Ensuring Patient Access and Effective Drug Enforcement Act of 2016
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S 483 — Ensuring Patient Access and Effective Drug Enforcement Act of 2016
Last action — Became Public Law No: 114-145. (TXT | PDF)
No card. One bill, free forever — alerts when it moves.
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✓Introduced
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✓In Committee
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✓Passed Senate
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✓Passed House
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✓To Executive
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6Enacted
This bill has been enacted into law. Introduced February 12, 2015. Enacted.
Summary
Ensuring Patient Access and Effective Drug Enforcement Act of 2016 Amends the Controlled Substances Act to define: (1) "factors as may be relevant to and consistent with the public health and safety," for purposes of the Attorney General's determination of whether registering an applicant to manufacture or distribute a controlled substance in schedule I or II is in the public interest, as factors that are relevant to and consistent with the findings of such Act; and (2) "imminent danger to the public health or safety," for purposes of the suspension of such a registration, to mean that in the absence of an immediate suspension order, controlled substances will continue to be distributed or dispensed by a registrant who knows or should know, through fulfilling the obligations of the registrant under such Act, that the dispensing is outside the usual course of professional practice, that the distribution or dispensing poses a present or foreseeable risk of adverse health consequences or death due to the abuse or misuse of the controlled substances, or that the controlled substances will continue to be diverted outside of legitimate distribution channels. Requires an order to show cause as to why such a registration should not be denied, revoked, or suspended to: (1) contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated; (2) direct the applicant or registrant to appear before the Attorney General at a specific place and time within 30 days after receipt of the order; and (3) notify the applicant or registrant of the opportunity to submit a corrective action plan on or before such appearance. Requires the Attorney General, upon review of any such plan, to determine whether denial, revocation, or suspension proceedings should be discontinued or deferred for purposes of modifications to such plan. Makes such requirements inapplicable to the issuance of an immediate suspension order. Directs the Department of Health and Human Services, acting through the Food and Drug Administration and the Centers for Disease Control and Prevention, to submit a report identifying: (1) obstacles to legitimate patient access to controlled substances; (2) issues with diversion of controlled substances; and (3) how collaboration between federal, state, local, and tribal law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances.
Bill Text
We don't have the full text on file for this bill yet.
Read S 483 on the official United States source →Action History
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Became Public Law No: 114-145. (TXT | PDF)
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Signed by President.
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Presented to President.
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Motion to reconsider laid on the table Agreed to without objection.
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On passage Passed without objection. (text: CR H1618-1619)
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Considered by unanimous consent. (consideration: CR H1618-1619)
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Mr. Lance asked unanimous consent to take from the Speaker's table and consider.
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Held at the desk.
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Received in the House.
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Message on Senate action sent to the House.
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Passed Senate with an amendment by Unanimous Consent. (consideration: CR S1605-1606; text as passed Senate: CR S1605-1606)
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Placed on Senate Legislative Calendar under General Orders. Calendar No. 368.
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Committee on the Judiciary. Reported by Senator Grassley with an amendment in the nature of a substitute. Without written report.
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Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
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Read twice and referred to the Committee on the Judiciary.
Sponsors
- Orrin Hatch · Primary
Sponsorship breakdown
Export CSV (upgrade) →1 sponsors · 0 co-sponsors · 546 not signed on
Sponsors (1)
Co-sponsors (0)
None.
Not signed on (546)
546 members have not signed on to this bill.
Show all 546 →"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.
Subjects
Frequently asked questions
- What does S 483 do?
- Ensuring Patient Access and Effective Drug Enforcement Act of 2016 Amends the Controlled Substances Act to define: (1) "factors as may be relevant to and consistent with the public health and safety," for purposes of the Attorney General's determination of whether registering an applicant to manufacture or distribute a controlled substance in schedule I or II is in the public interest, as factors that are relevant to and consistent with the findings of such Act; and (2) "imminent danger to the public health or safety," for purposes of the suspension of such a registration, to mean that in the absence of an immediate suspension order, controlled substances will continue to be distributed or dispensed by a registrant who knows or should know, through fulfilling the obligations of the registrant under such Act, that the dispensing is outside the usual course of professional practice, that the distribution or dispensing poses a present or foreseeable risk of adverse health consequences or death due to the abuse or misuse of the controlled substances, or that the controlled substances will continue to be diverted outside of legitimate distribution channels. Requires an order to show cause as to why such a registration should not be denied, revoked, or suspended to: (1) contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated; (2) direct the applicant or registrant to appear before the Attorney General at a specific place and time within 30 days after receipt of the order; and (3) notify the applicant or registrant of the opportunity to submit a corrective action plan on or before such appearance. Requires the Attorney General, upon review of any such plan, to determine whether denial, revocation, or suspension proceedings should be discontinued or deferred for purposes of modifications to such plan. Makes such requirements inapplicable to the issuance of an immediate suspension order. Directs the Department of Health and Human Services, acting through the Food and Drug Administration and the Centers for Disease Control and Prevention, to submit a report identifying: (1) obstacles to legitimate patient access to controlled substances; (2) issues with diversion of controlled substances; and (3) how collaboration between federal, state, local, and tribal law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances.
- Who sponsors S 483?
- S 483 is sponsored by Orrin Hatch (R).
- What is the current status of S 483?
- This bill has been enacted into law. Introduced February 12, 2015. Enacted.
- Where can I track S 483?
- Track S 483 free on One Click Politics — get push/email alerts when it moves.
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