21 USC 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 accordance with this section.
(b) Licensure
Terms Used In 21 USC 831
- agent: means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser. See 21 USC 802
- Contract: A legal written agreement that becomes binding when signed.
- controlled substance: means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of this subchapter. See 21 USC 802
- dispense: means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for such delivery. See 21 USC 802
- distribute: means to deliver (other than by administering or dispensing) a controlled substance or a listed chemical. See 21 USC 802
- drug: has the meaning given that term by section 321(g)(1) of this title. See 21 USC 802
- Drug Enforcement Administration: means the Drug Enforcement Administration in the Department of Justice. See 21 USC 802
- homepage: means the opening or main page or screen of the website of an online pharmacy that is viewable on the Internet. See 21 USC 802
- Internet: means collectively the myriad of computer and telecommunications facilities, including equipment and operating software, which comprise the interconnected worldwide network of networks that employ the Transmission Control Protocol/Internet Protocol, or any predecessor or successor protocol to such protocol, to communicate information of all kinds by wire or radio. See 21 USC 802
- practice of telemedicine: means , for purposes of this subchapter, the practice of medicine in accordance with applicable Federal and State laws by a practitioner (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system referred to in section 1395m(m) of title 42, which practice&mdash. See 21 USC 802
- practitioner: means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research. See 21 USC 802
- State: means a State of the United States, the District of Columbia, and any commonwealth, territory, or possession of the United States. See 21 USC 802
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 applicable 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 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 certificate 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 degree, and States of licensure of any practitioner who has a contractual 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 dispense a controlled 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 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 online 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 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 address 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 operational as of the effective date of this section, 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 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 compacted 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 practitioner described in subparagraph (B) as an Internet Eligible 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 practitioner 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 contractor 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 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 practitioner a special registration to engage in the practice of telemedicine for purposes of section 802(54)(E) of this title if the practitioner, upon application for such special registration—
(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 telemedicine 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 acting in the scope of such employment or contract and is registered under section 823(g) of this title in any State or is utilizing the registration of a hospital or clinic 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 Attorney 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 registration under this subsection shall be conducted 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 Secretary of Veterans Affairs the authorization of that emergency prescription, in accordance with such requirements as the Secretary of Veterans Affairs shall, by regulation, establish.
(2) To Attorney General
Not later than 30 days after the date that a prescription described in subparagraph (A) is issued, the Secretary of Veterans Affairs shall report to the Attorney General the authorization of that emergency prescription.
(j) Clarification concerning prescription transfers
Any transfer between pharmacies of information relating to a prescription for a controlled substance shall meet the applicable requirements under regulations promulgated by the Attorney General under this chapter.