Continuing the federal laws related to pharmaceuticals and the FDA, this week, we present the
- Drug Quality and Security Act (DQSA) of 2013
H.R. 3204 Drug Quality and Security Act (DQSA) of 2013
The DQSA incorporates and brings up to date the court decisions regarding the Food and Drug Modernization Act of 1997. It resulted from the New England Compounding Center (NECC) tragedy where there were 64 deaths and hundreds sickened in 14,000 patients. The outbreak of fungal meningitis occurred in 2012 and was traced to fungal contamination in three lots of compounded methylprednisolone suspension for epidural steroid injections.
The law amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs; it exempts compounded drugs from new drug requirements, labeling requirements, and track and trace requirements if the drug is compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility and meets applicable requirements. It establishes requirements for 503a traditional compounding pharmacies and for 503b outsourcing facilities.
Next week. we will review the DQSA and discuss its implementation.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
IJPC
Remington: The Science and Practice of Pharmacy Twenty-second edition
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