Module 6

04/10/2024

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US OTC MONOGRAPHS

• Examples include: ● Analgesics ● Cold remedies ● Laxatives ● Contraceptives ● Sunscreen products

● OTC monograph search: https://dps.fda.gov/omuf/monographsearch

The Organisation for Professionals in Regulatory Affairs

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OTC monographs – regulatory changes

The CARES Act:

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• Coronavirus Aid, Relief, and Economic Security Act (CARES Act)

• ..includes statutory provisions that reform and modernize the way OTC monograph drugs are regulated in the USA. • Replaces the rulemaking process with an administrative order process for issuing, revising, and amending OTC monographs. • Provides FDA with the authority to assess and collect user fees dedicated to OTC monograph drug activities.

The Organisation for Professionals in Regulatory Affairs

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