I
107TH CONGRESS
2D SESSION
H. R. 5217
To amend the Federal Food, Drug, and Cosmetic Act to authorize the
Secretary of Health and Human Services to grant waivers permitting
individuals to import prescription drugs from Canada, to amend such
Act with respect to the sale of prescription drugs through the Internet,
and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
JULY 25, 2002
Mr. BROWN of Ohio (for himself, Mr. ALLEN, Mr. BERRY, Mr. PALLONE, and
Mr. STRICKLAND) introduced the following bill; which was referred to the
Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
authorize the Secretary of Health and Human Services
to grant waivers permitting individuals to import pre-
scription drugs from Canada, to amend such Act with
respect to the sale of prescription drugs through the
Internet, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Affordable Drugs Ac-
cess Act’’.
SEC. 2. WAIVER REQUIREMENT FOR PERSONAL IMPORTA-
TION OF PRESCRIPTION DRUGS FROM CAN-
ADA.
(a) IN GENERAL.—Chapter VIII of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.)
is amended by adding at the end the following section:
‘‘WAIVER REQUIREMENT FOR PERSONAL IMPORTATION
OF PRESCRIPTION DRUGS FROM CANADA
‘‘SEC. 805. (a) IN GENERAL.—With respect to the
importation by individuals of prescription drugs from Can-
ada, the Secretary shall in accordance with this section
establish by regulation a waiver of prohibitions under this
Act that apply to the importation of drugs. Such a waiver
shall permit an individual to import into the United States
any prescription drug that—
‘‘(1) is imported from Canada for personal use
by the individual (not for resale);
‘‘(2) is approved by the Secretary under section
505, is manufactured in an establishment registered
with the Secretary under section 510, and is not a
controlled substance in schedule I, II, or III under
section 202(c) of the Controlled Substances Act;
‘‘(3) is imported from a Canadian pharmacy
that has submitted to the Secretary a registration
that identifies the pharmacy and provides docu-
mentation that the pharmacy is licensed in Canada;
‘‘(4) is imported in a quantity that does not
(for that instance of importation) exceed a 90-day
supply;
‘‘(5) at the time of importation, is accompanied
by a copy of a valid prescription for the drug for the
individual, issued in the United States by a practi-
tioner in accordance with section 503(b), or is ac-
companied by documentation that verifies the
issuance of such a prescription for the individual;
‘‘(6) is in the form of a final finished dosage;
and
‘‘(7) is imported under such other conditions as
the Secretary determines to be necessary to ensure
public safety.
‘‘(b) STUDY; LIMITATION
ON WAIVER REQUIRE-
MENT.—
‘‘(1) STUDY.—During the one-year period be-
ginning on the effective date of this section, the Sec-
retary shall conduct a study of prescription drugs
imported from Canada under subsection (a), and of
prescription drugs that are imported into the United
States from other countries for personal use, in
order to determine the authenticity and quality of
such drugs.
‘‘(2) LIMITATION.—If through the study under
paragraph (1) the Secretary determines that drugs
imported under subsection (a) present a significant
threat to the public health, the following applies:
‘‘(A) The Secretary may, in order to pro-
tect the public health, establish one or more
conditions for the importation from Canada of
prescription drugs for personal use that are dif-
ferent than the conditions described in such
subsection, in which case any conflicting condi-
tion described in such subsection ceases to
apply.
‘‘(B) The Secretary may publish in the
Federal Register a statement that, pursuant to
this section, the Secretary has determined that
waivers under this section should be terminated
in order to protect the public health. Effective
on the date on which such a statement is so
published, this section ceases to have any legal
effect.
‘‘(c) AUTHORITY REGARDING OTHER COUNTRIES.—
If through the study under subsection (b)(1) the Secretary
determines that drugs imported under subsection (a) do
not present a significant threat to the public health, or
if under authority of subsection (b)(2)(A) the Secretary
establishes conditions in order to protect the public health,
the Secretary may, in the case of such countries in addi-
tion to Canada as the Secretary determines to be appro-
priate, establish by regulation a waiver of prohibitions
under this Act that apply to the importation of drugs,
under which waiver individuals are permitted to import
into the United States prescription drugs that meet the
conditions that apply under subsection (a) (or under sub-
section (b)(2)(A), as the case may be). Such regulations
may establish country-specific conditions, as determined
appropriate by the Secretary to protect the public health.
‘‘(d) DEFINITION.—For purposes of this section, the
term ‘prescription drug’ means a drug that is subject to
section 503(b).’’.
(b) ASSESSMENT REGARDING ADDITIONAL AGENCY
INSPECTORS AT PORTS OF ENTRY.—The Secretary of
Health and Human Services shall conduct an assessment
to determine the additional number of inspectors that
should be added for the Food and Drug Administration
at ports of entry into the United States in order to provide
adequate assurance that drugs imported into the United
States meet the standards of the Federal Food, Drug, and
Cosmetic Act. Not later than 180 days after the date of
the enactment of this Act, the Secretary shall submit to
the Congress a report describing the findings of the as-
sessment.
SEC. 3. CONTROLLED SUBSTANCES; IMPORTATION WITH-
OUT VALID PRESCRIPTIONS.
Section 1006(a)(2) of the Controlled Substances Im-
port and Export Act (21 U.S.C. 956(a)(2)) is amended
by striking ‘‘that exceeds 50 dosage units’’ and all that
follows and inserting the following: ‘‘that exceeds 10 dos-
age units of the controlled substance, except that if the
individual is importing more than one such controlled sub-
stance into the United States, the combined total number
of dosage units of such substances imported by the indi-
vidual may not exceed 10 dosage units.’’.
SEC. 4. INTERNET SALES OF PRESCRIPTION DRUGS.
(a) IN GENERAL.—Chapter 5 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 503A the following section:
‘‘SEC. 503B. INTERNET SALES OF PRESCRIPTION DRUGS.
‘‘(a) REQUIREMENTS REGARDING INFORMATION ON
INTERNET SITE.—
‘‘(1) IN GENERAL.—A person may not dispense
a prescription drug pursuant to a sale of the drug
by such person if—
‘‘(A) the purchaser of the drug submitted
the purchase order for the drug, or conducted
any other part of the sales transaction for the
drug, through an Internet site; and
‘‘(B) such site, or any other Internet site
used by such person for purposes of sales of a
prescription drug, fails to meet each of the re-
quirements specified in paragraph (2) (other
than a site or pages on a site that are not in-
tended to be accessed by purchasers or prospec-
tive purchasers).
‘‘(2) REQUIREMENTS.—With respect to an
Internet site, the requirements referred to in sub-
paragraph (B) of paragraph (1) for a person to
whom such paragraph applies are as follows:
‘‘(A) Each page of the site shall include ei-
ther the following information or a link to a
page that provides the following information:
‘‘(i) The name of such person; the ad-
dress of the principal place of business of
the person with respect to sales of pre-
scription drugs through the Internet; and
the telephone number for such place of
business.
‘‘(ii) Each State in which the person
is authorized by law to dispense prescrip-
tion drugs.
‘‘(iii) The name of each individual
who serves as a pharmacist for purposes of
the site, and each State in which the indi-
vidual is authorized by law to dispense pre-
scription drugs.
‘‘(iv) If the person provides for med-
ical consultations through the site for pur-
poses of providing prescriptions, the name
of each individual who provides such con-
sultations; each State in which the indi-
vidual is licensed or otherwise authorized
by law to provide such consultations; and
the type or types of health professions for
which the individual holds such licenses or
other authorizations.
‘‘(B) A link to which paragraph (1) applies
shall be clearly visible on the page involved,
shall not be of a size smaller than other links
on the page (if any), and shall include in the
caption for the link the words ‘licensing and
contact information’.
‘‘(b) INTERNET
SALES
WITHOUT
APPROPRIATE
MEDICAL RELATIONSHIPS.—