21 U.S.C. § 828 — Order forms

Page 828 TITLE 21—FOOD AND DRUGS § 828 (6) That section 830(b)(3) of this title (relat- ing to mail order reporting) applies with re- spect 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. (j) Electronic reporting format All of the reports required under this section shall be provided in an electronic format. (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; Pub. L. 115–271, title III, § 3273(a), Oct. 24, 2018, 132 Stat. 3952; Pub. L. 117–215, title I, § 103(b)(1)(D), Dec. 2, 2022, 136 Stat. 2263.) Editorial Notes 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 2022—Subsec. (d)(2). Pub. L. 117–215 substituted ‘‘823(g)’’ for ‘‘823(f)’’ in introductory provisions. 2018—Subsecs. (f) to (i). Pub. L. 115–271, § 3273(a)(1), (2), added subsec. (f) and redesignated former subsecs. (f) to (h) as (g) to (i), respectively. Subsec. (j). Pub. L. 115–271, § 3273(a)(3), added subsec. (j). 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), sub- stituted ‘‘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 re- spect 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 pre- scribed or administered in the course of maintenance treatment or detoxification treatment of an indi- vidual’’. 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 regu- larly engages in the dispensing or administering of con- trolled substances and charges his patients, either sep- arately 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 con- trolled substances in schedule II, III, IV, or V, to any practitioner who dispenses such substances to his pa- tients, unless the practitioner is regularly engaged in charging his patients, either separately or together with charges for other professional services, for sub- stances so dispensed’’. Subsec. (g). Pub. L. 98–473, § 515, added subsec. (g). 1978—Subsec. (c). Pub. L. 95–633, § 110, inserted provi- sion 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 con- trolled substances’’ and made section applicable to any narcotic controlled substance prescribed or adminis- tered in the course of maintenance treatment or de- toxification treatment of an individual. 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 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. 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. PURPOSE Pub. L. 115–271, title III, § 3272, Oct. 24, 2018, 132 Stat. 3952, provided that: ‘‘(a) IN GENERAL.—The purpose of this chapter [see section 3271 of Pub. L. 115–271, set out as a Short Title of 2018 Amendment note under section 801 of this title] is to provide drug manufacturers and distributors with access to anonymized information through the Auto- mated Reports and Consolidated Orders System to help drug manufacturers and distributors identify, report, and stop suspicious orders of opioids and reduce diver- sion rates. ‘‘(b) RULE OF CONSTRUCTION.—Nothing in this chapter should be construed to absolve a drug manufacturer, drug distributor, or other Drug Enforcement Adminis- tration registrant from the responsibility of the manu- facturer, distributor, or other registrant to— ‘‘(1) identify, stop, and report suspicious orders; or ‘‘(2) maintain effective controls against diversion in accordance with section 303 of the Controlled Sub- stances Act (21 U.S.C. 823) or any successor law or as- sociated regulation.’’ § 828. Order forms (a) Unlawful distribution of controlled sub- stances It shall be unlawful for any person to dis- tribute 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) and regulations prescribed by him pursuant to this section. (b) Nonapplicability of provisions Nothing in subsection (a) shall apply to— (1) the exportation of such substances from the United States in conformity with sub- chapter II; (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 connec- tion with the distribution by the owner of the substance to a third person, this paragraph shall not relieve the distributor from compli- ance with subsection (a); or Page 829 TITLE 21—FOOD AND DRUGS § 829 (3) the delivery of such a substance for the purpose of disposal by an ultimate user, long- term 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) distributes a con- trolled 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 author- ized 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 or- ders. (2) Every person who gives an order required under subsection (a) 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) 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 inspec- tion 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) 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 in- tent thereby to procure the distribution of such substances. (2) The Attorney General may charge reason- able 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 sec- tion controlled substances for any purpose other than their use, distribution, dispensing, or ad- ministration in the conduct of a lawful business in such substances or in the course of his profes- sional 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.) 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 practi- tioner, 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, ex- cept that in emergency situations, as prescribed by the Secretary by regulation after consulta- tion with the Attorney General, such drug may be dispensed upon oral prescription in accord- ance with section 503(b) of that Act [21 U.S.C. 353(b)]. Prescriptions shall be retained in con- formity with the requirements of section 827 of this title. No prescription for a controlled sub- stance in schedule II may be refilled. (b) Schedule III and IV substances Except when dispensed directly by a practi- tioner, 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 practi- tioner. (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 Cos- metic Act [21 U.S.C. 301 et seq.] should be so con- sidered 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 prescrip- tion 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 prescrip- tion. (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 profes- sional practice by— (i) a practitioner who has conducted at least 1 in-person medical evaluation of the patient; or