21 U.S.C. 352: Misbranded drugs and devices

2022

• Pub. L. 117–328, §3630(a)(1)–(3), substituted "drugs or devices for coverage" for "drugs for coverage", "drug or device" for "drug" in two places, "under section 355 of this title or under section 262(a) of title 42" for "under section 355 of this title or under section 262(a) of ti… (Consolidated Appropriations Act, 2023) Law text · (a)
• Pub. L. 117–328, §3630(a)(1)(B), substituted "drug or device" for "drug" in two places. (Consolidated Appropriations Act, 2023) Law text · (a)
• Pub. L. 117–328, §3630(a)(1)(B), (2), substituted "drug or device" for "drug" and "under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42" for "under section 355 of this title or under section 262 of title 42". (Consolidated Appropriations Act, 2023) Law text · (a)
• Pub. L. 117–328, §3630(a)(4), added subsec. (gg). (Consolidated Appropriations Act, 2023) Law text · (gg)

2020

• Pub. L. 116–136 added subsecs. (ee) and (ff). (Coronavirus Aid, Relief, and Economic Security Act" or the "CARES Act) Law text · (ee), (ff)

2018

• Pub. L. 115–234 added par. (3). Law text · (w)

2016

• Pub. L. 114–255, §3037, designated existing provisions as par. (1), substituted "a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs for coverage or… (21st Century Cures Act) Law text · (a)
• Pub. L. 114–255, §3044(b)(2), added subsec. (dd). (21st Century Cures Act) Law text · (dd)

2013

• Pub. L. 113–54, §103(b), added par. (bb). Law text · (bb)
• Pub. L. 113–54, §206(b), added par. (cc). Law text · (cc)

2012

• Pub. L. 112–144, §714(c), inserted "if it is a drug and was imported or offered for import by a commercial importer of drugs not duly registered under section 381(s) of this title," after "not duly registered under section 360 of this title,". (Food and Drug Administration Safety and Innovation Act) Law text · (o)
• Pub. L. 112–144, §702(a), struck out "in any State" after "establishment". (Food and Drug Administration Safety and Innovation Act) Law text · (o)
• Pub. L. 112–193 substituted "379j–42(a)(4)" for "379j–41(a)(4)". Law text · (aa)
• Pub. L. 112–144, §306, added par. (aa). (Food and Drug Administration Safety and Innovation Act) Law text · (aa)

2007

• Pub. L. 110–85, §906(a), inserted "and in the case of published direct-to-consumer advertisements the following statement printed in conspicuous text: 'You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800-FDA-1088.'… (Food and Drug Administration Amendments Act of 2007) Law text · (n)
• Pub. L. 110–85, §901(d)(6), substituted "section 371(a) of this title" for "the procedure specified in section 371(e) of this title". (Food and Drug Administration Amendments Act of 2007) Law text · (n)
• Pub. L. 110–85, §901(d)(3)(A), inserted at end "In the case of an advertisement for a drug subject to section 353(b)(1) of this title presented directly to consumers in television or radio format and stating the name of the drug and its conditions of use, the major statement relating to side effect… (Food and Drug Administration Amendments Act of 2007) Law text · (n)
• Pub. L. 110–85, §902(a), added pars. (y) and (z). (Food and Drug Administration Amendments Act of 2007) Law text · (y), (z)

2006

• Pub. L. 109–462 added par. (x). (Dietary Supplement and Nonprescription Drug Consumer Protection Act) Law text · (x)

2005

• Pub. L. 109–43 amended par. (u) generally. Prior to amendment, par. (u) read as follows: "If it is a device, unless it, or an attachment thereto, prominently and conspicuously bears the name of the manufacturer of the device, a generally recognized abbreviation of such name, or a unique a… Law text · (u)

2004

• Pub. L. 108–214, in last sentence, inserted "or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establishments" after "in health care facilities", inserted comma after "means", substituted "requi… Law text · (f)
• Pub. L. 108–282 added par. (w). Law text · (w)

2002

• Pub. L. 107–250, §206, inserted at end "Required labeling for prescription devices intended for use in health care facilities may be made available solely by electronic means provided that the labeling complies with all applicable requirements of law and, that the manufacturer affords hea… (Medical Device User Fee and Modernization Act of 2002) Law text · (f)
• Pub. L. 107–250, §301(a), which directed amendment of section by adding par. (u) at end, was executed by adding par. (u) before par. (v) to reflect the probable intent of Congress. (Medical Device User Fee and Modernization Act of 2002) Law text · (u)
• Pub. L. 107–250, §302(a)(1), added par. (v). (Medical Device User Fee and Modernization Act of 2002) Law text · (v)

1997

• Pub. L. 105–115, §114(a), inserted at end "Health care economic information provided to a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations… (Food and Drug Administration Modernization Act of 1997) Law text · (a)
• Pub. L. 105–115, §126(b), struck out par. (d) which read as follows: "If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha eucaine, barbituric acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morph… (Food and Drug Administration Modernization Act of 1997) Law text · (d)
• Pub. L. 105–115, §412(c), amended subpar. (1) generally. Prior to amendment, subpar. (1) read as follows: "If it is a drug, unless (A) its label bears, to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula), (i) the es… (Food and Drug Administration Modernization Act of 1997) Law text · (e)
• Pub. L. 105–115, §125(a)(2)(B), struck out par. (k) which read as follows: "If it is, or purports to be, or is represented as a drug composed wholly or partly of insulin, unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to section 356 o… (Food and Drug Administration Modernization Act of 1997) Law text · (k)
• Pub. L. 105–115, §125(b)(2)(D), struck out par. (l) which read as follows: "If it is, or purports to be, or is represented as a drug (except a drug for use in animals other than man) composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bac… (Food and Drug Administration Modernization Act of 1997) Law text · (l)

1993

• Pub. L. 103–80, §3(m)(1), substituted "of such ingredient, except that" for "of such ingredient: Provided, That". · (e)
• Pub. L. 103–80, §3(m)(2), substituted "users, except that where" for "users: Provided, That where". · (f)
• Pub. L. 103–80, §3(m)(3), substituted "prescribed therein. The method" for "prescribed therein: Provided, That the method" and "Pharmacopoeia, except that" for "Pharmacopoeia: Provided further, That,". · (g)
• Pub. L. 103–80, §3(m)(4), substituted ", except that (A)" for ": Provided, That (A)". · (n)

1992

• Pub. L. 102–571 substituted "379e" for "376". · (m)
• Pub. L. 102–300 added cl. (3). · (t)

1978

• Pub. L. 95–633 inserted provision relating to the construction of the Convention on Psychotropic Substances. · (n)

1976

• Pub. L. 94–295, §5(a), substituted "subparagraph (3)" for "subparagraph (2)" in subpar. (1), added subpar. (2), redesignated former subpar. (2) as (3) and in subpar. (3) as so redesignated substituted "subparagraph (1)" for "this paragraph (e)", and added subpar. (4). · (e)
• Pub. L. 94–295, §3(e)(2), substituted "dosage or manner," for "dosage,". · (j)
• Pub. L. 94–295, §9(b)(2), substituted "the intended use of which is for" for "the intended use of which in or on drugs is for". · (m)
• Pub. L. 94–295, §4(b)(2), substituted "If it was manufactured" for "If it is a drug and was manufactured" and inserted ", if it was not included in a list required by section 360(j) of this title, if a notice or other information respecting it was not provided as required by such section … · (o)
• Pub. L. 94–295, §3(e)(1), added pars. (q) to (t). · (q), (r), (s), (t)

1970

• Pub. L. 91–601 added par. (p). · (p)

1968

• Pub. L. 90–399 inserted "(except a drug for use in animals other than man)" after "represented as a drug". · (l)

1962

• Pub. L. 87–781, §112(a), designated existing provisions as subpar. (1), substituted ", unless (A) its label bears, to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula), (i) the established name (as defined in subparagra… · (e)
• Pub. L. 87–781, §112(b), provided that if there is an inconsistency between the provisions of this par. and those of par. (e), as to the name of a drug, the requirements of par. (e) should prevail. · (g)
• Pub. L. 87–781, §105(c), substituted "bacitracin, or any other antibiotic drug" for "or bacitracin." · (l)
• Pub. L. 87–781, §131(a), added par. (n). · (n)
• Pub. L. 87–781, §305, added par. (o). · (o)

1960

• Pub. L. 86–618 added par. (m). · (m)