21 U.S.C. § 829 — Prescriptions

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 Page 830 TITLE 21—FOOD AND DRUGS § 829 (ii) a covering practitioner. (B)(i) The term ‘‘in-person medical evalua- tion’’ means a medical evaluation that is con- ducted with the patient in the physical pres- ence of the practitioner, without regard to whether portions of the evaluation are con- ducted 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 med- ical evaluation of the patient or an evalua- tion 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 en- gaged 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 sub- stances (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 pa- tient or the practitioner that wrote the pre- scription; and (D) the total quantity dispensed in all par- tial fillings does not exceed the total quan- tity prescribed. (2) Remaining portions (A) In general Except as provided in subparagraph (B), re- maining portions of a partially filled pre- scription for a controlled substance in sched- ule 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 par- tially 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 clas- sification 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 prescrip- tion 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 At- torney 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, as amended by Pub. L. 117–328, div. FF, title I, § 1271(a), Dec. 29, 2022, 136 Stat. 5685, provided that: ‘‘(a) IN GENERAL.—The Secretary of Health and Human Services, in consultation with the Adminis- trator of the Drug Enforcement Administration, Com- Page 831 TITLE 21—FOOD AND DRUGS § 829a missioner of Food and Drugs, Director of the Centers for Disease Control and Prevention, and Assistant Sec- retary for Mental Health and Substance Use, shall de- velop and disseminate not later than 1 year after the date of enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022 [Dec. 29, 2022], and update periodically thereafter, as appropriate, mate- rials for pharmacists, health care providers, and pa- tients on— ‘‘(1) circumstances under which a pharmacist may, consistent with section 309 of the Controlled Sub- stances Act (21 U.S.C. 829) and regulations there- under, including section 1306.04 of title 21, Code of Federal Regulations, decline to fill a prescription for a controlled substance because the pharmacist sus- pects the prescription is fraudulent, forged, or of doubtful, questionable, or suspicious origin; and ‘‘(2) other Federal requirements pertaining to de- clining to fill a prescription under such cir- cumstances, 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 verify the identity of the patient; ‘‘(2) pharmacists on how to decline to fill a pre- scription and actions to take after declining to fill a prescription; and ‘‘(3) other health care practitioners and the public on a pharmacist’s ability to decline to fill prescrip- tions 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 pro- grams and materials required under subsection (a), the Secretary of Health and Human Services shall seek input from relevant national, State, and local associa- tions, boards of pharmacy, medical societies, licensing boards, health care practitioners, and patients, includ- ing individuals with chronic pain. ‘‘(d) MATERIALS FOR TRAINING ON VERIFICATION OF IDENTITY.—Not later than 1 year after the date of en- actment of this subsection [Dec. 29, 2022], the Secretary of Health and Human Services, after seeking stake- holder input in accordance with subsection (c), shall— ‘‘(1) update the materials developed under sub- section (a) to include information for pharmacists on how to verify the identity of the patient; and ‘‘(2) disseminate, as appropriate, the updated mate- rials.’’ 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 Gen- eral under this subchapter, for the purpose of ad- ministering 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 con- trolled substance, as applicable, at the loca- tion listed on the practitioner’s certificate of registration issued under this subchapter; (2) the controlled substance is a narcotic drug in schedule III, IV, or V to be adminis- tered for the purpose of maintenance or de- toxification treatment and is to be adminis- tered by injection or implantation; (3) the pharmacy and the practitioner are authorized to conduct the activities specified in this section under the law of the State in which such activities take place; (4) the prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dis- pensing to patients; (5) except as provided in subsection (b), the controlled substance is to be administered only to the patient named on the prescription not later than 45 days after the date of receipt of the controlled substance by the practi- tioner; and (6) notwithstanding any exceptions under section 827 of this title, the prescribing practi- tioner, and the practitioner administering the controlled substance, as applicable, maintain complete and accurate records of all con- trolled substances delivered, received, admin- istered, or otherwise disposed of under this section, including the persons to whom con- trolled substances were delivered and such other information as may be required by regu- lations of the Attorney General. (b) Modification of number of days before which controlled substance shall be administered (1) Initial 2-year period During the 2-year period beginning on Octo- ber 24, 2018, the Attorney General, in coordina- tion with the Secretary, may reduce the num- ber of days described in subsection (a)(5) if the Attorney General determines that such reduc- tion will— (A) reduce the risk of diversion; or (B) protect the public health. (2) Modifications after submission of report After the date on which the report described in section 3204(b) of the SUPPORT for Patients and Communities Act is submitted, the Attor- ney General, in coordination with the Sec- retary, may modify the number of days de- scribed in subsection (a)(5). (3) Minimum number of days Any modification under this subsection shall be for a period of not less than 7 days. (Pub. L. 91–513, title II, § 309A, as added Pub. L. 115–271, title III, § 3204(a), Oct. 24, 2018, 132 Stat. 3945; amended Pub. L. 117–215, title I, § 103(b)(1)(E), Dec. 2, 2022, 136 Stat. 2263; Pub. L. 117–328, div. FF, title I, §§ 1262(b)(2), 1264, Dec. 29, 2022, 136 Stat. 5682, 5685.) Editorial Notes REFERENCES IN TEXT Section 3204(b) of the SUPPORT for Patients and Communities Act, referred to in subsec. (b)(2), is sec- tion 3204(b) of Pub. L. 115–271, title III, Oct. 24, 2018, 132 Stat. 3946, which is not classified to the Code. AMENDMENTS 2022—Subsec. (a)(2). Pub. L. 117–328, § 1262(b)(2), which directed substitution of ‘‘the controlled substance is a narcotic drug in schedule III, IV, or V to be adminis- tered for the purpose of maintenance or detoxification