(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 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 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 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) 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

Terms Used In 21 USC 379r

  • Amendment: A proposal to alter the text of a pending bill or other measure by striking out some of it, by inserting new language, or both. Before an amendment becomes part of the measure, thelegislature must agree to it.
  • State: means a State, the District of Columbia, the Commonwealth of Puerto Rico, or any other territory or possession of the United States. See 1 USC 7
  • Statute: A law passed by a legislature.

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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