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Capitol Health Call
January 8, 2014

The Drug Quality and Security Act Becomes Law

Author Affiliations

Copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2014;311(2):128. doi:10.1001/jama.2013.285757

The Drug Quality and Security Act, signed into law November 27, will clarify federal law regarding pharmacy compounding. It also creates a new uniform framework for tracking drugs from the manufacturer to the pharmacy and is designed to reduce drug thefts and counterfeiting.

The law’s compounding element was a response to the 2012 fungal meningitis outbreak that brought attention to legal and regulatory gaps that enabled the compounding pharmacy to disregard basic procedures needed to ensure the manufacture of sterile products. Under the new law, traditional local pharmacies will continue to be regulated primarily by state boards of pharmacy, while large-scale compounders intending to operate outside the bounds of traditional pharmacy practice, which they were previously designated, can register as an outsourcing facility that is subject to oversight by the Food and Drug Administration.

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