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​IACP Files Comments for FDA's Insanitary Conditions at Compounding Facilities Draft Guidance

Monday, October 3, 2016   (0 Comments)
Posted by: Dagmar Anderson
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IACP has submitted comments to FDA regarding the Draft Guidance for Industry: Insanitary Conditions at Compounding Facilities.


"IACP understands and supports the need to protect public health. However, when providing guidance, it is essential that FDA adheres to the plain language of statutes and Congressional intent that preserve patient and prescriber access to vital compounded medications. Ensuring compounded medications are not prepared under insanitary conditions should be of the upmost importance, however, Guidance to the matter for state licensed pharmacies should ensure that proper adherence to State law and USP General Chapters <795> and <797> are not superseded. 

The current draft guidance fails to follow Congressional intent, current State laws or regulations and USP General Chapters <795> and <797> as it pertains to pharmaceutical compounding. It also appears to attempt to exert current Good Manufacturing Practices (cGMP) on pharmacies which are clearly exempt from these requirements via Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act).


IACP is concerned, both from the language contained in this guidance and from the agency’s recent announcement on inspections, effective August 1, 2016, that the FDA will attempt to use findings regarding insanitary conditions as a mechanism to find a pharmacy not compliance with Section 503A and hold the pharmacy as an unregistered Outsourcing Facility or Manufacturer." 

Please click here to view IACP's entire comments to FDA.

IACP Members are Welcome to Use our Comments

You are welcome to copy and paste IACP's comments, or simply comment that you support IACP's submitted comments. COMMENTS ARE DUE: by October 3, 2016 - Midnight.

How To Submit Comments for FDA’s Insanitary Conditions at Compounding Facilities Draft Guidance for Industry

IACP has put together some how-to instructions on filing FDA comments to make this as convenient as possible for you.

Click here to access How-To Instructions on Filing Comments with FDA.

Remember. The more comments we submit to the FDA the better for our patients and our profession. Please join IACP in doing so!

Email with any questions.

International Academy of Compounding Pharmacists
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Missouri City, TX 77459

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