This part widens a definition. A request to change a testing method can now count as one kind of order request. The method must follow an agreed standard.
“(vii) the addition or modification of a testing procedure applicable to one or more OTC monograph drugs, provided that such additional or modified testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality”
The section amends section 744L(9)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-71(9)(A)). The standard has to be one set by a national or international standards development organization and recognized by the Secretary through the process described in guidance for industry first published in July 2023, or any successor guidance.
What the document actually says
“(vii) the addition or modification of a testing procedure applicable to one or more OTC monograph drugs, provided that such additional or modified testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality”
That sentence, in plain words
Adding or changing a test for these drugs now counts. The new test must follow an agreed standard.
What this is about
Firms can ask the agency to change the rules for a drug. This adds one more kind of ask to the list. It covers how a drug is tested.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026, Public Law 119-37, sec. 6503, 139 Stat. 637 (2025). https://www.govinfo.gov/content/pkg/PLAW-119publ37/html/PLAW-119publ37.htm
This page
“Definitions,” Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026, section 6503. Read the Mandate, https://readthemandate.org/continuing-appropriations-agriculture-legislative/section-6503/ (retrieved August 26, 2026).
Cite the document when the claim is about what the document says. Cite this page when the indexing, the wording or the record of what has happened is what is being relied on.
What This Page Covers, and What It Leaves Out
The new clause added to the definition, and what it requires of a testing procedure.
Two small edits that fix punctuation and add a missing word in the clauses before it.
The section works by amending the Federal Food, Drug, and Cosmetic Act. That law is not indexed here, so this file does not say what an OTC monograph order request is or what follows from making one.
