[Congressional Record Volume 167, Number 64 (Wednesday, April 14, 2021)]
[House]
[Pages H1764-H1765]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




         ENSURING COMPLIANCE AGAINST DRUG DIVERSION ACT OF 2021

  Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the 
bill (H.R. 1899) 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.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 1899

       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 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 by 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) 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;
       ``(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.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New 
Jersey (Mr. Pallone) and the gentleman from Florida (Mr. Bilirakis) 
each will control 20 minutes.
  The Chair recognizes the gentleman from New Jersey.


                             General Leave

  Mr. PALLONE. Madam Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to revise and extend their remarks 
and include extraneous material on H.R. 1899.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Madam Speaker, I yield myself such time as I may 
consume.
  Madam Speaker, I rise today in support of H.R. 1899, the Ensuring 
Compliance Against Drug Diversion Act.
  The Drug Enforcement Administration is charged with regulating 
controlled substances and manages access to these substances through a 
registration system. This system is meant to identify entities that 
manufacture, distribute, and dispense controlled substances, such as 
opioids; as well as to prevent diversion of these substances. We rely 
on the DEA to maintain the integrity of this system as one way to stop 
illicit diversion before it starts.
  However, a 2018 Government Accountability Office report found over 
700 registrants in the DEA's system may have been ineligible for 
registration under the Controlled Substances Act. In fact, the GAO 
found that some of these registrants were reportedly deceased, did not 
possess State-level authority, or were incarcerated for offenses 
related to controlled substances.
  If we are to curb rising substance abuse in the U.S., we must ensure, 
Madam Speaker, that bad actors are prevented from having access to 
these substances. The legislation we are considering today would 
terminate the

[[Page H1765]]

controlled substance registration of any registrant if the registrant 
dies, ceases legal existence, discontinues business or professional 
practice, or surrenders their registration. This bill also codifies DEA 
authority to ensure accuracy of registrations and limit the transfer of 
such registrations.
  I thank the lead sponsor of this bill, Representative Griffith, for 
his leadership on this issue.
  Madam Speaker, I urge my colleagues to support this bill, and I 
reserve the balance of my time.
  Mr. BILIRAKIS. Madam Speaker, I yield myself such time as I may 
consume.
  Madam Speaker, I rise today in support of this legislation, which was 
introduced by Representative Griffith.
  In order to prevent people who have not been vetted by authorities in 
dispensing controlled substances, this bill would clarify that the 
transfer of any controlled substance registration without written 
consent from the Drug Enforcement Administration, DEA, is prohibited.
  A 2018 Energy and Commerce Committee report, which summarized the 
committee's bipartisan investigation into the distribution of 
prescription opioids by wholesale drug distributors, and the DEA's 
subsequent enforcement practices found that an opioid distributor and 
its pharmacy customer did not go through the appropriate process of 
transferring a registration to a new pharmacy owner.
  Failing to contact the DEA appropriately and to verify whether the 
agency approved the transfer of a registration to dispense controlled 
substances creates a serious risk that could lead to drug diversion.
  Madam Speaker, of course, I urge a ``yes'' vote on this.
  Madam Speaker, I yield such time as he may consume to the gentleman 
from Virginia (Mr. Griffith).

                              {time}  1415

  Mr. GRIFFITH. Madam Speaker, I rise today in support of H.R. 1899, 
the Ensuring Compliance Against Drug Diversion Act. This is a small but 
very important step that could play a key role in helping contain the 
opioid epidemic.
  License to distribute opioids is not a commodity to be freely bought 
and sold. We must ensure that those who wish to engage in opioid 
distribution earn the ability to do so.
  An investigation, as the Speaker has heard, published by the Energy 
and Commerce Oversight and Investigations Subcommittee in 2018 found 
that the current procedures for transferring the licenses to distribute 
controlled substances lacked sufficient accountability.
  In one instance, a distributor and its pharmacy customer did not go 
through the appropriate process of transferring registration to a new 
pharmacy owner, but the mistake wasn't caught until long, long 
afterward. As a result, there was a period of time during which the DEA 
was unaware that a particular pharmacy was distributing controlled 
substances.
  Failing to properly verify whether a transfer has been approved 
creates a serious risk of drug diversion. This bill amends the 
Controlled Substances Act to prohibit the transfer of any DEA 
registration without consent from the agency.
  By requiring written approval from the DEA before the transfer of 
registration, we decrease the risk of controlled substances falling 
into the hands of those who have not been vetted by appropriate 
regulatory authorities.
  Mr. BILIRAKIS. Madam Speaker, I urge passage of this very good bill. 
I yield back the balance of my time.
  Mr. PALLONE. Madam Speaker, I also urge support for the bill, and I 
yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from New Jersey (Mr. Pallone) that the House suspend the 
rules and pass the bill, H.R. 1899.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Mr. WEBER of Texas. Madam Speaker, on that I demand the yeas and 
nays.
  The SPEAKER pro tempore. Pursuant to section 3(s) of House Resolution 
8, the yeas and nays are ordered.
  Pursuant to clause 8 of rule XX, further proceedings on this motion 
are postponed.

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