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News & Press: Breaking News

FDA Issues Final Rule Amending List of Drug Products Not to Be Compounded

Thursday, October 6, 2016   (2 Comments)
Posted by: IACP
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The U.S. Food and Drug Administration (FDA) today issued a final rule amending FDA’s list of drug products that "may not be compounded under certain sections of the Food, Drug, and Cosmetic Act (FD&C Act) that allow the marketing of unapproved compounded drugs."

 

Click here to read more from FDA.

Please note: this FDA final rule pertains to the updating of the “do not compound” or “negative” list. The list is effective 30 days from tomorrow.

Click here for the proposed new list which begins on page 31 of FDA's document.

IACP's Takeaway on the FDA Rule

IACP's Executive Vice President John Voliva, RPh, has thoroughly reviewed the FDA's final rule. His observations include:

  • To our knowledge this is the first proposed FDA final rule since the passage of the Drug Quality & Security Act (DQSA).
  • The final rule does not include any content we were not anticipating except for:
    • No change to how adenosine phosphate is listed. FDA argues that adenosine mono-, di- and triphosphate are not currently available for use in compounding by 503A pharmacies because they do not has USP  monographs nor do they appear in an FDA approved product;
    • Oxycodone without abuse deterrent properties has NOT been added to the list.
  • Remember: The negative list only applies to human drug compounding.

"IACP appreciates FDA's efforts to develop the list of drugs removed from the market for safety or efficacy reasons via the formal rule making process. It allows IACP members, our allies in the industry and legislators to see the FDA's thought process in creating and administering the list. IACP hopes the formal rule making process can be extended by the Agency to other regulatory initiatives the FDA is undertaking for compounding, especially those already identified as published draft guidances." 

Please email iacpinfo@iacprx.org if you have any questions. 

 

Comments...

Dagmar E. Anderson (Anderson) says...
Posted Wednesday, October 12, 2016
Masoud - check out IACP EVP John Voliva's article for clarification. https://iacp.site-ym.com/page/FDALists101216
Masoud Rashidi says...
Posted Thursday, October 6, 2016
Why don't I see domperidone? Does that mean it's ok to compound?

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