<num style="-uslm-dtd:enum" value="IV">TITLE IV—</num><heading style="-uslm-dtd:header">LEGAL MANUFACTURE, DISTRIBUTION, AND SALE OF PRECURSOR CHEMICALS </heading> <section style="-uslm-dtd:section" identifier="/us/sComp/104/237/tIV/s401" styleType="OLC"> <num style="-uslm-dtd:enum" value="401">SEC. 401.<ref style="-uslm-dtd:footnote-ref" idref="ID41812E58D11F4E56AEBC301E418D5BAB" class="footnoteRef">1</ref> </num><footnote id="ID41812E58D11F4E56AEBC301E418D5BAB" style="-uslm-dtd:footnote"><sup style="-uslm-dtd:superscript">1</sup><p style="-uslm-dtd:para; margin-left:1em">Section 401 of Public Law 104–237 (21 U.S.C. 802 note).</p></footnote><heading style="-uslm-dtd:header">DIVERSION OF CERTAIN PRECURSOR CHEMICALS. </heading> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/104/237/tIV/s401/a" styleType="OLC"> <num style="-uslm-dtd:enum" value="a">(a) </num><content style="-uslm-dtd:text"><elided style="-uslm-dtd:omitted-text">* * *</elided></content> <elided style="-uslm-dtd:omitted-text">* * * * * * *</elided> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/104/237/tIV/s401/d" styleType="OLC"> <num style="-uslm-dtd:enum" value="d">(d) </num><heading style="-uslm-dtd:header">Regulation of Retail Sales.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/104/237/tIV/s401/d/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">Pseudoephedrine.—</heading> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/104/237/tIV/s401/d/1/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><heading style="-uslm-dtd:header">Limit.—</heading> <clause style="-uslm-dtd:clause" identifier="/us/sComp/104/237/tIV/s401/d/1/A/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">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.</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/104/237/tIV/s401/d/1/A/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><heading style="-uslm-dtd:header">Conditions.—</heading><content style="-uslm-dtd:text">In order to establish a single-transaction 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.</content> </clause> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/104/237/tIV/s401/d/1/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><heading style="-uslm-dtd:header">Violation.—</heading><content style="-uslm-dtd:text">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 years 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.</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/104/237/tIV/s401/d/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Phenylpropanolamine.—</heading> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/104/237/tIV/s401/d/2/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><heading style="-uslm-dtd:header">Limit.—</heading> <clause style="-uslm-dtd:clause" identifier="/us/sComp/104/237/tIV/s401/d/2/A/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">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 phenylpropanolamine base for retail distributors. Notwithstanding any other provision of law, the single-transaction threshold quantity for phenylpropanolamine-containing compounds may not be lowered beyond that established in this paragraph.</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/104/237/tIV/s401/d/2/A/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><heading style="-uslm-dtd:header">Conditions.—</heading><content style="-uslm-dtd:text">In order to establish a single-transaction limit of 24 grams of phenylpropanolamine 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 phenylpropanolamine 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 used as a significant source of precursor chemicals for illegal manufacture of a controlled substance in bulk.</content> </clause> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/104/237/tIV/s401/d/2/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><heading style="-uslm-dtd:header">Violation.—</heading><content style="-uslm-dtd:text">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 years 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.</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/104/237/tIV/s401/d/3" styleType="OLC"> <num style="-uslm-dtd:enum" value="3">(3) </num><heading style="-uslm-dtd:header">Significant number of instances.—</heading> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/104/237/tIV/s401/d/3/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">For purposes of this subsection, isolated or infrequent use, or use in insubstantial quantities, of ordinary over-the-counter pseudoephedrine or phenylpropanolamine, as defined in section 102(45) of the Controlled Substances Act, as added by section 401(b) of this Act, and sold at the retail level for the illicit manufacture of methamphetamine or amphetamine may not be used by the Attorney General as the basis for establishing the conditions under paragraph (1)(A)(ii) of this subsection, with respect to pseudoephedrine, and paragraph (2)(A)(ii) of this subsection, with respect to phenylpropanolamine.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/104/237/tIV/s401/d/3/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><heading style="-uslm-dtd:header">Considerations and report.—</heading><chapeau style="-uslm-dtd:text">The Attorney General shall—</chapeau> <clause style="-uslm-dtd:clause" identifier="/us/sComp/104/237/tIV/s401/d/3/B/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">in establishing a finding under paragraph (1)(A)(ii) or (2)(A)(ii) of this subsection, consult with the Secretary of Health and Human Services in order to consider the effects on public health that would occur from the establishment of new single transaction limits as provided in such paragraph; and</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/104/237/tIV/s401/d/3/B/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">upon establishing a finding, transmit a report to the Committees on the Judiciary in both, respectively, the House of Representatives and the Senate in which the Attorney General will provide the factual basis for establishing the new single transaction limits.</content> </clause> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/104/237/tIV/s401/d/4" styleType="OLC"> <num style="-uslm-dtd:enum" value="4">(4) </num><heading style="-uslm-dtd:header">Definition of business.—</heading><content style="-uslm-dtd:text">For purposes of this subsection, the term “<term style="-uslm-dtd:term">business</term>” means the entity that makes the direct sale and does not include the parent company of a business not involved in a direct sale regulated by this subsection.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/104/237/tIV/s401/d/5" styleType="OLC"> <num style="-uslm-dtd:enum" value="5">(5) </num><heading style="-uslm-dtd:header">Judicial review.—</heading><content style="-uslm-dtd:text">Any regulation promulgated by the Attorney General under this section shall be subject to judicial review pursuant to section 507 of the Controlled Substances Act (21 U.S.C. 877).</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/104/237/tIV/s401/e" styleType="OLC"> <num style="-uslm-dtd:enum" value="e">(e) </num><heading style="-uslm-dtd:header">Effect on Thresholds.—</heading><content style="-uslm-dtd:text">Nothing in the amendments made by subsection (b) or the provisions of subsection (d) shall affect the authority of the Attorney General to modify thresholds (including cumulative thresholds) for retail distributors for products other than ordinary over-the-counter pseudoephedrine or phenylpropanolamine products (as defined in section 102(45) of the Controlled Substances Act, as added by this section) or for non-retail distributors, importers, or exporters.</content> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/104/237/tIV/s401/f" styleType="OLC"> <num style="-uslm-dtd:enum" value="f">(f) </num><heading style="-uslm-dtd:header">Combination Ephedrine Products.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/104/237/tIV/s401/f/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">In general.—</heading><chapeau style="-uslm-dtd:text">For the purposes of this section, combination ephedrine products shall be treated the same as pseudoephedrine products, except that—</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/104/237/tIV/s401/f/1/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">a single transaction limit of 24 grams shall be effective as of the date of enactment of this Act and shall apply to sales of all combination ephedrine products, notwithstanding the form in which those products are packaged, made by retail distributors or distributors required to submit a report under section 310(b)(3) of the Controlled Substances Act (as added by section 402 of this Act);</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/104/237/tIV/s401/f/1/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><chapeau style="-uslm-dtd:text">for regulated transactions for combination ephedrine products other than sales described in subparagraph (A), the transaction limit shall be—</chapeau> <clause style="-uslm-dtd:clause" identifier="/us/sComp/104/237/tIV/s401/f/1/B/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">1 kilogram of ephedrine base, effective on the date of enactment of this Act; or</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/104/237/tIV/s401/f/1/B/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">a threshold other than the threshold described in clause (i), if established by the Attorney General not earlier than 1 year after the date of enactment of this Act; and</content> </clause> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/104/237/tIV/s401/f/1/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">the penalties provided in subsection (d)(1)(B) of this section shall take effect on the date of enactment of this Act for any individual or business that violates the single transaction limit of 24 grams for combination ephedrine products.</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/104/237/tIV/s401/f/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Definition.—</heading><content style="-uslm-dtd:text">For the purposes of this section, the term “<term style="-uslm-dtd:term">combination ephedrine product</term>” means a drug product containing ephedrine or its salts, optical isomers, or salts of optical isomers and therapeutically significant quantities of another active medicinal ingredient.</content> <elided style="-uslm-dtd:omitted-text">* * * * * * *</elided> </paragraph> </subsection> </section>