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FDA Issues Revised Draft Guidance on Reporting Drug Sample Information Under the ACA

22 July 2014
On July 11, FDA issued new draft guidance concerning drug sample reporting mandated under the Affordable Care Act (ACA).  The guidance, Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act, replaces agency’s earlier April 2012 guidance, Compliance Policy on Reporting Drug Sample Distribution Information.  In this new document, the agency provides more detailed direction  to manufacturers and authorized distributors of record submitting sample information under section 6004 of the ACA.  For instance, the guidance provides definitions relevant to drug sample submissions, information on the Electronic Submissions Gateway, and FDA’s interpretation of section 6004, including who should submit the drug information, how it should be submitted, and what information should be included.  It also announces an updated enforcement policy, requiring the submission of data for the 2014 calendar year by April 1, 2015.

To ensure comments are considered before work begins on the final version, comments on the draft should be submitted by October 9, 2014.  The draft guidance is available here.


The author thanks Katelyn Ruiz for her assistance.

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