On May 2, 2023, the United States Food and Drug Administration (FDA) finalized administrative orders as deemed by Over the Counter (OTC) Monograph Reform in the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

The FDA posted five additional deemed final orders, completing the process of posting 33 deemed final orders for 32 different monograph therapeutic categories and one for non-monograph conditions as part of OTC monograph reform under the CARES Act.

In September 2021, the FDA issued a Federal Register Notice (FRN) to explain the process for posting the deemed final orders and posted the first batch of four. The recent posting of the remaining five include first aid antiseptics, first aid antibiotics, laxatives, external analgesics, and anticaries drug products monograph categories.

The deemed final orders for the monograph therapeutic categories provide the OTC monograph conditions for each therapeutic category as of the date of enactment of the CARES Act and define the conditions under which a drug is generally recognized as safe and effective (GRASE) for each therapeutic category.

Under Title 21 of the Code of Federal Regulations, drugs with Category III ingredients (those that need more data for safety and effectiveness) under a Tentative Final Monograph and Category I ingredients subject to an Advance Notice of Proposed Rulemaking may be legally marketed as OTC drugs. The FDA intends to issue a notice to withdraw the regulations establishing final monographs in Title 21 of the Code of Federal Regulations in the future.

The industry still has many questions on OTC monograph reform, and what it means for the previous category III drugs and conditions. In the final deemed orders, Category III ingredients and conditions are not included. The FDA has responded to frequently asked questions surrounding ingredients and conditions which can be found on the Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act | FDA page.

While OTC monograph reform is a significant milestone towards improving the OTC drug market and consumer safety, there is still much work to be done. We are excited to see progress being made towards safer and more effective over-the-counter drugs and we are committed to staying up to date on regulatory changes that impact consumers and our clients.

If you have any questions about how this news affects you, don’t hesitate to contact us at clinicalandregulatory-info@lumanity.com.

All of the deemed final orders can be found on OTC Monographs@FDA.