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News & Press: Breaking News

FDA Announces Inspection Procedural Change and Releases Additional FDA Guidance Documents

Tuesday, July 12, 2016   (0 Comments)
Posted by: Dagmar Anderson
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FDA Announces Inspection Procedural Change and Releases Additional FDA Guidance Documents 

Inspections Procedure Change

On July 12th, FDA posted a notice announcing a change in its procedure for inspections of certain human drug compounders, which will take effect on August 1, 2016. FDA has stated it's making this change in response to stakeholder input. Click here to view FDA's notice.


One of IACP's primary 2016 Compounders on Capitol Hill Asks (click here to view) challenged FDA's inspections of 503A compounding pharmacies using Current Good Manufacturing Standards (cGMPs) instead of under U.S. Pharmacopeial (USP) or other standards established by state pharmacy laws and regulations.

Specifically IACP has questioned why: (1) records of inspections (483s) based on cGMPs were published to the FDA’s website publicly, for all to see, even when FDA later determined the pharmacy was in compliance with section 503A and handed the pharmacy investigation back to the State Board of Pharmacy, and (2) the FDA would not always give pharmacies copies of the 483 when they were leaving the inspection. Essentially, pharmacies had to guess whether one would be issued and what would be in it.


Now according to FDA, the inspector will have to make a preliminary determination that the pharmacy is or is not a 503A and alert them to that within the 483.  
Although IACP is certainly encouraged by the July 12th notice, we are working to obtain clarification on what FDA will use to determine what constitutes a 503A pharmacy. It should be noted – we rarely see a Federal agency publish this type of notification where they outline a course correction in their procedures without some sort of influence. It is through the work of IACP, our members, the DQSA Coalition and our Congressional allies that result in the type of notification we saw the FDA publish today.


Thank you AGAIN to our Members for all of your efforts in making our CCH 2016 Asks heard by your congressional representatives. We also thank all of our current members and all of those who donate to the OneFund campaign – without your support, our work would not be possible! IACP will keep you apprised of any updates on this matter.


FDA Releases Additional Guidance

FDA released two draft guidance documents on July 8th regarding compounded drug products which are “essentially copies” of commercially available drugs under Section 503A and 503B. The guidance documents can be found at the below links.


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

IACP is reviewing these guidance documents and will provide a summary to the IACP membership.


Please email IACP at with any questions. Thanks for your support!

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