[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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