OTC Monograph Reform Update – Final Deemed Final Orders Posted by FDA

May 4, 2023By Deborah L. Livornese

FDA posted the last five “deemed final orders” under OTC monograph reform this week.  All 33 of the final orders can now be found at OTCMONOGRAPHS@FDA.  Under the 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (see our blog post here), all final monographs (i.e., the regulations formerly found in 21 C.F.R. parts 331 through 358) were deemed to be final administrative orders as of the CARES Act effective date.  As part of the implementation of monograph reform, the deemed orders were to be posted on FDA’s website.

As the first step in implementing this provision of the CARES Act, FDA issued a Federal Register notice on September 21, 2021, announcing the availability of the first group of deemed final administrative orders (see our blog post here).  The initial group posted also included the administrative order containing a list of certain active ingredients offered for certain OTC uses FDA had found to be non-monograph conditions (former 21 CFR § 310.545).  The deemed final orders posted this week are from the therapeutic areas of anticaries drug products, external analgesics, first aid antibiotics, first aid antiseptics, and laxatives.

At the moment, all 33 final monographs can be found on FDA’s website and in the CFR (on-line and in the paper volumes for those of us who still look forward to the new color each year).  FDA announced that it will be taking the next step of issuing a notice to withdraw the regulations establishing final monographs in the CFR.  With that withdrawal, the administrative tasks associated with changing final monographs from regulations to final administrative orders will be complete and the 21 CFR volume including Part 300 et seq will be noticeably thinner next year.