Hyman Phelps and McNamara
Firm Publications

The Need for Clarity: Where Should FDA Focus Its Resources When Implementing the Compounding Provisions of the Drug Quality and Security Act?
February 4, 2014

After months of Congressional consideration throughout the year, on November 27, 2013,
President Obama signed into law the Drug Quality and Security Act1 (DQSA). Title I of the
DQSA, titled the Compounding Quality Act, both removes the unconstitutional advertising and
promotion provisions that for years plagued Section 503A of the Federal Food, Drug, and Cosmetic
Act (FDCA)2 and attempts to clarify long-standing confusion concerning enforcement of 503A.3
The law became effective upon enactment, and Section 503A again is enforceable nationwide.

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