[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.
____________________