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21 U.S.C. § 379r — National uniformity for nonprescription drugs
Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** Except as provided in subsection (b), (c)(1), (d), (e), or (f), no State or political subdivision of a State may establish or continue in effect any requirement—
(1) that relates to the regulation of a drug that is not subject to the requirements of section 353(b)(1) or 353(f)(1)(A) of this title; and
(2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter, the Poison Prevention Packaging Act of 1970 ([15 U.S.C. 1471](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1471&num=0&edition=prelim) et seq.), or the Fair Packaging and Labeling Act ([15 U.S.C. 1451](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1451&num=0&edition=prelim) et seq.).
**(b) Exemption**
(1) **In general** — Upon application of a State or political subdivision thereof, the Secretary may by regulation, after notice and opportunity for written and oral presentation of views, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a State or political subdivision requirement that—
(A) protects an important public interest that would otherwise be unprotected, including the health and safety of children;
(B) would not cause any drug to be in violation of any applicable requirement or prohibition under Federal law; and
(C) would not unduly burden interstate commerce.
(2) **Timely action** — The Secretary shall make a decision on the exemption of a State or political subdivision requirement under paragraph (1) not later than 120 days after receiving the application of the State or political subdivision under paragraph (1).
**(c) Scope**
(1) **In general** — This section shall not apply to—
(A) any State or political
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Stable record: federal_law:legal_authorities:record_usc_390146f52d2eb5280a16a9bc
Source file: Laws/federal/codes/united-states-code/title-21/section-379r-national-uniformity-for-nonprescription-drugs--ad7b6144dc.md
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Source location: Title 21, Chapter 9, § 379r; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) In general** Except as provided in subsection (b), (c)(1), (d), (e), or (f), no State or political subdivision of a State may establish or continue in effect any requirement—
(1) that relates to the regulation of a drug that is not subject to the requirements of section 353(b)(1) or 353(f)(1)(A) of this title; and
(2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter, the Poison Prevention Packaging Act of 1970 ([15 U.S.C. 1471](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1471&num=0&edition=prelim) et seq.), or the Fair Packaging and Labeling Act ([15 U.S.C. 1451](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1451&num=0&edition=prelim) et seq.).
**(b) Exemption**
(1) **In general** — Upon application of a State or political subdivision thereof, the Secretary may by regulation, after notice and opportunity for written and oral presentation of views, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a State or political subdivision requirement that—
(A) protects an important public interest that would otherwise be unprotected, including the health and safety of children;
(B) would not cause any drug to be in violation of any applicable requirement or prohibition under Federal law; and
(C) would not unduly burden interstate commerce.
(2) **Timely action** — The Secretary shall make a decision on the exemption of a State or political subdivision requirement under paragraph (1) not later than 120 days after receiving the application of the State or political subdivision under paragraph (1).
**(c) Scope**
(1) **In general** — This section shall not apply to—
(A) any State or political subdivision requirement that relates to the practice of pharmacy; or
(B) any State or political subdivision requirement that a drug be dispensed only upon the prescription of a practitioner licensed by law to administer such drug.
(2) **Safety or effectiveness** — For purposes of subsection (a), a requirement that relates to the regulation of a drug shall be deemed to include any requirement relating to public information or any other form of public communication relating to a warning of any kind for a drug.
**(d) Exceptions**
(1) **In general** — In the case of a drug described in subsection (a)(1) that is not the subject of an application approved under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or [section 357 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section357&num=0&edition=prelim) (as in effect on the day before November 21, 1997) or a final order under [section 355h of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355h&num=0&edition=prelim) by the Secretary establishing conditions under which the drug is generally recognized as safe and effective, subsection (a) shall apply only with respect to a requirement of a State or political subdivision of a State that relates to the same subject as, but is different from or in addition to, or that is otherwise not identical with—
(A) a regulation or order in effect with respect to the drug pursuant to a statute described in subsection (a)(2); or
(B) any other requirement in effect with respect to the drug pursuant to an amendment to such a statute made on or after November 21, 1997.
(2) **State initiatives** — This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997.
**(e) No effect on product liability law** Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.
**(f) State enforcement authority** Nothing in this section shall prevent a State or political subdivision thereof from enforcing, under any relevant civil or other enforcement authority, a requirement that is identical to a requirement of this chapter.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Nonprescription drugs marketed without an approved application** Nonprescription drugs marketed without an approved drug application under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), as of March 27, 2020, shall be treated in accordance with this subsection.
(1) **Drugs subject to a final monograph; category I drugs subject to a tentative final monograph** — A drug is deemed to be generally recognized as safe and effective under [section 321(p)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321/p/1&num=0&edition=prelim), not a new drug under [section 321(p) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321/p&num=0&edition=prelim), and not subject to [section 353(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/b/1&num=0&edition=prelim), if—
(A) the drug is—
(i) in conformity with the requirements for nonprescription use of a final monograph issued under part 330 of title 21, Code of Federal Regulations (except as provided in paragraph (2)), the general requirements for nonprescription drugs, and conditions or requirements under subsections (b), (c), and (k); and
(ii) except as permitted by an order issued under subsection (b) or, in the case of a minor change in the drug, in conformity with an order issued under subsection (c), in a dosage form that, immediately prior to March 27, 2020, has been used to a material extent and for a material time under [section 321(p)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321/p/2&num=0&edition=prelim); or
(B) the drug is—
(i) clas
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.
**(b) Filing application; contents**
(1)
(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application—
(i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use;
(ii) a full list of the articles used as components of such drug;
(iii) a full statement of the composition of such drug;
(iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug;
(v) such samples of such drug and of the articles used as components thereof as the Secretary may require;
(vi) specimens of the labeling proposed to be used for such drug;
(vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and
(viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—
(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or
(II) claims a method of using such drug for which approv
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Federal law — U.S. Code and appendices · legal_authorities
For the purpose of this Act—
(1) The term “Commission” means the Consumer Product Safety Commission.
(2) The term “household substance” means any substance which is customarily produced or distributed for sale for consumption or use, or customarily stored, by individuals in or about the household and which is—
(A) a hazardous substance as that term is defined in [section 1261(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1261/f&num=0&edition=prelim);
(B) a food, drug, or cosmetic as those terms are defined in [section 321 of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321&num=0&edition=prelim); or
(C) a substance intended for use as fuel when stored in a portable container and used in the heating, cooking, or refrigeration system of a house.
(3) The term “package” means the immediate container or wrapping in which any household substance is contained for consumption, use, or storage by individuals in or about the household, and, for purposes of [section 1473(a)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1473/a/2&num=0&edition=prelim), also means any outer container or wrapping used in the retail display of any such substance to consumers. Such term does not include—
(A) any shipping container or wrapping used solely for the transportation of any household substance in bulk or in quantity to manufacturers, packers, or processors, or to wholesale or retail distributors thereof, or
(B) any shipping container or outer wrapping used by retailers to ship or deliver any household substance to consumers unless it is the only such container or wrapping.
(4) The term “special packaging” means packaging that is designed or
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Process for qualification**
(1) **In general** — The Secretary shall establish a process for the qualification of drug development tools for a proposed context of use under which—
(A)
(i) a requestor initiates such process by submitting a letter of intent to the Secretary; and
(ii) the Secretary accepts or declines to accept such letter of intent;
(B)
(i) if the Secretary accepts the letter of intent, a requestor submits a qualification plan to the Secretary; and
(ii) the Secretary accepts or declines to accept the qualification plan; and
(C)
(i) if the Secretary accepts the qualification plan, the requestor submits to the Secretary a full qualification package;
(ii) the Secretary determines whether to accept such qualification package for review; and
(iii) if the Secretary accepts such qualification package for review, the Secretary conducts such review in accordance with this section.
(2) **Acceptance and review of submissions**
(A) *In general* — Subparagraphs (B), (C), and (D) shall apply with respect to the treatment of a letter of intent, a qualification plan, or a full qualification package submitted under paragraph (1) (referred to in this paragraph as “qualification submissions”).
(B) *Acceptance factors; nonacceptance* — The Secretary shall determine whether to accept a qualification submission based on factors which may include the scientific merit of the qualification submission. A determination not to accept a submission under paragraph (1) shall not be construed as a final determination by the Secretary under this section regarding the qualification of a drug development tool for its proposed context of use.
(C) *Prioritization of qualification review* — The Secretary may prioritize the review of
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 357
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Federal law — U.S. Code and appendices · legal_authorities
Informed consumers are essential to the fair and efficient functioning of a free market economy. Packages and their labels should enable consumers to obtain accurate information as to the quantity of the contents and should facilitate value comparisons. Therefore, it is hereby declared to be the policy of the Congress to assist consumers and manufacturers in reaching these goals in the marketing of consumer goods.
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Federal law — U.S. Code and appendices · legal_authorities
For the purposes of this chapter—
**(a)**
(1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
**(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
**(c)** The term “Department” means Department of Health and Human Services.
**(d)** The term “Secretary” means the Secretary of Health and Human Services.
**(e)** The term “person” includes individual, partnership, corporation, and association.
**(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
**(g)**
(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif
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Federal law — U.S. Code and appendices · legal_authorities
Page 1410
TITLE 15—COMMERCE AND TRADE
§§ 1411 to 1420
Section 1410a, Pub. L. 89–563, title I, § 124, as added
Pub. L. 93–492, title I, § 106, Oct. 27, 1974, 88 Stat. 1481,
related to petitions of interested persons to commence
proceedings on orders issued under sections 1392 and
1412(b) of this title. See sections 30103 and 30162 of Title
49.
Section 1410b, Pub. L. 89–563, title I, § 125, as added
Pub. L. 93–492, title I, § 109, Oct. 27, 1974, 88 Stat. 1482;
amended S. Res. 4, Feb. 4, 1977; H. Res. 549, Mar. 25, 1980,
related to occupant restraint systems. See section 30124
of Title 49.
PART B—DISCOVERY, NOTIFICATION, AND
REMEDY OF MOTOR VEHICLE DEFECTS
§§ 1411 to 1420. Repealed. Pub. L. 103–272, § 7(b),
July 5, 1994, 108 Stat. 1379
Section 1411, Pub. L. 89–563, title I, § 151, as added
Pub. L. 93–492, title I, § 102(a), Oct. 27, 1974, 88 Stat. 1470,
related to notification respecting manufacturer’s find-
ing of defect or failure to comply with motor vehicle
safety standard. See section 30118 of Title 49, Transpor-
tation.
Section 1412, Pub. L. 89–563, title I, § 152, as added
Pub. L. 93–492, title I, § 102(a), Oct. 27, 1974, 88 Stat. 1470,
related to notification of Secretary’s finding of defect
or failure to comply with motor vehicle safety stand-
ard, publication in Federal Register, and opportunity
to present data, views, and arguments. See section
30118 of Title 49.
Section 1413, Pub. L. 89–563, title I, § 153, as added
Pub. L. 93–492, title I, § 102(a), Oct. 27, 1974, 88 Stat. 1471;
amended Pub. L. 97–331, § 4(b), Oct. 15, 1982, 96 Stat. 1620;
Pub. L. 102–240, title II, § 2504(a), Dec. 18, 1991, 105 Stat.
2083, related to contents, time, and method of notifica-
tion regarding manufacturer’s finding of defect or fail-
ure to comply with m
Source: Supplied 2024 U.S. Code historical extraction · 15 U.S.C. § 1451
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Federal law — U.S. Code and appendices · legal_authorities
Page 1416
TITLE 15—COMMERCE AND TRADE
§ 1461
chapter 2 of this title. For complete classification of
this Act to the Code, see section 58 of this title and Ta-
bles.
The Federal Food, Drug, and Cosmetic Act, referred
to in text, is act June 25, 1938, ch. 675, 52 Stat. 1040,
which is classified generally to chapter 9 (§ 301 et seq.)
of Title 21, Food and Drugs, For complete classification
of this Act to the Code, see section 301 of Title 21 and
Tables.
The Federal Hazardous Substances Labeling Act, re-
ferred to in text, is Pub. L. 86–613, July 12, 1960, 74 Stat.
372, which is classified generally to chapter 30 (§ 1261 et
seq.) of this title. For complete classification of this
Act to the Code, see Short Title note set out under sec-
tion 1261 of this title and Tables.
§ 1461. Effect upon State law
It is hereby declared that it is the express in-
tent of Congress to supersede any and all laws of
the States or political subdivisions thereof inso-
far as they may now or hereafter provide for the
labeling of the net quantity of contents of the
package of any consumer commodity covered by
this chapter which are less stringent than or re-
quire information different from the require-
ments of section 1453 of this title or regulations
promulgated pursuant thereto.
(Pub. L. 89–755, § 12, Nov. 3, 1966, 80 Stat. 1302.)
CHAPTER
39A—SPECIAL
PACKAGING
OF
HOUSEHOLD SUBSTANCES FOR PROTEC-
TION OF CHILDREN
Sec.
1471.
Definitions.
1472.
Special packaging standards.
1472a.
Special packaging for liquid nicotine con-
tainers.
1473.
Conventional packages, marketing.
1474.
Regulations for special packaging standards.
1475.
Repealed.
1476.
Preemption of Federal standards.
1477.
Enforcement by State Attorneys General.
§ 1471. Definitions
For the purpos
Source: Supplied 2024 U.S. Code historical extraction · 15 U.S.C. § 1471
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Federal law — U.S. Code and appendices · legal_authorities
Page 627
TITLE 21—FOOD AND DRUGS
§ 379r
PART
F—NATIONAL
UNIFORMITY
FOR
NON-
PRESCRIPTION
DRUGS
AND
PREEMPTION
FOR
LABELING OR PACKAGING OF COSMETICS
§ 379r. National uniformity for nonprescription
drugs
(a) In general
Except as provided in subsection (b), (c)(1), (d),
(e), or (f), no State or political subdivision of a
State may establish or continue in effect any re-
quirement—
(1) that relates to the regulation of a drug
that is not subject to the requirements of sec-
tion 353(b)(1) or 353(f)(1)(A) of this title; and
(2) that is different from or in addition to, or
that is otherwise not identical with, a require-
ment under this chapter, the Poison Preven-
tion Packaging Act of 1970 (15 U.S.C. 1471 et
seq.), or the Fair Packaging and Labeling Act
(15 U.S.C. 1451 et seq.).
(b) Exemption
(1) In general
Upon application of a State or political sub-
division thereof, the Secretary may by regula-
tion, after notice and opportunity for written
and oral presentation of views, exempt from
subsection (a), under such conditions as may
be prescribed in such regulation, a State or po-
litical subdivision requirement that—
(A) protects an important public interest
that would otherwise be unprotected, includ-
ing the health and safety of children;
(B) would not cause any drug to be in vio-
lation of any applicable requirement or pro-
hibition under Federal law; and
(C) would not unduly burden interstate
commerce.
(2) Timely action
The Secretary shall make a decision on the
exemption of a State or political subdivision
requirement under paragraph (1) not later
than 120 days after receiving the application of
the State or political subdivision under para-
graph (1).
(c) Scope
(1) In general
This section shall not apply to—
(A) any State or political su
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 379r
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