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.
(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.
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.
Amendment by Pub. L. 110–425effective 180 days after Oct. 15, 2008, except as otherwise provided, see section 3(j) ofPub. L. 110–425, set out as a note under section
802 of this title.
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)).”
The table below lists the classification updates, since Jan. 3, 2012, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.
The most recent Classification Table update that we have noticed was Tuesday, August 13, 2013
An empty table indicates that we see no relevant changes listed in the classification tables. If you suspect that our system may be missing something, please double-check with the Office of the Law Revision Counsel.