TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 311

TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 311 

at retail of a scheduled listed chemical product and is required under subsection (b)(3) to submit a report of the sales trans- action to the Attorney General is subject to the following: 

(A) The person shall, prior to shipping the product, confirm the identity of the purchaser in accordance with procedures established by the Attorney General. The At- torney General shall by regulation establish such proce- dures. 

(B) The person may not sell more than 7.5 grams of ephedrine base, pseudoephedrine base, or phenyl- propanolamine base in such products per customer during a 30-day period. 

(C) Each regulated person who makes a sale at retail of a scheduled listed chemical product and is required under subsection (b)(3) to submit a report of the sales transaction to the Attorney General may not sell any scheduled listed chemical product at retail unless such reg- ulated person has submitted to the Attorney General a self-certification including a statement that the seller un- derstands each of the requirements that apply under this paragraph and under subsection (d) and agrees to comply with the requirements. The Attorney General shall by reg- ulation establish criteria for certifications of mail-order distributors that are consistent with the criteria estab- lished for the certifications of regulated sellers under para- graph (1)(B).
(3) EXEMPTIONS FOR CERTAIN PRODUCTS.—Upon the appli- 

cation of a manufacturer of a scheduled listed chemical prod- uct, the Attorney General may by regulation provide that the product is exempt from the provisions of subsection (d) and paragraphs (1) and (2) of this subsection if the Attorney Gen- eral determines that the product cannot be used in the illicit manufacture of methamphetamine. 

ADDITIONAL REQUIREMENTS RELATING TO ONLINE PHARMACIES AND TELEMEDICINE 

SEC. 311. ø21 U.S.C. 831¿ (a) IN GENERAL.—An online phar- macy 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 accordance with this section. 

(b) LICENSURE.—Each online pharmacy shall comply with the requirements of State law concerning the licensure of pharmacies in each State from which it, and in each State to which it, delivers, distributes, or dispenses or offers to deliver, distribute, or dispense controlled substances by means of the Internet, pursuant to appli- cable licensure requirements, as determined by each such State. 

(c) INTERNET PHARMACY SITE DISCLOSURE INFORMATION.— 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 

January 16, 2018 As Amended Through P.L. 115-91, Enacted December 12, 2017 

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Sec. 311 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 72 

the homepage, the following information for each pharmacy that delivers, distributes, or dispenses controlled substances pursuant to orders made on, through, or on behalf of, that website: 

(1) The name and address of the pharmacy as it appears on the pharmacy’s Drug Enforcement Administration certifi- cate of registration. 

(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 pharmacy is licensed to dispense controlled substances. 

(5) A certification that the pharmacy is registered under this part to deliver, distribute, or dispense by means of the Internet controlled substances. 

(6) The name, address, telephone number, professional de- gree, and States of licensure of any practitioner who has a con- tractual relationship 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 dis- pense a controlled substance to a person who has a valid pre- scription issued for a legitimate medical purpose based upon a medical relationship with a prescribing practitioner. This in- cludes at least one prior in-person medical evaluation or med- ical evaluation via telemedicine in accordance with applicable requirements of section 309.’’.
(d) NOTIFICATION.— 

(1) IN GENERAL.—Thirty days prior to offering a controlled substance for sale, delivery, distribution, or dispensing, the on- line pharmacy shall notify the Attorney General, in such form and manner as the Attorney General shall determine, and the State boards of pharmacy in any States in which the online pharmacy offers to sell, deliver, distribute, or dispense con- trolled 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 no- tify the Attorney General and the applicable State boards of pharmacy, under penalty of perjury, that the informa- tion disclosed on its Internet site under subsection (c) is true and accurate; 

(B) the online pharmacy’s Internet site address and a certification that the online pharmacy shall notify the At- torney 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 operational as of the effective date of this sec- 

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73 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 311 

tion, shall notify the Attorney General and applicable 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 General shall by regulation require, a declaration that it has made such notification to the Attorney Gen- eral. 

(f) REPORTS.—Any statement, declaration, notification, or dis- closure required under this section shall be considered a report re- quired to be kept under this part. 

(g) NOTICE AND DESIGNATIONS CONCERNING INDIAN TRIBES.— (1) IN GENERAL.—For purposes of sections 102(52) and 512(c)(6)(B), the Secretary shall notify the Attorney General, at such times and in such manner as the Secretary and the Attor- ney General determine appropriate, of the Indian tribes or trib- al organizations with which the Secretary has contracted or compacted under the Indian Self-Determination and Education Assistance Act for the tribes or tribal organizations to provide 

pharmacy services.
(2) DESIGNATIONS.— 

(A) IN GENERAL.—The Secretary may designate a prac- titioner described in subparagraph (B) as an Internet Eli- gible Controlled Substances Provider. Such designations shall be made only in cases where the Secretary has found that there is a legitimate need for the practitioner to be so designated because the population served by the practi- tioner is in a sufficiently remote location that access to medical services is limited. 

(B) PRACTITIONERS.—A practitioner described in this subparagraph is a practitioner who is an employee or con- tractor of the Indian Health Service, or is working for an Indian tribe or tribal organization under its contract or compact under the Indian Self-Determination and Edu- cation Assistance Act with the Indian Health Service. 

(h) SPECIAL REGISTRATION FOR TELEMEDICINE.—
(1) IN GENERAL.—The Attorney General may issue to a 

practitioner a special registration to engage in the practice of telemedicine for purposes of section 102(54)(E) if the practi- tioner, upon application for such special registration— 

(A) demonstrates a legitimate need for the special reg- istration; and 

(B) is registered under section 303(f) in the State in which the patient will be located when receiving the tele- medicine treatment, unless the practitioner— 

(i) is exempted from such registration in all States under section 302(d); or 

(ii) is an employee or contractor of the Depart- ment of Veterans Affairs who is acting in the scope of such employment or contract and is registered under section 303(f) in any State or is utilizing the registra- tion of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f). 

As Amended Through P.L. 115-91, Enacted December 12, 2017 

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