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Administrative Order Details

 

Order Title: Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (ID: OTC000008) - Federal Register Notice

Status

Proposed Order

Summary

FDA is issuing this proposed order to amend and revise the final administrative order, Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, as deemed by sections 505G(b)(8) and 505G(k)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h(b)(8) and 355h(k)(2)(B)) (Deemed Final Order). This proposed order, if finalized, would replace the Deemed Final Order in its entirety with new conditions under which nonprescription sunscreen drug products would be determined to be generally recognized as safe and effective (GRASE) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  It also sets forth certain characteristics that would establish that a sunscreen drug product is not GRASE, proposed to be codified in “Non-Monograph Conditions NM020:  Sunscreen Drug Products for Over-the-Counter Human Use.” This proposed order also proposes to amend and revise “OTC Monograph M016, Skin Protectant Drug Products for Over-the-Counter Human Use,” to address nonprescription sunscreen drug products that are also subject to provisions of that monograph.

You may submit comments for OTC000008 electronically in docket number FDA-1978-N-0018 in the Federal eRulemaking Portal at https://www.regulations.gov.  See the Federal Register Notice of Availability for instructions. Comments must be submitted by November 12, 2021.  Supporting documents can be viewed in the docket.

As stated in the Notice of Availability, FDA will consider all comments that were timely submitted to the public docket for the 2019 proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use”, (84 FR 6204 (Feb. 26, 2019)), to be constructively submitted as comments on the proposed order being issued today.  To enable the Agency to review and address these comments (and future comments that may be submitted on this proposed order) as expeditiously as possible, we request that commenters do not resubmit comments on this proposed order previously submitted on the proposed rule.

 

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