In this section:
The term "importer" means a pharmacist or wholesaler.
The term "pharmacist" means a person licensed by a State to practice pharmacy, including the dispensing and selling of prescription drugs.
The term "prescription drug" means a drug subject to sectionof this title, other than-
The term "qualifying laboratory" means a laboratory in the United States that has been approved by the Secretary for the purposes of this section.
The term "wholesaler" means a person licensed as a wholesaler or distributor of prescription drugs in the United States under sectionof this title.
The term "wholesaler" does not include a person authorized to import drugs under sectionof this title.
The Secretary, after consultation with the United States Trade Representative and the Commissioner of U.S. Customs and Border Protection, shall promulgate regulations permitting pharmacists and wholesalers to import prescription drugs from Canada into the United States.
The regulations under subsection (b) shall-
The regulations under subsection (b) shall require an importer of a prescription drug under subsection (b) to submit to the Secretary the following information and documentation:
The Secretary shall maintain information and documentation submitted under paragraph (1) for such period of time as the Secretary determines to be necessary.
The regulations under subsection (b) shall require-
be supplied by the manufacturer of the prescription drug to the pharmacist or wholesaler; and
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.
The Secretary shall require that importations of a specific prescription drug or importations by a specific importer under subsection (b) 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).
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.
Notwithstanding any other provision of this section, sectionof 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.
Congress declares that in the enforcement against individuals of the prohibition of importation of prescription drugs and devices, the Secretary should-
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.
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.
In particular, the Secretary shall by regulation grant individuals a waiver to permit individuals to import into the United States a prescription drug that-
Nothing in this section limits the authority of the Secretary relating to the importation of prescription drugs, other than with respect to sectionof this title as provided in this section.
This section shall become effective only if the Secretary certifies to the Congress that the implementation of this section will-
If, after the date that is 1 year after the effective date of the regulations under subsection (b) 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.
The Secretary shall not submit a certification under subparagraph (A) unless, after a hearing on the record under sectionsand of title 5, the Secretary-
There are authorized to be appropriated such sums as are necessary to carry out this section.
21 U.S.C. § 384
June 25, 1938, ch. 675, §804, as added Pub. L. 108-1732003; amended Pub. L. 114-125Feb. 24, 2016, 130 Stat. 210.
PRIOR PROVISIONSA prior section 384, act June 25, 1938, ch. 675, §804, as added Pub. L. 106-3872000, related to importation of covered products, prior to repeal by Pub. L. 108-1732003.
CHANGE OF NAME"Commissioner of U.S. Customs and Border Protection" substituted for "Commissioner of Customs" in subsec. (b) on authority of section 802(d)(2) of Pub. L. 114-125, set out as a note under sectionof Title 6, Domestic Security.
TRANSFER OF FUNCTIONSFor transfer of functions, personnel, assets, and liabilities of the United States Customs Service of the Department of the Treasury, including functions of the Secretary of the Treasury relating thereto, to the Secretary of Homeland Security, and for treatment of related references, see sections, , ,and of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section of Title 6. For establishment of U.S. Customs and Border Protection in the Department of Homeland Security, treated as if included in Pub. L. 107-296 as of Nov. 25, 2002, see section of Title 6, as amended generally by Pub. L. 114-125, and section 802(b) of Pub. L. 114-125, set out as a note under section of Title 6.
STUDY AND REPORT ON IMPORTATION OF DRUGS Pub. L. 108-1732003, directed the Secretary of Health and Human Services to conduct a study on the importation of drugs into the United States pursuant to this section and to submit to Congress, not later than 12 months after Dec. 8, 2003, a report providing the findings of such study.