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IACP Files Comments for FDA's Draft Guidance Compounded Drug Products That Are Essentially Copies

Tuesday, October 11, 2016   (2 Comments)
Posted by: IACP
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October 11, 2016


IACP Files Comments for FDA's Draft Guidance Compounded Drug Products That Are Essentially Copies

IACP has submitted comments to the Food & Drug Administration (FDA) regarding the Draft Guidance:Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act



 "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 to preserve patient and prescriber access to vital compounded medications. Providing clear direction as to the FDA’s thoughts regarding this important subject help not only guide Agency investigators during inspections but gives additional insight to the pharmacy industry as a whole on what the FDA expects from this practice of pharmacy.  


IACP is concerned with several main points of the proposed guidance, which we outline below, and we look forward to starting a dialog with the Agency on proposed solutions to the issues raised by our Academy."


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 TONIGHT at 11:59 pm EASTERN time.

How To Submit Comments for FDA’s Draft Guidance Compounded Drug Products That Are Essentially Copies

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
4638 Riverstone Blvd.
Missouri City, TX 77459


Dagmar E. Anderson (Anderson) says...
Posted Monday, October 24, 2016
IACP Members: Please call IACP at 281/933-8400 or email if you have questions on the comments IACP filed with FDA on its Draft Guidance on Compounded Drug Products that are Essentially Copies. Please also stay tuned to our Capitol Connections member newsletter and member alerts as we continually keep Members posted on process status.
Mike Boehmer says...
Posted Thursday, October 20, 2016
Folks, these are some PANSY arguments from IACP. I expect much more forceful representation. These jokers are trying to gut our profession, which I have worked in for over 25 years and we all face going back to retail or retiring. I didn't work for NECC, didn't kill anyone nor did I overcharge or dispense crappy products, yet I get punished, along with every patient and doctor in America for one companies illegal behavior. If the FDA gave a CRAP about public health, they would recognize that pharmacists are quite capable of making MANY products with BETTER quality, BETTER design and BETTER PRICES than their jacked up system of tyranny. Do something, while there still is an IACP. You are on borrowed time, just like us.

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