Public Law 117-53 | Public Law 117–53: To amend the Controlled Substances Act to provide for the modification, transfer, and termination of a registration to manufacture, distribute, or dispense controlled substances or list I chemicals, and for other purposes.

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PUBLIC LAW 117–53—NOV. 10, 2021

135 STAT. 411

Public Law

117–53

117th Congress

An Act

To amend the Controlled Substances Act to provide for the modification, transfer, and termination of a registration to manufacture, distribute, or dispense controlled substances or list I chemicals, and for other purposes.

Nov. 10, 2021

[H.R. 1899]

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

Ensuring Compliance Against Drug Diversion Act

of 2021.

21 USC 801 note.

SECTION 1.

SHORT TITLE.

This Act may be cited as the “

Ensuring Compliance Against Drug Diversion Act of 2021

”.

SEC. 2.

MODIFICATION, TRANSFER, AND TERMINATION OF REGISTRATION TO MANUFACTURE, DISTRIBUTE, OR DISPENSE CONTROLLED SUBSTANCES.

Subsection (a) of section 302 of the Controlled Substances Act (21 U.S.C. 822)

is amended

adding

at the end the following new paragraph:

“(3)

(A)

Except as provided in subparagraph (C), the registration of any registrant under this title to manufacture, distribute, or dispense controlled substances or list I chemicals terminates if and when such registrant—

“(i)

dies;

“(ii)

ceases legal existence;

“(iii)

discontinues business or professional practice; or

“(iv)

surrenders such registration.

“(B)

Notification.

In the case of such a registrant who ceases legal existence or discontinues business or professional practice, such registrant shall promptly notify the Attorney General in writing of such fact.

“(C)

No registration under this title to manufacture, distribute, or dispense controlled substances or list I chemicals, and no authority conferred thereby, may be assigned or otherwise transferred except upon such conditions as the Attorney General may specify and then only pursuant to written consent. A registrant to whom a registration is assigned or transferred pursuant to the preceding sentence may not manufacture, distribute, or dispense controlled substances or list I chemicals pursuant to such registration until the Attorney General receives such written consent.

“(D)

In the case of a registrant under this title to manufacture, distribute, or dispense controlled substances or list I chemicals desiring to discontinue business or professional practice altogether or with respect to controlled substances and list I chemicals (without assigning or transferring such business or professional practice to another entity), such registrant shall return to the Attorney General for cancellation—

“(i)

the registrant’s certificate of registration;135 STAT. 412

“(ii)

any unexecuted order forms in the registrant’s possession; and

“(iii)

any other documentation that the Attorney General may require.”

SEC. 3.

DETERMINATION OF BUDGETARY EFFECTS.

The budgetary effects of this Act, for the purpose of complying with the Statutory Pay-As-You-Go Act of 2010, shall be determined by reference to the latest statement titled “Budgetary Effects of PAYGO Legislation” for this Act, submitted for printing in the Congressional Record by the Chairman of the House Budget Committee, provided that such statement has been submitted prior to the vote on passage.

Approved November 10, 2021.

LEGISLATIVE HISTORY—H.R. 1899:

CONGRESSIONAL RECORD, Vol. 167 (2021):

Apr. 14, 15, considered and passed House.

Oct. 26, considered and passed Senate.

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