FDA Finishes Posting OTC Drug Deemed Final Orders

FDA posted 5/2 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 over-the-counter drug monograph reform under the CARES Act. All of the deemed final orders are here.

The agency says 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. “Such deemed final orders provide the conditions under which a drug is generally recognized as safe and effective for each therapeutic category, and these orders may be amended, revoked, or otherwise modified via the administrative order process.” Monograph categories with deemed final orders posted 5/2 include first aid antiseptics, laxatives, external analgesics, and anticaries drug products.