On September 21, 2021, the United States Food and Drug Administration (âFDAâ or âthe Agencyâ) announced the release of the first batch of final administrative orders for over-the-counter (âOTCâ) drug monographs . This decision marks a new era in the regulation of over-the-counter drugs. Codified by the Coronavirus Aid, Relief and Economic Security Act (âCARES Actâ), the new administrative process replaces the time-consuming and resource-intensive rulemaking procedures for the establishment. , revision and modification of over-the-counter drug monographs. In its announcement, the FDA also outlined the process for making final administrative orders available to the public as well as the agency’s plans to withdraw regulations establishing final OTC drug monographs before the law is passed. CARES.
The CARES law
The CARES Act of March 2020 added Section 505G to the Federal Food, Drug, and Cosmetic Act (âFDCAâ) (21 USC Â§ 355g). This new section modernizes the over-the-counter drug review process, which was originally established in 1972. As part of the over-the-counter drug review, each therapeutic class has its own over-the-counter monograph. The FDA considers a drug to be generally recognized as safe and effective (âGRASEâ) if the product meets the conditions described in an over-the-counter monograph. These conditions include, among others, the specified active ingredients, uses / indications, doses, routes of administration, labeling and testing.
Historically, the FDA has established, revised and amended an OTC monograph through the regulation of notices and comments under the Administrative Procedure Act (âAPAâ). The new FDCA Â§ 505G replaces cumbersome rule making procedures with a more streamlined final administrative order process. In addition, the CARES law stipulated that certain existing final or provisional monographs, which establish the conditions of use and represent the most recent version of the conditions of use, are “considered” as final administrative orders.[i] The FDA notes that these “deemed” final administrative orders “provide the current over-the-counter drug monograph terms that are in effect for each therapeutic class they treat.”[ii] “Deemed” orders are interpreted as including all technical modifications necessary to properly harmonize an order with the FDCA and any other final order.
Availability of âdeemedâ final administrative orders
In its September 2021 Federal Register Notice, the FDA announced the process for making âdeemedâ final administrative orders available to the public. By reviewing the existing OTC monograph regulations and associated regulatory histories for each OTC therapeutic category, the Agency identified 32 âdeemedâ final administrative orders and assigned OTC monograph numbers to each resulting âdeemedâ prescription (for example, over-the-counter human antacid products are associated with the OTC monograph number, M001). The Agency has created an IT system with a web portal, OTC Monographs @ FDA, to host published final administrative orders. When posting administrative orders, the FDA will assign an “Order ID” sequentially (eg, OTC000001, OTC000002, etc.).
On September 21, the Agency published its first batch of four âdeemedâ final administrative orders:
Over-the-Counter Antiflatulent Products for Human Use (M002; OTC000001)
Over-the-counter nighttime sleeping pills for humans (M010; OTC000002)
Over-the-counter otic topical pharmaceuticals for human use (M014; OTC000003)
Over-the-counter medicinal products for corn and calluses for human use (M030; OTC000004)
Each âdeemedâ final administrative decree includes âsummaryâ and âcontextâ sections. The âContextâ section describes the proposed and final applicable rules that make up the order and all the technical differences between the rules and the order.
The FDA intends to release the remaining âdeemedâ final administrative orders in batches on an ongoing basis. The Agency will not advertise the availability of these remaining orders in the Federal Register. Instead, the FDA intends to update its OTC monograph webpage and associated OTC monograph web portal, which will also include proposed orders, final orders, and interim final orders to add, change, or remove conditions from OTC monograph.
Withdrawal of the final over-the-counter monograph regulation
In accordance with the CARES Act, the FDA also announced that it would withdraw regulations for final over-the-counter monographs and review procedures for over-the-counter drugs. The agency said it will issue a notice (without public comment) to withdraw these regulations âat a later date once all final prescriptions deemed relevant have been postedâ on the FDA’s new OTC monograph web portal.[iii] Prior to the withdrawal of these regulations, the FDA warns that the public should refer to over-the-counter monographs posted on the web portal, “to the extent that the corresponding deemed final order has been added to the portal.”[iv]
Nelson Mullins continues to closely monitor OTC developments and the new administrative ordering process.
[i] The CARES Act also considers certain OTC monograph regulations in effect on March 26, 2020 (for example, 21 CFR Â§ 310.545) to be final administrative orders. The FDA may ultimately decide to incorporate some of these regulations into the relevant final administrative orders incorporating an OTC monograph.
[ii] Final Administrative Orders for Over-the-Counter Monographs, 86 Fed. Reg. 52474, 52475 (September 21, 2021).