[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5853 Introduced in House (IH)]

112th CONGRESS
  2d Session
                                H. R. 5853

    To prohibit wholesalers from purchasing prescription drugs from 
pharmacies, and to enhance information and transparency regarding drug 
              wholesalers engaged in interstate commerce.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 22, 2012

 Mr. Cummings introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
    To prohibit wholesalers from purchasing prescription drugs from 
pharmacies, and to enhance information and transparency regarding drug 
              wholesalers engaged in interstate commerce.

    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 ``Gray Market Drug Reform and 
Transparency Act of 2012''.

SEC. 2. PROHIBITION AGAINST WHOLESALE DISTRIBUTORS PURCHASING 
              PRESCRIPTION DRUGS FROM PHARMACIES.

    (a) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(aaa) The purchase or receipt by any person required to report 
under section 510(b)(3) (relating to wholesale distributors of 
prescription drugs) of any drug subject to section 503(b)(1) from a 
pharmacy or pharmacist, except that this paragraph does not apply to 
the return of a drug to the wholesale distributor from which the 
particular drug was purchased.''.
    (b) Misbranding.--Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(aa) If it is purchased or received in violation of section 
301(aaa) (prohibiting the purchase or receipt of prescription drugs by 
wholesale distributors from pharmacists).''.

SEC. 3. REPORTING BY WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS.

    (a) Reporting Requirement.--
            (1) In general.--Section 510 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360) is amended--
                    (A) in subsection (b), by adding at the end the 
                following:
    ``(3) On or before December 31 of each year, every person engaged 
in the wholesale distribution in interstate commerce of drugs subject 
to section 503(b)(1) shall report to the Secretary such person's name, 
contact information for such person's principal officer (or the 
designee thereof), such person's places of business, such person's 
licensing information (including the type of license and expiration 
date) for each State in which such person is so engaged, and such other 
information as the Secretary deems appropriate.'';
                    (B) in subsection (c), by adding at the end: 
                ``Every person upon first engaging in the wholesale 
                distribution in interstate commerce of drugs subject to 
                section 503(b)(1) shall immediately report to the 
                Secretary the information described in subsection 
                (b)(3).''; and
                    (C) in subsection (d), by adding at the end the 
                following: ``Every person duly reporting in accordance 
                with the foregoing subsections shall immediately report 
                to the Secretary with respect to any additional 
                establishment which the person owns or operates in any 
                State and in which the person begins the wholesale 
                distribution in interstate commerce of drugs subject to 
                section 503(b)(1).''.
            (2) Reporting number.--Subsection (e) of section 510 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is 
        amended--
                    (A) by striking ``registration number'' and 
                inserting ``registration or reporting number''; and
                    (B) by inserting ``or reporting in accordance with 
                subsections (b)(3), (c), or (d)'' after ``registered in 
                accordance with this section''.
            (3) Public availability; database.--Subsection (f) of 
        section 510 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 360) is amended--
                    (A) by striking ``(f)'' and inserting ``(f)(1)''; 
                and
                    (B) by adding at the end the following:
    ``(2)(A) The Secretary, acting directly or by entering into a 
contract with a private entity, shall establish and maintain a database 
including all information reported under subsection (b)(3), the second 
sentence of subsection (c), and the second sentence of subsection (d).
    ``(B) Subject to subparagraph (C), the Secretary shall make the 
information in such database publicly available, including on the 
public Website of the Food and Drug Administration.
    ``(C) The Secretary may choose to restrict the Secretary's 
disclosure of any information reported under subsection (b)(3), (c), or 
(d)--
            ``(i) that relates to a storage facility; and
            ``(ii) whose disclosure would, as determined by the 
        Secretary, compromise the security of such facility.''.
            (4) Conforming amendments.--
                    (A) Section 301(p) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 331(p)) is amended by inserting 
                ``the failure to report in accordance with subsection 
                (b)(3), (c), or (d) of section 510,'' after ``The 
                failure to register in accordance with section 510 or 
                905,''.
                    (B) Section 502(o) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 352(o)) is amended by inserting 
                ``if it was distributed in interstate commerce by a 
                person in violation of the reporting requirements of 
                subsection (b)(3), (c), or (d) of section 510,'' before 
                ``if it was not included''.
                    (C) Section 510 of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 360) is amended--
                            (i) in subsection (g)--
                                    (I) in paragraph (3), by adding 
                                ``or'' at the end;
                                    (II) by striking paragraph (4);
                                    (III) by redesignating paragraph 
                                (5) as paragraph (4);
                                    (IV) in paragraph (4) (as so 
                                redesignated), by inserting ``or 
                                reporting, as applicable,''; and
                                    (V) by striking the matter 
                                following paragraph (4) (as so 
                                redesignated);
                            (ii) in subsection (h), by adding at the 
                        end the following: ``Every establishment in any 
                        State used by a person required to report under 
                        subsection (b)(3), (c), or (d) for the 
                        wholesale distribution in interstate commerce 
                        of drugs subject to section 503(b)(1) shall be 
                        subject to inspection pursuant to section 
                        704.''; and
                            (iii) in subsection (j), by adding at the 
                        end the following:
    ``(4) The provisions of this subsection shall apply with respect to 
a person required to report under subsection (b)(3), (c), or (d) for 
the wholesale distribution in interstate commerce of drugs subject to 
section 503(b)(1) to the same extent and in the same manner as such 
provisions apply to persons required to register under subsection (b), 
(c), (d), or (i), except that--
            ``(A) any reference to manufacturing shall be treated as a 
        reference to wholesale distribution; and
            ``(B) any reference to a drug shall be treated as a 
        reference to a drug subject to section 503(b)(1).''; and
                    (D) in subsection (p), by inserting ``and reports 
                under subsection (b)(3), (c), and (d)'' before ``shall 
                be submitted''.
    (b) Information on State Actions Against Wholesale Distributors of 
Prescription Drugs.--Paragraph (2) of section 510(f) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360(f)), as added by subsection 
(a)(3)(B) of this section, is amended--
            (1) in subparagraph (A), by adding at the end of the 
        subparagraph the following: ``Such database shall also include 
        information on actions (such as suspension or revocation of 
        licensing) taken by States against persons engaged in wholesale 
        distribution of drugs subject to section 503(b)(1).''; and
            (2) by adding at the end the following:
                    ``(D) The Secretary shall encourage States to 
                report the type of information described in the second 
                sentence of subparagraph (A) to the Food and Drug 
                Administration--
                            ``(i) in a consistent manner; and
                            ``(ii) on a voluntary basis.''.
    (c) Fees for Reporting.--Subchapter C of chapter VII (21 U.S.C. 
379f et seq.) is amended by adding at the end the following:

``PART 7--FEES RELATING TO WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS

``SEC. 744. AUTHORITY TO ASSESS AND COLLECT FEES.

    ``(a) In General.--For fiscal year 2013 and each subsequent fiscal 
year, the Secretary shall assess and collect fees under this section 
from each person that reports under section 510(b)(3) to engage in the 
wholesale distribution in interstate commerce of drugs subject to 
section 503(b)(1).
    ``(b) Establishment of Amount.--
            ``(1) In general.--Not later than 1 year after the date of 
        the enactment of the Gray Market Drug Reform and Transparency 
        Act of 2012, the Secretary shall promulgate a final regulation 
        establishing the amount of fees under this section for the 
        period of fiscal years 2013 through 2017 so as to generate a 
        total revenue amount not exceeding the Secretary's estimate of 
        100 percent of the costs described in subsection (c) during 
        such period.
            ``(2) Consideration.--In establishing the amount of fees 
        under this section, the Secretary shall take into consideration 
        the amount of annual revenues of a person to be assessed such 
        fees in comparison with the amount of annual revenues of other 
        persons to be assessed such fees.
    ``(c) Costs To Be Funded Through Fees.--The fees authorized by this 
section shall only be collected and available to pay the costs incurred 
by the Food and Drug Administration in--
            ``(1) implementing the reporting requirement under section 
        510(b)(3); and
            ``(2) establishing and maintaining an up-to-date database 
        of the information collected pursuant to such requirement.
    ``(d) Crediting and Availability Fees.--Fees authorized under 
subsection (a) shall be collected and available for obligation only to 
the extent and in the amount provided in advance in appropriation Acts. 
Such fees are authorized to remain available until expended. Such sums 
as may be necessary may be transferred from the Food and Drug 
Administration salaries and expenses appropriation account without 
fiscal year limitation to such appropriation account for salaries and 
expenses with such fiscal year limitation. The sums transferred shall 
be available solely for the costs described in subsection (c).
    ``(e) Authorization of Appropriations.--For each of the fiscal 
years 2013 through 2017, there is authorized to be appropriated for 
fees under this section an amount equal to the total revenue amount 
determined under subsection (b) for the fiscal year.
    ``(f) Offset.--If the sum of the cumulative amount of fees 
collected under this section for the fiscal years 2013 through 2015 and 
the amount of fees estimated to be collected under this section for 
fiscal year 2016 exceeds the cumulative amount appropriated pursuant to 
subsection (e) for the fiscal years 2013 through 2016, the excess shall 
be credited to the appropriation account of the Food and Drug 
Administration as provided in subsection (d), and shall be subtracted 
from the amount of fees that would otherwise be authorized to be 
collected under this section pursuant to appropriation Acts for fiscal 
year 2017.''.

SEC. 4. IDENTIFICATION OF SALES PRICE FOR DRUGS IN SHORTAGE.

    (a) Identification of Sales Price for Drugs in Shortage.--Paragraph 
(1) of section 503(e) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 353(e)) is amended--
            (1) in subparagraph (A), by inserting before the period at 
        the end the following: ``, the amount paid for such drug by the 
        person receiving it if such drug is in shortage at the time of 
        the sale, and the amount paid for such drug for any prior sale 
        that occurred at a time when such drug was in shortage''; and
            (2) by adding at the end the following new subparagraph:
    ``(C) In this paragraph, the term `in shortage' means listed on the 
public Website of the Food and Drug Administration, at the time of the 
sale to be identified in the statement required by subparagraph (A), as 
being in shortage.''.
    (b) Applicability.--The amendment made by subsection (a) applies 
only with respect to sales of a drug occurring on or after the date 
that is 1 year after the date of the enactment of this Act.
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