Sec. 4. Amendments to the Controlled Substances Act

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Part C of the Controlled Substances Act ( 21 U.S.C. 821 et seq. ) is amended by adding at the end the following: In this section— the term covered dispenser — means a dispenser— that is required to register under section 302(a)(2); and dispenses a controlled substance in schedule II; and does not include a dispenser that is— registered to dispense opioid agonist treatment medication under section 303(g)(1); and operating in that capacity; the term covered distributor means a distributor— that is required to register under section 302(a)(1); and distributes a controlled substance in schedule II; the term covered manufacturer means a manufacturer— that is required to register under section 302(a)(1); and manufactures a controlled substance in schedule II; the term covered officer , with respect to a covered person means— in the case of a covered person that is not an individual— the chief executive officer of the covered person; the president of the covered person; the chief medical officer of the covered person; or the chief counsel of the covered person; and in the case of a covered person that is an individual, that individual; and the term covered person means— a covered dispenser; a covered distributor; or a covered manufacturer.

Not later than 180 days after the date of enactment of this section, and each year thereafter, each covered officer of a covered person shall submit to the Attorney General, for each controlled substance in schedule II dispensed, distributed, or manufactured by the covered person, a certification— signed by the covered officer; and certifying that— the covered person maintains effective controls against diversion of the controlled substance into channels other than legitimate medical, scientific, research, or industrial channels; all information contained in any record, inventory, or report required to be kept or submitted to the Attorney General by the covered person under section 307, or under any regulation issued under that section, is accurate; and the covered person is in compliance with all applicable requirements under Federal law relating to reporting suspicious orders for controlled substances.

Not later than 180 days after the date of enactment of this section, and each year thereafter, each covered officer of a covered manufacturer shall submit to the Secretary, for each controlled substance in schedule II manufactured by the covered manufacturer, a certification— signed by the covered officer; and certifying that the controlled substance is not misbranded, as described in section 502 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 352 ). Not later than 30 days after the date on which a covered officer of a covered manufacturer is required to submit a certification under paragraph

(1)and fails to do so, the Secretary shall notify the Attorney General of the failure by the covered officer to submit the certification. Not later than 30 days after the date on which the Secretary becomes aware that a certification submitted under paragraph

(1)contains a materially false statement or representation relating to the misbranding of a controlled substance with respect to the year for which the certification is submitted, the Secretary shall notify the Attorney General that the certification contains the materially false statement or representation. . Part D of title II of the Controlled Substances Act ( 21 U.S.C. 841 et seq. ) is amended by adding at the end the following: In this section, the terms covered dispenser , covered distributor , covered manufacturer , covered officer , and covered person have the meanings given those terms in section 313. It shall be unlawful for a covered officer of a covered person to fail to submit a certification required under section 313(b), without regard to the state of mind of the covered officer. It shall be unlawful for a covered officer of a covered manufacturer to fail to submit a certification required under section 313(c)(1), without regard to the state of mind of the covered officer. It shall be unlawful for a covered officer of a covered person to submit a certification required under section 313(b), without regard to the state of mind of the covered officer, that contains a materially false statement or representation relating to the information required to be certified under that section for the year for which the certification is submitted. It shall be unlawful for a covered officer of a covered manufacturer to submit a certification required under section 313(c)(1), without regard to the state of mind of the covered officer, that contains a materially false statement or representation relating to the misbranding of a controlled substance with respect to the year for which the certification is submitted. Except as provided in paragraph (2), a covered officer who violates subsection

(b)shall be subject to a civil penalty of not more than $25,000. A covered officer who knowingly violates subsection (b)(2) shall be subject to criminal penalties under section 403(d). There is established in the Treasury a fund to be known as the Comprehensive Addiction Resources Fund . There shall be transferred to the Comprehensive Addiction Resources Fund 100 percent of— any civil penalty paid to the United States under this section; and any fine paid to the United States under section 403(d) for a knowing violation of subsection (b)(2) of this section. Amounts transferred to the Comprehensive Addiction Fund under paragraph

(2)shall— remain available until expended; and be made available to supplement amounts appropriated to carry out title XXXIV of the Public Health Service Act. . Section 403 of the Controlled Substances Act ( 21 U.S.C. 843 ) is amended— in subsection (d)(1)— by inserting or knowingly violates section 424(b)(2) after any person who violates this section ; and by striking violation of this section and inserting such a violation ; and in subsection (f)— in paragraph (1), by striking or 416 and inserting or section 416, or knowing violations of section 424(b)(2) ; and in paragraph (3), by inserting or knowing violations of section 424(b)(2) before the period at the end. The table of contents for the Comprehensive Drug Abuse Prevention and Control Act of 1970 ( Public Law 91–513 ; 84 Stat. 1236) is amended— by inserting after the item relating to section 311 the following: Sec. 312. Suspicious orders. Sec. 313. Certifications relating to diversion controls and misbranding. ; and by inserting after the item relating to section 423 the following: Sec. 424. Certifications by covered officers. . The amendments made by subsections

(b)and

(c)of this section shall take effect on the date that is 180 days after the date of enactment of this Act.

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