HR 4084 — To repeal the amendments made to the Controlled Substances Act by the Ensuring Patient Access and Effective Drug Enforcement Act of 2016.

(a) Manufacturers of controlled substances in schedule I or II The Attorney General shall register an applicant to manufacture controlled substances in schedule I or II if he determines that such registration is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. In determining the public interest, the following factors shall be considered: (1) maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule I or II compounded therefrom into other than legitimate medical, scientific, research, or industrial channels, by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes; (2) compliance with applicable State and local law; (3) promotion of technical advances in the art of manufacturing these substances and the development of new substances; (4) prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dispensing of such substances; (5) past experience in the manufacture of controlled substances, and the existence in the establishment of effective control against diversion; and (6) such other factors as may be relevant to and consistent with the public health and safety. (b) Distributors of controlled substances in schedule I or II The Attorney General shall register an applicant to distribute a controlled substance in schedule I or II unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered: (1) maintenance of effective control against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels; (2) compliance with applicable State and local law; (3) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances; (4) past experience in the distribution of controlled substances; and (5) such other factors as may be relevant to and consistent with the public health and safety. (c) Manufacturers of marijuana for research purposes (1) (A) As it relates to applications to manufacture marijuana for research purposes, when the Attorney General places a notice in the Federal Register to increase the number of entities registered under this chapter to manufacture marijuana to supply appropriately registered researchers in the United States, the Attorney General shall, not later than 60 days after the date on which the Attorney General receives a completed application— (i) approve the application; or (ii) request supplemental information. (B) For purposes of subparagraph (A), an application shall be deemed complete when the applicant has submitted documentation showing each of the following: (i) The requirements designated in the notice in the Federal Register are satisfied. (ii) The requirements under this chapter are satisfied. (iii) The applicant will limit the transfer and sale of any marijuana manufactured under this subsection— (I) to researchers who are registered under this chapter to conduct research with controlled substances in schedule I; and (II) for purposes of use in preclinical research or in a clinical investigation pursuant to an investigational new drug exemption under 355(i) 1 of this title. (iv) The applicant will transfer or sell any marijuana manufactured under this subsection only with prior, written consent for the transfer or sale by the Attorney General. (v) The applicant has completed the application and review process under subsection (a) for the bulk manufacture of controlled substances in schedule I....

(a) Grounds A registration pursuant to section 823 of this title to manufacture, distribute, or dispense a controlled substance or a list I chemical may be suspended or revoked by the Attorney General upon a finding that the registrant— (1) has materially falsified any application filed pursuant to or required by this subchapter or subchapter II; (2) has been convicted of a felony under this subchapter or subchapter II or any other law of the United States, or of any State, relating to any substance defined in this subchapter as a controlled substance or a list I chemical; (3) has had his State license or registration suspended, revoked, or denied by competent State authority and is no longer authorized by State law to engage in the manufacturing, distribution, or dispensing of controlled substances or list I chemicals or has had the suspension, revocation, or denial of his registration recommended by competent State authority; (4) has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined under such section; or (5) has been excluded (or directed to be excluded) from participation in a program pursuant to section 1320a–7(a) of title 42. A registration pursuant to section 823(h) of this title to dispense a narcotic drug for maintenance treatment or detoxification treatment may be suspended or revoked by the Attorney General upon a finding that the registrant has failed to comply with any standard referred to in section 823(h) of this title. (b) Limits of revocation or suspension The Attorney General may limit revocation or suspension of a registration to the particular controlled substance or list I chemical with respect to which grounds for revocation or suspension exist. (c) Service of show cause order; proceedings (1) Before taking action pursuant to this section, or pursuant to a denial of registration under section 823 of this title, the Attorney General shall serve upon the applicant or registrant an order to show cause why registration should not be denied, revoked, or suspended. (2) An order to show cause under paragraph (1) shall— (A) contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated by the applicant or registrant; (B) direct the applicant or registrant to appear before the Attorney General at a time and place stated in the order, but not less than 30 days after the date of receipt of the order; and (C) notify the applicant or registrant of the opportunity to submit a corrective action plan on or before the date of appearance. (3) Upon review of any corrective action plan submitted by an applicant or registrant pursuant to paragraph (2), the Attorney General shall determine whether denial, revocation, or suspension proceedings should be discontinued, or deferred for the purposes of modification, amendment, or clarification to such plan. (4) Proceedings to deny, revoke, or suspend shall be conducted pursuant to this section in accordance with subchapter II of chapter 5 of title 5. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this subchapter or any other law of the United States. (5) The requirements of this subsection shall not apply to the issuance of an immediate suspension order under subsection (d). (d) Suspension of registration in cases of imminent danger (1) The Attorney General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this section, in cases where he finds that there is an imminent danger to the public health or safety. A failure to comply with a standard referred to in section 823(h) of this title may be treated under this subsection as grounds for immediate suspension of a registration granted under such section. A suspension under this subsection shall continue in effect until the conclusion of ...