Ensuring Patient Access and Effective Drug Enforcement Act of 2016
Public Law 114-145 · S. 483 · 114th Congress · began in the Senate
Signed by Barack Obama (D) on Apr 19, 2016 · Crime and Law Enforcement
Sponsor: Sen. Orrin Hatch (R-UT)
Cosponsors (4): Sen. Sheldon Whitehouse, Sen. Marco Rubio,
Passage votes
- HouseUnanimous consent
- SenateUnanimous consent
Data notes
The final version of the law, as each chamber passed it. A chamber that passed it by voice vote or unanimous consent has no count. “Method not stated” means the record does not say how the chamber voted. Where the record has a member-by-member vote, the “Who voted for it” section shows who voted yea.
Summary
The Congressional Research Service’s plain-language summary of what the law does.
Ensuring Patient Access and Effective Drug Enforcement Act of 2016
(Sec. 2) This bill amends the Controlled Substances Act to define phrases related to the Drug Enforcement Administration's (DEA's) authority to register manufacturers, distributors, and dispensers of controlled substances.
Currently, the DEA registers a controlled substances manufacturer, distributor, or dispenser if it is in the public interest after considering certain factors, including factors relevant to and consistent with the public health and safety. This bill defines "factors as may be relevant to and consistent with the public health and safety" to mean factors relevant to and consistent with the specified purposes of the Controlled Substances Act.
Additionally, current law allows the DEA to immediately suspend a registration to prevent imminent danger to the public health and safety. This bill defines "imminent danger to the public health and safety" to mean an immediate threat of death, serious bodily harm, or abuse of a controlled substance due to a registrant's failure to maintain effective controls against diversion.
The bill revises and expands the required elements of an order to show cause issued by the DEA before it denies, revokes, or suspends a registration for a Controlled Substances Act violation. An order to show cause must specifically state the legal basis for the action and notify the registrant of the opportunity to submit a corrective action plan.
(Sec. 3) The Food and Drug Administration, the Substance Abuse and Mental Health Services Administration, the Agency for Research and Quality, and the Centers for Disease Control and Prevention, in coordination with the DEA, must report to Congress on:
• obstacles to legitimate patient access to controlled substances;
• diversion of controlled substances;
• how collaboration between law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances;
• the availability of and gaps in medical education, training opportunities, and comprehensive clinical guidance for pain management and opioid prescribing;
• enhancements to prescription drug monitoring programs; and
• improvements to prescription opioid reporting requirements.
Committees
The committees the bill was sent to, and what each did with it.
Data notes
A committee links to its page only where it exists in the current Congress; older and renamed committees are named without a link.
Related bills
1 bill the Library of Congress relates to this one.
H.R. 471Related bill
Ensuring Patient Access and Effective Drug Enforcement Act of 2015
Data notes
Related bills are identified by the Congressional Research Service, the House and the Senate: companion and identical bills, bills with similar text, bills that were folded into this law, and rules that brought it to the floor. A bill that is itself a public law in this site’s data links here; the others link to Congress.gov.
Timeline
From introduction to signing, newest first: the committees, the floor and the president. 16 actions.
- Apr 19, 2016Became lawBecame law · Became Public Law No: 114-145.
- Became lawBecame law · Signed by President.
- Apr 14, 2016FloorFloor · Presented to President.
- Apr 12, 2016FloorFloor · Motion to reconsider laid on the table Agreed to without objection.
- FloorFloor · On passage Passed without objection.
- FloorFloor · Considered by unanimous consent.
- FloorFloor · Mr. Lance asked unanimous consent to take from the Speaker's table and consider.
- Mar 21, 2016FloorFloor · Held at the desk.
- FloorFloor · Received in the House.
- Mar 18, 2016FloorFloor · Message on Senate action sent to the House.
- Mar 17, 2016FloorFloor · Passed Senate with an amendment by Unanimous Consent.
- Feb 11, 2016CalendarCalendar · Placed on Senate Legislative Calendar under General Orders. Calendar No. 368.
- CommitteeCommittee · Committee on the Judiciary. Reported by Senator Grassley with an amendment in the nature of a substitute. Without written report.
- CommitteeCommittee · Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
- Feb 12, 2015CommitteeCommittee · Read twice and referred to the Committee on the Judiciary.
- IntroducedIntroduced · Introduced in Senate
Data notes
Every action the Library of Congress lists for the bill, from introduction to signing, plus the dated committee hearings. The source lists many steps twice (the chamber’s own entry and the Library of Congress copy, or a presidential and a became-law entry with the same words); those are shown once. Amendments are listed in their own section.
Amendments
No amendments to this bill are on record.
Data notes
Amendments offered to this bill in either chamber, as the Library of Congress records them: each with a status read from its last recorded step: agreed to, rejected, withdrawn, ruled out of order, fell with another amendment, or offered with no vote recorded (most Senate amendments are only ever offered). The wording of each amendment is the source’s. Amendments to amendments and amendments to other bills are not listed.
Official record
The bill’s full text is on Congress.gov. Data through Oct 7, 2026.