Page:United States Statutes at Large Volume 102 Part 1.djvu/137

 P U B U C LAW 100-293—APR. 22, 1988

102 STAT. 99

drugs subject to subsection (b)- Such guidelines shall prescribe Records, requirements for the storsige and handling of such drugs and for the establishment and maintenance of records of the distributions of such drugs. "(3) For the purposes of this subsection— "(A) the term 'authorized distributors of record' means those distributors with whom a manufacturer has established an ongoing relationship to distribute such manufacturer's products, and "(B) the term 'wholesale distribution' means distribution of drugs subject to subsection (b) to other than the consumer or patient but does not include intracompany sales and does not include distributions of drugs described in subsection (c)(3)(B).". SEC. 7. PENALTIES.

(a) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331) is amended by adding at the end the following: "(t) The importation of a drug in violation of section 801(d)(l), the sale, purchase, or trade of a drug or drug sample or the offer to sell, purchase, or trade a drug or drug sample in violation of section 503(c), the sale, purchase, or trade of a coupon, the offer to sell, purchase, or trade such a coupon, or the counterfeiting of such a coupon in violation of section 503(c)(2), the distribution of a drug sample in violation of section 503(d) or the failure to otherwise comply with the requirements of section 503(d), or the distribution of drugs in violation of section 503(e) or the failure to otherwise comply with the requirements of section 503(e).". (b) PENALTIES.—Section 303 (21 U.S.C. 333) is amended— (1) by inserting "(1)" after "(a)", (2) by redesignating subsection (b) as paragraph (2) and by striking out "subsection (a)" in such subsection and inserting in lieu thereof "paragraph (1)", and (3) by inserting after subsection (a) the following: "(b)(1) Notwithstanding subsection (a), any person who violates section 301(t) because of an importation of a drug in violation of section SOKdXD, because of a sale, purchase, or trade of a drug or drug sample or the offer to sell, purchase, or trade a drug or drug sample in violation of section 503(c), because of the sale, purchase, or trade of a coupon, the offer to sell, purchgise, or trade such a coupon, or the counterfeiting of such a coupon in violation of section 503(c)(2), or the distribution of drugs in violation of section 503(e)(2)(A) shall be imprisoned for not more than 10 years or fined not more than $250,000, or both. "(2) Any manufacturer or distributor who distributes drug samples by means other than the mail or common carrier whose representative, during the course of the representatives employment or association with that manufacturer or distributor, violated section 301(t) because of a violation of section 503(c)(l) or violated any State law prohibiting the sale, purchase, or trade of a drug sample subject to section 503(b) or the offer to sell, purchase, or trade such a drug sample shall, upon conviction of the representative for such violation, be subject to the following civil penalties: "(A) A civil penalty of not more than $50,000 for each of the first two such violations resulting in a conviction of any representative of the manufacturer or distributor in any 10-year period.

�