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  4. OTC Monograph Reform: OTC Sunscreen Drugs - 12/15/2021 - 12/15/2021
  1. News & Events for Human Drugs


Event Title
OTC Monograph Reform: OTC Sunscreen Drugs
December 15, 2021

December 15, 2021
3:00 PM - 4:00 PM ET

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On September 24, 2021, FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs. FDA posted the deemed final order (DFO) for sunscreens which sets the current requirements for marketing OTC sunscreen products. FDA also posted the proposed order for sunscreens to amend and revise this deemed final order for OTC sunscreens products.

This webinar will:

  • Discuss the DFO for OTC sunscreen drugs and proposed order for OTC sunscreen drugs
  • Compare and contrast the major provisions of the DFO for OTC sunscreen drugs and the proposed order for OTC sunscreen drug


  • Overview of OTC sunscreen drugs
  • Relevant regulatory history for OTC sunscreen drugs
  • Overview of OTC Monograph Reform
  • DFO for OTC sunscreen drugs
  • Proposed Order for OTC sunscreen drugs


  • General public with an interest in nonprescription (also known as over-the-counter or OTC) drugs
  • Regulatory affairs professionals involved in the development or marketing of OTC drugs
  • Foreign regulators following the development or marketing of OTC drugs
  • Consultants focused on OTC drug development or marketing
  • Clinical research coordinators
  • Importers of OTC drugs


Steven Adah, PhD.
Associate Director of Monographs
Office of Nonprescription Drugs (ONPD) | CDER | FDA



Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been:

  • pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.


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