SECTION 1. IMPORTATION OF COVERED PRODUCTS FOR PERSONAL USE.

    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 section 804'' 
        after ``paragraph (2)''; and
            (2) by adding at the end the following:

``SEC. 804. IMPORTATION OF COVERED PRODUCTS FOR PERSONAL USE.

    ``(a) General Authority With Respect to Personal Baggage.--
            ``(1) Regulations.--
                    ``(A) In general.--Notwithstanding sections 301(d), 
                301(t), and 801(a), the Secretary shall promulgate 
                regulations permitting individuals to import into the 
                United States from Canada, in personal baggage, a 
                covered product that meets--
                            ``(i) the conditions described in 
                        subparagraph (B); and
                            ``(ii) such additional criteria as the 
                        Secretary may specify in order to ensure the 
                        safety of patients in the United States.
                    ``(B) Conditions.--A covered product may be 
                imported under such regulations if--
                            ``(i) the intended use of the product is 
                        appropriately identified;
                            ``(ii) the product is not considered to 
                        represent a significant health risk (as 
                        determined by the Secretary without any 
                        consideration given to the cost or availability 
                        of such a product in the United States); and
                            ``(iii) the individual seeking to import 
                        the product--
                                    ``(I) affirms in writing that the 
                                product is for the personal use of the 
                                individual;
                                    ``(II) seeks to import an amount of 
                                the product appropriate for personal 
                                use, such as a 3-month supply; and
                                    ``(III) provides the name and 
                                address of a health professional 
                                licensed to prescribe drugs in the 
                                United States that is responsible for 
                                treatment with the product or provides 
                                evidence that the product is for the 
                                continuation of a treatment begun in a 
                                foreign country.
                                    ``(IV) provides a detailed 
                                description of the covered product 
                                being imported, including the name, 
                                amount, and market value of the 
                                product;
                                    ``(V) provides the time when and 
                                the place where the covered product is 
                                purchased;
                                    ``(VI) provides the port of entry 
                                to which the covered product is 
                                destined;
                                    ``(VII) provides the name, address, 
                                and telephone number of the individual 
                                who is importing the covered product; 
                                and
                                    ``(VIII) provides any other 
                                information that the Secretary 
                                determines to be necessary, including 
                                such information as the Secretary 
                                determines to be appropriate to 
                                identify the facility in which the 
                                product was manufactured.
            ``(2) Promulgation.--In promulgating regulations under 
        paragraph (1), the Secretary shall consult with the United 
        States Trade Representative and the Commissioner of Customs.
    ``(b) General Authority With Respect to Mail Order.--
            ``(1) Regulations.--Notwithstanding sections 301(d), 
        301(t), and 801(a), the Secretary shall promulgate regulations 
        permitting individuals to import into the United States from 
        Canada, by mail order, a covered product that meets such 
        criteria as the Secretary specifies to ensure the safety of 
        patients in the United States. The Secretary shall refer to the 
        criteria described in subsection (a)(1), and, to the extent 
        practicable, use such criteria as a guide in promulgating such 
        regulations.
            ``(2) Promulgation.--In promulgating regulations under 
        paragraph (1), the Secretary shall consult with the United 
        States Trade Representative and the Commissioner of Customs.
            ``(3) Records.--Any information documenting the importation 
        of a covered product under the regulations described in 
        paragraph (1) shall be gathered and maintained by the Secretary 
        for such period as the Secretary determines to be appropriate.
    ``(c) Study and Report.--
            ``(1) Study.--The Secretary shall conduct a study on the 
        imports permitted under this section, taking into consideration 
        the information received under subsections (a)(4) and (b)(3). 
        In conducting the study, the Secretary shall evaluate the 
        safety and purity of the products imported, and other patent 
        and trade issues that may have an effect on the safety or 
        availability of such products.
            ``(2) Report.--Not later than 5 years after the date of 
        enactment of this section, the Secretary shall prepare and 
        submit to Congress a report containing the study described in 
        paragraph (1).
    ``(d) Construction.--Nothing in this section shall be construed to 
limit the statutory, regulatory, or enforcement authority of the 
Secretary relating to importation of covered products, other than the 
importation described in subsections (a) and (b).
    ``(e) Limitation.--Information collected pursuant to this section 
shall be subject to the provisions of section 522a of title 5, United 
States Code (commonly known as the `Privacy Act of 1974').
    ``(f) Definitions.--In this section:
            ``(1) Covered product.--The term `covered product' means a 
        prescription drug under section 503(b)(1).
            ``(2) Market value.--The term `market value' means the 
        price actually paid for the covered product in Canada or, in 
        the case of a gift, the price at which the covered product is 
        being sold in Canada.''.
Allows importation of such product if: (1) the intended use is appropriately identified; (2) the product is not considered to represent a significant health risk; and (3) the individual seeking to import the product affirms that it is for personal use, seeks only to import enough for personal use, describes the product and identifies its importer, and provides the name and address of a licensed health professional responsible for treatment with the product or provides evidence that the product continues a treatment begun in a foreign country.
Requires the Secretary to study and report to Congress on such permitted imports.
A bill to amend the Federal Food, Drug, and cosmetic Act to permit importation in personal baggage and through mail order of certain covered products for personal use from Canada, and for other purposes.