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:
- Advance Notice of Proposed Rulemaking (ANPR)
- Tentative Final Monograph (TFM)
- Final Monograph
Each step was followed by a period of public
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:
- Category I – treated as Category III TFM ingredient and may remain on the market pending a further FDA decision
- Category II – must be removed from the market within 180 days of March 27, 2020
- Category III – may remain on the market pending a further FDA decision
- Category I – Final Rule
- Category II – same as ANPR Category II
- 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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CARES Act Introduces OTC Monograph Reform SafeGuardS.
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