S. 483: 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

114th Congress · introduced 2015-02-12 · Crime and Law Enforcement · Latest: Became Public Law No: 114-145.

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Official title

Ensuring Patient Access and Effective Drug Enforcement Act of 2016

Plain summary

(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. 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.

Congressional Research Service summary (Public Law), quoted unchanged (nonpartisan). Read the source.

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Alternatives

Needs sources: no published alternatives yet (for example a different bill, a law instead of an amendment, or keeping current law). We only show items backed by a published source. Suggest one.

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Officials and money

Sponsor: Sen. Hatch, Orrin G. [R-UT] · 4 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Sheldon Whitehouse (D-RI), Bill Cassidy (R-LA)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Sources

• Congressional Research Service summary (Public Law)
• Congress.gov
• Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-114s483.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/114/s>

Record fed-us-cong114-s483 · catalog fed-us-congress-bills-cong114 · updated 2026-11-15 by psicol fed-bills-cong114