Page:United States Statutes at Large Volume 102 Part 1.djvu/136

 102 STAT. 98

Records.

Reports.

PUBLIC LAW 100-293—APR. 22, 1988 "(ii) at the written request of such a licensed practitioner, to pharmacies of hospitals or other health care entities. A written request for drug samples shall be made on a form which contains the practitioner's name, address, and professional designation, the identity of the drug sample requested, the quantity of drug samples requested, the name of the manufacturer or distributor of the drug sample, the date of the request and signature of the practitioner making the request. ' (B) Drug manufacturers or distributors shall store drug samples under conditions that will maintain their stability, integrity, and effectiveness and will assure that the drug samples will be free of contamination, deterioration, and adulteration. "(C) Drug manufacturers or distributors shall conduct, at least annually, a complete and accurate inventory of all drug samples in the possession of representatives of the manufacturer or distributor. Drug manufacturers or distributors shall maintain lists of the names and address of each of their representatives who distribute drug samples and of the sites where drug samples are stored. Drug manufacturers or distributors shall maintain records for at least 3 years of all drug samples distributed, destroyed, or returned to the manufacturer or distributor, of eill inventories maintained under this subparagraph, of all thefts or significant losses of drug samples, and of all requests made under subparagraph (A) for drug samples. Records and lists maintained under this subparagraph shall be made available by the drug manufacturer or distributor to the Secretary upon request, "(D) Drug manufacturers or distributors shall notify the Secretary of any significant loss of drug samples and any known theft of drug samples. "(E) Drug manufacturers or distributors shall report to the Secretary any conviction of their representatives for violations of section 503(c)(1) or a State law because of the sale, purchase, or trade of a drug sample or the offer to sell, purchase, or trade a drug sample. "(F) Drug manufacturers or distributors shall provide to the Secretary the name and telephone number of the individual responsible for responding to a request for information respecting drug samples.". SEC. 6. WHOLESALE DISTRIBUTORS.

Records.

R^ulations.

Section 503 (as amended by section 5 of this Act) is amended by adding at the end the following: "(e)(1) Each person who is engaged in the wholesale distribution of drugs subject to subsection (b) and who is not an authorized distributor of record of such drugs shall provide to each wholesale distributor of such drugs a statement identifying each sale of the drug (including the date of the sale) before the sale to such wholesale distributor. Each manufacturer shall maintain at its corporate offices a current list of such authorized distributors. "(2)(A) No person may engage in the wholesale distribution in interstate commerce of drugs subject to subsection (b) in a State unless such person is licensed by the State in accordance with the guidelines issued under subparagraph (B). "(B) The Secretary shall by regulation issue guidelines establishing minimum standards, terms, and conditions for the licensing of persons to make wholesale distributions in interstate commerce of

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