By Cynthia L. Meyer and Justine E. Lenehan
Last week, FDA posted to its new web portal, OTC Monographs@FDA, the first six of 32 final administrative orders for over-the-counter (OTC) drugs created under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), thus beginning to fully implement the process of transitioning to the new OTC drug review procedures established by the CARES Act. Each of the 6 new administrative orders embodies an OTC monograph under the new framework:
- OTC000001 – Over-the-Counter Monograph M002: Antiflatulent Products for Over-the-Counter Human Use
- OTC000002 – Over-the-Counter Monograph M010: Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use
- OTC000003 – Over-the-Counter Monograph M014: Topical Otic Drug Products for Over-the-Counter Human Use
- OTC000004 – Over-the-Counter Monograph M030: Corn and Callus Remover Drug Products for Over-the-Counter Human Use
- OTC000005 – Over-the-Counter Monograph M016: Skin Protectant Drug Products for Over-the-Counter Human Use
- OTC000006 – Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (at this same time, FDA posted a proposed order (OTC000008) proposing to amend M020 – the OTC monograph for sunscreen drug products).
FDA also posted a final order (OTC000007) embodying the non-monograph conditions codified at 21 C.F.R. § 310.545 pursuant to which insufficient data exist to establish GRASE-status for the use of a myriad of active ingredients in OTC drug products.
The final administrative orders do not introduce any new substantive requirements or conditions, as these deemed final administrative orders took effect as of the date of enactment of the CARES Act, and the substance of these monographs mirror their respective already-existing final monographs codified in the Code of Federal Regulations.
However, as required by the CARES Act, FDA issued a proposed revised order for OTC sunscreen products and transitioned its ongoing rulemaking with respect to sunscreens under this new framework. The deemed final order embodying M020 reflects the pre-CARES Act marketing conditions for sunscreens and will remain in effect until the proposed order is finalized. The proposed order would substantively establish the same provisions as those proposed in FDA’s 2019 proposed rule. See an earlier KKB Insight post covering the 2019 proposed rule. The newly-published proposed order will undergo a 45-day public comment period, and FDA will consider all public comments timely submitted to the 2019 proposed rule during its review. Note, however, that a revised final order may still be some ways off, as the CARES Act precludes a revised final order from taking effect less than one year following its issuance.
Once all of the relevant deemed final orders have been posted to OTC Monographs@FDA, FDA intends to withdraw (or revise, as appropriate) the regulations establishing final monographs and governing the old OTC drug review procedures in title 21 of the Code of Federal Regulations. Publication of these first orders shows FDA’s progress in implementing the new OTC regulatory framework established by the CARES Act. We will continue to monitor FDA’s progress in posting final administrative orders for OTC monographs on its new web portal, OTC Monographs@FDA.
An earlier KKB Insight post summarized key changes to the Federal Food, Drug, and Cosmetic Act (FDCA) made by the CARES Act. As discussed there, the CARES Act overhauled the OTC drug review process by conferring FDA the authority to issue administrative orders in order to add, remove, or change “generally recognized as safe and effective” (GRASE) conditions for an OTC monograph.
As of March 27, 2020, the date of enactment of the CARES Act, the newly created section 505G(b)(8) of the FDCA described the terms upon which certain existing final monographs and tentative final monographs were deemed to be final orders. Since that time, FDA has reviewed all final monographs published in the Code of Federal Regulations and the rulemaking histories for each monograph therapeutic category and identified 32 final orders created as a result of the CARES Act. FDA assigned an OTC monograph number to each of the deemed final orders which corresponds to a particular part or subpart of the Code of Federal Regulations, where applicable.
FDA now plans to harmonize each of the 32 deemed final orders embodying OTC monographs (for example, with respect to terminology and cross references and making other minor changes) and make such deemed final orders available on a rolling basis. The recently posted final administrative orders are the first group of these 32 deemed final orders.
The CARES Act also deemed other regulations that established requirements for specific OTC drugs as final orders if the regulations applied to drugs subject to certain provisions of the law. For example, 21 C.F.R. § 201.326 sets forth certain labeling requirements regarding warnings for OTC drug products containing internal analgesic and antipyretic active ingredients – FDA identified this regulation as a final order. FDA intends to either incorporate such a final order into one of the 32 deemed final orders referenced above, as appropriate, or post it as a separate, standalone final order to OTC Monographs@FDA.
 FDCA, § 505G(k)(2)(A).
 84 Fed. Reg. 6,204 (Feb. 26, 2019).
 86 Fed. Reg. 52,474, 52,476 (Sept. 21, 2021).
 86 Fed. Reg. at 52,475.
 86 Fed. Reg. at 52,475, 52,477. To the extent the regulation also applies to a drug that is not subject to section 505G(a)(1)-(4) or an order under section 505G, the regulation will remain the Code of Federal Regulations.