Page:United States Statutes at Large Volume 100 Part 5.djvu/269

 PUBLIC LAW 99-660—NOV. 14, 1986 Public Law 99-660 99th Congress

100 STAT. 3743

An Act

To require States to develop, establish, and implement State comprehensive mental health plans.

Nov. 14, 1986 [S. 1744]

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

TITLE I—DRUG EXPORTS SEC. 101. SHORT TITLE, REFERENCE.

Drug Export j Amendments Act of 1986. 21 USC 301 note.

(a) SHORT TITLE.—This title may be cited as the "Drug Export Amendments Act of 1986". (b) REFERENCE.—Whenever in this title an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be a reference to a section or other provision of the Federal Food, Drug, and Cosmetic Act.

21 USC 301.

SEC. 102. EXPORT AUTHORITY.

Chapter VIII is amended— (1) by inserting after the chapter heading the following:

21 USC 381 et seq.

"IMPORTS AND EXPORTS", and

(2) by inserting after section 801 the following: "EXPORTS OF CERTAIN UNAPPROVED PRODUCTS

"SEC. 802. (a) A drug (including a biological product) intended for human or animal use— (1) which— "(A) requires approval by the Secretary under section 505 or section 512, or "(B) requires licensing by the Secretary under section 351 of the Public Health Service Act or by the Secretary of Agriculture under the Act of March 4, 1913 (known as the Virus Serum Toxin Act), before it may be introduced or delivered for introduction into interstate commerce to a country, and "(2) which does not have such approval or license, which is not exempt from such sections or Act, and which is introduced or delivered for introduction into interstate commerce to a country, is adulterated, misbranded, and in violation of such sections or Act unless the export of the drug is authorized under subsection (b). "(b)(1) A drug (including a biological product) may, upon approval of an application submitted under paragraph (3), be exported if— "(A) the drug contains the same active ingredient as a— "(i) new drug—

Animals. 21 USC 382. 21 USC 355. 21 USC 360b. Commerce and trade. 42 USC 262. 21 USC 151 note.

�