PlainBillCongress, translated.Legislation. Context. Public interest.Became Public Law No: 114-145.
Congressional Research Service
Version 49 · Public Law · Apr 19, 2016
(This measure has not been amended since it was reported to the Senate on February 11, 2016. The summary of that version is repeated here.)
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.
Showing the opening paragraphs of the official summary.
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.
People & committees
Sen. Hatch, Orrin G. [R-UT] · R–UT
Legislative record
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Became Public Law No: 114-145.
Became Public Law No: 114-145.
Signed by President.
Signed by President.
Presented to President.
Presented to President.
Motion to reconsider laid on the table Agreed to without objection.
On passage Passed without objection. (text: CR H1618-1619)
Passed/agreed to in House: On passage Passed without objection.(text: CR H1618-1619)
Considered by unanimous consent. (consideration: CR H1618-1619)
Mr. Lance asked unanimous consent to take from the Speaker's table and consider.
Held at the desk.
Received in the House.
Message on Senate action sent to the House.
Passed Senate with an amendment by Unanimous Consent. (consideration: CR S1605-1606; text as passed Senate: CR S1605-1606)
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(consideration: CR S1605-1606; text as passed Senate: CR S1605-1606)
Placed on Senate Legislative Calendar under General Orders. Calendar No. 368.
Committee on the Judiciary. Reported by Senator Grassley with an amendment in the nature of a substitute. Without written report.
Committee on the Judiciary. Reported by Senator Grassley with an amendment in the nature of a substitute. Without written report.
Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
Read twice and referred to the Committee on the Judiciary.
Introduced in Senate
Primary sources
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Source last updated: Aug 10, 2026. Consult Congress.gov for the current record.
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