Title: Preventing Pill Mills Through Data Sharing Act
Policy area: Crime and Law Enforcement

Summary:
Preventing Pill Mills Through Data Sharing Act
This bill expands reporting requirements concerning the sale, delivery, or disposal of controlled substances that apply to drug manufacturers and distributors, including by extending the requirements to pharmacies and increasing the frequency of the reporting.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8732 Introduced in House (IH)]

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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.

    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 ``Preventing Pill Mills Through Data 
Sharing Act''.

SEC. 2. REPORTING REQUIREMENTS.

    (a) Records and Reports of Registrants.--Section 307 of the 
Controlled Substances Act (21 U.S.C. 827) is amended--
            (1) in subsection (d), by striking ``(d)(1)'' and all that 
        follows through the end of paragraph (1) and inserting the 
        following:
    ``(d)(1)(A) Except as provided in subparagraph (B), every person 
registered under section 303 shall, not less frequently than monthly, 
make reports to the Attorney General through the Automated Reports and 
Consolidated Orders System, or any subsequent automated system 
developed by the Drug Enforcement Administration to monitor controlled 
substances, of every sale, delivery, or other disposal by the person of 
any controlled substance, identifying by the registration number 
assigned under this title the person or establishment (unless exempt 
from registration under section 302(d)) to whom such sale, delivery, or 
other disposal was made.
    ``(B) Subparagraph (A) shall not apply to--
            ``(i) the retail sale or delivery of a controlled substance 
        by a pharmacy registered under section 303 to another pharmacy 
        registered under that section to fulfill a specific patient 
        need, as defined in section 581 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360eee); or
            ``(ii) the retail dispensing of a controlled substance by a 
        pharmacy registered under section 303.
    ``(C) A person registered under section 303 that does not sell, 
deliver, or otherwise dispose of a controlled substance during a month 
shall not be required to submit a report for that month under 
subparagraph (A).''; and
            (2) in subsection (f)--
                    (A) in paragraph (1)--
                            (i) in the matter preceding subparagraph 
                        (A)--
                                    (I) by striking ``manufacturer and 
                                distributor registrants'' and inserting 
                                ``persons registered under section 
                                303''; and
                                    (II) by striking ``selected'';
                            (ii) in subparagraph (A)--
                                    (I) by inserting ``or pharmacy'' 
                                after ``distributor''; and
                                    (II) by inserting before the period 
                                at the end the following: ``to whom 
                                controlled substances are 
                                distributed''; and
                            (iii) in subparagraph (B), by striking 
                        ``opioids'' and inserting ``controlled 
                        substances'';
                    (B) in paragraph (2)--
                            (i) by striking ``made available not 
                        later'' and inserting the following: ``made 
                        available--
            ``(A) not later'';
                            (ii) by striking the period at the end and 
                        inserting a semicolon; and
                            (iii) by adding at the end the following:
            ``(B) in a format that allows the raw data to be queried 
        and sorted for analytical purposes; and
            ``(C) in a manner such that the information may be accessed 
        simultaneously by more than 1 user at each registered location 
        of a specific manufacturer, distributor, or pharmacy.''; and
                    (C) in paragraph (3)--
                            (i) in subparagraph (A), by striking 
                        ``registered manufacturers and distributors'' 
                        and inserting ``persons registered under 
                        section 303''; and
                            (ii) in subparagraph (B), by striking 
                        ``registered manufacturer or distributor'' and 
                        inserting ``person registered under section 
                        303''.
    (b) Penalties.--
            (1) In general.--Section 402 of the Controlled Substances 
        Act (21 U.S.C. 842) is amended--
                    (A) in subsection (a), by striking paragraph (17) 
                and inserting the following:
            ``(17) in the case of a person registered under section 
        303, to fail to review the most recent information, directly 
        related to the customers of the person, made available by the 
        Attorney General in accordance with section 307(f).''; and
                    (B) in subsection (c)(1)(B), by striking clause 
                (ii) and inserting the following:
    ``(ii) In the case of a violation described in clause (i) committed 
by a person registered under section 303 and related to the reporting 
of suspicious orders of controlled substances, failing to maintain 
effective controls against diversion of such substances, or failing to 
review the most recent information made available by the Attorney 
General in accordance with section 307(f), the penalty shall not exceed 
$100,000.''.
            (2) Technical and conforming amendment.--Section 402(a)(16) 
        of the Controlled Substances Act (21 U.S.C. 842(a)(16)) is 
        amended by striking ``section 825 of this title'' and inserting 
        ``section 305''.
    (c) Automated Reports and Consolidated Orders System.--Section 
503(c)(1) of the Controlled Substances Act (21 U.S.C. 873(c)(1)) is 
amended--
            (1) by inserting after ``of States'' the following: ``, and 
        to the Committee on the Judiciary of the Senate, the Committee 
        on Health, Education, Labor, and Pensions of the Senate, the 
        Caucus on International Narcotics Control of the Senate, the 
        Committee on the Judiciary of the House of Representatives, and 
        the Committee on Energy and Commerce of the House of 
        Representatives,'';
            (2) by inserting after ``registrants,'' the following: 
        ``including unusual volumes of controlled substances that are 
        disposed of rather than sold, and unusual numbers of deleted 
        transactions of high volumes of controlled substances,''; and
            (3) by striking ``contained in schedule II,''.

SEC. 3. REGULATIONS AND GUIDANCE.

    Not later than 90 days after the date of enactment of this Act, the 
Attorney General shall--
            (1) amend part 1304 of title 21, Code of Federal 
        Regulations, to implement the amendments made by section 2, 
        including the requirements that--
                    (A) persons registered under section 303 of the 
                Controlled Substances Act (21 U.S.C. 823) make the 
                reports under section 307(d)(1) of that Act (21 U.S.C. 
                827(d)(1)) on a monthly basis; and
                    (B) the reports described in subparagraph (A) 
                include all controlled substances; and
            (2) issue guidance to persons described in paragraph (1)(A) 
        to clarify the meaning of each of the data sets contained in 
        the Automated Reports and Consolidated Orders System.
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