§379r — Title 21 Food and Drugs | U.S. Code

Summary

States may not make or keep rules about certain nonprescription drugs that are different from or add to federal rules. This ban covers rules that conflict with requirements under the federal drug laws, the Poison Prevention Packaging Act, or the Fair Packaging and Labeling Act. It applies to drugs not covered by the specific federal provisions in sections 353(b)(1) or 353(f)(1)(A). The Secretary of Health and Human Services may allow a state rule to stay if the state asks and the rule protects an important public interest (like children’s safety), does not break federal law, and does not unfairly hurt interstate trade. The Secretary must decide within 120 days. The rule does not affect state pharmacy practice laws or rules that make a drug prescription-only. State rules include public warnings and communications. State product liability laws are unchanged. States may enforce rules that are identical to federal requirements.

Title 21, §379r

Food and Drugs — Source: USLM XML via OLRC

(a)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 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).

(b)(1)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)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)(1)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)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)(1)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 or section 357 of this title (as in effect on the day before November 21, 1997) or a final order under section 355h of this title 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)This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997.

(e)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)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.

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Poison Prevention Packaging Act of 1970, referred to in subsec. (a)(2), is Pub. L. 91–601, Dec. 30, 1970, 84 Stat. 1670, which is classified principally to chapter 39A (§ 1471 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see

Short Title

note set out under section 1471 of Title 15 and Tables. The Fair Packaging and Labeling Act, referred to in subsec. (a)(2), is Pub. L. 89–755, Nov. 3, 1966, 80 Stat. 1296, which is classified generally to chapter 39 (§ 1451 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see

Short Title

note set out under section 1451 of Title 15 and Tables.

Amendments

2020—Subsec. (d)(1). Pub. L. 116–136, § 3851(c)(1), in introductory provisions, substituted “final order under section 355h of this title” for “final regulation promulgated” and struck out “and not misbranded” after “safe and effective”. Subsec. (d)(1)(A). Pub. L. 116–136, § 3851(c)(2), substituted “regulation or order in effect” for “regulation in effect”.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an

Effective Date

of 1997 Amendment note under section 321 of this title.

§379r National uniformity for nonprescription drugs

Summary

Title 21, §379r

Notes & Related Subsidiaries

Editorial Notes

References in Text

Short Title

Short Title

Amendments

Statutory Notes and Related Subsidiaries

Effective Date

Effective Date

Citations & Metadata