Source: http://www.law.cornell.edu/uscode/text/21/384?quicktabs_8=1
Timestamp: 2013-05-25 07:37:14
Document Index: 104200251

Matched Legal Cases: ['§ 384', '§ 384', '§ 384', '§ 804', '§ 1121', '§ 804', '§ 1', '§ 745', '§ 1121', '§ 1122']

21 USC § 384 - Importation of prescription drugs | Title 21 - Food and Drugs | U.S. Code | LII / Legal Information Institute
USC › Title 21 › Chapter 9 › Subchapter VIII › § 384	prevnext
21 USC § 384 - Importation of prescription drugs
Importer The term “importer” means a pharmacist or wholesaler.
Pharmacist The term “pharmacist” means a person licensed by a State to practice pharmacy, including the dispensing and selling of prescription drugs.
Prescription drug The term “prescription drug” means a drug subject to section 353
(b) of this title, other than—
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.
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.
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.
Exclusion The term “wholesaler” does not include a person authorized to import drugs under section 381
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.
Limitation The regulations under subsection (b) of this section shall—
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:
Documentation from the foreign seller specifying—
In the case of a prescription drug that is shipped directly from the first foreign recipient of the prescription drug from the manufacturer:
Certification from the importer or manufacturer of the prescription drug that the prescription drug—
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.
Testing The regulations under subsection (b) of this section shall require—
if the tests are conducted by the importer—
that information needed to—
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.
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.
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.
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.
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—
exercise discretion to permit individuals to make such importations in circumstances in which—
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.
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.
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—
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.
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—
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.
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—
(June 25, 1938, ch. 675, § 804, as added Pub. L. 108–173, title XI, § 1121(a),Dec. 8, 2003, 117 Stat. 2464.)
A prior section 384, act June 25, 1938, ch. 675, § 804, as added Pub. L. 106–387, § 1(a) [title VII, § 745(c)(2)], Oct. 28, 2000, 114 Stat. 1549, 1549A–36, related to importation of covered products, prior to repeal by Pub. L. 108–173, title XI, § 1121(a),Dec. 8, 2003, 117 Stat. 2464.
Pub. L. 108–173, title XI, § 1122,Dec. 8, 2003, 117 Stat. 2469, 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.