Page:United States Statutes at Large Volume 110 Part 5.djvu/34

 110 STAT. 3108 PUBLIC LAW 104-237—OCT. 3, 1996 (c) REINSTATEMENT OF LEGAL DRUG EXEMPTION. — Section 204 of the Controlled Substances Act (21 U.S.C. 814) is amended by adding at the end the following new subsection: Regulations. " (e) REINSTATEMENT OF EXEMPTION WiTH RESPECT TO EPHED- RINE, PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE DRUG PROD- UCTS. —Pursuant to subsection (d)(1), the Attorney General shall by regulation reinstate the exemption with respect to a particular ephedrine, pseudoephedrine, or phenylpropanolamine drug product if the Attorney General determines that the drug product is manufactured and distributed in a manner that prevents diversion. In making this determination the Attorney General shall consider the factors listed in subsection (d)(2). Any regulation issued pursuant to this subsection may be amended or revoked based on the factors listed in subsection (d)(4).". 21 USC 802 note. (d) REGULATION OF RETAIL SALES.— (1) PSEUDOEPHEDRINE. — (A) LIMIT.— (i) IN GENERAL.—Not sooner than the effective date of this section and subject to the requirements of clause (ii), the Attorney General may establish by regulation a single-transaction limit of 24 grams of pseudoephedrine base for retail distributors. Notwithstanding any other provision of law, the single-transaction threshold quantity for pseudoephedrine-containing compounds may not be lowered beyond that established in this paragraph. (ii) CONDITIONS.—In order to establish a singletransaction limit of 24 grams of pseudoephedrine base, the Attorney General shall establish, following notice, comment, and an informal hearing that since the date of enactment of this Act there are a significant number of instances where ordinary over-the-counter pseudoephedrine products as established in paragraph (45) of section 102 of the Controlled Substances Act (21 U.S.C. 802(45)), as added by this Act, sold by retail distributors as established in paragraph (46) in section 102 of the Controlled Substances Act (21 U.S.C. 802(46)), are being widely used as a significant source of precursor chemicals for illegal manufacture of a controlled substance for distribution or sale. (B) VIOLATION.— Any individual or business that violates the thresholds established in this paragraph shall, with respect to the first such violation, receive a warning letter from the Attorney General and, if a business, the business shall be required to conduct mandatory education of the sales employees of the firm with regard to the legal sales of pseudoephedrine. For a second violation occurring within 2 years of the first violation, the business or individual shall be subject to a civil penalty of not more than $5,000. For any subsequent violation occurring within 2 yegirs of the previous violation, the business or individual shall be subject to a civil penalty not to exceed the amount of the previous civil penalty plus $5,000. (2) PHENYLPROPANOLAMINE. — (A) LIMIT.— (i) IN GENERAL.— Not sooner than the effective date of this section and subject to the requirements of clause

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