News & Publications

ASRM Joins Call to Congress to Reform FDA Legislation to Address Unsafe Drug Manufacturing by Compounding Pharmacies

September 12 , 2013
by: ASRM Office of Public Affairs
Published in ASRM Bulletin: Volume 15, Number 27

As Members of Congress return to work after their month long August recess, ASRM has joined the Working Group on Pharmaceutical Safety in its call to Congress to close loopholes in the Federal Food, Drug, and Cosmetic Act (FFDCA) which have allowed for the unsafe manufacturing of drugs by compounding pharmacies. The practices have resulted in serious disease outbreaks and over 60 deaths.
 
While recognizing the importance of preserving access to compounded drugs when patients cannot be treated with an FDA-approved product for documented medical reasons, the working group has issued a policy statement calling for specific legislative remedies to safeguard the public health.
 
Broadly, the policy statement recommends: 

  • The restriction of  manufacturing of medications that do not meet federal safety, efficacy, or quality standards and are produced under the guise of pharmacy compounding outside of FDA oversight. 
     
  • The prohibition of the compounding of what are essentially copies of commercial products, unless there is a significant medical rationale for an individual patient. 
     
  • The requirement to disclose to patients when they are receiving a compounded product that is exempt from FDA evaluation and oversight for safety, efficacy, and manufacturing quality. 

The full text of the policy statement which includes specific recommendations can be found at http://www.4rxsafety.org/resources/ 


The ASRM Bulletin is published by ASRM's Office of Public Affairs to inform Society members of important recent developments. Republication or any other use of the contents of the Bulletin without permission is prohibited. To request permission to quote or excerpt material from the Bulletin, contact Sean Tipton at stipton@asrm-dc.org.   

Contact

Sean Tipton
Phone: 202-863-2494
Email: stipton@asrm-dc.org

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