102 STAT. 100
PUBLIC LAW 100-293—APR. 22, 1988
"(B) A civil penalty of not more than $1,000,000 for each violation resulting in a conviction of any representative after the second conviction in any 10-year period. For the purposes of this paragraph, multiple convictions of one or more persons arising out of the same event or transaction, or a related series of events or transactions, shall be considered as one violation. "(3) Any manufacturer or distributor who violates section 301(t) because of a failure to make a report required by section 503(d)(3)(E) shall be subject to a civil penalty of not more than $100,000. "(4)(A) If a manufacturer or distributor or any representative of such manufacturer or distributor provides information leading to the arrest and conviction of any representative of that manufacturer or distributor for a violation of section 301(t) because of a sale, purchase, or trade or offer to purchase, sell, or trade a drug sample in violation of section 503(c)(1) or for a violation of State law prohibiting the sale, purchase, or trade or offer to sell, purchase, or trade a drug sample, the conviction of such representative shall not be considered as a violation for purposes of paragraph (2). "(B) If, in an action brought under paragraph (2) against a manufacturer or distributor relating to the conviction of a representative of such manufacturer or distributor for the sale, purchase, or trade of a drug or the offer to sell, purchase, or trade a drug, it is shown, by clear and convincing evidence— "(i) that the manufacturer or distributor conducted, before the arrest of such representative for the violation which resulted in such conviction, an investigation of events or transactions which would have led to the reporting of information leading to the arrest and conviction of such representative for such purchase, sale, or trade or offer to purchase, sell, or trade, or "(ii) that, except in the case of the conviction of a representative employed in a supervisory function, despite diligent implementation by the manufacturer or distributor of an independent audit and security system designed to detect such a violation, the manufacturer or distributor could not reasonably have been expected to have detected such violation, the conviction of such representative shall not be considered as a conviction for purposes of paragraph (2). "(5) If a person provides information leading to the arrest and conviction of a person for a violation of section 301(t) because of the sale, purchase, or trade of a drug sample or the offer to sell, purchase, or trade a drug sample in violation of section 503(c)(1), such person shall be entitled to one-half of the criminal fine imposed and collected for such violation but not more than $125,000.". 21 USC 353 note.
SEC. 8. EFFECTIVE DATE.
(a) GENERAL RULE.—Except as provided in subsection (b), this Act and the amendments made by this Act shall take effect upon the expiration of 90 days after the date of the enactment of this Act 03) EXCEPTION.—
Regulations.
(1) Section 503(d) of the Federal Food, Drug, and Cosmetic Act (as added by section 5 of this Act) shall take effect upon the expiration of 180 days after the date of the enactment of this Act. (2) The Secretary of Health and Human Services shall by regulation issue the guidelines required by section 503(e)(2)(B) of
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