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 following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period 

to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee 

concerned 

A BILL 

To modify reporting requirements under the Controlled 

Substances Act. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Preventing Pill Mills 

5 Through Data Sharing Act’’. 

6 SEC. 2. REPORTING REQUIREMENTS. 

7 (a) RECORDS AND REPORTS OF REGISTRANTS.—Sec8 tion 307 of the Controlled Substances Act (21 U.S.C. 827) 

9 is amended— 


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1 (1) in subsection (d), by striking ‘‘(d)(1)’’ and 

2 all that follows through the end of paragraph (1) 

3 and inserting the following: 

4 ‘‘(d)(1)(A) Except as provided in subparagraph (B), 

5 every person registered under section 303 shall, not less 

6 frequently than monthly, make reports to the Attorney 

7 General through the Automated Reports and Consolidated 

8 Orders System, or any subsequent automated system de9 veloped by the Drug Enforcement Administration to mon10 itor controlled substances, of every sale, delivery, or other 

11 disposal by the person of any controlled substance, identi12 fying by the registration number assigned under this title 

13 the person or establishment (unless exempt from registra14 tion under section 302(d)) to whom such sale, delivery, 

15 or other disposal was made. 

16 ‘‘(B) Subparagraph (A) shall not apply to— 

17 ‘‘(i) the retail sale or delivery of a controlled 

18 substance by a pharmacy registered under section 

19 303 to another pharmacy registered under that sec20 tion to fulfill a specific patient need, as defined in 

21 section 581 of the Federal Food, Drug, and Cos22 metic Act (21 U.S.C. 360eee); or 

23 ‘‘(ii) the retail dispensing of a controlled sub24 stance by a pharmacy registered under section 303. 


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1 ‘‘(C) A person registered under section 303 that does 

2 not sell, deliver, or otherwise dispose of a controlled sub3 stance during a month shall not be required to submit a 

4 report for that month under subparagraph (A).’’; and 

5 (2) in subsection (f)— 

6 (A) in paragraph (1)— 

7 (i) in the matter preceding subpara8 graph (A)— 

9 (I) by striking ‘‘manufacturer 

10 and distributor registrants’’ and in11 serting ‘‘persons registered under sec12 tion 303’’; and 

13 (II) by striking ‘‘selected’’; 

14 (ii) in subparagraph (A)— 

15 (I) by inserting ‘‘or pharmacy’’ 

16 after ‘‘distributor’’; and 

17 (II) by inserting before the pe18 riod at the end the following: ‘‘to 

19 whom controlled substances are dis20 tributed’’; and 

21 (iii) in subparagraph (B), by striking 

22 ‘‘opioids’’ and inserting ‘‘controlled sub23 stances’’; 

24 (B) in paragraph (2)— 


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1 (i) by striking ‘‘made available not 

2 later’’ and inserting the following: ‘‘made 

3 available— 

4 ‘‘(A) not later’’; 

5 (ii) by striking the period at the end 

6 and inserting a semicolon; and 

7 (iii) by adding at the end the fol8 lowing: 

9 ‘‘(B) in a format that allows the raw data to be 

10 queried and sorted for analytical purposes; and 

11 ‘‘(C) in a manner such that the information 

12 may be accessed simultaneously by more than 1 user 

13 at each registered location of a specific manufac14 turer, distributor, or pharmacy.’’; and 

15 (C) in paragraph (3)— 

16 (i) in subparagraph (A), by striking 

17 ‘‘registered manufacturers and distribu18 tors’’ and inserting ‘‘persons registered 

19 under section 303’’; and 

20 (ii) in subparagraph (B), by striking 

21 ‘‘registered manufacturer or distributor’’ 

22 and inserting ‘‘person registered under sec23 tion 303’’. 

24 (b) PENALTIES.— 


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1 (1) IN GENERAL.—Section 402 of the Con2 trolled Substances Act (21 U.S.C. 842) is amend3 ed— 

4 (A) in subsection (a), by striking para5 graph (17) and inserting the following: 

6 ‘‘(17) in the case of a person registered under 

7 section 303, to fail to review the most recent infor8 mation, directly related to the customers of the per9 son, made available by the Attorney General in ac10 cordance with section 307(f).’’; and 

11 (B) in subsection (c)(1)(B), by striking 

12 clause (ii) and inserting the following: 

13 ‘‘(ii) In the case of a violation described in clause (i) 

14 committed by a person registered under section 303 and 

15 related to the reporting of suspicious orders of controlled 

16 substances, failing to maintain effective controls against 

17 diversion of such substances, or failing to review the most 

18 recent information made available by the Attorney General 

19 in accordance with section 307(f), the penalty shall not 

20 exceed $100,000.’’. 

21 (2) TECHNICAL AND CONFORMING AMEND22 MENT.—Section 402(a)(16) of the Controlled Sub23 stances Act (21 U.S.C. 842(a)(16)) is amended by 

24 striking ‘‘section 825 of this title’’ and inserting 

25 ‘‘section 305’’. 


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1 (c) AUTOMATED REPORTS AND CONSOLIDATED OR2 DERS SYSTEM.—Section 503(c)(1) of the Controlled Sub3 stances Act (21 U.S.C. 873(c)(1)) is amended— 

4 (1) by inserting after ‘‘of States’’ the following: 

5 ‘‘, and to the Committee on the Judiciary of the 

6 Senate, the Committee on Health, Education, Labor, 

7 and Pensions of the Senate, the Caucus on Inter8 national Narcotics Control of the Senate, the Com9 mittee on the Judiciary of the House of Representa10 tives, and the Committee on Energy and Commerce 

11 of the House of Representatives,’’; 

12 (2) by inserting after ‘‘registrants,’’ the fol13 lowing: ‘‘including unusual volumes of controlled 

14 substances that are disposed of rather than sold, 

15 and unusual numbers of deleted transactions of high 

16 volumes of controlled substances,’’; and 

17 (3) by striking ‘‘contained in schedule II,’’. 

18 SEC. 3. REGULATIONS AND GUIDANCE. 

19 Not later than 90 days after the date of enactment 

20 of this Act, the Attorney General shall— 

21 (1) amend part 1304 of title 21, Code of Fed22 eral Regulations, to implement the amendments 

23 made by section 2, including the requirements 

24 that— 


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1 (A) persons registered under section 303 

2 of the Controlled Substances Act (21 U.S.C. 

3 823) make the reports under section 307(d)(1) 

4 of that Act (21 U.S.C. 827(d)(1)) on a monthly 

5 basis; and 

6 (B) the reports described in subparagraph 

7 (A) include all controlled substances; and 

8 (2) issue guidance to persons described in para9 graph (1)(A) to clarify the meaning of each of the 

10 data sets contained in the Automated Reports and 

11 Consolidated Orders System. 

Æ 


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