21 U.S.C. § 384 : US Code - Section 384: Importation of prescription drugs

Search 21 U.S.C. § 384 : US Code - Section 384: Importation of prescription drugs

    (a) Definitions
      In this section:
      (1) Importer
        The term "importer" means a pharmacist or wholesaler.
      (2) Pharmacist
        The term "pharmacist" means a person licensed by a State to
      practice pharmacy, including the dispensing and selling of
      prescription drugs.
      (3) Prescription drug
        The term "prescription drug" means a drug subject to section
      353(b) of this title, other than - 
          (A) a controlled substance (as defined in section 802 of this
        title);
          (B) a biological product (as defined in section 262 of title
        42);
          (C) an infused drug (including a peritoneal dialysis
        solution);
          (D) an intravenously injected drug;
          (E) a drug that is inhaled during surgery; or
          (F) a drug which is a parenteral drug, the importation of
        which pursuant to subsection (b) of this section is determined
        by the Secretary to pose a threat to the public health, in
        which case section 381(d)(1) of this title shall continue to
        apply.
      (4) Qualifying laboratory
        The term "qualifying laboratory" means a laboratory in the
      United States that has been approved by the Secretary for the
      purposes of this section.
      (5) Wholesaler
        (A) In general
          The term "wholesaler" means a person licensed as a wholesaler
        or distributor of prescription drugs in the United States under
        section 353(e)(2)(A) of this title.
        (B) Exclusion
          The term "wholesaler" does not include a person authorized to
        import drugs under section 381(d)(1) of this title.
    (b) Regulations
      The Secretary, after consultation with the United States Trade
    Representative and the Commissioner of Customs, shall promulgate
    regulations permitting pharmacists and wholesalers to import
    prescription drugs from Canada into the United States.
    (c) Limitation
      The regulations under subsection (b) of this section shall - 
        (1) require that safeguards be in place to ensure that each
      prescription drug imported under the regulations complies with
      section 355 of this title (including with respect to being safe
      and effective for the intended use of the prescription drug),
      with sections 351 and 352 of this title, and with other
      applicable requirements of this chapter;
        (2) require that an importer of a prescription drug under the
      regulations comply with subsections (d)(1) and (e) of this
      section; and
        (3) contain any additional provisions determined by the
      Secretary to be appropriate as a safeguard to protect the public
      health or as a means to facilitate the importation of
      prescription drugs.
    (d) Information and records
      (1) In general
        The regulations under subsection (b) of this section shall
      require an importer of a prescription drug under subsection (b)
      of this section to submit to the Secretary the following
      information and documentation:
          (A) The name and quantity of the active ingredient of the
        prescription drug.
          (B) A description of the dosage form of the prescription
        drug.
          (C) The date on which the prescription drug is shipped.
          (D) The quantity of the prescription drug that is shipped.
          (E) The point of origin and destination of the prescription
        drug.
          (F) The price paid by the importer for the prescription drug.
          (G) Documentation from the foreign seller specifying - 
            (i) the original source of the prescription drug; and
            (ii) the quantity of each lot of the prescription drug
          originally received by the seller from that source.

          (H) The lot or control number assigned to the prescription
        drug by the manufacturer of the prescription drug.
          (I) The name, address, telephone number, and professional
        license number (if any) of the importer.
          (J)(i) In the case of a prescription drug that is shipped
        directly from the first foreign recipient of the prescription
        drug from the manufacturer:
            (I) Documentation demonstrating that the prescription drug
          was received by the recipient from the manufacturer and
          subsequently shipped by the first foreign recipient to the
          importer.
            (II) Documentation of the quantity of each lot of the
          prescription drug received by the first foreign recipient
          demonstrating that the quantity being imported into the
          United States is not more than the quantity that was received
          by the first foreign recipient.
            (III)(aa) In the case of an initial imported shipment,
          documentation demonstrating that each batch of the
          prescription drug in the shipment was statistically sampled
          and tested for authenticity and degradation.
            (bb) In the case of any subsequent shipment, documentation
          demonstrating that a statistically valid sample of the
          shipment was tested for authenticity and degradation.

          (ii) In the case of a prescription drug that is not shipped
        directly from the first foreign recipient of the prescription
        drug from the manufacturer, documentation demonstrating that
        each batch in each shipment offered for importation into the
        United States was statistically sampled and tested for
        authenticity and degradation.
          (K) Certification from the importer or manufacturer of the
        prescription drug that the prescription drug - 
            (i) is approved for marketing in the United States and is
          not adulterated or misbranded; and
            (ii) meets all labeling requirements under this chapter.

          (L) Laboratory records, including complete data derived from
        all tests necessary to ensure that the prescription drug is in
        compliance with established specifications and standards.
          (M) Documentation demonstrating that the testing required by
        subparagraphs (J) and (L) was conducted at a qualifying
        laboratory.
          (N) Any other information that the Secretary determines is
        necessary to ensure the protection of the public health.
      (2) Maintenance by the Secretary
        The Secretary shall maintain information and documentation
      submitted under paragraph (1) for such period of time as the
      Secretary determines to be necessary.
    (e) Testing
      The regulations under subsection (b) of this section shall
    require - 
        (1) that testing described in subparagraphs (J) and (L) of
      subsection (d)(1) of this section be conducted by the importer or
      by the manufacturer of the prescription drug at a qualified
      laboratory;
        (2) if the tests are conducted by the importer - 
          (A) that information needed to - 
            (i) authenticate the prescription drug being tested; and
            (ii) confirm that the labeling of the prescription drug
          complies with labeling requirements under this chapter;

        be supplied by the manufacturer of the prescription drug to the
        pharmacist or wholesaler; and
          (B) that the information supplied under subparagraph (A) be
        kept in strict confidence and used only for purposes of testing
        or otherwise complying with this chapter; and

        (3) may include such additional provisions as the Secretary
      determines to be appropriate to provide for the protection of
      trade secrets and commercial or financial information that is
      privileged or confidential.
    (f) Registration of foreign sellers
      Any establishment within Canada engaged in the distribution of a
    prescription drug that is imported or offered for importation into
    the United States shall register with the Secretary the name and
    place of business of the establishment and the name of the United
    States agent for the establishment.
    (g) Suspension of importation
      The Secretary shall require that importations of a specific
    prescription drug or importations by a specific importer under
    subsection (b) of this section be immediately suspended on
    discovery of a pattern of importation of that specific prescription
    drug or by that specific importer of drugs that are counterfeit or
    in violation of any requirement under this section, until an
    investigation is completed and the Secretary determines that the
    public is adequately protected from counterfeit and violative
    prescription drugs being imported under subsection (b) of this
    section.
    (h) Approved labeling
      The manufacturer of a prescription drug shall provide an importer
    written authorization for the importer to use, at no cost, the
    approved labeling for the prescription drug.
    (i) Charitable contributions
      Notwithstanding any other provision of this section, section
    381(d)(1) of this title continues to apply to a prescription drug
    that is donated or otherwise supplied at no charge by the
    manufacturer of the drug to a charitable or humanitarian
    organization (including the United Nations and affiliates) or to a
    government of a foreign country.
    (j) Waiver authority for importation by individuals
      (1) Declarations
        Congress declares that in the enforcement against individuals
      of the prohibition of importation of prescription drugs and
      devices, the Secretary should - 
          (A) focus enforcement on cases in which the importation by an
        individual poses a significant threat to public health; and
          (B) exercise discretion to permit individuals to make such
        importations in circumstances in which - 
            (i) the importation is clearly for personal use; and
            (ii) the prescription drug or device imported does not
          appear to present an unreasonable risk to the individual.
      (2) Waiver authority
        (A) In general
          The Secretary may grant to individuals, by regulation or on a
        case-by-case basis, a waiver of the prohibition of importation
        of a prescription drug or device or class of prescription drugs
        or devices, under such conditions as the Secretary determines
        to be appropriate.
        (B) Guidance on case-by-case waivers
          The Secretary shall publish, and update as necessary,
        guidance that accurately describes circumstances in which the
        Secretary will consistently grant waivers on a case-by-case
        basis under subparagraph (A), so that individuals may know with
        the greatest practicable degree of certainty whether a
        particular importation for personal use will be permitted.
      (3) Drugs imported from Canada
        In particular, the Secretary shall by regulation grant
      individuals a waiver to permit individuals to import into the
      United States a prescription drug that - 
          (A) is imported from a licensed pharmacy for personal use by
        an individual, not for resale, in quantities that do not exceed
        a 90-day supply;
          (B) is accompanied by a copy of a valid prescription;
          (C) is imported from Canada, from a seller registered with
        the Secretary;
          (D) is a prescription drug approved by the Secretary under
        subchapter V of this chapter;
          (E) is in the form of a final finished dosage that was
        manufactured in an establishment registered under section 360
        of this title; and
          (F) is imported under such other conditions as the Secretary
        determines to be necessary to ensure public safety.
    (k) Construction
      Nothing in this section limits the authority of the Secretary
    relating to the importation of prescription drugs, other than with
    respect to section 381(d)(1) of this title as provided in this
    section.
    (l) Effectiveness of section
      (1) Commencement of program
        This section shall become effective only if the Secretary
      certifies to the Congress that the implementation of this section
      will - 
          (A) pose no additional risk to the public's health and
        safety; and
          (B) result in a significant reduction in the cost of covered
        products to the American consumer.
      (2) Termination of program
        (A) In general
          If, after the date that is 1 year after the effective date of
        the regulations under subsection (b) of this section and before
        the date that is 18 months after the effective date, the
        Secretary submits to Congress a certification that, in the
        opinion of the Secretary, based on substantial evidence
        obtained after the effective date, the benefits of
        implementation of this section do not outweigh any detriment of
        implementation of this section, this section shall cease to be
        effective as of the date that is 30 days after the date on
        which the Secretary submits the certification.
        (B) Procedure
          The Secretary shall not submit a certification under
        subparagraph (A) unless, after a hearing on the record under
        sections 556 and 557 of title 5, the Secretary - 
            (i)(I) determines that it is more likely than not that
          implementation of this section would result in an increase in
          the risk to the public health and safety;
            (II) identifies specifically, in qualitative and
          quantitative terms, the nature of the increased risk;
            (III) identifies specifically the causes of the increased
          risk; and
            (IV)(aa) considers whether any measures can be taken to
          avoid, reduce, or mitigate the increased risk; and
            (bb) if the Secretary determines that any measures
          described in item (aa) would require additional statutory
          authority, submits to Congress a report describing the
          legislation that would be required;
            (ii) identifies specifically, in qualitative and
          quantitative terms, the benefits that would result from
          implementation of this section (including the benefit of
          reductions in the cost of covered products to consumers in
          the United States, allowing consumers to procure needed
          medication that consumers might not otherwise be able to
          procure without foregoing other necessities of life); and
            (iii)(I) compares in specific terms the detriment
          identified under clause (i) with the benefits identified
          under clause (ii); and
            (II) determines that the benefits do not outweigh the
          detriment.
    (m) Authorization of appropriations
      There are authorized to be appropriated such sums as are
    necessary to carry out this section.