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News & Press: Breaking News

FDA Releases 2018 Compounding Policy Priorities Plan

Friday, January 19, 2018   (0 Comments)
Posted by: IACP
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The Food & Drug Administration (FDA) has released a 2018 Compounding Policy Priorities Plan. Please click here to view.

 

FDA also issued a final guidance on mixing, diluting, or repackaging biological products, which describes the conditions under which the agency does not intend to take action when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling. According to FDA, "These policies are intended to minimize public health risks, while preserving access to these products for patients who have a medical need for them."

 

The International Academy of Compounding Pharmacists (IACP) is thoroughly analyzing and obtaining our members' input on the new proposals as described in FDA's plan. IACP will not take a formal position until the new revised draft GFI/MOU are released and we have the specific details.

 

IACP remains hopeful that any future guidance or proposed rules will reflect the input the agency has received from IACP and other pharmacy and provider groups on how their policies affect patient access to critical compounded medications.We continue to be united in a mission to preserve patient safety and access to needed compounded medications pursuant to state and federal laws and regulations.

For more information:

 

· 2018 Compounding Policy Priority Plan

· Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act

· Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

· Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application


Please email IACP with questions or comments at iacpinfo@iacprx.org.


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