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IACP Files Comments for FDA’s Prescription Requirement Under Section 503A Guidance

Monday, July 11, 2016   (0 Comments)
Posted by: Dagmar Anderson
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IACP Files Comments for FDA’s Prescription Requirement Under Section 503A Guidance



IACP has submitted comments to FDA regarding the Draft Guidance for Industry: Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act.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 that preserve patient and prescriber access to vital compounded medications. Compounding for office administration and anticipatory compounding play two vital roles in today’s modern healthcare system and any guidance put forth must address the ability for patients and prescribers to obtain these medications in a timely and economical manner.

The current draft guidance fails to follow Congressional intent and current State laws or regulations as it pertains to compounding for office administration and also places new burdens on both the pharmacy and the prescriber when attempting to adhere to the Agency’s new interpretation on anticipatory compounding. Additionally, this guidance, coupled with the guidance titled “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act” (Docket No. FDA-2016-D-0271), sets forth two different interpretations of the “prescription requirement” the Agency refers to many times in these guidances. As such, the guidance introduces even more restriction and confusion into the realm of pharmacy practice and will greatly affect patient care."


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


We Need All Members to Comment!


We need to show FDA and our Congressional representatives how important this issue is for our patients and practitioners. The more comments submitted to FDA, the better. Please make your voice heard.  

You are welcome to copy and paste IACP's comments, or simply comment that you support IACP's submitted comments. COMMENTS ARE DUE: by July 18, 2016. 


How To Submit Comments for FDA’s Prescription Requirement Under Section 503A Guidance


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.

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