21 U.S.C. § 831 — Additional requirements relating to online

Page 837 TITLE 21—FOOD AND DRUGS § 831 Pub. L. 109–177, title VII, § 711(c)(3), Mar. 9, 2006, 120 Stat. 261, provided that: ‘‘The amendments made by paragraphs (1) and (2) [amending this section] apply on and after the expiration of the 30-day period beginning on the date of the enactment of this Act [Mar. 9, 2006].’’ EFFECTIVE DATE OF 1993 AMENDMENT Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title. EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100–690 effective 120 days after Nov. 18, 1988, see section 6061 of Pub. L. 100–690, set out as a note under section 802 of this title. EFFECTIVE DATE; TIME TO SUBMIT PIPERIDINE REPORT; REQUIRED INFORMATION Pub. L. 95–633, title II, § 203(a), Nov. 10, 1978, 92 Stat. 3776, provided that: ‘‘(1) Except as provided under paragraph (2), the amendments made by this title [enacting this section and amending sections 841 to 843 of this title] shall take effect on the date of the enactment of this Act [Nov. 10, 1978]. ‘‘(2) Any person required to submit a report under section 310(a)(1) of the Controlled Substances Act [sub- sec. (a)(1) of this section] respecting a distribution, sale, or importation of piperidine during the 90 days after the date of the enactment of this Act [Nov. 10, 1978] may submit such report any time up to 97 days after such date of enactment. ‘‘(3) Until otherwise provided by the Attorney Gen- eral by regulation, the information required to be re- ported by a person under section 310(a)(1) of the Con- trolled Substances Act (as added by section 202(a)(2) of this title) [subsec. (a)(1) of this section] with respect to the person’s distribution, sale, or importation of piper- idine shall— ‘‘(A) be the information described in subparagraphs (A) and (B) of such section, and ‘‘(B) except as provided in paragraph (2) of this sub- section, be reported not later than seven days after the date of such distribution, sale, or importation.’’ REPEALS Pub. L. 96–359, § 8(b), Sept. 26, 1980, 94 Stat. 1194, re- pealed section 203(d) of Pub. L. 95–633, which had pro- vided for the repeal of this section effective Jan. 1, 1981. REGULATIONS Pub. L. 111–268, § 6(b), Oct. 12, 2010, 124 Stat. 2848, pro- vided that: ‘‘In promulgating the regulations author- ized by section 2 [amending this section], the Attorney General may issue regulations on an interim basis as necessary to ensure the implementation of this Act by the effective date [see Effective Date of 2010 Amend- ment note above].’’ Pub. L. 95–633, title II, § 203(b), Nov. 10, 1978, 92 Stat. 3777, required the Attorney General to publish proposed interim regulations for piperidine reporting under sec- tion 830(a) of this title not later than 30 days after en- actment, and final interim regulations not later than 75 days after enactment, such final interim regulations to be effective on and after the ninety-first day after enactment. REPORT TO PRESIDENT AND CONGRESS ON EFFECTIVENESS OF TITLE II OF PUB. L. 95–633 Pub. L. 95–633, title II, § 203(c), Nov. 10, 1978, 92 Stat. 3777, required the Attorney General to analyze and evaluate the impact and effectiveness of the amend- ments made by title II of Pub. L. 95–633, and report to the President and Congress not later than Mar. 1, 1980. § 831. Additional requirements relating to online pharmacies and telemedicine (a) In general An online pharmacy shall display in a visible and clear manner on its homepage a statement that it complies with the requirements of this section with respect to the delivery or sale or offer for sale of controlled substances and shall at all times display on the homepage of its Internet site a declaration of compliance in ac- cordance with this section. (b) Licensure Each online pharmacy shall comply with the requirements of State law concerning the licen- sure of pharmacies in each State from which it, and in each State to which it, delivers, distrib- utes, or dispenses or offers to deliver, distribute, or dispense controlled substances by means of the Internet, pursuant to applicable licensure requirements, as determined by each such State. (c) Internet pharmacy site disclosure informa- tion Each online pharmacy shall post in a visible and clear manner on the homepage of each Internet site it operates, or on a page directly linked thereto in which the hyperlink is also visible and clear on the homepage, the following information for each pharmacy that delivers, distributes, or dispenses controlled substances pursuant to orders made on, through, or on be- half of, that website: (1) The name and address of the pharmacy as it appears on the pharmacy’s Drug Enforce- ment Administration certificate of registra- tion. (2) The pharmacy’s telephone number and email address. (3) The name, professional degree, and States of licensure of the pharmacist-in- charge, and a telephone number at which the pharmacist-in-charge can be contacted. (4) A list of the States in which the phar- macy is licensed to dispense controlled sub- stances. (5) A certification that the pharmacy is reg- istered under this part to deliver, distribute, or dispense by means of the Internet con- trolled substances. (6) The name, address, telephone number, professional degree, and States of licensure of any practitioner who has a contractual rela- tionship to provide medical evaluations or issue prescriptions for controlled substances, through referrals from the website or at the request of the owner or operator of the website, or any employee or agent thereof. (7) The following statement, unless revised by the Attorney General by regulation: ‘‘This online pharmacy will only dispense a con- trolled substance to a person who has a valid prescription issued for a legitimate medical purpose based upon a medical relationship with a prescribing practitioner. This includes at least one prior in-person medical evaluation or medical evaluation via telemedicine in ac- cordance with applicable requirements of sec- tion 309.’’. (d) Notification (1) In general Thirty days prior to offering a controlled substance for sale, delivery, distribution, or dispensing, the online pharmacy shall notify the Attorney General, in such form and man- ner as the Attorney General shall determine, Page 838 TITLE 21—FOOD AND DRUGS § 831 and the State boards of pharmacy in any States in which the online pharmacy offers to sell, deliver, distribute, or dispense controlled substances. (2) Contents The notification required under paragraph (1) shall include— (A) the information required to be posted on the online pharmacy’s Internet site under subsection (c) and shall notify the Attorney General and the applicable State boards of pharmacy, under penalty of perjury, that the information disclosed on its Internet site under subsection (c) is true and accurate; (B) the online pharmacy’s Internet site ad- dress and a certification that the online pharmacy shall notify the Attorney General of any change in the address at least 30 days in advance; and (C) the Drug Enforcement Administration registration numbers of any pharmacies and practitioners referred to in subsection (c), as applicable. (3) Existing online pharmacies An online pharmacy that is already oper- ational as of the effective date of this section, shall notify the Attorney General and applica- ble State boards of pharmacy in accordance with this subsection not later than 30 days after such date. (e) Declaration of compliance On and after the date on which it makes the notification under subsection (d), each online pharmacy shall display on the homepage of its Internet site, in such form as the Attorney Gen- eral shall by regulation require, a declaration that it has made such notification to the Attor- ney General. (f) Reports Any statement, declaration, notification, or disclosure required under this section shall be considered a report required to be kept under this part. (g) Notice and designations concerning Indian tribes (1) In general For purposes of sections 802(52) and 882(c)(6)(B) of this title, the Secretary shall notify the Attorney General, at such times and in such manner as the Secretary and the Attorney General determine appropriate, of the Indian tribes or tribal organizations with which the Secretary has contracted or com- pacted under the Indian Self-Determination and Education Assistance Act [25 U.S.C. 5301 et seq.] for the tribes or tribal organizations to provide pharmacy services. (2) Designations (A) In general The Secretary may designate a practi- tioner described in subparagraph (B) as an Internet Eligible Controlled Substances Pro- vider. Such designations shall be made only in cases where the Secretary has found that there is a legitimate need for the practi- tioner to be so designated because the popu- lation served by the practitioner is in a suf- ficiently remote location that access to medical services is limited. (B) Practitioners A practitioner described in this subpara- graph is a practitioner who is an employee or contractor of the Indian Health Service, or is working for an Indian tribe or tribal or- ganization under its contract or compact under the Indian Self-Determination and Education Assistance Act [25 U.S.C. 5301 et seq.] with the Indian Health Service. (h) Special registration for telemedicine (1) In general The Attorney General may issue to a practi- tioner a special registration to engage in the practice of telemedicine for purposes of sec- tion 802(54)(E) of this title if the practitioner, upon application for such special registra- tion— (A) demonstrates a legitimate need for the special registration; and (B) is registered under section 823(g) of this title in the State in which the patient will be located when receiving the telemedi- cine treatment, unless the practitioner— (i) is exempted from such registration in all States under section 822(d) of this title; or (ii) is an employee or contractor of the Department of Veterans Affairs who is act- ing in the scope of such employment or contract and is registered under section 823(g) of this title in any State or is uti- lizing the registration of a hospital or clin- ic operated by the Department of Veterans Affairs registered under section 823(g) of this title. (2) Regulations Not later than 1 year after October 24, 2018, in consultation with the Secretary, the Attor- ney General shall promulgate final regulations specifying— (A) the limited circumstances in which a special registration under this subsection may be issued; and (B) the procedure for obtaining a special registration under this subsection. (3) Denials Proceedings to deny an application for reg- istration under this subsection shall be con- ducted in accordance with section 824(c) of this title. (i) Reporting of telemedicine by VHA during medical emergency situations (1) In general Any practitioner issuing a prescription for a controlled substance under the authorization to conduct telemedicine during a medical emergency situation described in section 802(54)(F) of this title shall report to the Sec- retary of Veterans Affairs the authorization of that emergency prescription, in accordance with such requirements as the Secretary of Veterans Affairs shall, by regulation, estab- lish. (2) To Attorney General Not later than 30 days after the date that a prescription described in subparagraph (A) is Page 839 TITLE 21—FOOD AND DRUGS § 841 issued, the Secretary of Veterans Affairs shall report to the Attorney General the authoriza- tion of that emergency prescription. (j) Clarification concerning prescription trans- fers Any transfer between pharmacies of informa- tion relating to a prescription for a controlled substance shall meet the applicable require- ments under regulations promulgated by the At- torney General under this chapter. (Pub. L. 91–513, title II, § 311, as added Pub. L. 110–425, § 3(d)(1), Oct. 15, 2008, 122 Stat. 4825; amended Pub. L. 115–271, title III, § 3232, Oct. 24, 2018, 132 Stat. 3950; Pub. L. 117–215, title I, § 103(b)(1)(F), Dec. 2, 2022, 136 Stat. 2263.) Editorial Notes REFERENCES IN TEXT Section 309, referred to in subsec. (c)(7), is section 309 of Pub. L. 91–513, which is classified to section 829 of this title. For effective date of this section, referred to in sub- sec. (d)(3), see Effective Date note below. The Indian Self-Determination and Education Assist- ance Act, referred to in subsec. (g)(1), (2)(B), is Pub. L. 93–638, Jan. 4, 1975, 88 Stat. 2203, which is classified principally to chapter 46 (§ 5301 et seq.) of Title 25, Indi- ans. For complete classification of this Act to the Code, see Short Title note set out under section 5301 of Title 25 and Tables. This chapter, referred to in subsec. (j), was in the original ‘‘this Act’’, meaning Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236. For complete classification of this Act to the Code, see Short Title note set out under sec- tion 801 of this title and Tables. AMENDMENTS 2022—Subsec. (h)(1)(B). Pub. L. 117–215 substituted ‘‘823(g)’’ for ‘‘823(f)’’ wherever appearing. 2018—Subsec. (h)(2). Pub. L. 115–271 amended par. (2) generally. Prior to amendment, text read as follows: ‘‘The Attorney General shall, with the concurrence of the Secretary, promulgate regulations specifying the limited circumstances in which a special registration under this subsection may be issued and the procedures for obtaining such a special registration.’’ Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective 180 days after Oct. 15, 2008, except as otherwise provided, see section 3(j) of Pub. L. 110–425, set out as an Effective Date of 2008 Amendment note under section 802 of this title. § 832. Suspicious orders (a) Reporting Each registrant shall— (1) design and operate a system to identify suspicious orders for the registrant; (2) ensure that the system designed and op- erated under paragraph (1) by the registrant complies with applicable Federal and State privacy laws; and (3) upon discovering a suspicious order or se- ries of orders, notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business. (b) Suspicious order database (1) In general Not later than 1 year after October 24, 2018, the Attorney General shall establish a central- ized database for collecting reports of sus- picious orders. (2) Satisfaction of reporting requirements If a registrant reports a suspicious order to the centralized database established under paragraph (1), the registrant shall be consid- ered to have complied with the requirement under subsection (a)(3) to notify the Adminis- trator of the Drug Enforcement Administra- tion and the Special Agent in Charge of the Division Office of the Drug Enforcement Ad- ministration for the area in which the reg- istrant is located or conducts business. (c) Sharing information with the States (1) In general The Attorney General shall prepare and make available information regarding sus- picious orders in a State, including informa- tion in the database established under sub- section (b)(1), to the point of contact for pur- poses of administrative, civil, and criminal oversight relating to the diversion of con- trolled substances for the State, as designated by the Governor or chief executive officer of the State. (2) Timing The Attorney General shall provide informa- tion in accordance with paragraph (1) within a reasonable period of time after obtaining the information. (3) Coordination In establishing the process for the provision of information under this subsection, the At- torney General shall coordinate with States to ensure that the Attorney General has access to information, as permitted under State law, possessed by the States relating to prescrip- tions for controlled substances that will assist in enforcing Federal law. (Pub. L. 91–513, title II, § 312, as added Pub. L. 115–271, title III, § 3292(b), Oct. 24, 2018, 132 Stat. 3956.) PART D—OFFENSES AND PENALTIES § 841. Prohibited acts A (a) Unlawful acts Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally— (1) to manufacture, distribute, or dispense, or possess with intent to manufacture, dis- tribute, or dispense, a controlled substance; or (2) to create, distribute, or dispense, or pos- sess with intent to distribute or dispense, a counterfeit substance. (b) Penalties Except as otherwise provided in section 849, 859, 860, or 861 of this title, any person who vio- lates subsection (a) of this section shall be sen- tenced as follows: (1)(A) In the case of a violation of subsection (a) of this section involving—