---
kind: "section"
citation: "42 U.S.C. § 285o–4"
title: "42"
title_heading: "The Public Health and Welfare"
number: "285o–4"
heading: "Medication Development Program"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/285o-4"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter III — National Research Institutes"
  - "Part C — Specific Provisions Respecting National Research Institutes"
  - "Subpart 15 — national institute on drug abuse"
---

# §285o–4. Medication Development Program

- (a) **Establishment—** There is established in the Institute a Medication Development [Program](/usc/42/274l–1.md?p=4) through which the [Director](/usc/42/11851.md?p=5) of such Institute shall—
  - (1) conduct periodic meetings with the Commissioner of Food and [Drugs](/usc/42/11851.md?p=4) to discuss measures that may facilitate the approval process of [drug](/usc/42/11851.md?p=4) abuse [treatments](/usc/42/11851.md?p=11);
  - (2) encourage and promote (through grants, contracts, international collaboration, or otherwise) expanded research [programs](/usc/42/274l–1.md?p=4), investigations, experiments, community trials, and studies, into the development and use of medications to treat [drug](/usc/42/11851.md?p=4) addiction;
  - (3) establish or provide for the establishment of research facilities;
  - (4) report on the activities of other relevant [agencies](/usc/42/8262.md?p=1) relating to the development and use of pharmacotherapeutic [treatments](/usc/42/11851.md?p=11) for [drug](/usc/42/11851.md?p=4) addiction;
  - (5) collect, analyze, and disseminate data useful in the development and use of pharmacotherapeutic [treatments](/usc/42/11851.md?p=11) for [drug](/usc/42/11851.md?p=4) addiction and collect, catalog, analyze, and disseminate through international channels, the results of such research;
  - (6) directly or through grants, contracts, or cooperative agreements, support training in the fundamental sciences and clinical disciplines related to the pharmacotherapeutic [treatment](/usc/42/11851.md?p=11) of [drug](/usc/42/11851.md?p=4) abuse, including the use of training stipends, fellowships, and awards where appropriate; and
  - (7) coordinate the activities conducted under this section with related activities conducted within the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Mental Health, and other appropriate institutes and shall consult with the [Directors](/usc/42/11851.md?p=5) of such Institutes.
- (b) **Duties—** In carrying out the activities described in [subsection (a)](#a), the [Director](/usc/42/11851.md?p=5) of the Institute—
  - (1) shall collect and disseminate through publications and other appropriate means, information pertaining to the research and other activities under this section;
  - (2) shall make grants to or enter into contracts and cooperative agreements with individuals and public and private entities to further the goals of the [program](/usc/42/274l–1.md?p=4);
  - (3) may, in accordance with [section 289e of this title](/usc/42/289e.md), and in consultation with the National [Advisory Council](/usc/42/274l–1.md?p=1) on [Drug](/usc/42/11851.md?p=4) Abuse, acquire, construct, improve, [repair](/usc/42/300j–21.md?p=4), operate, and maintain pharmacotherapeutic research centers, laboratories, and other necessary facilities and equipment, and such other real or personal property as the [Director](/usc/42/11851.md?p=5) determines necessary, and may, in consultation with such [Advisory Council](/usc/42/274l–1.md?p=1), make grants for the [construction](/usc/42/300s–3.md?p=7) or renovation of facilities to carry out the purposes of this section;
  - (4) may accept voluntary and uncompensated [services](/usc/42/201.md?p=a);
  - (5) may accept gifts, or donations of [services](/usc/42/201.md?p=a), money, or property, real, personal, or mixed, tangible or intangible; and
  - (6) shall take necessary action to ensure that all channels for the dissemination and [exchange](/usc/42/300gg–91.md?p=d-21) of scientific knowledge and information are maintained between the Institute and the other scientific, medical, and biomedical disciplines and organizations nationally and internationally.
- (c) **Report—**
  - (1) **In general—** Not later than December 31, 1992, and each December 31 thereafter, the [Director](/usc/42/11851.md?p=5) of the Institute shall submit to the Office of National [Drug](/usc/42/11851.md?p=4) Control Policy established under [section 1501](/usc/42/1501.md)[^1] of title 21 a report, in accordance with paragraph (3), that describes the objectives and activities of the [program](/usc/42/274l–1.md?p=4) assisted under this section.
  - (2) **National Drug Control Strategy—** The [Director](/usc/42/11851.md?p=5) of National [Drug](/usc/42/11851.md?p=4) Control Policy shall incorporate, by reference or otherwise, each report submitted under this subsection in the National [Drug](/usc/42/11851.md?p=4) Control Strategy submitted the following February 1 under [section 1504](/usc/42/1504.md)[^1] of title 21.
- (d) **“Pharmacotherapeutics” defined—** For purposes of this section, the term “pharmacotherapeutics” means medications used to treat the symptoms and disease of [drug](/usc/42/11851.md?p=4) abuse, including medications to—
  - (1) block the effects of abused [drugs](/usc/42/11851.md?p=4);
  - (2) reduce the craving for abused [drugs](/usc/42/11851.md?p=4);
  - (3) moderate or eliminate withdrawal symptoms;
  - (4) block or reverse the toxic effect of abused [drugs](/usc/42/11851.md?p=4); or
  - (5) prevent relapse in persons who have been detoxified from [drugs](/usc/42/11851.md?p=4) of abuse.

## Footnotes

[^1]: See References in Text note below.

## Source credit

(July 1, 1944, ch. 373, title IV, § 464P, as added Pub. L. 102–321, title I, § 123(b), July 10, 1992, 106 Stat. 362; amended Pub. L. 103–43, title XX, § 2008(b)(10), June 10, 1993, 107 Stat. 211; Pub. L. 109–482, title I, § 103(b)(35), Jan. 15, 2007, 120 Stat. 3688.)

## Notes

### Editorial Notes

### References in Text

Sections 1501 and 1504 of title 21, referred to in subsec. (c), were repealed by Pub. L. 100–690, title I, § 1009, Nov. 18, 1988, 102 Stat. 4188.

### Amendments

2007—Subsec. (e). Pub. L. 109–482 struck out heading and text of subsec. (e). Text read as follows: “For the purpose of carrying out this section, there are authorized to be appropriated $85,000,000 for fiscal year 1993, and $95,000,000 for fiscal year 1994.”

1993—Subsec. (b)(6). Pub. L. 103–43 substituted “Institute” for “Administration”.

### Statutory Notes and Related Subsidiaries

### Effective Date of 2007 Amendment

Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.

### Effective Date

Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as an Effective Date of 1992 Amendment note under section 236 of this title.

### Report by Institute on Medicine

Pub. L. 102–321, title VII, § 701, July 10, 1992, 106 Stat. 436, directed Secretary of Health and Human Services to enter into a contract with a public or nonprofit private entity to conduct a study concerning (1) role of the private sector in development of anti-addiction medications, including legislative proposals designed to encourage private sector development of such medications, (2) process by which anti-addiction medications receive marketing approval from Food and Drug Administration, including an assessment of feasibility of expediting marketing approval process in a manner consistent with maintaining safety and effectiveness of such medications, (3) with respect to pharmacotherapeutic treatments for drug addiction (A) recommendations with respect to a national strategy for developing such treatments and improvements in such strategy, (B) state of the scientific knowledge concerning such treatments, and (C) assessment of progress toward development of safe, effective pharmacological treatments for drug addiction, and (4) other related information determined appropriate by the authors of the study, and to submit to Congress a report of the results of such study not later than 18 months after July 10, 1992.