US FDA releases 5 New Over the Counter (OTC) Monographs (final orders)


In May 2023, the U.S. Food and Drug Administration (FDA) issued five more final orders completing the process of publishing different monographs as part of the over the counter (OTC) monograph reform under the Act CARES.


The Final orders provide the conditions under which a drug is generally recognized as safe and effective (GRASE) for each therapeutic category, and these orders may be amended, revoked, or otherwise modified through the administrative order process.

These final orders provided for the therapeutic categories of monographs provide the conditions of the OTC monographs for each therapeutic category as of the date of enactment of the CARES Act.

Monograph categories with final orders:

  • First aid antiseptics
  • First aid antibiotics
  • Laxatives
  • External analgesics
  • Anticaries drug products.

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