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21 U.S.C. § 831 — Additional requirements relating to online pharmacies and telemedicine
Federal law — U.S. Code and appendices · legal_authorities
**(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 co
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Source file: Laws/federal/codes/united-states-code/title-21/section-831-additional-requirements-relating-to-online-pharmacies-and-telemedicine--29d526b362.md
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Source location: Title 21, Chapter 13, § 831; chapter-013-drug-abuse-prevention-and-control.md
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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 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title25-section5301&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title25-section5301&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section802/54/E&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823/g&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section822/d&num=0&edition=prelim); 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823/g&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823/g&num=0&edition=prelim).
(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section824/c&num=0&edition=prelim).
**(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section802/54/F&num=0&edition=prelim) 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.
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Federal law — U.S. Code and appendices · legal_authorities
The Congress makes the following findings and declarations:
(1) Many of the drugs included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people.
(2) The illegal importation, manufacture, distribution, and possession and improper use of controlled substances have a substantial and detrimental effect on the health and general welfare of the American people.
(3) A major portion of the traffic in controlled substances flows through interstate and foreign commerce. Incidents of the traffic which are not an integral part of the interstate or foreign flow, such as manufacture, local distribution, and possession, nonetheless have a substantial and direct effect upon interstate commerce because—
(A) after manufacture, many controlled substances are transported in interstate commerce,
(B) controlled substances distributed locally usually have been transported in interstate commerce immediately before their distribution, and
(C) controlled substances possessed commonly flow through interstate commerce immediately prior to such possession.
(4) Local distribution and possession of controlled substances contribute to swelling the interstate traffic in such substances.
(5) Controlled substances manufactured and distributed intrastate cannot be differentiated from controlled substances manufactured and distributed interstate. Thus, it is not feasible to distinguish, in terms of controls, between controlled substances manufactured and distributed interstate and controlled substances manufactured and distributed intrastate.
(6) Federal control of the intrastate incidents of the traffic in controlled substances is essential to the effective control of the interstate incidents
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 801
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Mandatory application** All provisions of sections 5305(b), 5306, 5307, 5321(c) and (d), 5323, 5324(k) and (l), 5325(a) through (k), and 5332 of this title and section 314 of Public Law 101–512 (coverage under chapter 171 of title 28, commonly known as the “Federal Tort Claims Act”), to the extent not in conflict with this subchapter, shall apply to compacts and funding agreements authorized by this subchapter.
**(b) Discretionary application** At the request of a participating Indian tribe, any other provision of subchapter I of this chapter, to the extent such provision is not in conflict with this subchapter, shall be made a part of a funding agreement or compact entered into under this subchapter. The Secretary is obligated to include such provision at the option of the participating Indian tribe or tribes. If such provision is incorporated it shall have the same force and effect as if it were set out in full in this subchapter. In the event an Indian tribe requests such incorporation at the negotiation stage of a compact or funding agreement, such incorporation shall be deemed effective immediately and shall control the negotiation and resulting compact and funding agreement.
Source: Supplied U.S. Code snapshot — release unconfirmed · 25 U.S.C. § 5301
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Schedule II substances** Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.], may be dispensed without the written prescription of a practitioner, except that in emergency situations, as prescribed by the Secretary by regulation after consultation with the Attorney General, such drug may be dispensed upon oral prescription in accordance with section 503(b) of that Act [[21 U.S.C. 353(b)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/b&num=0&edition=prelim)]. Prescriptions shall be retained in conformity with the requirements of [section 827 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section827&num=0&edition=prelim). No prescription for a controlled substance in schedule II may be refilled.
**(b) Schedule III and IV substances** Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule III or IV, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.], may be dispensed without a written or oral prescription in conformity with section 503(b) of that Act [[21 U.S.C. 353(b)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/b&num=0&edition=prelim)]. Such prescriptions may not be filled or refilled more than six months after the date the
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 829
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Federal law — U.S. Code and appendices · legal_authorities
As used in this subchapter:
(1) The term “addict” means any individual who habitually uses any narcotic drug so as to endanger the public morals, health, safety, or welfare, or who is so far addicted to the use of narcotic drugs as to have lost the power of self-control with reference to his addiction.
(2) The term “administer” refers to the direct application of a controlled substance to the body of a patient or research subject by—
(A) a practitioner (or, in his presence, by his authorized agent), or
(B) the patient or research subject at the direction and in the presence of the practitioner,
whether such application be by injection, inhalation, ingestion, or any other means.
(3) The term “agent” means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser; except that such term does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman, when acting in the usual and lawful course of the carrier’s or warehouseman’s business.
(4) The term “Drug Enforcement Administration” means the Drug Enforcement Administration in the Department of Justice.
(5) The term “control” means to add a drug or other substance, or immediate precursor, to a schedule under part B of this subchapter, whether by transfer from another schedule or otherwise.
(6) The term “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. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986.
(7) The term “counterfeit substance” means a controlled substance which, or the container or labelin
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 802
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Unlawful acts** Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally—
(1) to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance; or
(2) to create, distribute, or dispense, or possess with intent to distribute or dispense, a counterfeit substance.
**(b) Penalties** Except as otherwise provided in section 849, 859, 860, or 861 of this title, any person who violates subsection (a) of this section shall be sentenced as follows:
(1)
(A) In the case of a violation of subsection (a) of this section involving—
(i) 1 kilogram or more of a mixture or substance containing a detectable amount of heroin;
(ii) 5 kilograms or more of a mixture or substance containing a detectable amount of—
(I) coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed;
(II) cocaine, its salts, optical and geometric isomers, and salts of isomers;
(III) ecgonine, its derivatives, their salts, isomers, and salts of isomers; or
(IV) any compound, mixture, or preparation which contains any quantity of any of the substances referred to in subclauses (I) through (III);
(iii) 280 grams or more of a mixture or substance described in clause (ii) which contains cocaine base;
(iv) 100 grams or more of phencyclidine (PCP) or 1 kilogram or more of a mixture or substance containing a detectable amount of phencyclidine (PCP);
(v) 10 grams or more of a mixture or substance containing a detectable amount of lysergic acid diethylamide (LSD);
(vi) 400 grams or more of a mixture or substance containing a detectable amount of N-phenyl-N- [
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 841
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Federal law — U.S. Code and appendices · legal_authorities
Page 837
TITLE 21—FOOD AND DRUGS
§ 831
Pub. L. 109–177, title VII, § 711(c)(3), Mar. 9, 2006, 120
Stat. 261, provided that: ‘‘The amendments made by
paragraphs (1) and (2) [amending this section] apply on
and after the expiration of the 30-day period beginning
on the date of the enactment of this Act [Mar. 9, 2006].’’
EFFECTIVE DATE OF 1993 AMENDMENT
Amendment by Pub. L. 103–200 effective on date that
is 120 days after Dec. 17, 1993, see section 11 of Pub. L.
103–200, set out as a note under section 802 of this title.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective 120 days after
Nov. 18, 1988, see section 6061 of Pub. L. 100–690, set out
as a note under section 802 of this title.
EFFECTIVE DATE; TIME TO SUBMIT PIPERIDINE REPORT;
REQUIRED INFORMATION
Pub. L. 95–633, title II, § 203(a), Nov. 10, 1978, 92 Stat.
3776, provided that:
‘‘(1) Except as provided under paragraph (2), the
amendments made by this title [enacting this section
and amending sections 841 to 843 of this title] shall take
effect on the date of the enactment of this Act [Nov. 10,
1978].
‘‘(2) Any person required to submit a report under
section 310(a)(1) of the Controlled Substances Act [sub-
sec. (a)(1) of this section] respecting a distribution,
sale, or importation of piperidine during the 90 days
after the date of the enactment of this Act [Nov. 10,
1978] may submit such report any time up to 97 days
after such date of enactment.
‘‘(3) Until otherwise provided by the Attorney Gen-
eral by regulation, the information required to be re-
ported by a person under section 310(a)(1) of the Con-
trolled Substances Act (as added by section 202(a)(2) of
this title) [subsec. (a)(1) of this section] with respect to
the person’s distribution, sale, or importat
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 831
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.
Federal law — U.S. Code and appendices · legal_authorities
Page 709
TITLE 25—INDIANS
§ 5301
Sec.
5325.
Contract funding and indirect costs.
5326.
Indian Health Service: availability of
funds for Indian self-determination or
self-governance contract or grant sup-
port costs.
5327.
Department of the Interior: availability
of funds for Indian self-determination
or self-governance contract or grant
support costs.
5328.
Rules and regulations.
5329.
Contract or grant specifications.
5330.
Rescission of contract or grant and as-
sumption of control of program, etc.;
authority; grounds; procedure; correc-
tion of violation as prerequisite to new
contract or grant agreement; construc-
tion with occupational safety and
health requirements.
5331.
Contract disputes and claims.
5332.
Sovereign
immunity
and
trusteeship
rights unaffected.
SUBCHAPTER II—CONTRACTS WITH STATES
5341.
Donations for Indians; use of gifts; an-
nual report to Congress.
5342.
Contracts for education, medical atten-
tion, relief and social welfare of Indi-
ans.
5343.
Use of Government property by States
and Territories.
5344.
Rules and regulations; minimum stand-
ards of service.
5345.
Contracts
for
education
in
public
schools; submission of education plan
by contractor as prerequisite; criteria
for approval of plan by Secretary of
the Interior; participation by non-In-
dian students.
5346.
Local committee of Indian parents in
school districts having school boards
composed of non-Indian majority.
5347.
Reimbursement to school districts for
educating non-resident students.
5348.
Computation of student count.
SUBCHAPTER III—INDIAN EDUCATION
ASSISTANCE
5351.
School construction, acquisition, or ren-
ovation contracts.
5352.
General education contract and grant
provisions and requirements; school
district qua
Source: Supplied 2024 U.S. Code historical extraction · 25 U.S.C. § 5301
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