Instructions: In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
Input: 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.
Output:
Gray Market Drug Reform and Transparency Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to: (1) make it a prohibited act and a misbranding for a wholesale distributor of prescription drugs to purchase or receive a prescription drug from a pharmacy or a pharmacist, (2) require annual reporting by wholesale distributors of prescription drugs, (3) require the Secretary of Health and Human Services (HHS) to establish and maintain a national database of information reported by wholesale distributors of prescription drugs and to require such database to include information on actions taken by states against wholesale distributors (e.g., disciplinary actions and license revocations), (4) require the Secretary to assess and collect fees from wholesale distributors of prescription drugs, and (5) require wholesale distributors of prescription drugs to provide to recipients of a prescription drug in shortage the sales price for such drug at the time of its sale and at the time of any prior sale of such drug when it was in shortage.