21 USC 831 - Additional requirements relating to online pharmacies and telemedicine

U.S Code last checked for updates: Oct 16, 2024

§ 831.

Additional requirements relating to online pharmacies and telemedicine

(a)

In general

(b)

Licensure

(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

(2)

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

(e)

Declaration of compliance

(f)

Reports

(g)

Notice and designations concerning Indian tribes

(1)

In general

(2)

Designations

(A)

In general

(B)

Practitioners

(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

(i)

Reporting of telemedicine by VHA during medical emergency situations

(1)

In general

(2)

To Attorney General

(j)

Clarification concerning prescription transfers

(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.)

cite as: 21 USC 831