Preventing Pill Mills Through Data Sharing Act

I 116TH CONGRESS 2D SESSION H. R. 8732 To modify reporting requirements under the Controlled Substances Act. IN THE HOUSE OF REPRESENTATIVES NOVEMBER 9, 2020 Ms. CASTOR of Florida (for herself and Mr. MCKINLEY) introduced the fol- lowing bill; which was referred to the Committee on Energy and Com- merce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consider- ation of such provisions as fall within the jurisdiction of the committee concerned A BILL To modify reporting requirements under the Controlled Substances Act. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Preventing Pill Mills 4 Through Data Sharing Act’’. 5 SEC. 2. REPORTING REQUIREMENTS. 6 (a) RECORDS AND REPORTS OF REGISTRANTS.—Sec- 7 tion 307 of the Controlled Substances Act (21 U.S.C. 827) 8 is amended— 9 VerDate Sep 11 2014 04:23 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H8732.IH H8732 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 8732 IH (1) in subsection (d), by striking ‘‘(d)(1)’’ and 1 all that follows through the end of paragraph (1) 2 and inserting the following: 3 ‘‘(d)(1)(A) Except as provided in subparagraph (B), 4 every person registered under section 303 shall, not less 5 frequently than monthly, make reports to the Attorney 6 General through the Automated Reports and Consolidated 7 Orders System, or any subsequent automated system de- 8 veloped by the Drug Enforcement Administration to mon- 9 itor controlled substances, of every sale, delivery, or other 10 disposal by the person of any controlled substance, identi- 11 fying by the registration number assigned under this title 12 the person or establishment (unless exempt from registra- 13 tion under section 302(d)) to whom such sale, delivery, 14 or other disposal was made. 15 ‘‘(B) Subparagraph (A) shall not apply to— 16 ‘‘(i) the retail sale or delivery of a controlled 17 substance by a pharmacy registered under section 18 303 to another pharmacy registered under that sec- 19 tion to fulfill a specific patient need, as defined in 20 section 581 of the Federal Food, Drug, and Cos- 21 metic Act (21 U.S.C. 360eee); or 22 ‘‘(ii) the retail dispensing of a controlled sub- 23 stance by a pharmacy registered under section 303. 24 VerDate Sep 11 2014 04:23 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8732.IH H8732 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 8732 IH ‘‘(C) A person registered under section 303 that does 1 not sell, deliver, or otherwise dispose of a controlled sub- 2 stance during a month shall not be required to submit a 3 report for that month under subparagraph (A).’’; and 4 (2) in subsection (f)— 5 (A) in paragraph (1)— 6 (i) in the matter preceding subpara- 7 graph (A)— 8 (I) by striking ‘‘manufacturer 9 and distributor registrants’’ and in- 10 serting ‘‘persons registered under sec- 11 tion 303’’; and 12 (II) by striking ‘‘selected’’; 13 (ii) in subparagraph (A)— 14 (I) by inserting ‘‘or pharmacy’’ 15 after ‘‘distributor’’; and 16 (II) by inserting before the pe- 17 riod at the end the following: ‘‘to 18 whom controlled substances are dis- 19 tributed’’; and 20 (iii) in subparagraph (B), by striking 21 ‘‘opioids’’ and inserting ‘‘controlled sub- 22 stances’’; 23 (B) in paragraph (2)— 24 VerDate Sep 11 2014 04:23 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H8732.IH H8732 pbinns on DSKJLVW7X2PROD with BILLS 4 •HR 8732 IH (i) by striking ‘‘made available not 1 later’’ and inserting the following: ‘‘made 2 available— 3 ‘‘(A) not later’’; 4 (ii) by striking the period at the end 5 and inserting a semicolon; and 6 (iii) by adding at the end the fol- 7 lowing: 8 ‘‘(B) in a format that allows the raw data to be 9 queried and sorted for analytical purposes; and 10 ‘‘(C) in a manner such that the information 11 may be accessed simultaneously by more than 1 user 12 at each registered location of a specific manufac- 13 turer, distributor, or pharmacy.’’; and 14 (C) in paragraph (3)— 15 (i) in subparagraph (A), by striking 16 ‘‘registered manufacturers and distribu- 17 tors’’ and inserting ‘‘persons registered 18 under section 303’’; and 19 (ii) in subparagraph (B), by striking 20 ‘‘registered manufacturer or distributor’’ 21 and inserting ‘‘person registered under sec- 22 tion 303’’. 23 (b) PENALTIES.— 24 VerDate Sep 11 2014 04:23 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H8732.IH H8732 pbinns on DSKJLVW7X2PROD with BILLS 5 •HR 8732 IH (1) IN GENERAL.—Section 402 of the Con- 1 trolled Substances Act (21 U.S.C. 842) is amend- 2 ed— 3 (A) in subsection (a), by striking para- 4 graph (17) and inserting the following: 5 ‘‘(17) in the case of a person registered under 6 section 303, to fail to review the most recent infor- 7 mation, directly related to the customers of the per- 8 son, made available by the Attorney General in ac- 9 cordance with section 307(f).’’; and 10 (B) in subsection (c)(1)(B), by striking 11 clause (ii) and inserting the following: 12 ‘‘(ii) In the case of a violation described in clause (i) 13 committed by a person registered under section 303 and 14 related to the reporting of suspicious orders of controlled 15 substances, failing to maintain effective controls against 16 diversion of such substances, or failing to review the most 17 recent information made available by the Attorney General 18 in accordance with section 307(f), the penalty shall not 19 exceed $100,000.’’. 20 (2) TECHNICAL AND CONFORMING AMEND- 21 MENT.—Section 402(a)(16) of the Controlled Sub- 22 stances Act (21 U.S.C. 842(a)(16)) is amended by 23 striking ‘‘section 825 of this title’’ and inserting 24 ‘‘section 305’’. 25 VerDate Sep 11 2014 04:23 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H8732.IH H8732 pbinns on DSKJLVW7X2PROD with BILLS 6 •HR 8732 IH (c) AUTOMATED REPORTS AND CONSOLIDATED OR- 1 DERS SYSTEM.—Section 503(c)(1) of the Controlled Sub- 2 stances Act (21 U.S.C. 873(c)(1)) is amended— 3 (1) by inserting after ‘‘of States’’ the following: 4 ‘‘, and to the Committee on the Judiciary of the 5 Senate, the Committee on Health, Education, Labor, 6 and Pensions of the Senate, the Caucus on Inter- 7 national Narcotics Control of the Senate, the Com- 8 mittee on the Judiciary of the House of Representa- 9 tives, and the Committee on Energy and Commerce 10 of the House of Representatives,’’; 11 (2) by inserting after ‘‘registrants,’’ the fol- 12 lowing: ‘‘including unusual volumes of controlled 13 substances that are disposed of rather than sold, 14 and unusual numbers of deleted transactions of high 15 volumes of controlled substances,’’; and 16 (3) by striking ‘‘contained in schedule II,’’. 17 SEC. 3. REGULATIONS AND GUIDANCE. 18 Not later than 90 days after the date of enactment 19 of this Act, the Attorney General shall— 20 (1) amend part 1304 of title 21, Code of Fed- 21 eral Regulations, to implement the amendments 22 made by section 2, including the requirements 23 that— 24 VerDate Sep 11 2014 04:23 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H8732.IH H8732 pbinns on DSKJLVW7X2PROD with BILLS 7 •HR 8732 IH (A) persons registered under section 303 1 of the Controlled Substances Act (21 U.S.C. 2 823) make the reports under section 307(d)(1) 3 of that Act (21 U.S.C. 827(d)(1)) on a monthly 4 basis; and 5 (B) the reports described in subparagraph 6 (A) include all controlled substances; and 7 (2) issue guidance to persons described in para- 8 graph (1)(A) to clarify the meaning of each of the 9 data sets contained in the Automated Reports and 10 Consolidated Orders System. 11 Æ VerDate Sep 11 2014 04:23 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H8732.IH H8732 pbinns on DSKJLVW7X2PROD with BILLS