Read theMandate

Reauthorize certain programs that provide for opioid use disorder prevention, treatment, and recovery › Section 401

Delivery of a Controlled Substance by a Pharmacy to a Prescribing Practitioner

Section 401 · Sec. 401 ·

What this chapter is about

This part changes a rule in the drug control law. It rewrites one piece about drugs sent from a pharmacy to a prescriber. It names two kinds of drug that can be sent that way. One is given by shot or implant. The other carries a special safety plan.

3 proposals indexed from this chapter.

The document says “is amendedWho acts: CongressHow: statuteSec. 401 in the PDF
What the document says

“Section 309A(a) of the Controlled Substances Act (21 U.S.C. 829a(a)) is amended by striking paragraph (2) and inserting the following:”

To reauthorize certain programs that provide for opioid use disorder prevention, treatment, and recovery, and for other purposes, Sec. 401

The section strikes paragraph (2) of section 309A(a) of the Controlled Substances Act and puts new text in its place. That older statute is not indexed here, so what the struck paragraph said is not recorded.

What the document actually says

“Section 309A(a) of the Controlled Substances Act (21 U.S.C. 829a(a)) is amended by striking paragraph (2) and inserting the following:”

To reauthorize certain programs that provide for opioid use disorder prevention, treatment, and recovery, and for other purposes, Sec. 401
That sentence, in plain words

One piece of an older law is cut out. New words take its place. The new words follow right after.

What this is about

This part of the drug law is about a pharmacy sending a drug to a prescriber. The prescriber then gives it to the patient. This section changes one of the tests that must be met.

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.

The document says “is amendedWho acts: CongressHow: statuteSec. 401 in the PDF
What the document says

“by injection or implantation for the purpose of maintenance or detoxification treatment”

To reauthorize certain programs that provide for opioid use disorder prevention, treatment, and recovery, and for other purposes, Sec. 401

The replacement paragraph names, as the first of two categories, a drug in schedule III, IV or V that is to be given by injection or implantation for the purpose of maintenance or detoxification treatment.

What the document actually says

“by injection or implantation for the purpose of maintenance or detoxification treatment”

To reauthorize certain programs that provide for opioid use disorder prevention, treatment, and recovery, and for other purposes, Sec. 401
That sentence, in plain words

The first kind of drug is given by shot or by implant. It is used to hold a person steady or to help them come off a drug.

What this is about

An implant is placed under the skin. It releases the drug over time. Both forms are given by a health worker, not taken home.

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.

The document says “is amendedWho 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;”

To reauthorize certain programs that provide for opioid use disorder prevention, treatment, and recovery, and for other purposes, Sec. 401

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;”

To reauthorize certain programs that provide for opioid use disorder prevention, treatment, and recovery, and for other purposes, Sec. 401
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.

Share this page
How to cite this
  1. The document itself

    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

  2. This page

    “Delivery of a Controlled Substance by a Pharmacy to a Prescribing Practitioner,” Reauthorize certain programs that provide for opioid use disorder prevention, treatment, and recovery, section 401. Read the Mandate, https://readthemandate.org/pl-119-44/section-401/ (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 three things the section does: it strikes and replaces paragraph (2) of section 309A(a) of the Controlled Substances Act, and it sets out the two categories the replacement paragraph names.

Nothing. The section replaces one paragraph and the whole of the replacement is recorded here.

The section works by amending section 309A of the Controlled Substances Act, and refers to section 505-1 of the Federal Food, Drug, and Cosmetic Act. Neither is indexed here, so nothing is recorded about what the replaced paragraph said or about what a risk evaluation and mitigation strategy requires.