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Polsinelli - Environmental and Natural Resources

December 2013


Compounding Quality Act: Critical Implementation Begins Now for Stakeholders


Life Sciences Professionals:


Kevin R. Sweeney

Practice Area Chair


Ari M. Bai
Mary Beth Blake
Yu Cai
Elton F. Dean III
Kathryn J. Doty
Robert O. Enyard Jr.
Anita R. Estell
Geoffrey D. Fasel
Ron Galant
Melissa Gilmore
Kimberly A. Honeycutt
Andrew T. Hoyne
J. Morgan Kirley
Gregory M. Kratofil
Jane K. McCahill
Cortney E. Mendenhall
Tara A. Nealey
Jay E. Pietig
Andrea M. Porterfield
Rebecca C. Riley-Vargas
Thomas J. Schenkelberg
Kelley A. Schnieders
Teddy C. Scott
Christopher P. Simpson
Timothy D. Steffens
James M. Stipek
Steven K. Stranne
Kevin R. Sweeney
Tracey S. Truitt
Brian G. Wallace
Michael A. Williamson
Patrick C. Woolley


To learn more about our Life Sciences practice, or to contact one of our Life Sciences attorneys, click here.


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On Wednesday, December 4, FDA will publish six key documents in the implementation of the Compounding Quality Act, signed into law by President Obama on Monday, December 2. In addition, FDA has withdrawn its current guidance entitled "Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act," as well as CPG Section 460.200 of the Compliance Program Guidance Manual entitled "Pharmacy Compounding," which had until today represented FDA's stance on, and enforcement of, human drug compounding. Stakeholders are urged to review the documents, which will directly affect their businesses. FDA strongly requests all stakeholders to provide FDA with lists of what bulk APIs should be continued to be permitted to be used in compounding, what compounding practices will still be permitted under state pharmacy law, and other issues critical to the continuation of their businesses.

Advance copies of these proposed rules and notices are available here:

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