IV
106TH CONGRESS
2D SESSION
H. CON. RES. 420
Providing for corrections in the enrollment of the bill H.R. 4461.
IN THE HOUSE OF REPRESENTATIVES
OCTOBER 10, 2000
Ms. KAPTUR (for herself and Mr. Obey) submitted the following concurrent
resolution; which was referred to the Committee on Commerce, and in ad-
dition to the Committee on House Administration, for a period to be sub-
sequently determined by the Speaker, in each case for consideration of
such provisions as fall within the jurisdiction of the committee concerned
CONCURRENT RESOLUTION
Providing for corrections in the enrollment of the bill H.R.
4461.
Resolved by the House of Representatives (the Senate
concurring), That, in the enrollment of the bill (H.R.
4461) making appropriations for Agriculture, Rural De-
velopment, Food and Drug Administration, and Related
Agencies programs for the fiscal year ending September
30, 2001, and for other purposes, the Clerk of the House
shall strike section 745 and insert the following:
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SEC. 745. (a) SHORT TITLE.—This section may be
cited as the ‘‘Medicine Equity and Drug Safety Act of
2000’’.
(b) FINDINGS.—Congress makes the following find-
ings:
(1) The cost of prescription drugs for Ameri-
cans continues to rise at an alarming rate.
(2) Millions of Americans, including medicare
beneficiaries on fixed incomes, face a daily choice be-
tween purchasing life-sustaining prescription drugs,
or paying for other necessities, such as food and
housing.
(3) Many life-saving prescription drugs are
available in countries other than the United States
at substantially lower prices, even though such drugs
were developed and are approved for use by patients
in the United States.
(4) Many Americans travel to other countries to
purchase prescription drugs because the medicines
that they need are unaffordable in the United
States.
(5) Americans should be able to purchase medi-
cines at prices that are comparable to prices for
such medicines in other countries, but efforts to en-
able such purchases should not endanger the gold
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standard for safety and effectiveness that has been
established and maintained in the United States.
(c) IMPORTS AND EXPORTS.—Chapter VIII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381
et seq.) is amended—
(1) in section 801(d)(1), by inserting ‘‘and sec-
tion 804’’ after ‘‘paragraph (2)’’; and
(2) by adding at the end the following:
‘‘SEC. 804. IMPORTATION OF COVERED PRODUCTS.
‘‘(a) REGULATIONS.—
‘‘(1) IN GENERAL.—The Secretary, after con-
sultation with the United States Trade Representa-
tive and the Commissioner of Customs, shall promul-
gate regulations permitting a pharmacist or whole-
saler to import into the United States covered prod-
ucts. Such regulations shall be promulgated as expe-
ditiously as possible, but in no case later than two
years after the date of the enactment of the Medi-
cine Equity and Drug Safety Act of 2000.
‘‘(2) LIMITATION.—Regulations promulgated
under paragraph (1) shall—
‘‘(A) require that safeguards are in place
that provide a reasonable assurance to the Sec-
retary that each covered product that is im-
ported is safe and effective for its intended use;
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‘‘(B) require that the pharmacist or whole-
saler importing a covered product complies with
the provisions of paragraph (3); and
‘‘(C) contain such additional safeguards as
the Secretary may specify in order to ensure
the protection of the public health of patients in
the United States or to facilitate the importa-
tion of covered products.
‘‘(3) INFORMATION
AND
RECORDS.—Regula-
tions promulgated under paragraph (1) shall require
such pharmacist or wholesaler to provide informa-
tion and records to the Secretary, including—
‘‘(A) the name and amount of the active
ingredient of the product and description of the
dosage form;
‘‘(B) the date that such product is shipped
and the quantity of such product that is
shipped, the point of origin and the United
States consignee of such product, and the price
paid for such product;
‘‘(C) documentation from the foreign seller
specifying the original source of the product
and the amount of each lot of the product origi-
nally received;
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‘‘(D) the manufacturer’s lot or control
number of the product imported;
‘‘(E) the name, address, and telephone
number of the importer and consignee, includ-
ing the professional license number of the im-
porter, if the importer is a pharmacist or phar-
maceutical wholesaler;
‘‘(F) for a product that is—
‘‘(i) coming from the first foreign re-
cipient of the product who received such
product from the manufacturer—
‘‘(I) 
documentation 
dem-
onstrating that such product came
from such recipient and was received
by such recipient from such manufac-
turer;
‘‘(II) 
documentation 
of 
the
amount of each lot of the product re-
ceived by such recipient to dem-
onstrate that the amount being im-
ported into the United States is not
more than the amount that was re-
ceived by such recipient;
‘‘(III) 
documentation 
dem-
onstrating that a statistically valid
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sample of each lot was tested for authen-
ticity and degradation at an appropriate
Food and Drug Administration approved
United States laboratory by the importer
or manufacturer of such product, and
meets all labeling requirements under this
Act;
‘‘(G) complete data derived from all tests
necessary to assure that the product is in com-
pliance with established specifications and
standards, including laboratory records; and
‘‘(H) any other information that the Sec-
retary determines is necessary to ensure the
protection of the public health of patients in the
United States.
‘‘(4) RECORDS MAINTAINED BY SECRETARY.—
Records described in paragraph (3) shall be main-
tained by the Secretary for a period of time deter-
mined to be necessary by the Secretary.
‘‘(5) RECORDS
MAINTAINED
BY
IMPORTER.—
The pharmacist or wholesaler who imports a covered
product as described in paragraph (1) shall maintain
records documenting the resale price for such prod-
uct for a period of time specified by the Secretary.
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Such records shall be provided upon request to fa-
cilitate the studies under this section.
‘‘(b) TESTING.—
‘‘(1) IN GENERAL.—Testing referred to in sub-
paragraphs (F) and (G) of subsection (a)(3) may be
conducted by the pharmacist or wholesaler who is
importing such product, or by the manufacturer of
the product, in a Food and Drug Administration ap-
proved laboratory. Such testing may also be con-
ducted by an independent laboratory under contract
with such pharmacist, wholesaler, or manufacturer.
‘‘(2) AUTHENTICATION.—
‘‘(A) IN
GENERAL.—In conducting tests
under paragraph (1), the manufacturer of such
product shall provide to the pharmacist or
wholesaler, information—
‘‘(i) to authenticate such product and
confirm that the labeling of such product
complies with labeling requirements under
this Act; and
‘‘(ii) to indicate if such product is eli-
gible for importation under this section.
‘‘(B) 
CONFIDENTIALITY.—Information
supplied under subparagraph (A) and sub-
section (a)(3)(A) shall not be disclosed for any
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purpose not authorized by this section. Any per-
son who knowingly and willingly discloses such
information for purposes not authorized by this
section shall be imprisoned for a period not to
exceed 18 months, fined in accordance with title
18, United States Code, or both.
‘‘(3) DISCRETION.—The Secretary may waive
or modify testing requirements described under sub-
section (a)(3) if agreements have been entered into
by the Secretary that ensure the safety and effec-
tiveness of the product imported from a specific
country, or through a specific distribution chain cer-
tified by the Secretary.
‘‘(c) APPROVED LABELING.—The manufacturer of a
covered product shall provide to the importer involved
written authorization for the importer to use at no cost
the approved labeling for such product.
‘‘(d) NON-DISCRIMINATION.—No manufacturer of a
covered product may take actions that discriminate
against, or cause other persons to discriminate against,
United States pharmacists or wholesalers regarding the
sale or distribution of covered products.
‘‘(e) STUDY AND REPORT.—
‘‘(1) STUDY.—The General Accounting Office
shall conduct a study on the imports permitted
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under this section, taking into consideration the in-
formation received under subsection (a). In con-
ducting such study, the Office shall—
‘‘(A) evaluate importer’s compliance with
regulations, determine the number of ship-
ments, if any, permitted under this section that
have been determined to be counterfeit, mis-
branded, or adulterated; and
‘‘(B) consult with the United States Trade
Representative and United States Patent and
Trademark Office to evaluate the effect of im-
portations permitted under this Act on trade
and patent rights under Federal law.
‘‘(2) REPORT.—Not later than 5 years after the
effective date of final regulations issued pursuant to
this section, the General Accounting Office shall pre-
pare and submit to Congress a report containing the
study described in paragraph (1).
‘‘(f) CONSTRUCTION.—Nothing in this section shall
be construed to limit the statutory, regulatory, or enforce-
ment authority of the Secretary relating to importation
of covered products, other than the importation described
in subsection (a).
‘‘(g) DEFINITIONS.—In this section:
‘‘(1) COVERED PRODUCT.—
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‘‘(A) IN
GENERAL.—The term ‘covered
product’ means a prescription drug product
under section 503(b)(1) that meets the applica-
ble requirements of section 505, and is ap-
proved by the Food and Drug Administration
and manufactured in a facility identified in the
approved application and is not adulterated
under section 501 or misbranded under section
502.
‘‘(B) CHARITABLE
CONTRIBUTIONS; PAR-
ENTERAL DRUGS.—Notwithstanding any other
provision of this section, section 801(d)(1)—
‘‘(i) continues to apply to a covered
product donated at no cost by the manu-
facturer of the drug to a charitable or hu-
manitarian organization, including the
United Nations and affiliates, or to a gov-
ernment of a foreign country; and
‘‘(ii) continues to apply to a covered
product that is a parenteral drug the im-
portation of which pursuant to subsection
(a) is determined by the Secretary to pose
a threat to the public health.
‘‘(2) PHARMACIST.—The term ‘pharmacist’
means a person licensed to practice pharmacy under
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State law, including the dispensing and selling of
prescription drugs, or an entity licensed or otherwise
authorized as a pharmacy under State law.
‘‘(3) WHOLESALER.—The term ‘wholesaler’
means a person licensed as a wholesaler or dis-
tributor of prescription drug products in the United
States pursuant to section 503(e)(2)(A).
‘‘(4) DISCRIMINATION.—The term ‘discrimina-
tion’ includes with respect to United States phar-
macists or wholesalers a contract provision, a limita-
tion on supply, or other measure which has the ef-
fect of providing U.S. pharmacists or wholesalers ac-
cess to covered products on terms or conditions that
are less favorable than the terms or conditions pro-
vided to any foreign purchaser (other than a chari-
table purchaser) of such products, or otherwise has
the effect of restricting the access of United States
pharmacists or wholesalers to prescription drugs
that can be imported into the United States under
this section.
‘‘(h) FUNDING.—For the purpose of carrying out this
section—
‘‘(1) there is hereby appropriated, out of any
money in the Treasury not otherwise appropriated,
$23,000,000 for fiscal year 2001; and
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that is applicable to such manufacturer or importer, re-
spectively, shall be imprisoned for not more than 10 years
or fined not more than $1,000,000, or both.’’.
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