2021 US Code
Title 21 - Food and Drugs
Chapter 13 - Drug Abuse Prevention and Control
Subchapter I - Control and Enforcement
Part C - Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances
Sec. 829 - Prescriptions

Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], may be dispensed without the written prescription of a practitioner, except that in emergency situations, as prescribed by the Secretary by regulation after consultation with the Attorney General, such drug may be dispensed upon oral prescription in accordance with section 503(b) of that Act [21 U.S.C. 353(b)]. Prescriptions shall be retained in conformity with the requirements of section 827 of this title. No prescription for a controlled substance in schedule II may be refilled.

Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule III or IV, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], may be dispensed without a written or oral prescription in conformity with section 503(b) of that Act [21 U.S.C. 353(b)]. Such prescriptions may not be filled or refilled more than six months after the date thereof or be refilled more than five times after the date of the prescription unless renewed by the practitioner.

No controlled substance in schedule V which is a drug may be distributed or dispensed other than for a medical purpose.

Whenever it appears to the Attorney General that a drug not considered to be a prescription drug under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] should be so considered because of its abuse potential, he shall so advise the Secretary and furnish to him all available data relevant thereto.

(1) No controlled substance that is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] may be delivered, distributed, or dispensed by means of the Internet without a valid prescription.

(2) As used in this subsection:

(3) Nothing in this subsection shall apply to—

(Pub. L. 91–513, title II, §309, Oct. 27, 1970, 84 Stat. 1260; Pub. L. 110–425, §2, Oct. 15, 2008, 122 Stat. 4820; Pub. L. 114–198, title VII, §702(a), July 22, 2016, 130 Stat. 740.)

The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (a), (b), (d), and (e)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Schedules II, III, IV, and V, referred to in subsecs. (a) to (c), are set out in section 812(c) of this title.

2016—Subsec. (f). Pub. L. 114–198 added subsec. (f).

2008—Subsec. (e). Pub. L. 110–425 added subsec. (e).

Amendment by Pub. L. 110–425 effective 180 days after Oct. 15, 2008, except as otherwise provided, see section 3(j) of Pub. L. 110–425, set out as a note under section 802 of this title.

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

Pub. L. 114–198, title VII, §702(b), July 22, 2016, 130 Stat. 741, provided that: "Nothing in this section [amending this section] shall be construed to affect the authority of the Attorney General to allow a prescription for a controlled substance in schedule III, IV, or V of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) to be partially filled."

Pub. L. 116–215, div. B, title III, §1302, Dec. 11, 2020, 134 Stat. 1046, provided that: "Not later than 180 days after the date of enactment of this Act [Dec. 11, 2020], the Attorney General shall revise section 1306.07(b) of title 21, Code of Federal Regulations, so that practitioners, in accordance with applicable State, Federal, or local laws relating to controlled substances, are allowed to dispense not more than a three-day supply of narcotic drugs to one person or for one person's use at one time for the purpose of initiating maintenance treatment or detoxification treatment (or both)."

Pub. L. 115–271, title III, §3212, Oct. 24, 2018, 132 Stat. 3947, provided that:

"(a) In General.—Not later than 1 year after the date of enactment of this Act [Oct. 24, 2018], the Secretary of Health and Human Services, in consultation with the Administrator of the Drug Enforcement Administration, Commissioner of Food and Drugs, Director of the Centers for Disease Control and Prevention, and Assistant Secretary for Mental Health and Substance Use, shall develop and disseminate, as appropriate, materials for pharmacists, health care providers, and patients on—

"(b) Materials Included.—In developing materials under subsection (a), the Secretary of Health and Human Services shall include information for—

"(c) Stakeholder Input.—In developing the programs and materials required under subsection (a), the Secretary of Health and Human Services shall seek input from relevant national, State, and local associations, boards of pharmacy, medical societies, licensing boards, health care practitioners, and patients, including individuals with chronic pain."

Pub. L. 101–647, title XIX, §1902(c), Nov. 29, 1990, 104 Stat. 4852, provided that any prescription for anabolic steroids subject to refill on or after Nov. 29, 1990, could be refilled without restriction under subsec. (a) of this section.