On September 20, 2021, the Food and Drug Administration (FDA) announced that as part of the Over-the-Counter (OTC) Monograph Reform under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), it had posted an initial batch of four deemed Final Administrative Orders for the following therapeutic categories:1
- Nighttime Sleep-Aid Drug Products for OTC Human Use
- Antiflatulent Drug Products for OTC Human Use
- Topical Otic Drug Products for OTC Human Use
- Corn and Callus Remover Drug Products for OTC Human Use
On March 27, 2020, then-President Trump signed into law H.R. 748, The CARES Act, which added section 505G to the Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355g), which reformed and modernized the OTC drug review process first established in 1972. The law replaced the OTC drug monograph rulemaking process with an Administrative Order Process that allows FDA, among other things, to amend an OTC drug monograph more efficiently.2 Most importantly, as part of this new process, FDA will convert the current OTC drug monographs (both final and tentative, if certain conditions are met) into “Final Administrative Orders.” These Final Administrative Orders were established by the CARES Act and took effect on the date that the CARES Act was enacted (March 27, 2020).3
The agency identified a total of 32 Final Administrative Orders that were created by the enactment of the CARES Act.4 As noted by FDA, some of the Final Administrative Orders that were created by the CARES ACT are based on OTC monographs that were set forth in both proposed and final rules and provide “a baseline of conditions that are generally recognized as safe and effective for each OTC monograph therapeutic category.” 5This initial batch of “deemed” Final Administrative Orders does not make any substantive changes to the old monographs. Generally, the Final Administrative Orders incorporate the requirements of the old monographs, including any technical amendments, formatting and harmonizing language.
Unlike the old OTC drug monographs, all Final Administrative Orders will be posted on FDA’s new web portal, OTC Monographs@FDA. FDA will use a phased approach for issuing Final Administrative Orders for the remainder of the 32 orders. In the future, the issuance of these orders will be announced on the FDA’s new web portal and not in the Federal Register.
Finally, FDA also announced plans to issue a Federal Register notice to withdraw the old OTC drug monographs from the Code of Federal Regulations (CFR) “at a later date once all the relevant deemed final orders have been posted” on the agency’s new OTC monograph web portal. Final Administrative Orders will not be codified in the CFR.
We see this update as an exciting new chapter in OTC drug history and will continue to closely follow the developments in this space.
- See FDA In Brief: FDA Posts an Initial Batch of Four Deemed Final Administrative Orders for Over-the-Counter Drugs, available at FDA In Brief: FDA Posts an Initial Batch of Four Deemed Final Administrative Orders for Over-the-Counter Drugs | FDA; see also, Federal Register :: Final Administrative Orders for Over-the-Counter Monographs; Availability, 86 Fed. Reg. 52,474 (September 21, 2021).
- The Administrative Order Process can be initiated by either industry (i.e., any person or group of persons marketing, manufacturing, processing or developing a drug) or the agency itself (i.e., FDA). Industry can request that FDA issue an administrative order by submitting an OTC monograph order request (OMAR) to FDA. Notably, FDA can initiate an expedited procedure for issuing an administrative order under two circumstances: (1) when a drug poses an imminent hazard to public health or (2) when a change in the labeling of a drug, class of drugs or combination of drugs is reasonably expected to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug.
- See 86 Fed. Reg. 52, 475.