Notes on 21 U.S.C. § 353 : US Code - Notes

Search Notes on 21 U.S.C. § 353 : US Code - Notes

(June 25, 1938, ch. 675, Sec. 503, 52 Stat. 1051; Oct. 26, 1951,
ch. 578, Sec. 1, 65 Stat. 648; Pub. L. 87-781, title I, Sec.
104(e)(2), Oct. 10, 1962, 76 Stat. 785; Pub. L. 91-601, Sec. 6(e),
formerly Sec. 7(e), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub.
L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981, 95 Stat. 716;
Pub. L. 100-293, Secs. 4-6, Apr. 22, 1988, 102 Stat. 96-98; Pub. L.
100-670, title I, Sec. 105, Nov. 16, 1988, 102 Stat. 3983; Pub. L.
101-629, Sec. 16(a), Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102-
108, Sec. 2(d), Aug. 17, 1991, 105 Stat. 550; Pub. L. 102-300,
Sec. 6(d), June 16, 1992, 106 Stat. 240; Pub. L. 102-353, Secs.
2(a)-(c), 4, Aug. 26, 1992, 106 Stat. 941, 942; Pub. L. 104-250,
Sec. 5(a), Oct. 9, 1996, 110 Stat. 3155; Pub. L. 105-115, title I,
Secs. 123(e), 126(a), (c)(1), (2), Nov. 21, 1997, 111 Stat. 2324,
2327, 2328; Pub. L. 107-250, title II, Sec. 204, Oct. 26, 2002, 116
Stat. 1611; Pub. L. 108-282, title I, Sec. 102(b)(5)(F), Aug. 2,
2004, 118 Stat. 903.)
REFERENCES IN TEXT
Section 357 of this title, referred to in subsec. (g)(5)(C)(i),
was repealed by Pub. L. 105-115, title I, Sec. 125(b)(1), Nov. 21,
1997, 111 Stat. 2325.
CODIFICATION
In subsec. (b)(5), "sections 4721, 6001, and 6151 of title 26"
and "section 4761 of title 26" substituted for "section 3220 of the
Internal Revenue Code (26 U.S.C. 3220)" and "section 3238(b) of the
Internal Revenue Code (26 U.S.C. 3238(b))", respectively, on
authority of section 7852(b) of Title 26, Internal Revenue Code.
AMENDMENTS
2004 - Subsec. (f)(1)(A)(ii). Pub. L. 108-282, Sec.
102(b)(5)(F)(i), substituted "360b of this title, a conditionally-
approved application under section 360ccc of this title, or an
index listing under section 360ccc-1 of this title" for "360b of
this title".
Subsec. (f)(3). Pub. L. 108-282, Sec. 102(b)(5)(F)(ii),
substituted "section 360b, 360ccc, or 360ccc-1" for "section 360b".
2002 - Subsec. (g)(1). Pub. L. 107-250, Sec. 204(1)(A),
substituted "shall in accordance with this subsection assign an
agency center" for "shall designate a component of the Food and
Drug Administration" in first sentence of introductory provisions.
Subsec. (g)(1)(A) to (C). Pub. L. 107-250, Sec. 204(1)(B),
substituted "the agency center charged" for "the persons charged".
Subsec. (g)(4). Pub. L. 107-250, Sec. 204(3), added par. (4).
Former par. (4) redesignated (5).
Subsec. (g)(5). Pub. L. 107-250, Sec. 204(2), (4), redesignated
par. (4) as (5), added subpar. (A), and redesignated former
subpars. (A) and (B) as (B) and (C), respectively.
1997 - Subsec. (b)(1)(A) to (C). Pub. L. 105-115, Sec. 126(c)(1),
redesignated subpars. (B) and (C) as (A) and (B), respectively, and
struck out former subpar. (A), which read as follows: "is a habit-
forming drug to which section 352(d) of this title applies; or".
Subsec. (b)(3). Pub. L. 105-115, Sec. 126(c)(2), struck out
reference to section 352(d) of this title before "355".
Subsec. (b)(4). Pub. L. 105-115, Sec. 126(a), amended par. (4)
generally. Prior to amendment, par. (4) read as follows: "A drug
which is subject to paragraph (1) of this subsection shall be
deemed to be misbranded if at any time prior to dispensing its
label fails to bear the statement 'Caution: Federal law prohibits
dispensing without prescription'. A drug to which paragraph (1) of
this subsection does not apply shall be deemed to be misbranded if
at any time prior to dispensing its label bears the caution
statement quoted in the preceding sentence."
Subsec. (g)(4)(A). Pub. L. 105-115, Sec. 123(e)(1), substituted
"section 262(i) of title 42" for "section 262(a) of title 42".
Subsec. (g)(4)(B)(iii). Pub. L. 105-115, Sec. 123(e)(2),
substituted "biologics license application under subsection (a)"
for "product or establishment license under subsection (a) or (d)".
1996 - Subsec. (f)(1)(A). Pub. L. 104-250 inserted ", other than
a veterinary feed directive drug intended for use in animal feed or
an animal feed bearing or containing a veterinary feed directive
drug," after "other than man" in introductory provisions.
1992 - Subsec. (d)(1). Pub. L. 102-353, Sec. 4(1), amended par.
(1) generally. Prior to amendment, par. (1) read as follows:
"Except as provided in paragraphs (2) and (3), no representative of
a drug manufacturer or distributor may distribute any drug sample."
Subsec. (d)(2). Pub. L. 102-353, Sec. 4(2), substituted
"authorized distributor of record" for "distributor" wherever
appearing.
Subsec. (d)(3). Pub. L. 102-353, Sec. 4(2), substituted
"authorized distributor of record" for "distributor" and
"authorized distributors of record" for "distributors" wherever
appearing.
Subsec. (e)(1). Pub. L. 102-353, Sec. 4(3), amended par. (1)
generally. Prior to amendment, par. (1) read as follows: "Each
person who is engaged in the wholesale distribution of drugs
subject to subsection (b) of this section and who is not an
authorized distributor of record of such drugs shall provide to
each wholesale distributor of such drugs a statement identifying
each sale of the drug (including the date of the sale) before the
sale to such wholesale distributor. Each manufacturer shall
maintain at its corporate offices a current list of such authorized
distributors."
Subsec. (e)(2)(A). Pub. L. 102-353, Sec. 2(a), (d), temporarily
inserted "or has registered with the Secretary in accordance with
paragraph (3)". See Termination Date of 1992 Amendment note below.
Subsec. (e)(3). Pub. L. 102-353, Sec. 2(b), (d), temporarily
added par. (3). Former par. (3) redesignated (4). See Termination
Date of 1992 Amendment note below.
Subsec. (e)(4). Pub. L. 102-353, Sec. 4(4), inserted "and
subsection (d) of this section" after "For the purposes of this
subsection".
Pub. L. 102-353, Sec. 2(b), (d), temporarily redesignated par.
(3) as (4). See Termination Date of 1992 Amendment note below.
Subsec. (f)(1)(B). Pub. L. 102-353, Sec. 2(c), which directed the
substitution of "an order" for "and order", could not be executed
because "and order" did not appear in subpar. (B).
Subsec. (g)(3). Pub. L. 102-300 substituted "clearance" for
"approval".
1991 - Subsec. (c). Pub. L. 102-108, Sec. 2(d)(3), redesignated
subsec. (c), relating to veterinary prescription drugs, as (f).
Former subsec. (f) redesignated (g).
Subsec. (c)(2), (3)(B)(v). Pub. L. 102-108, Sec. 2(d)(1), made
technical amendment to reference to subsection (b) of this section
involving corresponding provision of original act.
Subsec. (d)(3)(E). Pub. L. 102-108, Sec. 2(d)(2), made technical
amendment to reference to subsection (c)(1) of this section
involving corresponding provision of original act.
Subsec. (f). Pub. L. 102-108, Sec. 2(d)(4), redesignated subsec.
(f), relating to regulation of combination products, as (g).
Pub. L. 102-108, Sec. 2(d)(3), redesignated subsec. (c), relating
to veterinary prescription drugs, as (f).
Subsec. (g). Pub. L. 102-108, Sec. 2(d)(4), redesignated subsec.
(f), relating to regulation of combination products, as (g).
1990 - Pub. L. 101-629, Sec. 16(a)(1), substituted "Exemptions
and consideration for certain drugs, devices, and biological
products" for "Exemptions in case of drugs and devices" in section
catchline.
Subsec. (f). Pub. L. 101-629, Sec. 16(a)(2), added subsec. (f).
1988 - Subsec. (c). Pub. L. 100-670 added subsec. (c) relating to
veterinary prescription drugs.
Pub. L. 100-293, Sec. 4, added subsec. (c) relating to sales
restrictions.
Subsec. (d). Pub. L. 100-293, Sec. 5, added subsec. (d).
Subsec. (e). Pub. L. 100-293, Sec. 6, added subsec. (e).
1970 - Subsec. (b)(2). Pub. L. 91-601 included exemption from
packaging requirements of subsec. (p) of section 352 of this title.
1962 - Subsec. (b)(1)(C). Pub. L. 87-781 substituted "approved"
for "effective".
1951 - Subsec. (b). Act Oct. 26, 1951, amended subsec. (b)
generally to protect the public from abuses in the sale of potent
prescription drugs, and to relieve retail pharmacists and the
public from unnecessary restrictions on the dispensation of drugs
that are safe to use without supervision of a doctor.
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as a note under section 321 of this title.
TERMINATION DATE OF 1992 AMENDMENT
Section 2(d) of Pub. L. 102-353 provided that: "Effective
September 14, 1994, the amendments made by subsections (a) and (b)
[amending this section] shall no longer be in effect."
EFFECTIVE DATE OF 1988 AMENDMENT
Section 8 of Pub. L. 100-293 provided that:
"(a) General Rule. - Except as provided in subsection (b), this
Act and the amendments made by this Act [amending this section and
sections 331, 333, and 381 of this title and enacting provisions
set out as notes under this section and section 301 of this title]
shall take effect upon the expiration of 90 days after the date of
the enactment of this Act [Apr. 22, 1988].
"(b) Exception. -
"(1) Section 503(d) of the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 353(d)] (as added by section 5 of this Act) shall take
effect upon the expiration of 180 days after the date of the
enactment of this Act [Apr. 22, 1988].
"(2) The Secretary of Health and Human Services shall by
regulation issue the guidelines required by section 503(e)(2)(B)
of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
353(e)(2)(B)] (as added by section 6 of this Act) not later than
180 days after the date of the enactment of this Act. Section
503(e)(2)(A) of such Act shall take effect upon the expiration of
2 years after the date such regulations are promulgated and take
effect."
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
regulations establishing special packaging standards effective no
sooner than 180 days or later than one year from date regulations
are final, or an earlier date published in Federal Register, see
section 8 of Pub. L. 91-601, set out as an Effective Date note
under section 1471 of Title 15, Commerce and Trade.
EFFECTIVE DATE OF 1962 AMENDMENT
Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
107 of Pub. L. 87-781, set out as a note under section 321 of this
title.
EFFECTIVE DATE OF 1951 AMENDMENT
Amendment by act Oct. 26, 1951, effective six months after Oct.
26, 1951, see section 3 of act Oct. 26, 1951, set out as a note
under section 333 of this title.
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator 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.
EFFECTIVE MEDICATION GUIDES
Pub. L. 104-180, title VI, Sec. 601, Aug. 6, 1996, 110 Stat.
1593, provided that:
"(a) In General. - Not later than 30 days after the date of
enactment of this Act [Aug. 6, 1996], the Secretary of the
Department of Health and Human Services shall request that national
organizations representing health care professionals, consumer
organizations, voluntary health agencies, the pharmaceutical
industry, drug wholesalers, patient drug information database
companies, and other relevant parties collaborate to develop a long-
range comprehensive action plan to achieve goals consistent with
the goals of the proposed rule of the Food and Drug Administration
on 'Prescription Drug Product Labeling: Medication Guide
Requirements' (60 Fed. Reg. 44182; relating to the provision of
oral and written prescription information to consumers).
"(b) Goals. - Goals consistent with the proposed rule described
in subsection (a) are the distribution of useful written
information to 75 percent of individuals receiving new precriptions
[sic] by the year 2000 and to 95 percent by the year 2006.
"(c) Plan. - The plan described in subsection (a) shall -
"(1) identify the plan goals;
"(2) assess the effectiveness of the current private-sector
approaches used to provide oral and written prescription
information to consumers;
"(3) develop guidelines for providing effective oral and
written prescription information consistent with the findings of
any such assessment;
"(4) contain elements necessary to ensure the transmittal of
useful information to the consuming public, including being
scientifically accurate, non-promotional in tone and content,
sufficiently specific and comprehensive as to adequately inform
consumers about the use of the product, and in an understandable,
legible format that is readily comprehensible and not confusing
to consumers expected to use the product.[;]
"(5) develop a mechanism to assess periodically the quality of
the oral and written prescription information and the frequency
with which the information is provided to consumers; and
"(6) provide for compliance with relevant State board
regulations.
"(d) Limitation on the Authority of the Secretary. - The
Secretary of the Department of Health and Human Services shall have
no authority to implement the proposed rule described in subsection
(a), or to develop any similar regulation, policy statement, or
other guideline specifying a uniform content or format for written
information voluntarily provided to consumers about prescription
drugs if, (1) not later than 120 days after the date of enactment
of this Act [Aug. 6, 1996], the national organizations described in
subsection (a) develop and submit to the Secretary for Health and
Human Services a comprehensive, long-range action plan (as
described in subsection (a)) which shall be acceptable to the
Secretary of Health and Human Services; (2) the aforementioned plan
is submitted to the Secretary of Health and Human Services for
review and acceptance: Provided, That the Secretary shall give due
consideration to the submitted plan and that any such acceptance
shall not be arbitrarily withheld; and (3) the implementation of
(a) a plan accepted by the Secretary commences within 30 days of
the Secretary's acceptance of such plan, or (b) the plan submitted
to the Secretary commences within 60 days of the submission of such
plan if the Secretary fails to take any action on the plan within
30 days of the submission of the plan. The Secretary shall accept,
reject or suggest modifications to the plan submitted within 30
days of its submission. The Secretary may confer with and assist
private parties in the development of the plan described in
subsections (a) and (b).
"(e) Secretary Review. - Not later than January 1, 2001, the
Secretary of the Department of Health and Human Services shall
review the status of private-sector initiatives designed to achieve
the goals of the plan described in subsection (a), and if such
goals are not achieved, the limitation in subsection (d) shall not
apply, and the Secretary shall seek public comment on other
initiatives that may be carried out to meet such goals."
CONGRESSIONAL FINDINGS
Section 2 of Pub. L. 100-293 provided that: "The Congress finds
the following:
"(1) American consumers cannot purchase prescription drugs with
the certainty that the products are safe and effective.
"(2) The integrity of the distribution system for prescription
drugs is insufficient to prevent the introduction and eventual
retail sale of substandard, ineffective, or even counterfeit
drugs.
"(3) The existence and operation of a wholesale submarket,
commonly known as the 'diversion market', prevents effective
control over or even routine knowledge of the true sources of
prescription drugs in a significant number of cases.
"(4) Large amounts of drugs are being reimported to the United
States as American goods returned. These imports are a health and
safety risk to American consumers because they may have become
subpotent or adulterated during foreign handling and shipping.
"(5) The ready market for prescription drug reimports has been
the catalyst for a continuing series of frauds against American
manufacturers and has provided the cover for the importation of
foreign counterfeit drugs.
"(6) The existing system of providing drug samples to
physicians through manufacturer's representatives has been abused
for decades and has resulted in the sale to consumers of
misbranded, expired, and adulterated pharmaceuticals.
"(7) The bulk resale of below wholesale priced prescription
drugs by health care entities, for ultimate sale at retail, helps
fuel the diversion market and is an unfair form of competition to
wholesalers and retailers that must pay otherwise prevailing
market prices.
"(8) The effect of these several practices and conditions is to
create an unacceptable risk that counterfeit, adulterated,
misbranded, subpotent, or expired drugs will be sold to American
consumers."
(!1) See References in Text note below.