21 U.S. Code § 831 - Additional requirements relating to online pharmacies and telemedicine | U.S. Code | US Law | LII / Legal I

21 U.S. Code § 831 - Additional requirements relating to online pharmacies and telemedicine | U.S. Code | US Law | LII / Legal Information Institute
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21 U.S. Code § 831 - Additional requirements relating to online pharmacies and telemedicine
U.S. Code
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(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
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
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.
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 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
CFR Title
Parts
21
1301
1304
1306
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