Page:United States Statutes at Large Volume 106 Part 2.djvu/61

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PUBLIC LAW 102-353—AUG. 26, 1992 106 STAT. 941 Public Law 102-353 102d Congress An Act To amend the Federal Food, Drug, and Cosmetic Act to coordinate Federal and Aug. 26, 1992 State regulation of wholesale drug distribution, and for other purposes. [S. 3163] Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, Prescription SECTION 1. SHORT TITLE AND REFERENCE. A.'VSoTM®"*® of 1992. (a) SHORT TITLE. —Th is Act may be cited as the "Prescription 21 USC 30i note. Drug Amendments of 1992". (b) REFERENCE. — Whenever in this Act an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or otiier provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act. SEC. 2. DISTRIBUTOR REGISTRATION. (a) REQUIREMENT. —Section 503(e)(2)(A) (21 U.S.C. 353(e)(2)(A)) is amended by inserting before the period the following: "or has registered with the Secretary in accordance with paragraph (3)". (b) REGISTRATION. — Section 503(e) (21 U.S.C. 353(e)) is amended by redesignating paragraph (3) as paragraph (4) and by inserting after paragraph (2) the following: "(3) Any person who engages in the wholesale distribution in interstate commerce of drugs that are subject to subsection (b) in a State that does not have a program that meets the guidelines established under paragraph (2)(B) shall register with the Secretary the following: "(A) llie person's name and place of business. "(B) The name of each establishment the person owns or operates that is engaged in the wholesale distribution of drugs in a State that does not have a program to license persons engaged in such distribution. ". (c) TECHNICAL. —Section 503(f)(1)(B) (21 U.S.C. 353(f)(1)(B)) is amended by striking out "and order" and inserting in lieu thereof "an order". (d) SUNSET. —Effective September 14, 1994, the amendments made by subsections (a) and (b) shall no longer be in effect. SEC 3. PENALTY CLARIFICATION. (a) SCIENTER. —Paragraph (1) of section 303(b) (21 U.S.C. 333(b)) 21 USC 353 note, is amended to read as follows: "(b)(1) Notwithstanding subsection (a), any person who violates section 301(t) by— "(A) knowingly importing a drug in violation of section 801(d)(1), "(B) knowingly selling, purchasing, or trading a drug or drug sample or knowingly offering to sell, purchase, or trade a drug or drug sample, in violation of section 503(c)(1),