Title 21 United States Code (USC) Controlled Substances Act
SUBCHAPTER I — CONTROL AND ENFORCEMENT
Part C — Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances
(a) Schedule II substances
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.
(b) Schedule III and IV substances
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.
(c) Schedule V substances
No controlled substance in schedule V which is a drug may be distributed or dispensed other than for a medical purpose.
(d) Non-prescription drugs with abuse potential
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.
(e) Controlled substances dispensed by means of the Internet
(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:
(A) The term "valid prescription" means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by—
(i) a practitioner who has conducted at least 1 in-person medical evaluation of the patient; or
(ii) a covering practitioner.
(B)(i) The term "in-person medical evaluation" means a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals.
(ii) Nothing in clause (i) shall be construed to imply that 1 in-person medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice.
(C) The term "covering practitioner" means, with respect to a patient, a practitioner who conducts a medical evaluation (other than an in-person medical evaluation) at the request of a practitioner who—
(i) has conducted at least 1 in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine, within the previous 24 months; and
(ii) is temporarily unavailable to conduct the evaluation of the patient.
(3) Nothing in this subsection shall apply to—
(A) the delivery, distribution, or dispensing of a controlled substance by a practitioner engaged in the practice of telemedicine; or
(B) the dispensing or selling of a controlled substance pursuant to practices as determined by the Attorney General by regulation, which shall be consistent with effective controls against diversion.
(f) Partial fills of schedule II controlled substances
(1) Partial fills
A prescription for a controlled substance in schedule II may be partially filled if—
(A) it is not prohibited by State law;
(B) the prescription is written and filled in accordance with this subchapter, regulations prescribed by the Attorney General, and State law;
(C) the partial fill is requested by the patient or the practitioner that wrote the prescription; and
(D) the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.
(2) Remaining portions
(A) In general
Except as provided in subparagraph (B), remaining portions of a partially filled prescription for a controlled substance in schedule II—
(i) may be filled; and
(ii) shall be filled not later than 30 days after the date on which the prescription is written.
(B) Emergency situations
In emergency situations, as described in subsection (a), the remaining portions of a partially filled prescription for a controlled substance in schedule II—
(i) may be filled; and
(ii) shall be filled not later than 72 hours after the prescription is issued.
(3) Currently lawful partial fills
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.
( 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 .)
References in Text
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).
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 section 802 of 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 (21 U.S.C. 812(c)) to be partially filled."
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 the date of enactment of the amendments made by this section [Nov. 29, 1990] may be refilled without restriction under section 309(a) of the Controlled Substances Act (21 U.S.C. 829(a))."
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).