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Title 21, Food and DrugsRelease 119-110

§831 Additional Requirements Relating to Online Pharmacies and Telemedicine

Title 21 › CHAPTER 13 — DRUG ABUSE PREVENTION AND CONTROL › SUBCHAPTER I — CONTROL AND ENFORCEMENT › Part C — Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances › § 831

Last updated Sep 22, 2026|Official source

Summary

Online pharmacies must show a clear statement on their homepage saying they follow these rules for selling or shipping controlled drugs. They must follow the pharmacy license laws of any State they ship from or to. The homepage (or a clearly linked page) must list the pharmacy’s DEA name and address, phone and email, the pharmacist-in-charge (name, degree, States licensed, and contact number), the States where the pharmacy is licensed to dispense controlled drugs, a federal-registration notice that it is allowed to sell controlled drugs online, and the contact and license details for any practitioner who does medical evaluations or writes prescriptions through the website. The site must also say it will only fill controlled-drug prescriptions that come from a real medical relationship that includes at least one prior in-person or telemedicine exam as required under section 309. Thirty days before an online pharmacy starts offering controlled drugs, it must notify the Attorney General and the State boards of pharmacy. That notice must include the information posted on the website, the site address (and promise to give 30 days’ notice before any address change), and DEA registration numbers. A pharmacy already operating on the law’s effective date must give that notice within 30 days after the effective date. After notifying, the pharmacy must show a homepage declaration that it notified the Attorney General in the form the Attorney General requires. Any required statements or notices count as official reports to keep. The Secretary must tell the Attorney General which Indian tribes provide pharmacy services and may label certain Indian Health Service or tribal practitioners as eligible providers for remote populations. The Attorney General may grant a special telemedicine registration to a practitioner who shows need and is registered in the State where the patient is located, with certain exceptions; final rules on when and how to get that registration had to be issued not later than 1 year after October 24, 2018. Veterans Health practitioners who issue emergency telemedicine controlled-drug prescriptions must report them to the Secretary of Veterans Affairs, and the Secretary must tell the Attorney General within 30 days after the prescription is issued. Any transfer of controlled-prescription information between pharmacies must follow the Attorney General’s regulations.

Full Legal Text

Title 21, §831

Food and Drugs, Source: USLM XML via OLRC

(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
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 section 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.

Legislative History

Notes & Related Subsidiaries

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 subsec. (d)(3), see

Effective Date

note below. The Indian Self-Determination and Education Assistance 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, Indians. 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 section 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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 831

Title 21, Food and Drugs

Last Updated

Sep 22, 2026

Release point: 119-110