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News & Press: Breaking News

FDA Issues Three New Draft Guidances

Monday, April 18, 2016   (1 Comments)
Posted by: Dagmar Anderson
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The Food & Drug Administration (FDA) has announced three new draft guidances related to the compounding of human drugs. Please click here to view.

 

IACP thoroughly is reviewing the three guidances, and will provide a detailed summary to members. Based on what we've analyzed to date, IACP is disappointed, once again, that the FDA is ignoring Congressional intent in regards to office-use compounding with the publication of these drafts. It is clear the FDA believes that non-hospital owned 503A pharmacies cannot participate in office-use compounding while in the same breath, allowing hospital-owned pharmacies (which are still under the jurisdiction of 503A) CAN participate in office-use compounding as long as certain restrictions are met. Statutorily, this makes absolutely no sense – how can one “type” of 503A pharmacy perform office-use while another may not? In addition, FDA’s draft guidance on anticipatory compounding is confusing at best and may ignore the clear language of the bill when it comes to defining this practice.

 

Please keep in mind this guidance is labeled as DRAFT guidance and as such, comments can be submitted within 90 days. Once IACP performs a thorough review of the proposed FDA guidances, IACP will engage the agency in the commenting process.

 

Please email IACP with any questions or comments at iacpinfo@iacprx.org.

Comments...

William Blair says...
Posted Tuesday, April 19, 2016
We have customers and patients who want to get involved by contacting their Senators and Representative to insure that they will continue to have access to compounded drugs. Please draft a letter that our customers and patients can send to their Congressmen requesting specific action. The letter should include to whom the letter should be sent.

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