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Capitol Connections Article FDA Update 12.13.13
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FDA Releases Draft Guidance Documents (CPGs) for Comment - IACP Members Please Submit Your Input!

The US Food and Drug Administration (FDA) today released its draft guidance documents (CPGs) for the new 503(b) and 503(a) sections of the Drug Quality and Security Act. 

Click here to review 503(b) section (Discusses how registration will be handled)

Click here to review 503(a) section (Please note page 5 and start at line 155) 

Both of these documents are open for comment and input to the FDA by February 4, 2014. IACP currently is reviewing and will be compiling our formal submission to the FDA.

ACTION ITEM: IACP strongly encourages all members to review these documents and submit comments on how these drafts may affect your business and your practice. Additionally, you should circulate these to physicians and other prescribers with whom you work so that they are informed of the pending changes as well. The electronic address for submitting comments to the FDA is including in each of the 503(b) and 503(a) documents.

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

FDA HR 3204 Stakeholder Conference Recording Available

If you'd like to listen to the FDA Pharmacy Compounding Stakeholder Conference held on Tuesday, December 3, 2013, a replay of the teleconference will be available for the next 30 days, by calling 1-203-369-3325<tel:1-203-369-3325>, or for international callers, 1-800-723-6769<tel:1-800-723-6769>. 

Click here for a transcript of the question & answer transcript from this FDA teleconference.

 

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