A schedule III, IV or V drug under a risk plan requiring monitoring after it is given
To reauthorize certain programs that provide for opioid use disorder prevention, treatment, and recovery, and for other purposes, section 401, Sec. 401.
Written by .
A schedule III, IV or V drug under a risk plan requiring monitoring after it is given
The document says “is amended”Who acts: CongressHow: statuteSec. 401 in the PDF
What the document says
“subject to a risk evaluation and mitigation strategy pursuant to section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1) that includes elements to assure safe use of the drug described in subsection (f)(3)(E) of such section, including a requirement for post-administration monitoring by a health care provider;”
The replacement paragraph names, as the second of two categories, a drug in schedule III, IV or V that is subject to a risk evaluation and mitigation strategy under section 505-1 of the Federal Food, Drug, and Cosmetic Act, where that strategy includes elements to assure safe use and requires monitoring by a health care provider after the drug is given.
What the document actually says
“subject to a risk evaluation and mitigation strategy pursuant to section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1) that includes elements to assure safe use of the drug described in subsection (f)(3)(E) of such section, including a requirement for post-administration monitoring by a health care provider;”
That sentence, in plain words
The second kind of drug carries a special safety plan. That plan must call for watching the patient after the dose. A health worker does the watching.
What this is about
Some drugs are sold only under extra safety steps. Those steps are set when the drug is approved. The older law that sets them is not indexed here.
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.
Reauthorize certain programs that provide for opioid use disorder prevention, treatment, and recovery, Public Law 119-44, sec. 401, 139 Stat. 689 (2025). https://www.govinfo.gov/content/pkg/PLAW-119publ44/html/PLAW-119publ44.htm
This page
“A schedule III, IV or V drug under a risk plan requiring monitoring after it is given,” Reauthorize certain programs that provide for opioid use disorder prevention, treatment, and recovery, section 401, Sec. 401. Read the Mandate, https://readthemandate.org/pl-119-44/proposal/sec401-rems/ (retrieved October 10, 2026).
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