21 USC 829(f)

21 USC 829(f).pdf

Recordkeeping Requirements for Partial Fills of Prescriptions for Schedule II Controlled Substances

21 USC 829(f)

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TITLE 21—FOOD AND DRUGS
Editorial Notes
REFERENCES IN TEXT

Schedules I and II, referred to in subsec. (a), are set
out in section 812(c) of this title.
AMENDMENTS
2010—Subsec. (b)(3). Pub. L. 111–273 added par. (3).
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE
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.

§ 829. Prescriptions
(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.

§ 829

(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

§ 829a

TITLE 21—FOOD AND DRUGS

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.)
Editorial Notes
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.
AMENDMENTS
2016—Subsec. (f). Pub. L. 114–198 added subsec. (f).
2008—Subsec. (e). Pub. L. 110–425 added subsec. (e).
Statutory Notes and Related Subsidiaries
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.
EFFECTIVE DATE
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.
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.’’
DISPENSATION OF NARCOTIC DRUGS FOR THE PURPOSE
OF RELIEVING ACUTE WITHDRAWAL SYMPTOMS FROM
OPIOID USE DISORDER
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).’’
PROGRAMS AND MATERIALS FOR TRAINING ON CERTAIN
CIRCUMSTANCES UNDER WHICH A PHARMACIST MAY
DECLINE TO FILL A PRESCRIPTION
Pub. L. 115–271, title III, § 3212, Oct. 24, 2018, 132 Stat.
3947, provided that:

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‘‘(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.

§ 829a. Delivery of a controlled substance by a
pharmacy to an administering practitioner
(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 to be administered for the purpose of maintenance or detoxification treatment under section 823(g)(2)
of this title 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;


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