United States · Bill · S
S. 2740 (116th)
Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019
Introduced
30 October 2019
Last action
14 December 2019 · Referred
Status
Referred to the Subcommittee on Health.
Sponsors
Sen. Isakson, Johnny [R-GA], Sen. Casey, Robert P., Jr. [D-PA], Sen. Braun, Mike [R-IN], Sen. Alexander, Lamar [R-TN], Sen. Murray, Patty [D-WA], Sen. Sinema, Kyrsten [I-AZ]
Subjects
Healthcare
Source updated
20 January 2026
Summary
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.
This text is taken from the official record. PoliticalRepo does not editorialize.
Timeline
30 October 2019
Introduced
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Source: IntroReferral
30 October 2019
Introduced
Introduced in Senate
Source: IntroReferral
31 October 2019
Reported
Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.
Source: Committee
5 November 2019
Calendars
Placed on Senate Legislative Calendar under General Orders. Calendar No. 290.
Source: Calendars
5 November 2019
Reported
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander without amendment. Without written report.
Source: Committee
5 November 2019
Reported
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander without amendment. Without written report.
Source: Committee
10 December 2019
Vote
Passed Senate without amendment by Yea-Nay Vote. 91 - 2. Record Vote Number: 389. (consideration: CR S6921-6930; text: CR S6921-6930)
Source: Floor
10 December 2019
Vote
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)
Source: Floor
11 December 2019
Introduced
Referred to the House Committee on Energy and Commerce.
Source: IntroReferral
11 December 2019
Floor
Received in the House.
Source: Floor
11 December 2019
Floor
Message on Senate action sent to the House.
Source: Floor
14 December 2019
Referred
Referred to the Subcommittee on Health.
Source: Committee
Votes
10 December 2019 · Bill Passed · On Passage of the Bill S. 2740 · Bill Passed · Official source
Yes 91 · No 2 · Abstain — · Absent/not voting 7
- Sen. Klobuchar, Amy [D-MN]Not Voting
- Sen. King, Angus S., Jr. [I-ME]Yea
- Sen. Cardin, Benjamin L. [D-MD]Yea
- Sen. Sasse, Ben [R-NE]Yea
Showing the first 4 recorded positions. Vote totals above are complete.
Versions
- Referred in House · 11 December 2019 · Download file
- Engrossed in Senate · 10 December 2019 · Download file
- Reported to Senate · 5 November 2019 · Download file
- Introduced in Senate · 30 October 2019 · Download file
Documents
11 official files
Referred in House (text)
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Leesvertaling
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Referred in House (text)
Referred in House · EN · 11 December 2019
Referred in House (PDF)
Referred in House · EN · 11 December 2019
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Engrossed in Senate (text)
Engrossed in Senate · EN · 10 December 2019
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Engrossed in Senate (PDF)
Engrossed in Senate · EN · 10 December 2019
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Passed Senate
summary · EN · 10 December 2019
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Reported to Senate (text)
Reported to Senate · EN · 5 November 2019
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Reported to Senate (PDF)
Reported to Senate · EN · 5 November 2019
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Reported to Senate
summary · EN · 5 November 2019
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Introduced in Senate (text)
Introduced in Senate · EN · 30 October 2019
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Introduced in Senate (PDF)
Introduced in Senate · EN · 30 October 2019
ViewDownloadOpen at official source
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Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.
Introduced in Senate
summary · EN · 30 October 2019
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.
Sponsors
- Sen. Isakson, Johnny [R-GA] · R · Sponsor
- Sen. Casey, Robert P., Jr. [D-PA] · D · Sponsor
- Sen. Braun, Mike [R-IN] · R · Cosponsor
- Sen. Alexander, Lamar [R-TN] · R · Cosponsor
- Sen. Murray, Patty [D-WA] · D · Cosponsor
- Sen. Sinema, Kyrsten [I-AZ] · D · Cosponsor
- · hsif00 · Standing
- · sshr00 · Standing
Related records
- related to → Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019
- related to → Lower Costs, More Cures Act of 2019
- related to → CARES Act
- related to → To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes.
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.congress.gov/bill/116th-congress/senate-bill/2740
- Open data entity: https://api.congress.gov/v3/bill/116/s/2740
- us · 116-s-2740 · source updated 20 January 2026