US Reforms OTC Drug Monograph Process under CARES Act

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law, providing economic relief for many families and small businesses. Within the Act were measures to reform and modernize the Over the Counter (OTC) Drug Monograph process.

In place since 1972, the traditional monograph process had multiple steps, including the requirement that the US Food and Drug Administration (FDA) issue:

1. Advance Notice of Proposed Rulemaking (ANPR)
2. Tentative Final Monograph (TFM)
3. Final Monograph

Each step was followed by a period of public comment.

Under the reform included in the CARES Act, the FDA can issue administrative orders in response to OTC Monograph Order Requests (OMORs). These requests can be initiated by either the FDA or industry. In addition, the Act’s changes mean new annual user fees will be assessed for any OTC monograph drug facility.

Products that are currently on the market and marketed under ANPR and TFM are updated accordingly:
o Category I – treated as Category III TFM ingredient and may remain on the market pending a further FDA decision
o Category II – must be removed from the market within 180 days of March 27, 2020
o Category III – may remain on the market pending a further FDA decision
• TFM:
o Category I – Final Rule
o Category II – same as ANPR Category II
o Category III – same as ANPR Category III

In addition to the changes being brought in around the OTC Drug Monograph process, 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.

In effect this, among other provisions, reverses the proposed changes to labeling and broad-spectrum testing requirements that were part of the proposed rulemaking. In relation to sunscreen products, the FDA is now required to issue a new order by September 2021, with an effective date at least one year later.

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For further information contact:
Joseph Scognamiglio
Technical Manager
Tel: 1-973-461-7937
LinkedIn: sgs-consumer-goods-&-retail

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