[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 147 Introduced in House (IH)]

112th CONGRESS
  1st Session
                                H. R. 147

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
 importation of prescription drugs and the sale of such drugs through 
                            Internet sites.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 5, 2011

   Mr. Paul 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 and the sale of such drugs through 
                            Internet sites.

    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 ``Prescription Drug Affordability 
Act''.

SEC. 2. FACILITATION OF IMPORTATION OF DRUGS APPROVED BY FOOD AND DRUG 
              ADMINISTRATION.

    (a) In General.--Chapter VIII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381 et seq.) is amended--
            (1) by striking section 804; and
            (2) in section 801(d)--
                    (A) by striking paragraph (2); and
                    (B) by striking ``(d)(1)'' and all that follows 
                through the end of paragraph (1) and inserting the 
                following:
    ``(d)(1)(A) A person who meets applicable legal requirements to be 
an importer of drugs described in subparagraph (B) may import such a 
drug (without regard to whether the person is a manufacturer of the 
drug) if the person submits to the Secretary an application to import 
the drug and the Secretary approves the application.
    ``(B) For purposes of subparagraph (A), the drugs described in this 
subparagraph are drugs that are subject to section 503(b)(1) or that 
are composed wholly or partly of insulin.
    ``(C) The Secretary shall approve an application under subparagraph 
(A) if the application demonstrates that the drug to be imported meets 
all requirements under this Act for the admission of the drug into the 
United States, including demonstrating that--
            ``(i) an application for the drug has been approved under 
        section 505, or as applicable, under section 351 of the Public 
        Health Service Act; and
            ``(ii) the drug is not adulterated or misbranded.
    ``(D) Not later than 60 days after the date on which an application 
under subparagraph (A) is submitted to the Secretary, the Secretary 
shall--
            ``(i) approve the application; or
            ``(ii) refuse to approve the application and provide to the 
        person who submitted the application the reason for such 
        refusal.
    ``(E) This paragraph may not be construed as affecting any right 
secured by patent.''.
    (b) Conforming Amendments.--Section 801(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(d)) is amended--
            (1) by redesignating paragraphs (3) and (4) as paragraphs 
        (2) and (3), respectively;
            (2) in subclause (III) of paragraph (2)(A)(i) (as 
        redesignated by this subsection), by striking ``paragraph (4)'' 
        and inserting ``paragraph (3)''; and
            (3) in paragraph (3) (as redesignated by this subsection), 
        by striking ``paragraph (3)'' each place such term appears and 
        inserting ``paragraph (2)''.

SEC. 3. INTERNET SALES OF PRESCRIPTION DRUGS.

    Section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 353(b)) is amended by adding at the end the following paragraph:
    ``(6)(A) With respect to the interstate sale of a prescription drug 
through an Internet site, the Secretary may not with respect to such 
sale take any action under this Act against any of the persons involved 
if--
            ``(i) the sale was made in compliance with this Act, the 
        Controlled Substances Act, and State laws that are applicable 
        to the sale of the drug; and
            ``(ii) accurate information regarding compliance with this 
        Act, the Controlled Substances Act, and such State laws is 
        posted on the Internet site.
    ``(B) For purposes of subparagraph (A), the sale of a prescription 
drug by a person shall be considered to be an interstate sale of the 
drug through an Internet site if--
            ``(i) the purchaser of the drug submits the purchase order 
        for the drug, or conducts any other part of the sales 
        transaction for the drug, through an Internet site; and
            ``(ii) pursuant to such sale, the person introduces the 
        drug into interstate commerce or delivers the drug for 
        introduction into such commerce.
    ``(C) Subparagraph (A) may not be construed as authorizing the 
Secretary to enforce any violation of State law.
    ``(D) For purposes of this paragraph, the term `prescription drug' 
means a drug that is subject to paragraph (1).''.

SEC. 4. REGULATIONS OF SECRETARY OF HEALTH AND HUMAN SERVICES; 
              EFFECTIVE DATE.

    (a) Regulations.--Before the expiration of the period specified in 
subsection (b), the Secretary of Health and Human Services shall 
promulgate regulations to carry out the amendments to the Federal Food, 
Drug, and Cosmetic Act that are made by sections 2 and 3.
    (b) Effective Date.--The amendments to the Federal Food, Drug, and 
Cosmetic Act that are made by sections 2 and 3 take effect upon the 
expiration of the one-year period beginning on the date of the 
enactment of this Act, without regard to whether the regulations 
required in subsection (a) have been promulgated.
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