S. 483 

One Hundred Fourteenth Congress 

of the 

United States of America 

AT THE SECOND SESSION 

Begun and held at the City of Washington on Monday, 

the fourth day of January, two thousand and sixteen 

An Act 

To improve enforcement efforts related to prescription drug diversion and abuse, 

and for other purposes. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘Ensuring Patient Access and 

Effective Drug Enforcement Act of 2016’’. 

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 
S. 483—2 

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).’’. 

SEC. 3. REPORT TO CONGRESS. 

(a) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, 

acting through the Commissioner of Food and Drugs, the Administrator of the Substance Abuse and Mental Health Services Administration, the Director of the Agency for Healthcare Research and 

Quality, and the Director of the Centers for Disease Control and 

Prevention, in coordination with the Administrator of the Drug 

Enforcement Administration and in consultation with the Secretary 

of Defense and the Secretary of Veterans Affairs, shall submit 

a report to the Committee on the Judiciary of the House of Representatives, the Committee on Energy and Commerce of the House 

of Representatives, the Committee on the Judiciary of the Senate, 

and the Committee on Health, Education, Labor, and Pensions 

of the Senate identifying— 

(1) obstacles to legitimate patient access to controlled substances; 

(2) issues with diversion of controlled substances; 

(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; 

(4) the availability of medical education, training opportunities, and comprehensive clinical guidance for pain management 

and opioid prescribing, and any gaps that should be addressed; 

(5) beneficial enhancements to State prescription drug monitoring programs, including enhancements to require comprehensive prescriber input and to expand access to the programs for appropriate authorized users; and 

(6) steps to improve reporting requirements so that the 

public and Congress have more information regarding prescription opioids, such as the volume and formulation of prescription 

opioids prescribed annually, the dispensing of such prescription 

opioids, and outliers and trends within large data sets. 
S. 483—3 

(b) CONSULTATION.—The report under subsection (a) shall incorporate feedback and recommendations from the following: 

(1) Patient groups. 

(2) Pharmacies. 

(3) Drug manufacturers. 

(4) Common or contract carriers and warehousemen. 

(5) Hospitals, physicians, and other health care providers. 

(6) State attorneys general. 

(7) Federal, State, local, and tribal law enforcement agencies. 

(8) Health insurance providers and entities that provide 

pharmacy benefit management services on behalf of a health 

insurance provider. 

(9) Wholesale drug distributors. 

(10) Veterinarians. 

(11) Professional medical societies and boards. 

(12) State and local public health authorities. 

(13) Health services research organizations. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.