On September 21, 2021, the U.S. Food and Drug Administration (“FDA” or the “Agency”) announced the posting of the first batch of final administrative orders for over-the-counter (“OTC”) drug monographs.  The move marks a new era in OTC drug regulation.  Codified by the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), the new administrative order process replaces time- and resource-intensive rulemaking procedures for establishing, revising, and amending OTC drug monographs.  In its announcement, FDA also outlined the process for making final administrative orders available to the public as well as the Agency’s plans to withdraw regulations that established final OTC drug monographs prior to the passage of the CARES Act.

The CARES Act

The March 2020 CARES Act added section 505G to the Federal Food, Drug, and Cosmetic Act (“FDCA”) (21 U.S.C. § 355g).  This new section modernizes the OTC drug review process, which was originally established in 1972.  Under OTC drug review, each therapeutic category has its own OTC monograph.  FDA considers a drug to be generally recognized as safe and effective (“GRASE”) if the product meets the conditions outlined in an OTC monograph.  Such conditions include, among others, specified active ingredients, uses/indications, doses, routes of administration, labeling, and testing.

Historically, FDA established, revised, and amended an OTC monograph through notice-and-comment rulemaking under the Administrative Procedure Act (“APA”).  New FDCA § 505G replaces laborious rulemaking procedures with a more streamlined final administrative order process.  Additionally, the CARES Act stipulated that certain existing final or tentative final monographs, which establish conditions of use and represent the most recently issued version of the conditions of use, are “deemed” to be final administrative orders.^[i]  FDA notes that such “deemed” final administrative orders “provide the current OTC drug monograph conditions that are in effect for each therapeutic category addressed by them.”^[ii]  “Deemed” orders are construed to include any technical amendments needed to appropriately harmonize an order with the FDCA and any other final orders.

Availability of “Deemed” Final Administrative Orders

In its September 2021 Federal Register notice, FDA announced the process for making “deemed” final administrative orders available to the public.  In reviewing existing OTC monograph regulations and associated rulemaking histories for each OTC monograph therapeutic category, the Agency identified 32 “deemed” final administrative orders and assigned OTC monograph numbers to each resulting “deemed” order (e.g., Antacid Products for OTC Human Use is associated with OTC monograph number, M001).  The Agency has created an IT system with a web portal, OTC Monographs@FDA, to house any posted final administrative orders.  When posting administrative orders, FDA will assign an “order ID” sequentially (e.g., OTC000001, OTC000002, etc.). 

On September 21, the Agency posted its first batch of four “deemed” final administrative orders:

• Antiflatulent Products for OTC Human Use (M002; OTC000001)

• Nighttime Sleep-Aid Drug Products for OTC Human Use (M010; OTC000002)

• Topical Otic Drug Products for OTC Human Use (M014; OTC000003)

• Corn and Callus Remover Drug Products for OTC Human Use (M030; OTC000004)

Each “deemed” final administrative order includes “summary” and “background” sections.  The “background” section outlines the applicable proposed and final rules that comprise the order and any technical differences between the rules and the order. 

FDA intends to post the remaining “deemed” final administrative orders in batches on a rolling basis.  The Agency will not announce the availability of these remaining orders in the Federal Register.  Rather, FDA intends to update its OTC monograph web page and the associated OTC monograph web portal, which will also include any proposed orders, final orders, and interim final orders to add, amend, or remove OTC monograph conditions.

Withdrawing OTC Final Monograph Regulations

In accordance with the CARES Act, FDA also announced that it will withdraw those regulations concerning OTC final monographs and the procedures governing OTC drug review.  The Agency clarified that it will issue a notice (without public comment) to withdraw such regulations “at a later date once all the relevant deemed final orders have been posted” on FDA’s new OTC monograph web portal.^[iii]  Prior to the withdrawal of these regulations, FDA cautions that the public should reference the OTC monographs posted on the web portal, “to the extent the corresponding deemed final order has been added to the portal.”^[iv]

^[i] The CARES Act also deems certain OTC monograph regulations in effect on March 26, 2020 (e.g., 21 CFR § 310.545) as final administrative orders.  FDA may ultimately decide to incorporate certain of these regulations into relevant final administrative orders embodying an OTC monograph.

^[ii] Final Administrative Orders for Over-the-Counter Monographs, 86 Fed. Reg. 52474, 52475 (Sept. 21, 2021).

^[iii] Id. at 52477.

^[iv] Id.