[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. ____________________