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S 2740 116th Congress Senate Health Administrative law and regulatory procedures Administrative remedies Child health Congressional oversight Cosmetics and personal care Department of Health and Human Services Drug safety, medical device, and laboratory regulation Government information and archives Government studies and investigations Inflation and prices Judicial review and appeals Marketing and advertising User charges and fees

Over-the-Counter Monograph User Fee Act of 2019

Introduced: October 30, 2019 See on congress.gov
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This bill died when the 116th Congress ended
It never became law before the 116th Congress (2019–2020) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 11 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Dec 14, 2019
Referred to the Subcommittee on Health.
Dec 11, 2019
Referred to the House Committee on Energy and Commerce.
Dec 11, 2019
Received in the House.
Dec 11, 2019
Message on Senate action sent to the House.
Dec 10, 2019
Passed Senate without amendment by Yea-Nay Vote. 91 - 2. Record Vote Number: 389. (consideration: CR S6921-6930; text: CR S6921-6930)
Dec 10, 2019
Passed/agreed to in Senate: Passed Senate without amendment by Yea-Nay Vote. 91 - 2. Record Vote Number: 389.(consideration: CR S6921-6930; text: CR S6921-6930)
Nov 5, 2019
Placed on Senate Legislative Calendar under General Orders. Calendar No. 290.
Nov 5, 2019
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander without amendment. Without written report.
Oct 31, 2019
Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.
Oct 30, 2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Oct 30, 2019
Introduced in Senate
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 Plain-English summary Congressional Research Service

Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019

This bill makes significant changes to the regulation by the Food and Drug Administration (FDA) of nonprescription (i.e., over-the-counter or OTC) drugs.

The bill establishes a new approval process for OTC medications. Specifically, it creates an FDA administrative order process for the evaluation of OTC products, replacing the present notice and comment rulemaking approach. Under the new process, the FDA may issue an administrative order determining that a specific OTC drug, class of drugs, or combination is generally regarded as safe and effective and not subject to the new drug application process. The FDA may also use the administrative order process to (1) determine that a drug, class of drugs, or combination poses an imminent hazard to the public health; or (2) require labeling changes to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug.

The bill provides for market exclusivity under certain circumstances. For drugs determined to be generally regarded as safe and effective pursuant to an administrative order requested by a sponsor (rather than initiated by the FDA), the requestor is granted 18 months of market exclusivity. This market exclusivity applies to an OTC drug with a new active ingredient or if the requestor conducted new human studies to get approval.

The bill allows a sponsor of a nonprescription sunscreen active ingredient or a combination of such ingredients that was subject to a proposed sunscreen order to transition to the administrative order process. Market exclusivity provisions also apply to new sunscreen active ingredients.

The FDA must establish a user fee program for OTC drugs.

What's happening now December 14, 2019

Referred to the Subcommittee on Health.

 Related & companion bills 4
  • HR 269 Related bill Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019
  • HR 19 Related bill Lower Costs, More Cures Act of 2019
  • HR 748 Related bill CARES Act
  • HR 3443 Related bill To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved…
 Bill text 4 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 3
 Cosponsors 1
All 1 Democratic 1
D
Murray, Patty
Washington · Nov 7, 2019
Cite this page click to expand
APA
U.S. Congress. (2026). S. 2740: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019. 116th Congress. Open America. https://openamerica.io/bill/116-S-2740/
MLA
"S. 2740: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-S-2740/.
Bluebook (legal)
S. 2740, 116th Cong. (2026), https://openamerica.io/bill/116-S-2740/.
Markdown link
[S. 2740: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019](https://openamerica.io/bill/116-S-2740/)
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