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The Compounding Quality Act: Summary

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.

Survey of Registered Voters

WGPS Survey of Registered Voters - September 18, 2013
WGPS Survey Results.pdf
Adobe Acrobat document [489.8 KB]

Policy Position Statement

Policy Statement on Pharmacy Compounding Legislation
A statement addressed to Congress that specifies policy recommendations that are critical to protect the public health and to uphold the integrity of the Federal Food Drug and Cosmetic Act.
Policy Statement on Pharmacy Compounding[...]
Adobe Acrobat document [217.0 KB]

Editorials and Commentary

Medical Journal Articles

Congressional Reports and FDA Investigations

Additional Resources

Recent Compounding-Related Outbreaks

Outbreak originating from Main Street Pharmacy in Newburn, Tennessee

Outbreak originating from New England Compounding Center in Framingham, Massachussetts:

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