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Code · STATUTE-COMPILATIONS · Ensuring Patient Access and Effective Drug Enforcement Act of 2016 · Sec. 2

Sec. 2. REGISTRATION PROCESS UNDER CONTROLLED SUBSTANCES ACT

535 words·~2 min read·/statute-compilations/comps-12007/sec-2

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## SEC. 2 REGISTRATION PROCESS UNDER CONTROLLED SUBSTANCES ACT ###
(a)Definitions ####
(1)Factors as may be relevant to and consistent with the public health and safety Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended by adding at the end the following: > > ### “(j) > > In this section, the phrase ‘factors as may be relevant to and consistent with the public health and safety’ means factors that are relevant to and consistent with the findings contained in section 101.” > . ####
(2)Imminent danger to the public health or safety Section 304(d) of the Controlled Substances Act (21 U.S.C. 824(d)) is amended— #####
(A)by striking “(d) The Attorney General” and inserting “(d)(1) The Attorney General”; and #####
(B)by adding at the end the following: > > #### “(2) > > In this subsection, the phrase ‘imminent danger to the public health or safety’ means that, due to the failure of the registrant to maintain effective controls against diversion or otherwise comply with the obligations of a registrant under this title or title III, there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration.” > . ###
(b)Opportunity To Submit Corrective Action Plan Prior to Revocation or Suspension Subsection
(c)of section 304 of the Controlled Substances Act (21 U.S.C. 824) is amended— ####
(1)by striking the last three sentences; ####
(2)by striking “(c) Before” and inserting “(c)(1) Before”; and ####
(3)by adding at the end the following: > > #### “(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, United States Code. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this title 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).” > .
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Sec. 2
REGISTRATION PROCESS UNDER CONTROLLED SUBSTANCES ACT
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