Browse Arkansas Code titles and sections
21 U.S.C. § 829 — Prescriptions
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
Stored review status: release_metadata_unconfirmed. A text match is a research starting point; applicability is not established.
Original supplied file — preserved unchanged
Download original Markdown file
File SHA-256: bb5f18d46662faf3391c4f4bf02afae3bd1d327e8d6b7db69ebee1c6d355ec39. The original may include catalog metadata, neighboring provisions, or embedded records outside this collection's scope. Search shows only the selected federal record. Historical editions and unverified snapshots are not a statement of current law.
Authority boundary: historical or unconfirmed source not current law verified.
Open the recorded source website ↗
Record provenance
Stable record: federal_law:legal_authorities:record_usc_6d6469acd61fa8f8397c6744
Source file: Laws/federal/codes/united-states-code/title-21/section-829-prescriptions--5ad4c3fd70.md
Pages: Not recorded – Not recorded
Passage SHA-256: f440caa86b7c974f3b96c63d2a2449ce0a367bba49cecd14451c57a7239a945b
Source location: Title 21, Chapter 13, § 829; chapter-013-drug-abuse-prevention-and-control.md
Stored source content
**(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 thereof or be refilled more than five times after the date of the prescription unless renewed by the practitioner.
**(c) Schedule V substances** No controlled substance in schedule V which is a drug may be distributed or dispensed other than for a medical purpose.
**(d) Non-prescription drugs with abuse potential** Whenever it appears to the Attorney General that a drug not considered to be a prescription drug 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.] should be so considered because of its abuse potential, he shall so advise the Secretary and furnish to him all available data relevant thereto.
**(e) Controlled substances dispensed by means of the Internet**
(1) No controlled substance that 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 delivered, distributed, or dispensed by means of the Internet without a valid prescription.
(2) As used in this subsection:
(A) The term “valid prescription” means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by—
(i) a practitioner who has conducted at least 1 in-person medical evaluation of the patient; or
(ii) a covering practitioner.
(B)
(i) The term “in-person medical evaluation” means a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals.
(ii) Nothing in clause (i) shall be construed to imply that 1 in-person medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice.
(C) The term “covering practitioner” means, with respect to a patient, a practitioner who conducts a medical evaluation (other than an in-person medical evaluation) at the request of a practitioner who—
(i) has conducted at least 1 in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine, within the previous 24 months; and
(ii) is temporarily unavailable to conduct the evaluation of the patient.
(3) Nothing in this subsection shall apply to—
(A) the delivery, distribution, or dispensing of a controlled substance by a practitioner engaged in the practice of telemedicine; or
(B) the dispensing or selling of a controlled substance pursuant to practices as determined by the Attorney General by regulation, which shall be consistent with effective controls against diversion.
**(f) Partial fills of schedule II controlled substances**
(1) **Partial fills** — A prescription for a controlled substance in schedule II may be partially filled if—
(A) it is not prohibited by State law;
(B) the prescription is written and filled in accordance with this subchapter, regulations prescribed by the Attorney General, and State law;
(C) the partial fill is requested by the patient or the practitioner that wrote the prescription; and
(D) the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.
(2) **Remaining portions**
(A) *In general* — Except as provided in subparagraph (B), remaining portions of a partially filled prescription for a controlled substance in schedule II—
(i) may be filled; and
(ii) shall be filled not later than 30 days after the date on which the prescription is written.
(B) *Emergency situations* — In emergency situations, as described in subsection (a), the remaining portions of a partially filled prescription for a controlled substance in schedule II—
(i) may be filled; and
(ii) shall be filled not later than 72 hours after the prescription is issued.
(3) **Currently lawful partial fills** — Notwithstanding paragraph (1) or (2), in any circumstance in which, as of the day before July 22, 2016, a prescription for a controlled substance in schedule II may be lawfully partially filled, the Attorney General may allow such a prescription to be partially filled.
Cross-references
Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.
Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
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
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Inventory** Except as provided in subsection (c)—
(1) every registrant under this subchapter shall, on May 1, 1971, or as soon thereafter as such registrant first engages in the manufacture, distribution, or dispensing of controlled substances, and every second year thereafter, make a complete and accurate record of all stocks thereof on hand, except that the regulations prescribed under this section shall permit each such biennial inventory (following the initial inventory required by this paragraph) to be prepared on such registrant’s regular general physical inventory date (if any) which is nearest to and does not vary by more than six months from the biennial date that would otherwise apply;
(2) on the effective date of each regulation of the Attorney General controlling a substance that immediately prior to such date was not a controlled substance, each registrant under this subchapter manufacturing, distributing, or dispensing such substance shall make a complete and accurate record of all stocks thereof on hand; and
(3) on and after May 1, 1971, every registrant under this subchapter manufacturing, distributing, or dispensing a controlled substance or substances shall maintain, on a current basis, a complete and accurate record of each such substance manufactured, received, sold, delivered, or otherwise disposed of by him, except that this paragraph shall not require the maintenance of a perpetual inventory.
**(b) Availability of records** Every inventory or other record required under this section (1) shall be in accordance with, and contain such relevant information as may be required by, regulations of the Attorney General, (2) shall (A) be maintained separately from all other records of the registrant, or (B) alternatively, in the case of nonnarcoti
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 827
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
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
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 831
Stored review status: release_metadata_unconfirmed. Incoming connection: Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Unlawful acts** It shall be unlawful for any person—
(1) who is subject to the requirements of part C to distribute or dispense a controlled substance in violation of [section 829 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section829&num=0&edition=prelim);
(2) who is a registrant to distribute or dispense a controlled substance not authorized by his registration to another registrant or other authorized person or to manufacture a controlled substance not authorized by his registration;
(3) who is a registrant to distribute a controlled substance in violation of [section 825 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section825&num=0&edition=prelim);
(4) to remove, alter, or obliterate a symbol or label required by [section 825 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section825&num=0&edition=prelim);
(5) to refuse or negligently fail to make, keep, or furnish any record, report, notification, declaration, order or order form, statement, invoice, or information required under this subchapter or subchapter II;
(6) to refuse any entry into any premises or inspection authorized by this subchapter or subchapter II;
(7) to remove, break, injure, or deface a seal placed upon controlled substances pursuant to section 824(f) or 881 of this title or to remove or dispose of substances so placed under seal;
(8) to use, to his own advantage, or to reveal, other than to duly authorized officers or employees of the United States, or to the courts when relevant in any judicial proceeding under this subchapter or subchapter II, any information acquired in the course of an inspection authorized by this subchapter concerning any method or process which
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 842
Stored review status: release_metadata_unconfirmed. Incoming connection: Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
Page 30
TITLE 21—FOOD AND DRUGS
§ 301
Sec.
398.
Notices to States regarding imported food.
399.
Grants to enhance food safety.
399a.
Office of the Chief Scientist.
399b.
Office of Women’s Health.
399c.
Improving the training of State, local, terri-
torial, and tribal food safety officials.
399d.
Employee protections.
399e.
Nanotechnology.
399f.
Ensuring
adequate
information
regarding
pharmaceuticals for all populations, par-
ticularly underrepresented subpopulations,
including racial subgroups.
399g.
Food and Drug Administration Intercenter
Institutes.
399h.
National Centers of Excellence in Advanced
and Continuous Pharmaceutical Manufac-
turing.
399i.
Food and Drug Administration Working Cap-
ital Fund.
SUBCHAPTER I—SHORT TITLE
§ 301. Short title
This chapter may be cited as the Federal
Food, Drug, and Cosmetic Act.
(June 25, 1938, ch. 675, § 1, 52 Stat. 1040.)
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES
Act June 23, 1939, ch. 242, §§ 1, 2, 53 Stat. 853, 854, pro-
vided that:
‘‘[SEC. 1] (a) The effective date of the following provi-
sions of the Federal Food, Drug, and Cosmetic Act is
hereby postponed until January 1, 1940: Sections 402(c)
[342(c) of this title]; 403(e)(1) [343(e)(1) of this title];
403(g), (h), (i), (j), and (k) [343(g) to (k) of this title];
501(a), (4) [351(a)(4) of this title]; 502(b), (d), (e), (f), (g),
and (h) [352(b), (d) to (h) of this title]; 601(e) [361(e) of
this title]; and 602(b) [362(b) of this title].
‘‘(b) The Secretary of Agriculture shall promulgate
regulations further postponing to July 1, 1940[,] the ef-
fective date of the provisions of sections 403(e)(1)
[343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g)
to (k)]; 502(b), (d), (
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 301
Stored review status: historical_2024_not_currentness_verified. The source passage cites 21 U.S.C. § 301. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Regulations for goods to be processed, labeled, or repacked elsewhere** The Secretary is directed to promulgate regulations exempting from any labeling or packaging requirement of this chapter drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such drugs and devices are not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment.
**(b) Prescription by physician; exemption from labeling and prescription requirements; misbranded drugs; compliance with narcotic and marihuana laws**
(1) A drug intended for use by man which—
(A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or
(B) is limited by an approved application under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) to use under the professional supervision of a practitioner licensed by law to administer such drug;
shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 353
Stored review status: release_metadata_unconfirmed. The source passage cites 21 U.S.C. § 353. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
Page 167
TITLE 21—FOOD AND DRUGS
§ 353
COUNTERFEITING OF DRUGS; CONGRESSIONAL FINDINGS
AND DECLARATION OF POLICY
Pub. L. 89–74, § 9(a), July 15, 1965, 79 Stat. 234, provided
that: ‘‘The Congress finds and declares that there is a
substantial traffic in counterfeit drugs simulating the
brand or other identifying mark or device of the manu-
facturer of the genuine article; that such traffic poses
a serious hazard to the health of innocent consumers of
such drugs because of the lack of proper qualifications,
facilities, and manufacturing controls on the part of
the counterfeiter, whose operations are clandestine;
that, while such drugs are deemed misbranded within
the meaning of section 502(i) of the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 352(i)], the controls for the
suppression of the traffic in such drugs are inadequate
because of the difficulty of determining the place of
interstate origin of such drugs and, if that place is dis-
covered, the fact that the implements for counter-
feiting are not subject to seizure, and that these factors
require enactment of additional controls with respect
to such drugs without regard to their interstate or
intrastate origins.’’
Provisions as effective Feb. 1, 1966, see section 11 of
Pub. L. 89–74, set out as an Effective Date of 1965
Amendment note under section 321 of this title.
Executive Documents
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Admin-
istrator to Secretary of Health, Education, and Welfare
[now Health and Human Services], and of Food and
Drug Administration in the Department of Agriculture
to Federal Security Agency, see notes set out under
section 321 of this title.
§ 353. Exemptions and consideration for certain
drugs, devices, and biological products
(a)
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 353
Stored review status: historical_2024_not_currentness_verified. The source passage cites 21 U.S.C. § 353. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
Page 829
TITLE 21—FOOD AND DRUGS
§ 829
(3) the delivery of such a substance for the
purpose of disposal by an ultimate user, long-
term care facility, or other person acting in
accordance with section 822(g) of this title.
(c) Preservation and availability
(1) Every person who in pursuance of an order
required under subsection (a) distributes a con-
trolled substance shall preserve such order for a
period of two years, and shall make such order
available for inspection and copying by officers
and employees of the United States duly author-
ized for that purpose by the Attorney General,
and by officers or employees of States or their
political subdivisions who are charged with the
enforcement of State or local laws regulating
the production, or regulating the distribution or
dispensing, of controlled substances and who are
authorized under such laws to inspect such or-
ders.
(2) Every person who gives an order required
under subsection (a) shall, at or before the time
of giving such order, make or cause to be made
a duplicate thereof on a form to be issued by the
Attorney General in blank in accordance with
subsection (d) and regulations prescribed by him
pursuant to this section, and shall, if such order
is accepted, preserve such duplicate for a period
of two years and make it available for inspec-
tion and copying by the officers and employees
mentioned in paragraph (1) of this subsection.
(d) Issuance
(1) The Attorney General shall issue forms
pursuant to subsections (a) and (c)(2) only to
persons validly registered under section 823 of
this title (or exempted from registration under
section 822(d) of this title). Whenever any such
form is issued to a person, the Attorney General
shall, before delivery thereof, insert therein the
name
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 829
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.