21 U.S.C. § 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 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)

15 U.S.C. 1471 15 U.S.C. 1451 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 ( et seq.), or the Fair Packaging and Labeling Act ( 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

section 355 of this title section 357 of this titleNovember 21, 1997section 355h of this titleIn the case of a drug described in subsection (a)(1) that is not the subject of an application approved under or (as in effect on the day before ) or a final order under 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)

November 21, 1997 any other requirement in effect with respect to the drug pursuant to an amendment to such a statute made on or after .

(2)

State initiatives

September 1, 1997This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to .

(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.

June 25, 1938, ch. 675, § 751 Pub. L. 105–115, title IV, § 412(a)Nov. 21, 1997111 Stat. 2373 Pub. L. 116–136, div. A, title III, § 3851(c)Mar. 27, 2020134 Stat. 454(, as added , , ; amended , , .)

Editorial Notes

References in Text

Pub. L. 91–601Dec. 30, 197084 Stat. 1670 section 1471 of Title 15The Poison Prevention Packaging Act of 1970, referred to in subsec. (a)(2), is , , , 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 and Tables.

Pub. L. 89–755Nov. 3, 196680 Stat. 1296 section 1451 of Title 15The Fair Packaging and Labeling Act, referred to in subsec. (a)(2), is , , , 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 and Tables.

Amendments

Pub. L. 116–136, § 3851(c)(1)section 355h of this title2020—Subsec. (d)(1). , in introductory provisions, substituted “final order under ” for “final regulation promulgated” and struck out “and not misbranded” after “safe and effective”.

Pub. L. 116–136, § 3851(c)(2)Subsec. (d)(1)(A). , substituted “regulation or order in effect” for “regulation in effect”.

Statutory Notes and Related Subsidiaries

Effective Date

Nov. 21, 1997section 501 of Pub. L. 105–115 section 321 of this titleSection effective 90 days after , except as otherwise provided, see , set out as an Effective Date of 1997 Amendment note under .