[Congressional Record Volume 166, Number 195 (Tuesday, November 17, 2020)]
[House]
[Pages H5819-H5820]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




         ENSURING COMPLIANCE AGAINST DRUG DIVERSION ACT OF 2020

  Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the 
bill (H.R. 4812) 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, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H. R. 4812

       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 2020''.

     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 Oregon (Mr. Walden) 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. 4812.
  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.
  I rise today in support of H.R. 4812, the Ensuring Compliance Against 
Drug Diversion Act.
  As I have already mentioned, the Drug Enforcement Administration, or 
DEA, has an established registration system for controlled substances, 
including opioids. This system is meant to identify entities that 
manufacture, distribute, and dispense these substances, 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 2016 Government Accountability Office report found over 
700 registrants in DEA's system may have been ineligible to have 
controlled substance registrations. GAO found that the registrants were 
reportedly deceased, did not possess State level authority, or were 
incarcerated for offenses related to controlled substances.
  This bill terminates the controlled substance registration of any 
registrant if the registrant dies, ceases legal existence, discontinues 
business or professional practice, or surrenders

[[Page H5820]]

their registration. The bill also codifies DEA's authority to ensure 
accuracy of registrations and limits the transfer of such 
registrations.
  Again, I want to thank the lead sponsor of this bill, Representative 
Griffith for his leadership, and I also thank Ranking Member Walden and 
the members of our committee for their bipartisan support.
  Madam Speaker, I urge my colleagues to support H.R. 4812, and I 
reserve the balance of my time.
                                         House of Representatives,


                             Committee on Energy and Commerce,

                                Washington, DC, November 16, 2020.
     Hon. Jerrold Nadler,
     Chair, Committee on Judiciary,
     Washington, DC.
       Dear Chairman Nadler: Thank you for consulting with the 
     Committee on Energy and Commerce and agreeing to be 
     discharged from further consideration of H.R. 4812, the 
     Ensuring Compliance Against Drug Diversion Act of 2020, so 
     that the bill may proceed expeditiously to the House floor.
       I agree that your forgoing further action on this measure 
     does not in any way diminish or alter the jurisdiction of 
     your committee or prejudice its jurisdictional prerogatives 
     on this measure or similar legislation in the future. I would 
     support your effort to seek appointment of an appropriate 
     number of conferees from your committee to any House-Senate 
     conference on this legislation.
       I will seek to place our letters on H.R. 4812 into the 
     Congressional Record during floor consideration of the bill. 
     I appreciate your cooperation regarding this legislation and 
     look forward to continuing to work together as this measure 
     moves through the legislative process.
           Sincerely,
                                               Frank Pallone, Jr.,
     Chairman.
                                  ____

                                         House of Representatives,


                                   Committee on the Judiciary,

                                Washington, DC, November 16, 2020.
     Hon. Frank Pallone, Jr.,
     Chairman, Committee on Energy and Commerce, House of 
         Representatives, Washington, DC.
       Dear Chairman Pallone: This is to advise you that the 
     Committee on the Judiciary has now had an opportunity to 
     review the provisions in H.R. 4812, the ``Ensuring Compliance 
     Against Drug Diversion Act of 2019,'' that fall within our 
     Rule X jurisdiction. I appreciate your consulting with us on 
     those provisions. The Judiciary Committee has no objection to 
     your including them in the bill for consideration on the 
     House floor, and to expedite that consideration is willing to 
     forgo action on H.R. 4812, with the understanding that we do 
     not thereby waive any future jurisdictional claim over those 
     provisions or their subject matters.
       In the event a House-Senate conference on this or similar 
     legislation is convened, the Judiciary Committee reserves the 
     right to request an appropriate number of conferees to 
     address any concerns with these or similar provisions that 
     may arise in conference.
       Please place this letter into the Congressional Record 
     during consideration of the measure on the House floor. Thank 
     you for the cooperative spirit in which you have worked 
     regarding this matter and others between our committees.
           Sincerely,
                                                   Jerrold Nadler,
                                                         Chairman.

  Mr. WALDEN. Madam Speaker, I yield myself such time as I may consume.
  I rise today in support of H.R. 4812, the Ensuring Compliance Against 
Drug Diversion Act spearheaded by Energy and Commerce Committee 
colleague Representative Morgan Griffith. I thank Mr. Griffith for his 
leadership on this and many other pieces of legislation.
  This legislation addresses a policy issue that was identified again 
in our 2018 Energy and Commerce Committee report summarizing the 
committee's bipartisan investigation into the distribution of 
prescription opioids by wholesale drug distributors and subsequent 
enforcement practices by the DEA.
  The investigative report that we issued 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. This is disturbing, because failing to appropriately contact the 
DEA and verify whether the agency approved the transfer of a 
registration to dispense controlled substances creates a serious risk 
that could lead to drug diversion.
  In order to prevent people who have not been vetted by the 
authorities from dispensing controlled substances, H.R. 4812 makes 
clear that the transfer of any controlled substance registration 
without written consent from the DEA will be prohibited.
  Madam Speaker, I urge support of this legislation, and I reserve the 
balance of my time.
  Mr. PALLONE. Madam Speaker, I have no speakers at this time, and I 
reserve the balance of my time.
  Mr. WALDEN. Madam Speaker, I yield as much time as he may consume to 
the gentleman from Virginia (Mr. Griffith), who has been a real 
workhorse on this and many other pieces of legislation.
  Mr. GRIFFITH. Madam Speaker, I rise today in support of H.R. 4812, 
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. Those who wish to distribute opioids must earn the ability to 
do so.
  An investigation performed by the Energy and Commerce Oversight and 
Investigations Subcommittee found that the current process of 
transferring controlled substance dispensation licenses does not create 
sufficient accountability.
  In the one instance you heard about before, 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 afterward. As a result, there was a period of 
time during which the DEA was unaware that particular pharmacy was 
distributing controlled substances.
  Now, in this case, as best I understand it, there was not a rogue 
individual, it was just a matter of an oversight. But what we are 
trying to do with this bill today is to make sure that in the future we 
don't have some rogue individual that comes in and buys somebody else's 
business or their license or their registration and doesn't go back to 
the DEA to get proper registration.
  Failing to appropriately contact the DEA and verify whether the 
agency approved a transfer creates a serious risk of drug diversion, 
and this bill amends the Controlled Substances Act to prohibit that 
transfer of any DEA registration without written consent from the 
agency.
  By requiring written approval from the DEA before the transfer of 
registration occurs, we decrease the risk of drug diversion by keeping 
controlled substances out of the hands of people that have not been 
vetted by the appropriate regulatory authorities.
  Madam Speaker, that is the purpose of the bill. I appreciate 
everyone's support on it.
  Mr. WALDEN. Madam Speaker, I again thank the gentleman from Virginia 
for his leadership on this and so much other legislation.
  Madam Speaker, I urge passage of the legislation, and I yield back 
the balance of my time.
  Mr. PALLONE. Madam Speaker, I urge support of this legislation, 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. 4812, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

                          ____________________