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News & Press: Breaking News

Congress Preserves Access to Compounded Meds including Compounding Language in Federal Funding Law

Monday, May 8, 2017   (0 Comments)
Posted by: Dagmar Anderson
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In a considerable win for patients who need compounded medications, the International Academy of Compounding Pharmacists (IACP), working with the DQSA Coalition, is very pleased to announce that the President has signed the Congressional Omnibus bill into law, HR244, which provides funding through September 30, 2017, and includes language that addresses the Memorandum of Understanding, office-use, and pharmacy inspections.

 

Champions in Congress have acted to preserve access to patients that turn to compounding for lifesaving medications. This bipartisan legislation includes critical language which clarifies congressional intent on several compounding regulations implementing the Drug Quality and Security Act (DQSA) of 2013. The regulations addressed are among those on which Congress had asked FDA for additional clarity and expressed strong concern that FDA implementation actions were drastically decreasing patient access to vital compounded medications.

 

These provisions can be found in the reports accompanying the omnibus appropriations bill the President signed, HR244, in the section funding the FDA. The report language is meant as a way to clarify congressional intent of the laws the agencies are basing their policies on, in this case the Drug Quality and Security Act (DQSA) of 2013. In this report, the Congress has clearly stated that the FDA is misinterpreting the DQSA in compounding policies and overstepping their regulatory authority, and directs the FDA to change their DQSA policies to align with statute and the congressional intent expressed in the report.

 

While not as powerful as legislation, this report language will give us a strong tool as we work with the Congress and the new administration, including Secretary Price and FDA Commissioner Gottlieb, towards FDA policies that adhere to the laws Congress writes and that protect both patient safety and patient access to critical compounded medications.

 

Please click here to review the report language accompanying the HR244 legislation which recently passed.

 

Please click here to view a summary of some of the specific compounding-related language and respective page numbers within the report.

 

In summary, the language calls on FDA to do the following:

 

·         Draft a new memorandum of understanding that does not include “dispensing” within the MOU.  Congress expressed concern that the FDA draft MOU includes both “dispensing” and “distribution” of compounded medications.  Congress made clear in the language that FDA does not possess this authority and specifically stated, “Congress only allowed the FDA to regulate distribution” under the MOU and “Congress did not intend to include dispensing of compounded drugs over state lines within the scope of the MOU.”

 

·         Release new guidance to allow 503A pharmacists to compound for “office-use” for prescribers, hospitals and other health systems.  Congress expressed concern that patient access is decreasing to compounded medications, due to FDA’s implementation actions of prohibiting all office-use compounding even where “this practice is authorized in the vast majority of states and was intended to be allowable under DQSA.” 

 

·         Cease inspecting state-licensed 503A pharmacies under current Good Manufacturing Practices (cGMPs).  Congress instructed FDA to inspect 503A pharmacies under USP standards or other applicably pharmacy inspection standards adopted by state law or regulation. Congress also stated that it “reminds the FDA that compounding pharmacies are not drug manufacturers, but rather, are state licensed and regulated health care providers that are inspected by state boards of pharmacy pursuant to state laws and regulations.”  Congress further stated, “compounding pharmacies are more appropriately inspected using USP standards or other pharmacy inspection standards adopted by state law or regulation in the state in which a pharmacy is licensed.” 

 

IACP would like to express our gratitude to the Representatives and Senators who worked tirelessly to preserve patient access to vital compounded medications, which can mean the different between life and death for the patients that depend upon these compounded medications. 

 

 

 


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