachussetts: