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 [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 [ ]. Prescriptions shall be retained in conformity with the requirements of section 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 [et seq.], may be dispensed without a written or oral prescription in conformity with section 503(b) of that Act [ ]. 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 [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.
A prescription for a controlled substance in schedule II may be partially filled if-
Except as provided in subparagraph (B), remaining portions of a partially filled prescription for a controlled substance in schedule II-
In emergency situations, as described in subsection (a), the remaining portions of a partially filled prescription for a controlled substance in schedule II-
Notwithstanding paragraph (1) or (2), in any circumstance in which, as of the day before July 22, 2016, a prescription for a controlled substance in schedule II may be lawfully partially filled, the Attorney General may allow such a prescription to be partially filled.
21 U.S.C. § 829
REFERENCES IN TEXTThe 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 sectionof this title and Tables.Schedules II, III, IV, and V, referred to in subsecs. (a) to (c), are set out in section of this title.
AMENDMENTS2016-Subsec. (f). Pub. L. 114-198 added subsec. (f).2008-Subsec. (e). Pub. L. 110-425 added subsec. (e).
EFFECTIVE DATE OF 2008 AMENDMENT 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 sectionof this title.
EFFECTIVE DATESection 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 sectionof this title.
CONSTRUCTION OF 2016 AMENDMENT 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 () to be partially filled."
DISPENSATION OF NARCOTIC DRUGS FOR THE PURPOSE OF RELIEVING ACUTE WITHDRAWAL SYMPTOMS FROM OPIOID USE DISORDERPub. L. 116-215, div. B, title III, §13021302,, 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)."
PROGRAMS AND MATERIALS FOR TRAINING ON CERTAIN CIRCUMSTANCES UNDER WHICH A PHARMACIST MAY DECLINE TO FILL A PRESCRIPTION Pub. L. 115-271, title III, §32123212,, 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-"(1) circumstances under which a pharmacist may, consistent with section 309 of the Controlled Substances Act ( 21 U.S.C. 829 ) and regulations thereunder, including section 1306.04 of title 21, Code of Federal Regulations, decline to fill a prescription for a controlled substance because the pharmacist suspects the prescription is fraudulent, forged, or of doubtful, questionable, or suspicious origin; and"(2) other Federal requirements pertaining to declining to fill a prescription under such circumstances, including the partial fill of prescriptions for certain controlled substances."(b) MATERIALS INCLUDED.-In developing materials under subsection (a), the Secretary of Health and Human Services shall include information for- "(1) pharmacists on how to decline to fill a prescription and actions to take after declining to fill a prescription; and"(2) other health care practitioners and the public on a pharmacist's ability to decline to fill prescriptions in certain circumstances and a description of those circumstances (as described in the materials developed under subsection (a)(1))."(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."
EFFECT OF SCHEDULING ON PRESCRIPTIONS 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.