21 U.S.C. § 829a: Delivery of a controlled…

Summary

A pharmacy may give a controlled drug to a registered practitioner so the practitioner can give it to a patient, if several rules are met. The drug must be delivered to the practitioner’s registered location. It must be a Schedule III, IV, or V drug given by injection or implant for maintenance or detox, or a drug that has a special safety program requiring post‑use monitoring. State law must allow the activity. The drug cannot be supplied as a general stock for dispensing to patients. Except as described below, it must be given only to the patient named on the prescription within 45 days after the practitioner gets it. The prescribing and administering practitioners must keep complete, accurate records of deliveries, receipts, uses, disposals, and to whom drugs were given. From October 24, 2018, for a 2‑year period the Attorney General, working with the Secretary, may shorten the 45‑day limit to reduce diversion or protect public health. After a required report is submitted, the Attorney General (with the Secretary) may change the 45‑day period again. Any change must be for at least 7 days.

Title 21, §829a

Food and Drugs, Source: USLM XML via OLRC

(a)In general

Notwithstanding section 802(10) of this title, a pharmacy may deliver a controlled substance to a practitioner in accordance with a prescription that meets the requirements of this subchapter and the regulations issued by the Attorney General under this subchapter, for the purpose of administering the controlled substance by the practitioner if—

(1)the controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance, as applicable, at the location listed on the practitioner’s certificate of registration issued under this subchapter;

(2)the controlled substance is a drug in schedule III, IV, or V to be administered—

(A)by injection or implantation for the purpose of maintenance or detoxification treatment; or

(B)subject to a risk evaluation and mitigation strategy pursuant to section 355–1 of this title 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;

(3)the pharmacy and the practitioner are authorized to conduct the activities specified in this section under the law of the State in which such activities take place;

(4)the prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients;

(5)except as provided in subsection (b), the controlled substance is to be administered only to the patient named on the prescription not later than 45 days after the date of receipt of the controlled substance by the practitioner; and

(6)notwithstanding any exceptions under section 827 of this title, the prescribing practitioner, and the practitioner administering the controlled substance, as applicable, maintain complete and accurate records of all controlled substances delivered, received, administered, or otherwise disposed of under this section, including the persons to whom controlled substances were delivered and such other information as may be required by regulations of the Attorney General.

(b)Modification of number of days before which controlled substance shall be administered

(1)Initial 2-year period

During the 2-year period beginning on October 24, 2018, the Attorney General, in coordination with the Secretary, may reduce the number of days described in subsection (a)(5) if the Attorney General determines that such reduction will—

(A)reduce the risk of diversion; or

(B)protect the public health.

(2)Modifications after submission of report

After the date on which the report described in section 3204(b) of the SUPPORT for Patients and Communities Act is submitted, the Attorney General, in coordination with the Secretary, may modify the number of days described in subsection (a)(5).

(3)Minimum number of days

Any modification under this subsection shall be for a period of not less than 7 days.

Notes & Related Subsidiaries

Editorial Notes

References in Text

Schedules III, IV, and V, referred to in subsec. (a)(2), are set out in section 812(c) of this title. section 3204(b) of the SUPPORT for Patients and Communities Act, referred to in subsec. (b)(2), is section 3204(b) of Pub. L. 115–271, title III, Oct. 24, 2018, 132 Stat. 3946, which is not classified to the Code.

Amendments

2025—Subsec. (a)(2). Pub. L. 119–44, § 401, added par. (2) and struck out former par. (2) which read as follows: “the controlled substance is a narcotic drug in schedule III, IV, or V to be administered for the purpose of maintenance or detoxification treatment and is to be administered by injection or implantation;”. Pub. L. 119–26, § 4(2)(B)(iii), amended Pub. L. 117–328, § 1262(b)(2). See 2022 Amendment note below. 2022—Subsec. (a)(2). Pub. L. 117–328, § 1262(b)(2), as amended by Pub. L. 119–26, § 4(2)(B)(iii), substituted “the controlled substance is a narcotic drug in schedule III, IV, or V to be administered for the purpose of maintenance or detoxification treatment and is to be administered by injection or implantation;” for “the controlled substance is to be administered for the purpose of maintenance or detoxification treatment under section 823(g)(2) and—” “(A) the practitioner who issued the prescription is a qualifying practitioner authorized under, and acting within the scope of that section; and “(B) the controlled substance is to be administered by injection or implantation;”. Pub. L. 117–215 substituted “823(h)(2)” for “823(g)(2)” in introductory provisions. Subsec. (a)(5). Pub. L. 117–328, § 1264, substituted “45 days” for “14 days”.

Statutory Notes and Related Subsidiaries

Effective Date

of 2025 Amendment Pub. L. 119–26, § 4, July 16, 2025, 139 Stat. 416, provided that the amendment made by section 4(2)(B)(iii) is effective as if included in the enactment of Pub. L. 117–328.

§829a Delivery of a Controlled Substance by a Pharmacy to an Administering Practitioner