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Polsinelli - Environmental and Natural Resources

November 2013


Congress Passes Compounding Quality Act


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


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The Senate approved a human prescription compounding bill (H.R. 3204) Monday by voice vote, sending it to President Obama for his signature. The bill had been in the works since last year, when a meningitis outbreak from contaminated steroid pain injections killed at least 64 people and sickened hundreds more. The source was ultimately traced to a now-closed pharmacy in Framingham, Mass., the New England Compounding Center (NECC), where inspectors found mold, standing water and other unsterile conditions.

Prior to the NECC outbreak, compounding pharmacies were regulated by state pharmacy boards, and the FDA said it didn't have the authority to properly regulate the industry. Its hope was that new legislation would change that. The bill had therefore been subject to debate between lawmakers, Agency representatives, industry, and consumer groups. The camps were often at odds over the scope of the new legislation, the extension of FDA authority, the purview of the states, and the practical implications of a new regulatory scheme.

Ultimately, the bill creates a new, voluntary category of "outsourcing facilities," which are those large compounding pharmacies that register with FDA and submit to federal quality standards and inspections. The bill's supporters hope that the new rubric creates competitive incentive to become an FDA-registered facility as a marketing advantage to sell to hospitals, clinics, and doctors choosing to buy from such facilities. Compounding pharmacists who do not register with the FDA will continue to be governed by state boards of pharmacy and will be subject to the existing law, which is part of the Federal Food, Drug, and Cosmetic Act.

FDA officials said they are pleased with the new legislation. "While this bill does not provide FDA with the additional authorities it sought, it provides a regulatory framework for certain compounders who register with the FDA," said FDA spokeswoman Erica Jefferson, adding that "the agency will continue enforcing the law to the full extent of its authority in order to protect public health."

There are many open questions about the bill itself and its practical implementation. We will cover these issues in-depth in upcoming articles.

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