An OTC product that complies with a monograph does not require an annual report. You need to initially comply with the applicable monograph and then ensure that if there are changes that you still comply with the monograph.
Since there was no IND, NDA or ANDA submitted there is nothing to update from an Annual Report perspective.
The OTC product must also comply with 21 CFR 201.66 which covers all OTC drug and drug-cosmetic products, whether marketed under a new drug marketing application (NDA), abbreviated new drug application (ANDA), or OTC drug monograph (or product not yet the subject of a final OTC drug monograph).
Darlene
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Darlene O'Banion
Regulatory QS
San Jose CA
USA
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Original Message:
Sent: 11-09-2011 10:58
From: Elena Martsen
Subject: Annual report for OTC drugs
Dear colleagues,
Could someone advise me on post-marketing requirements for OTC drugs, namely, annual report.
I realize that if OTC drug was approved under NDA or ANDA then those post-marketing requirements would apply, but what if OTC drug was approved under a monograph or under a citizen petition? Is there any requirement to submit AR?
Thanks in advance!
Sincerely,
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Elena Martsen
Chapel Hill NC
United States
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