21 USC 828

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§ 828

TITLE 21—FOOD AND DRUGS

(4) That all reports under this section must
include the registered person’s registration
number as well as the registration numbers,
names, and other identifying information of
vendors, suppliers, and customers, sufficient
to allow the Attorney General to track the receipt and distribution of the drug.
(5) That each dispensing practitioner shall
maintain for each prescription the name of the
prescribing practitioner, the prescribing practitioner’s Federal and State registration numbers, with the expiration dates of these registrations, verification that the prescribing
practitioner possesses the appropriate registration to prescribe this controlled substance, the patient’s name and address, the
name of the patient’s insurance provider and
documentation by a medical practitioner licensed and registered to prescribe the drug of
the patient’s medical need for the drug. Such
information shall be available for inspection
and copying by the Attorney General.
(6) That section 830(b)(3) of this title (relating to mail order reporting) applies with respect to gamma hydroxybutyric acid to the
same extent and in the same manner as such
section applies with respect to the chemicals
and drug products specified in subparagraph
(A)(i) of such section.
(Pub. L. 91–513, title II, § 307, Oct. 27, 1970, 84
Stat. 1258; Pub. L. 93–281, § 5, May 14, 1974, 88
Stat. 125; Pub. L. 95–633, title I, §§ 104, 110, Nov.
10, 1978, 92 Stat. 3772, 3773; Pub. L. 98–473, title II,
§§ 514, 515, Oct. 12, 1984, 98 Stat. 2074; Pub. L.
106–172, § 4, Feb. 18, 2000, 114 Stat. 9; Pub. L.
110–425, § 3(c), Oct. 15, 2008, 122 Stat. 4824.)
REFERENCES IN TEXT
Schedules II, III, IV, and V, referred to in subsec. (c),
are set out in section 812(c) of this title.
AMENDMENTS
2008—Subsec. (d). Pub. L. 110–425 designated existing
provisions as par. (1) and added par. (2).
2000—Subsec. (h). Pub. L. 106–172 added subsec. (h).
1984—Subsec. (c)(1)(A). Pub. L. 98–473, § 514(a), substituted ‘‘to the prescribing of controlled substances in
schedule II, III, IV, or V by practitioners acting in the
lawful course of their professional practice unless such
substance is prescribed in the course of maintenance or
detoxification treatment of an individual’’ for ‘‘with respect to any narcotic controlled substance in schedule
II, III, IV, or V, to the prescribing or administering of
such substance by a practitioner in the lawful course of
his professional practice unless such substance was prescribed or administered in the course of maintenance
treatment or detoxification treatment of an individual’’.
Subsec. (c)(1)(B). Pub. L. 98–473, § 514(b), substituted
‘‘to the administering of a controlled substance in
schedule II, III, IV, or V unless the practitioner regularly engages in the dispensing or administering of controlled substances and charges his patients, either separately or together with charges for other professional
services, for substances so dispensed or administered or
unless such substance is administered in the course of
maintenance treatment or detoxification treatment of
an individual’’ for ‘‘with respect to nonnarcotic controlled substances in schedule II, III, IV, or V, to any
practitioner who dispenses such substances to his patients, unless the practitioner is regularly engaged in
charging his patients, either separately or together
with charges for other professional services, for substances so dispensed’’.

Page 540

Subsec. (g). Pub. L. 98–473, § 515, added subsec. (g).
1978—Subsec. (c). Pub. L. 95–633, § 110, inserted provision following par. (3) relating to the construction of
the Convention on Psychotropic Substances.
Subsecs. (e), (f). Pub. L. 95–633 added subsec. (e) and
redesignated former subsec. (e) as (f).
1974—Subsec. (c)(1)(A). Pub. L. 93–281 substituted
‘‘any narcotic controlled substance’’ for ‘‘narcotic controlled substances’’ and made section applicable to any
narcotic controlled substance prescribed or administered in the course of maintenance treatment or detoxification treatment of an individual.
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 OF 1978 AMENDMENT
Amendment by Pub. L. 95–633 effective on date the
Convention on Psychotropic Substances enters into
force in the United States [July 15, 1980], see section 112
of Pub. L. 95–633, set out as an Effective Date note
under section 801a of this title.

§ 828. Order forms
(a) Unlawful distribution of controlled substances
It shall be unlawful for any person to distribute a controlled substance in schedule I or II to
another except in pursuance of a written order
of the person to whom such substance is distributed, made on a form to be issued by the Attorney General in blank in accordance with subsection (d) of this section and regulations prescribed by him pursuant to this section.
(b) Nonapplicability of provisions
Nothing in subsection (a) of this section shall
apply to—
(1) the exportation of such substances from
the United States in conformity with subchapter II of this chapter;
(2) the delivery of such a substance to or by
a common or contract carrier for carriage in
the lawful and usual course of its business, or
to or by a warehouseman for storage in the
lawful and usual course of its business; but
where such carriage or storage is in connection with the distribution by the owner of the
substance to a third person, this paragraph
shall not relieve the distributor from compliance with subsection (a) of this section; or
(3) the delivery of such a substance for the
purpose of disposal by an ultimate user, longterm care facility, or other person acting in
accordance with section 822(g) of this title.
(c) Preservation and availability
(1) Every person who in pursuance of an order
required under subsection (a) of this section distributes a controlled substance shall preserve
such order for a period of two years, and shall
make such order available for inspection and
copying by officers and employees of the United
States duly authorized for that purpose by the
Attorney General, and by officers or employees
of States or their political subdivisions who are
charged with the enforcement of State or local
laws regulating the production, or regulating
the distribution or dispensing, of controlled substances and who are authorized under such laws
to inspect such orders.

Page 541

TITLE 21—FOOD AND DRUGS

(2) Every person who gives an order required
under subsection (a) of this section shall, at or
before the time of giving such order, make or
cause to be made a duplicate thereof on a form
to be issued by the Attorney General in blank in
accordance with subsection (d) of this section
and regulations prescribed by him pursuant to
this section, and shall, if such order is accepted,
preserve such duplicate for a period of two years
and make it available for inspection and copying
by the officers and employees mentioned in
paragraph (1) of this subsection.
(d) Issuance
(1) The Attorney General shall issue forms
pursuant to subsections (a) and (c)(2) of this section only to persons validly registered under
section 823 of this title (or exempted from registration under section 822(d) of this title).
Whenever any such form is issued to a person,
the Attorney General shall, before delivery
thereof, insert therein the name of such person,
and it shall be unlawful for any other person (A)
to use such form for the purpose of obtaining
controlled substances or (B) to furnish such
form to any person with intent thereby to procure the distribution of such substances.
(2) The Attorney General may charge reasonable fees for the issuance of such forms in such
amounts as he may prescribe for the purpose of
covering the cost to the United States of issuing
such forms, and other necessary activities in
connection therewith.
(e) Unlawful acts
It shall be unlawful for any person to obtain
by means of order forms issued under this section controlled substances for any purpose other
than their use, distribution, dispensing, or administration in the conduct of a lawful business
in such substances or in the course of his professional practice or research.
(Pub. L. 91–513, title II, § 308, Oct. 27, 1970, 84
Stat. 1259; Pub. L. 111–273, § 3(b), Oct. 12, 2010, 124
Stat. 2860.)
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).

§ 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.

§ 829

(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