Page:United States Statutes at Large Volume 102 Part 1.djvu/135

 PUBLIC LAW 100-293—APR. 22, 1988

102 STAT. 97

"(v) a sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription executed in accordance with section 503(b). For purposes of this paragraph, the term 'entity' does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law and the term 'emergency medical reasons' includes transfers of a drug between health care entities or from a health care entity to a retail pharmacy undertaken to alleviate temporary shortages of the drug arising from delays in or interruptions of regular distribution schedules.". SEC. 5. DISTRIBUTION OF DRUG SAMPLES.

Section 503 (as amended by section 4 of this Act) is amended by adding at the end thereof the following: "(d)(1) Except as provided in paragraphs (2) and (3), no representative of a drug manufacturer or distributor may distribute any drug sample. "(2)(A) The manufacturer or distributor of a drug subject to subsection (b) may, in accordance with this paragraph, distribute drug samples by mail or common carrier to practitioners licensed to prescribe such drugs or, at the request of a licensed practitioner, to pharmacies of hospitals or other health care entities. Such a distribution of drug samples may only be made— "(i) in response to a written request for drug samples made on a form which meets the requirements of subparagraph (B), and "(ii) \. nder a system which requires the recipient of the drug sample to execute a written receipt for the drug sample upon its delivery and the return of the receipt to the manufacturer or distributor. "(B) A written request for a drug sample required by subparagraph (A)(i) shall contain— "(i) the name, address, professional designation, and signature of the practitioner making the request, "(ii) the identity of the drug sample requested and the quantity requested, (iii) the name of the manufacturer of the drug sample requested, and "(iv) the date of the request. "(C) Each drug manufacturer or distributor which makes distributions by mail or common carrier under this paragraph shall maintain, for a period of 3 years, the request forms submitted for such distributions and the receipts submitted for such distributions and shall maintain a record of distributions of drug samples which identifies the drugs distributed and the recipients of the distributions. Forms, receipts, and records required to be mainteiined under this subparagraph shall be made available by the drug manufacturer or distributor to Federal and State officials engaged in the regulation of drugs and in the enforcement of laws applicable to drugs. "(3) The manufacturer or distributor of a drug subject to subsection (b) may, by means other than mail or common carrier, distribute drug samples only if the manufacturer or distributor makes the distributions in accordance with subparagraph (A) and carries out the activities described in subparagraphs (B) through (F) as follows: "(A) Drug samples may only be distributed— "(i) to practitioners licensed to prescribe such drugs if they make a written request for the drug samples, or

Mail. Health care professionals.

Mail. Records. State and local governments.

Health care professionals.

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