21 Usc 830

§ 830

TITLE 21—FOOD AND DRUGS

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.
(Pub. L. 91–513, title II, § 309, Oct. 27, 1970, 84
Stat. 1260; Pub. L. 110–425, § 2, Oct. 15, 2008, 122
Stat. 4820; Pub. L. 114–198, title VII, § 702(a), July
22, 2016, 130 Stat. 740.)
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred
to in subsecs. (a), (b), (d), and (e)(1), is act June 25, 1938,
ch. 675, 52 Stat. 1040, which is classified generally to
chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this
title and Tables.
Schedules II, III, IV, and V, referred to in subsecs. (a)
to (c), are set out in section 812(c) of this title.
AMENDMENTS
2016—Subsec. (f). Pub. L. 114–198 added subsec. (f).
2008—Subsec. (e). Pub. L. 110–425 added subsec. (e).
EFFECTIVE DATE OF 2008 AMENDMENT
Amendment by Pub. L. 110–425 effective 180 days after
Oct. 15, 2008, except as otherwise provided, see section
3(j) of Pub. L. 110–425, set out as a note under section
802 of this title.
EFFECTIVE DATE
Section effective on first day of seventh calendar
month that begins after Oct. 26, 1970, see section 704 of
Pub. L. 91–513, set out as a note under section 801 of
this title.
CONSTRUCTION OF 2016 AMENDMENT
Pub. L. 114–198, title VII, § 702(b), July 22, 2016, 130
Stat. 741, provided that: ‘‘Nothing in this section
[amending this section] shall be construed to affect the
authority of the Attorney General to allow a prescription for a controlled substance in schedule III, IV, or V
of section 202(c) of the Controlled Substances Act (21
U.S.C. 812(c)) to be partially filled.’’
EFFECT OF SCHEDULING ON PRESCRIPTIONS
Pub. L. 101–647, title XIX, § 1902(c), Nov. 29, 1990, 104
Stat. 4852, provided that: ‘‘Any prescription for anabolic steroids subject to refill on or after the date of enactment of the amendments made by this section [Nov.
29, 1990] may be refilled without restriction under section 309(a) of the Controlled Substances Act (21 U.S.C.
829(a)).’’

§ 830. Regulation of listed chemicals and certain
machines
(a) Record of regulated transactions
(1) Each regulated person who engages in a
regulated transaction involving a listed chemical, a tableting machine, or an encapsulating
machine shall keep a record of the transaction
for two years after the date of the transaction.
(2) A record under this subsection shall be retrievable and shall include the date of the regulated transaction, the identity of each party to
the regulated transaction, a statement of the

Page 712

quantity and form of the listed chemical, a description of the tableting machine or encapsulating machine, and a description of the method of transfer. Such record shall be available for
inspection and copying by the Attorney General.
(3) It is the duty of each regulated person who
engages in a regulated transaction to identify
each other party to the transaction. It is the
duty of such other party to present proof of
identity to the regulated person. The Attorney
General shall specify by regulation the types of
documents and other evidence that constitute
proof of identity for purposes of this paragraph.
(b) Reports to Attorney General
(1) Each regulated person shall report to the
Attorney General, in such form and manner as
the Attorney General shall prescribe by regulation—
(A) any regulated transaction involving an
extraordinary quantity of a listed chemical,
an uncommon method of payment or delivery,
or any other circumstance that the regulated
person believes may indicate that the listed
chemical will be used in violation of this subchapter;
(B) any proposed regulated transaction with
a person whose description or other identifying characteristic the Attorney General furnishes in advance to the regulated person;
(C) any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person; and
(D) any regulated transaction in a tableting
machine or an encapsulating machine.
Each report under subparagraph (A) shall be
made at the earliest practicable opportunity
after the regulated person becomes aware of the
circumstance involved. A regulated person may
not complete a transaction with a person whose
description or identifying characteristic is furnished to the regulated person under subparagraph (B) unless the transaction is approved by
the Attorney General. The Attorney General
shall make available to regulated persons guidance documents describing transactions and circumstances for which reports are required under
subparagraph (A) and subparagraph (C).
(2) A regulated person that manufactures a
listed chemical shall report annually to the Attorney General, in such form and manner and
containing such specific data as the Attorney
General shall prescribe by regulation, information concerning listed chemicals manufactured
by the person. The requirement of the preceding
sentence shall not apply to the manufacture of
a drug product that is exempted under section
802(39)(A)(iv) of this title.
(3) MAIL ORDER REPORTING.—(A) As used in this
paragraph:
(i) The term ‘‘drug product’’ means an active
ingredient in dosage form that has been approved or otherwise may be lawfully marketed
under the Food, Drug, and Cosmetic Act 1 [21
U.S.C. 301 et seq.] for distribution in the
United States.
(ii) The term ‘‘valid prescription’’ means a
prescription which is issued for a legitimate
medical purpose by an individual practitioner
1 See

References in Text note below.

Page 713

TITLE 21—FOOD AND DRUGS

licensed by law to administer and prescribe
the drugs concerned and acting in the usual
course of the practitioner’s professional practice.
(B) Each regulated person who engages in a
transaction with a nonregulated person or who
engages in an export transaction which—
(i) involves ephedrine, pseudoephedrine, or
phenylpropanolamine (including drug products
containing these chemicals); and
(ii) uses or attempts to use the Postal Service or any private or commercial carrier;
shall, on a monthly basis, submit a report of
each such transaction conducted during the previous month to the Attorney General in such
form, containing such data, and at such times as
the Attorney General shall establish by regulation.
(C) The data required for such reports shall include—
(i) the name of the purchaser;
(ii) the quantity and form of the ephedrine,
pseudoephedrine, or phenylpropanolamine purchased; and
(iii) the address to which such ephedrine,
pseudoephedrine, or phenylpropanolamine was
sent.
(D) Except as provided in subparagraph (E),
the following distributions to a nonregulated
person, and the following export transactions,
shall not be subject to the reporting requirement in subparagraph (B):
(i) Distributions of sample packages of drug
products when such packages contain not
more than two solid dosage units or the equivalent of two dosage units in liquid form, not to
exceed 10 milliliters of liquid per package, and
not more than one package is distributed to an
individual or residential address in any 30-day
period.
(ii) Distributions of drug products by retail
distributors that may not include face-to-face
transactions to the extent that such distributions are consistent with the activities authorized for a retail distributor as specified in
section 802(49) of this title, except that this
clause does not apply to sales of scheduled
listed chemical products at retail.
(iii) Distributions of drug products to a resident of a long term care facility (as that term
is defined in regulations prescribed by the Attorney General) or distributions of drug products to a long term care facility for dispensing
to or for use by a resident of that facility.
(iv) Distributions of drug products pursuant
to a valid prescription.
(v) Exports which have been reported to the
Attorney General pursuant to section 954 or
971 of this title or which are subject to a waiver granted under section 971(f)(2) of this title.
(vi) Any quantity, method, or type of distribution or any quantity, method, or type of
distribution of a specific listed chemical (including specific formulations or drug products) or of a group of listed chemicals (including specific formulations or drug products)
which the Attorney General has excluded by
regulation from such reporting requirement
on the basis that such reporting is not necessary for the enforcement of this subchapter
or subchapter II.

§ 830

(E) The Attorney General may revoke any or
all of the exemptions listed in subparagraph (D)
for an individual regulated person if he finds
that drug products distributed by the regulated
person are being used in violation of this subchapter or subchapter II. The regulated person
shall be notified of the revocation, which will be
effective upon receipt by the person of such notice, as provided in section 971(c)(1) of this title,
and shall have the right to an expedited hearing
as provided in section 971(c)(2) of this title.
(c) Confidentiality of information obtained by Attorney General; non-disclosure; exceptions
(1) Except as provided in paragraph (2), any information obtained by the Attorney General
under this section which is exempt from disclosure under section 552(a) of title 5, by reason of
section 552(b)(4) of such title, is confidential and
may not be disclosed to any person.
(2) Information referred to in paragraph (1)
may be disclosed only—
(A) to an officer or employee of the United
States engaged in carrying out this subchapter, subchapter II, or the customs laws;
(B) when relevant in any investigation or
proceeding for the enforcement of this subchapter, subchapter II, or the customs laws;
(C) when necessary to comply with an obligation of the United States under a treaty or
other international agreement; or
(D) to a State or local official or employee in
conjunction with the enforcement of controlled substances laws or chemical control
laws.
(3) The Attorney General shall—
(A) take such action as may be necessary to
prevent unauthorized disclosure of information by any person to whom such information
is disclosed under paragraph (2); and
(B) issue guidelines that limit, to the maximum extent feasible, the disclosure of proprietary business information, including the
names or identities of United States exporters
of listed chemicals, to any person to whom
such information is disclosed under paragraph
(2).
(4) Any person who is aggrieved by a disclosure
of information in violation of this section may
bring a civil action against the violator for appropriate relief.
(5) Notwithstanding paragraph (4), a civil action may not be brought under such paragraph
against investigative or law enforcement personnel of the Drug Enforcement Administration.
(d) Scheduled listed chemicals; restrictions on
sales quantity; requirements regarding nonliquid forms
With respect to ephedrine base, pseudoephedrine base, or phenylpropanolamine base in
a scheduled listed chemical product—
(1) the quantity of such base sold at retail in
such a product by a regulated seller, or a distributor required to submit reports by subsection (b)(3) may not, for any purchaser, exceed a daily amount of 3.6 grams, without regard to the number of transactions; and
(2) such a seller or distributor may not sell
such a product in nonliquid form (including
gel caps) at retail unless the product is pack-

§ 830

TITLE 21—FOOD AND DRUGS

aged in blister packs, each blister containing
not more than 2 dosage units, or where the use
of blister packs is technically infeasible, the
product is packaged in unit dose packets or
pouches.
(e) Scheduled listed chemicals; behind-thecounter access; logbook requirement; training of sales personnel; privacy protections
(1) Requirements regarding retail transactions
(A) In general
Each regulated seller shall ensure that,
subject to subparagraph (F), sales by such
seller of a scheduled listed chemical product
at retail are made in accordance with the
following:
(i) In offering the product for sale, the
seller places the product such that customers do not have direct access to the
product before the sale is made (in this
paragraph referred to as ‘‘behind-thecounter’’ placement). For purposes of this
paragraph, a behind-the-counter placement of a product includes circumstances
in which the product is stored in a locked
cabinet that is located in an area of the facility involved to which customers do have
direct access.
(ii) The seller delivers the product directly into the custody of the purchaser.
(iii) The seller maintains, in accordance
with criteria issued by the Attorney General, a written or electronic list of such
sales that identifies the products by name,
the quantity sold, the names and addresses
of purchasers, and the dates and times of
the sales (which list is referred to in this
subsection as the ‘‘logbook’’), except that
such requirement does not apply to any
purchase by an individual of a single sales
package if that package contains not more
than 60 milligrams of pseudoephedrine.
(iv) In the case of a sale to which the requirement of clause (iii) applies, the seller
does not sell such a product unless the sale
is made in accordance with the following:
(I) The prospective purchaser—
(aa) presents an identification card
that provides a photograph and is issued by a State or the Federal Government, or a document that, with respect
to identification, is considered acceptable
for
purposes
of
sections
274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B)
of title 8, Code of Federal Regulations
(as in effect on or after March 9, 2006);
and
(bb) signs the written logbook and
enters in the logbook his or her name,
address, and the date and time of the
sale, or for transactions involving an
electronic logbook, the purchaser provides a signature using one of the following means:
(AA) Signing a device presented by
the seller that captures signatures in
an electronic format. Such device
shall display the notice described in
clause (v). Any device used shall preserve each signature in a manner
that clearly links that signature to

Page 714

the other electronically-captured
logbook information relating to the
prospective purchaser providing that
signature.
(BB) Signing a bound paper book.
Such bound paper book shall include,
for such purchaser, either (aaa) a
printed sticker affixed to the bound
paper book at the time of sale which
either displays the name of each
product sold, the quantity sold, the
name and address of the purchaser,
and the date and time of the sale, or
a unique identifier which can be
linked to that electronic information, or (bbb) a unique identifier
which can be linked to that information and which is written into the
book by the seller at the time of sale.
The purchaser shall sign adjacent to
the printed sticker or written unique
identifier related to that sale. Such
bound paper book shall display the
notice described in clause (v).
(CC) Signing a printed document
that includes, for such purchaser, the
name of each product sold, the quantity sold, the name and address of
the purchaser, and the date and time
of the sale. Such document shall be
printed by the seller at the time of
the sale. Such document shall contain a clearly identified signature
line for a purchaser to sign. Such
printed document shall display the
notice described in clause (v). Each
signed document shall be inserted
into a binder or other secure means
of document storage immediately
after the purchaser signs the document.
(II) The seller enters in the logbook
the name of the product and the quantity sold. Such information may be captured through electronic means, including through electronic data capture
through bar code reader or similar technology.
(III) The logbook maintained by the
seller includes the prospective purchaser’s name, address, and the date and
time of the sale, as follows:
(aa) If the purchaser enters the information, the seller must determine that
the name entered in the logbook corresponds to the name provided on such
identification and that the date and
time entered are correct.
(bb) If the seller enters the information, the prospective purchaser must
verify that the information is correct.
(cc) Such information may be captured through electronic means, including through electronic data capture through bar code reader or similar
technology.
(v) The written or electronic logbook includes, in accordance with criteria of the
Attorney General, a notice to purchasers
that entering false statements or mis-

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TITLE 21—FOOD AND DRUGS

representations in the logbook, or supplying false information or identification that
results in the entry of false statements or
misrepresentations, may subject the purchasers to criminal penalties under section
1001 of title 18, which notice specifies the
maximum fine and term of imprisonment
under such section.
(vi) Regardless of whether the logbook
entry is written or electronic, the seller
maintains each entry in the logbook for
not fewer than 2 years after the date on
which the entry is made.
(vii) In the case of individuals who are
responsible for delivering such products
into the custody of purchasers or who deal
directly with purchasers by obtaining payments for the products, the seller has submitted to the Attorney General a self-certification that all such individuals have, in
accordance with criteria under subparagraph (B)(ii), undergone training provided
by the seller to ensure that the individuals
understand the requirements that apply
under this subsection and subsection (d).
(viii) The seller maintains a copy of such
certification and records demonstrating
that individuals referred to in clause (vii)
have undergone the training.
(ix) If the seller is a mobile retail vendor:
(I) The seller complies with clause (i)
by placing the product in a locked cabinet.
(II) The seller does not sell more than
7.5 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine
base in such products per customer during a 30-day period.
(B) Additional provisions regarding certifications and training
(i) In general
A regulated seller may not sell any
scheduled listed chemical product at retail
unless the seller has submitted to the Attorney General the self-certification referred to in subparagraph (A)(vii). The certification is not effective for purposes of
the preceding sentence unless, in addition
to provisions regarding the training of individuals referred to in such subparagraph,
the certification includes a statement that
the seller understands each of the requirements that apply under this paragraph and
under subsection (d) and agrees to comply
with the requirements.
(ii) Issuance of criteria; self-certification
The Attorney General shall by regulation establish criteria for certifications
under this paragraph. The criteria shall—
(I) provide that the certifications are
self-certifications provided through the
program under clause (iii);
(II) provide that a separate certification is required for each place of business at which a regulated seller sells
scheduled listed chemical products at retail; and
(III) include criteria for training under
subparagraph (A)(vii).

§ 830

(iii) Program for regulated sellers
The Attorney General shall establish a
program regarding such certifications and
training in accordance with the following:
(I) The program shall be carried out
through an Internet site of the Department of Justice and such other means as
the Attorney General determines to be
appropriate.
(II) The program shall inform regulated sellers that section 1001 of title 18
applies to such certifications.
(III) The program shall make available
to such sellers an explanation of the criteria under clause (ii).
(IV) The program shall be designed to
permit the submission of the certifications through such Internet site.
(V) The program shall be designed to
automatically provide the explanation
referred to in subclause (III), and an acknowledgement that the Department has
received a certification, without requiring direct interactions of regulated sellers with staff of the Department (other
than the provision of technical assistance, as appropriate).
(iv) Availability of certification to State
and local officials
Promptly after receiving a certification
under subparagraph (A)(vii), the Attorney
General shall make available a copy of the
certification to the appropriate State and
local officials.
(v) Publication of list of self-certified persons
The Attorney General shall develop and
make available a list of all persons who
are currently self-certified in accordance
with this section. This list shall be made
publicly available on the website of the
Drug Enforcement Administration in an
electronically downloadable format.
(C) Privacy protections
In order to protect the privacy of individuals who purchase scheduled listed chemical
products, the Attorney General shall by regulation establish restrictions on disclosure
of information in logbooks under subparagraph (A)(iii). Such regulations shall—
(i) provide for the disclosure of the information as appropriate to the Attorney
General and to State and local law enforcement agencies; and
(ii) prohibit accessing, using, or sharing
information in the logbooks for any purpose other than to ensure compliance with
this subchapter or to facilitate a product
recall to protect public health and safety.
(D) False statements or misrepresentations
by purchasers
For purposes of section 1001 of title 18, entering information in the logbook under subparagraph (A)(iii) shall be considered a matter within the jurisdiction of the executive,
legislative, or judicial branch of the Government of the United States.
(E) Good faith protection
A regulated seller who in good faith releases information in a logbook under sub-

§ 830

TITLE 21—FOOD AND DRUGS

paragraph (A)(iii) to Federal, State, or local
law enforcement authorities is immune from
civil liability for such release unless the release constitutes gross negligence or intentional, wanton, or willful misconduct.
(F) Inapplicability of requirements to certain
sales
Subparagraph (A) does not apply to the
sale at retail of a scheduled listed chemical
product if a report on the sales transaction
is required to be submitted to the Attorney
General under subsection (b)(3).
(G) Certain measures regarding theft and diversion
A regulated seller may take reasonable
measures to guard against employing individuals who may present a risk with respect
to the theft and diversion of scheduled listed
chemical products, which may include, notwithstanding State law, asking applicants
for employment whether they have been
convicted of any crime involving or related
to such products or controlled substances.
(2) Mail-order reporting; verification of identity of purchaser; 30-day restriction on
quantities for individual purchasers
Each regulated person who makes a sale at
retail of a scheduled listed chemical product
and is required under subsection (b)(3) to submit a report of the sales transaction to the Attorney General is subject to the following:
(A) The person shall, prior to shipping the
product, confirm the identity of the purchaser in accordance with procedures established by the Attorney General. The Attorney General shall by regulation establish
such procedures.
(B) The person may not sell more than 7.5
grams of ephedrine base, pseudoephedrine
base, or phenylpropanolamine base in such
products per customer during a 30-day period.
(C) Each regulated person who makes a
sale at retail of a scheduled listed chemical
product and is required under subsection
(b)(3) to submit a report of the sales transaction to the Attorney General may not sell
any scheduled listed chemical product at retail unless such regulated person has submitted to the Attorney General a self-certification including a statement that the
seller understands each of the requirements
that apply under this paragraph and under
subsection (d) and agrees to comply with the
requirements. The Attorney General shall by
regulation establish criteria for certifications of mail-order distributors that are
consistent with the criteria established for
the certifications of regulated sellers under
paragraph (1)(B).
(3) Exemptions for certain products
Upon the application of a manufacturer of a
scheduled listed chemical product, the Attorney General may by regulation provide that
the product is exempt from the provisions of
subsection (d) and paragraphs (1) and (2) of
this subsection if the Attorney General determines that the product cannot be used in the
illicit manufacture of methamphetamine.

Page 716

(Pub. L. 91–513, title II, § 310, as added Pub. L.
95–633, title II, § 202(a), Nov. 10, 1978, 92 Stat. 3774;
amended Pub. L. 100–690, title VI, § 6052(a), Nov.
18, 1988, 102 Stat. 4312; Pub. L. 103–200, §§ 2(c), 10,
Dec. 17, 1993, 107 Stat. 2336, 2341; Pub. L. 104–237,
title II, § 208, title IV, § 402, Oct. 3, 1996, 110 Stat.
3104, 3111; Pub. L. 106–310, div. B, title XXXVI,
§ 3652, Oct. 17, 2000, 114 Stat. 1239; Pub. L. 109–177,
title VII, §§ 711(a)(2)(B), (b)(1), (c)(1), (2), (d),
716(b)(2), Mar. 9, 2006, 120 Stat. 257, 261, 267; Pub.
L. 110–415, § 2, Oct. 14, 2008, 122 Stat. 4349; Pub. L.
111–268, §§ 2, 3, Oct. 12, 2010, 124 Stat. 2847.)
REFERENCES IN TEXT
The Food, Drug, and Cosmetic Act, referred to in subsec. (b)(3)(A)(i), probably means the Federal Food,
Drug, and Cosmetic Act, act June 25, 1938, ch. 675, 52
Stat. 1040, which is classified generally to chapter 9
(§ 301 et seq.) of this title. For complete classification of
this Act to the Code, see section 301 of this title and
Tables.
This subchapter, referred to in subsecs. (b)(3)(D)(vi),
(E) and (e)(1)(C)(ii), was in the original ‘‘this title’’,
meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat.
1242, and is popularly known as the ‘‘Controlled Substances Act’’. For complete classification of title II to
the Code, see second paragraph of Short Title note set
out under section 801 of this title and Tables.
Subchapter II, referred to in subsecs. (b)(3)(D)(iv), (E)
and (c)(2)(A), (B), was in the original ‘‘title III’’, meaning title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285.
Part A of title III comprises subchapter II of this chapter. For classification of Part B, consisting of sections
1101 to 1105 of title III, see Tables.
AMENDMENTS
2010—Subsec. (e)(1)(B)(v). Pub. L. 111–268, § 3, added cl.
(v).
Subsec. (e)(2)(C). Pub. L. 111–268, § 2, added subpar.
(C).
2008—Subsec. (e)(1)(A)(iv) to (vi). Pub. L. 110–415
added cls. (iv) to (vi) and struck out former cls. (iv) to
(vi) which related to procedures for sales subject to the
logbook requirement.
2006—Subsec. (b)(3)(D)(ii). Pub. L. 109–177, § 711(c)(2),
inserted ‘‘, except that this clause does not apply to
sales of scheduled listed chemical products at retail’’
before period at end.
Pub. L. 109–177, § 711(a)(2)(B), substituted ‘‘section
802(49)’’ for ‘‘section 802(46)’’.
Subsec. (b)(3)(D)(v). Pub. L. 109–177, § 716(b)(2), substituted ‘‘section 971(f)(2)’’ for ‘‘section 971(e)(2)’’.
Subsec. (d). Pub. L. 109–177, § 711(b)(1), added subsec.
(d).
Subsec. (e)(1). Pub. L. 109–177, § 711(b)(1), added subsec.
heading and par. (1).
Subsec. (e)(2). Pub. L. 109–177, § 711(c)(1), added par.
(2).
Subsec. (e)(3). Pub. L. 109–177, § 711(d), added par. (3).
2000—Subsec. (b)(3). Pub. L. 106–310 added subpars.
(A), (D), and (E), redesignated former subpars. (A) and
(B) as (B) and (C), respectively, and inserted ‘‘or who
engages in an export transaction’’ after ‘‘nonregulated
person’’ in introductory provisions of subpar. (B).
1996—Subsec. (a)(1). Pub. L. 104–237, § 208, substituted
‘‘for two years after the date of the transaction.’’ for
the dash after ‘‘record of the transaction’’ and struck
out subpars. (A) and (B) which read as follows:
‘‘(A) for 4 years after the date of the transaction, if
the listed chemical is a list I chemical or if the transaction involves a tableting machine or an encapsulating machine; and
‘‘(B) for 2 years after the date of the transaction, if
the listed chemical is a list II chemical.’’
Subsec. (b)(3). Pub. L. 104–237, § 402, added par. (3).
1993—Subsec. (a)(1). Pub. L. 103–200, § 2(c)(1), substituted ‘‘list I chemical’’ for ‘‘precursor chemical’’ in
subpar. (A) and ‘‘a list II chemical’’ for ‘‘an essential
chemical’’ in subpar. (B).

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TITLE 21—FOOD AND DRUGS

Subsec. (b). Pub. L. 103–200, § 10, designated existing
provisions as par. (1), redesignated former pars. (1) to
(4) as subpars. (A) to (D), respectively, in concluding
provisions, substituted ‘‘subparagraph (A)’’ for ‘‘paragraph (1)’’ in two places, ‘‘subparagraph (B)’’ for ‘‘paragraph (2)’’, and ‘‘subparagraph (C)’’ for ‘‘paragraph (3)’’,
and added par. (2).
Subsec. (c)(2)(D). Pub. L. 103–200, § 2(c)(2), substituted
‘‘chemical control laws’’ for ‘‘precursor chemical
laws’’.
1988—Pub. L. 100–690 amended section generally, substituting provisions relating to regulation of listed
chemicals and certain machines for provisions relating
to reporting by any person who distributes, sells, or imports any piperidine.
EFFECTIVE DATE OF 2010 AMENDMENT
Pub. L. 111–268, § 6(a), Oct. 12, 2010, 124 Stat. 2848, provided that: ‘‘This Act [amending this section and section 842 of this title and enacting provisions set out as
notes under this section and section 801 of this title]
and the amendments made by this Act shall take effect
180 days after the date of enactment of this Act [Oct.
12, 2010].’’
EFFECTIVE DATE OF 2006 AMENDMENT
Pub. L. 109–177, title VII, § 711(b)(2), Mar. 9, 2006, 120
Stat. 261, provided that: ‘‘With respect to subsections
(d) and (e)(1) of section 310 of the Controlled Substances
Act [21 U.S.C. 830(d), (e)(1)], as added by paragraph (1)
of this subsection:
‘‘(A) Such subsection (d) applies on and after the
expiration of the 30-day period beginning on the date
of the enactment of this Act [Mar. 9, 2006].
‘‘(B) Such subsection (e)(1) applies on and after September 30, 2006.’’
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 [subsec. (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 General by regulation, the information required to be reported by a person under section 310(a)(1) of the Controlled 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 importation of piperidine shall—
‘‘(A) be the information described in subparagraphs
(A) and (B) of such section, and
‘‘(B) except as provided in paragraph (2) of this subsection, be reported not later than seven days after
the date of such distribution, sale, or importation.’’

REPEALS
Pub. L. 96–359, § 8(b), Sept. 26, 1980, 94 Stat. 1194, repealed section 203(d) of Pub. L. 95–633, which had provided for the repeal of this section effective Jan. 1, 1981.
REGULATIONS
Pub. L. 111–268, § 6(b), Oct. 12, 2010, 124 Stat. 2848, provided that: ‘‘In promulgating the regulations authorized by section 2 [amending this section], the Attorney
General may issue regulations on an interim basis as
necessary to ensure the implementation of this Act by
the effective date [see Effective Date of 2010 Amendment note above].’’
Pub. L. 95–633, title II, § 203(b), Nov. 10, 1978, 92 Stat.
3777, required the Attorney General to publish proposed
interim regulations for piperidine reporting under section 830(a) of this title not later than 30 days after enactment, and final interim regulations not later than
75 days after enactment, such final interim regulations
to be effective on and after the ninety-first day after
enactment.
REPORT TO PRESIDENT AND CONGRESS ON
EFFECTIVENESS OF TITLE II OF PUB. L. 95–633
Pub. L. 95–633, title II, § 203(c), Nov. 10, 1978, 92 Stat.
3777, required the Attorney General to analyze and
evaluate the impact and effectiveness of the amendments made by title II of Pub. L. 95–633, and report to
the President and Congress not later than Mar. 1, 1980.

§ 831. Additional requirements relating to online
pharmacies and telemedicine
(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-incharge, and a telephone number at which the
pharmacist-in-charge can be contacted.