PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 55 · Passed Senate · Dec 14, 2020
This bill provides statutory authority for the existing Food and Drug Administration (FDA) practice of defining active ingredient more narrowly as active moiety in certain situations, such as when determining whether a new drug is entitled to a market exclusivity period or providing priority review of drugs for treating rare pediatric diseases.
Generally, the FDA defines active moiety as the core molecule or ion in a drug responsible for the relevant physiological or pharmacological action. By contrast, the FDA defines an active ingredient as a component in a drug that is intended to furnish pharmacological activity or other direct effect. The FDA's existing practice of interpreting active ingredient as active moiety in certain situations, as statutorily authorized by this bill, tends to exclude some drugs from market exclusivity.
The bill replaces references to active ingredient with active moiety in various statutes authorizing FDA activities.
People & committees
Sen. Roberts, Pat [R-KS] · R–KS
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Held at the desk.
Received in the House.
Message on Senate action sent to the House.
Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S7470)
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(text of amendment in the nature of a substitute: CR S7470)
Measure laid before Senate by unanimous consent. (consideration: CR S7470)
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Primary sources
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Source last updated: Apr 21, 2025. Consult Congress.gov for the current record.
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