summary
Introduced
10/30/2019
10/30/2019
In Committee
12/14/2019
12/14/2019
Crossed Over
12/11/2019
12/11/2019
Passed
Dead
12/31/2020
12/31/2020
Introduced Session
116th Congress
Bill Summary
AN ACT To amend the Federal Food, Drug, and Cosmetic Act to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application, and for other purposes. 1
AI Summary
This bill, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019, amends the Federal Food, Drug, and Cosmetic Act to establish a new regulatory framework for certain nonprescription drugs that are marketed without an approved new drug application. The bill allows for the FDA to issue administrative orders to determine whether nonprescription drugs are generally recognized as safe and effective, and establishes a user fee program to provide funding for the FDA's activities related to over-the-counter monograph drugs. The bill also includes provisions to facilitate the review of sunscreen ingredients and make technical corrections to previous legislation.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (6)
Johnny Isakson (R)*,
Lamar Alexander (R),
Mike Braun (R),
Bob Casey (D),
Patty Murray (D),
Kyrsten Sinema (I),
Last Action
Referred to the Subcommittee on Health. (on 12/14/2019)
Official Document
bill text
bill summary
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bill summary
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bill summary
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