Page:United States Statutes at Large Volume 117.djvu/2484

 PUBLIC LAW 108–173—DEC. 8, 2003

117 STAT. 2465

effective for the intended use of the prescription drug), with sections 501 and 502, and with other applicable requirements of this Act; ‘‘(2) require that an importer of a prescription drug under the regulations comply with subsections (d)(1) and (e); 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) shall require an importer of a prescription drug under subsection (b) 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.

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