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US CARES Act Introduces OTC Monograph Reform

SafeGuardSCosmetics Personal Care and HouseholdMay 13, 2020

The US CARES Act includes OTC Monograph provisions to reform and modernize the regulatory framework for OTC drug products.

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act), introduced into Congress to provide economic relief for many families and small businesses, was signed into law on March 27, 2020.  Included in the CARES Act were reform measures for the Over the Counter (OTC) Drug Monograph process that attempts to reform and modernize the program.

The traditional monograph process, in place since 1972, was a multi-step and resource intensive process which required the US Food and Drug Administration (FDA) to issue an Advance Notice of Proposed Rulemaking (ANPR) before issuing a Tentative Final Monograph (TFM) and finally publishing the Final Monograph. Between each step was a public comment period. The reformed law allows the FDA to issue administrate orders in response to OTC Monograph Order Requests (OMORs). These requests can be either FDA or industry initiated. Additionally, new annual user fees will be assessed for any OTC monograph drug facility.

For products currently marketed under an OTC monograph, the Act outlines the new status of active ingredients which were marketed under ANPR or TFM conditions. Existing rulemakings will be considered as follows:

Category I
Category II
Category III
Advance Notice of Proposed Rulemaking (ANPR)
Treated as Category III TFM Ingredient (may remain on market pending further FDA decision)
Removed from market within 180 days of March 27, 2020
May remain on market pending further FDA decision
Tentative Final Monograph (TFM)Final RuleRemoved from market within 180 days of March 27, 2020
May remain on market pending further FDA decision

The CARES Act also sunsets the Sunscreen Innovation Act and permits the marketing of sunscreen drug products under the 1999 Final Monograph outlined in 21 CFR 352. Among other provisions, this effectively rolls back the proposed changes to labeling and broad spectrum testing requirements which were part of the proposed rulemaking.  The FDA will be required to issue a new order within 18 months (by September 2021) as it relates to sunscreen products, which will have an effective date at least one year thereafter.


[1] Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

With the development of new products, regulations for cosmetics, personal care and household are fast changing and increasingly complex. To stay up-to-date with the latest legislation, check out our powerful regulatory compliance platform, SGS Digicomply

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