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Breaking News HR 3204 FDA Releases Draft Guidance Documents (CPGs), 12.5.13
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FDA Releases Draft Guidance Documents (CPGs) for Comment


The US Food and Drug Administration (FDA) today released its draft guidance documents (CPGs) for the new 503(b) and 503(a) sections of the Drug Quality and Security Act.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

Please email IACP with any questions or CPG input at


Posted 12.5.13

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