21 U.S.C. § 829a — Delivery of a controlled substance by a

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 Page 832 TITLE 21—FOOD AND DRUGS § 830 1 See References in Text note below. treatment and is to be administered by injection or im- plantation;’’ for ‘‘the controlled substance is to be ad- ministered for the purpose of maintenance or detoxi- fication treatment under section 823(g)(2) and—’’ ‘‘(A) the practitioner who issued the prescription is a qualifying practitioner authorized under, and act- ing within the scope of that section; and ‘‘(B) the controlled substance is to be administered by injection or implantation;’’ was executed by making the substitution for ‘‘the controlled substance is to be administered for the purpose of maintenance or detoxification treatment under section 823(h)(2) and—’’ and subpars. (A) and (B), to reflect the probable intent of Congress and the intervening amendment by Pub. L. 117–215. See Amendment note below. Pub. L. 117–215 substituted ‘‘823(h)(2)’’ for ‘‘823(g)(2)’’ in introductory provisions. Subsec. (a)(5). Pub. L. 117–328, § 1264, substituted ‘‘45 days’’ for ‘‘14 days’’. § 830. Regulation of listed chemicals and certain machines (a) Record of regulated transactions (1) Each regulated person who engages in a regulated transaction involving a listed chem- ical, a tableting machine, or an encapsulating machine shall keep a record of the transaction for two years after the date of the transaction. (2) A record under this subsection shall be re- trievable and shall include the date of the regu- lated transaction, the identity of each party to the regulated transaction, a statement of the quantity and form of the listed chemical, a de- scription of the tableting machine or encap- sulating machine, and a description of the meth- od of transfer. Such record shall be available for inspection and copying by the Attorney General. (3) It is the duty of each regulated person who engages in a regulated transaction to identify each other party to the transaction. It is the duty of such other party to present proof of identity to the regulated person. The Attorney General shall specify by regulation the types of documents and other evidence that constitute proof of identity for purposes of this paragraph. (b) Reports to Attorney General (1) Each regulated person shall report to the Attorney General, in such form and manner as the Attorney General shall prescribe by regula- tion— (A) any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of this sub- chapter; (B) any proposed regulated transaction with a person whose description or other identi- fying characteristic the Attorney General fur- nishes in advance to the regulated person; (C) any unusual or excessive loss or dis- appearance of a listed chemical under the con- trol of the regulated person; and (D) any regulated transaction in a tableting machine or an encapsulating machine. Each report under subparagraph (A) shall be made at the earliest practicable opportunity after the regulated person becomes aware of the circumstance involved. A regulated person may not complete a transaction with a person whose description or identifying characteristic is fur- nished to the regulated person under subpara- graph (B) unless the transaction is approved by the Attorney General. The Attorney General shall make available to regulated persons guid- ance documents describing transactions and cir- cumstances for which reports are required under subparagraph (A) and subparagraph (C). (2) A regulated person that manufactures a listed chemical shall report annually to the At- torney General, in such form and manner and containing such specific data as the Attorney General shall prescribe by regulation, informa- tion concerning listed chemicals manufactured by the person. The requirement of the preceding sentence shall not apply to the manufacture of a drug product that is exempted under section 802(39)(A)(iv) of this title. (3) MAIL ORDER REPORTING.—(A) As used in this paragraph: (i) The term ‘‘drug product’’ means an active ingredient in dosage form that has been ap- proved or otherwise may be lawfully marketed under the Food, Drug, and Cosmetic Act 1 [21 U.S.C. 301 et seq.] for distribution in the United States. (ii) The term ‘‘valid prescription’’ means a prescription which is issued for a legitimate medical purpose by an individual practitioner licensed by law to administer and prescribe the drugs concerned and acting in the usual course of the practitioner’s professional prac- tice. (B) Each regulated person who engages in a transaction with a nonregulated person or who engages in an export transaction which— (i) involves ephedrine, pseudoephedrine, or phenylpropanolamine (including drug products containing these chemicals); and (ii) uses or attempts to use the Postal Serv- ice or any private or commercial carrier; shall, on a monthly basis, submit a report of each such transaction conducted during the pre- vious month to the Attorney General in such form, containing such data, and at such times as the Attorney General shall establish by regula- tion. (C) The data required for such reports shall in- clude— (i) the name of the purchaser; (ii) the quantity and form of the ephedrine, pseudoephedrine, or phenylpropanolamine pur- chased; and (iii) the address to which such ephedrine, pseudoephedrine, or phenylpropanolamine was sent. (D) Except as provided in subparagraph (E), the following distributions to a nonregulated person, and the following export transactions, shall not be subject to the reporting require- ment in subparagraph (B): (i) Distributions of sample packages of drug products when such packages contain not more than two solid dosage units or the equiv- alent of two dosage units in liquid form, not to exceed 10 milliliters of liquid per package, and not more than one package is distributed to an