[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5186 Introduced in House (IH)]







107th CONGRESS
  2d Session
                                H. R. 5186

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
                   importation of prescription drugs.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 23, 2002

Mr. Kingston (for himself, Mr. Gutknecht, Mr. Thune, Mr. Stump, Mrs. Jo 
   Ann Davis of Virginia, Mr. Kolbe, Mr. Dan Miller of Florida, Mrs. 
   Northup, Mrs. Emerson, Mr. Crowley, Mr. Bartlett of Maryland, Mr. 
 Baldacci, Mr. Paul, Mr. Duncan, Mr. Shays, Mr. Tancredo, Mr. Jones of 
North Carolina, Mr. Wamp, Mr. Pomeroy, and Mr. Hoekstra) 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 with respect to the 
                   importation of prescription drugs.

    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 ``Drug Importation Act of 2002''.

SEC. 2. IMPORTATION OF PRESCRIPTION DRUGS.

    (a) Personal Importation.--Section 801 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the 
following subsection:
    ``(p) The Secretary may not prevent an individual who is not in the 
business of importing prescription drugs within the meaning of 
subsection (g) from importing a prescription drug that (1) appears to 
be approved by the Secretary; (2) does not appear to be a narcotic 
drug; and (3) appears to be manufactured, prepared, propagated, 
compounded, or processed in an establishment registered pursuant to 
section 510.''.
    (b) Pharmacists.--
            (1) In general.--Section 801 of the Federal Food, Drug, and 
        Cosmetic Act, as amended by subsection (a) of this section, is 
        amended by adding at the end the following subsection:
    ``(q)(1) The Secretary shall by regulation carry out a program 
under which covered pharmacists are authorized to import into the 
United States prescription drugs that meet the standards described in 
subsection (a) for the importation of drugs (including with respect to 
denying entry to drugs that are adulterated or misbranded, or are not 
approved under section 505, or are not manufactured, prepared, 
propagated, compounded, or processed in establishments registered under 
section 510), subject to paragraphs (3) and (4) and subject to 
compliance with such procedures as the Secretary determines to be 
appropriate to facilitate determinations by the Secretary of whether 
the prescription drugs meet such standards.
    ``(2) Procedures under paragraph (1) may include requiring, as a 
condition of importing prescription drugs under such paragraph, that 
covered pharmacists register with the Secretary, and that the Secretary 
approve the chain of distribution of such drugs outside the United 
States.
    ``(3) A prescription drug may not be imported under paragraph (1) 
if such drug is a controlled substance in schedule I, II, or III under 
section 202(c) of the Controlled Substances Act or a biological product 
as defined in section 351 of the Public Health Service Act.
    ``(4) Regulations under paragraph (1) may authorize the use of 
alternative labeling for prescription drugs imported under such 
paragraph, which labeling for the drug involved meets the requirements 
of section 502 but is modified to the extent necessary to comply with 
applicable law regarding trademarks and copyrights. A prescription drug 
imported under paragraph (1) whose labeling is in accordance with such 
regulations may not be considered misbranded under section 502.
    ``(5) For purposes of this subsection:
            ``(A) The term `covered pharmacist' means, with respect to 
        the prescription drug involved, a pharmacist who lacks 
        authority under subsection (d)(1) to import the drug into the 
        United States.
            ``(B) The term `pharmacist' means a person licensed by a 
        State to practice pharmacy, including the dispensing and 
        selling of prescription drugs. Such term includes pharmacies 
        that are so licensed.
            ``(C) The term `prescription drug' means a drug subject to 
        section 503(b).''.
            (2) Regulations.--Not later than 180 days after the date of 
        the enactment of this Act, the Secretary of Health and Human 
        Services shall promulgate a final rule for carrying out the 
        program under section 801(q) of the Federal Food, Drug, and 
        Cosmetic Act (as added by paragraph (1) of this subsection) and 
        shall begin operation of such program.
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