summary
Introduced
06/24/2019
06/24/2019
In Committee
06/25/2019
06/25/2019
Crossed Over
Passed
Dead
12/31/2020
12/31/2020
Introduced Session
116th Congress
Bill Summary
Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 Over-the-Counter Monograph User Fee Act of 2019 Official Titles Official Titles - House of Representatives Official Title as Introduced To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes.
AI Summary
This bill, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019, aims to clarify the regulatory framework for certain nonprescription drugs that are marketed without an approved drug application. It establishes a process for the FDA to issue administrative orders determining if a drug is generally recognized as safe and effective, and it creates user fees for over-the-counter (OTC) monograph drug facilities and requests. The bill also amends provisions related to sunscreen active ingredients and requires the FDA to provide annual updates to Congress on the appropriate pediatric use of certain cough and cold OTC drugs.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (4)
Last Action
Sponsor introductory remarks on measure. (CR E971) (on 07/24/2019)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.congress.gov/bill/116th-congress/house-bill/3443/all-info |
| BillText | https://www.congress.gov/116/bills/hr3443/BILLS-116hr3443ih.pdf |
| Bill | https://www.congress.gov/116/bills/hr3443/BILLS-116hr3443ih.pdf.pdf |
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