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Executive Summary

Manufacturers and wholesalers are advised to confirm all deliveries of drug samples to medical practitioners by a written receipt, FDA says in an Aug. 1 industry guidance on the implementation of the Drug Diversion Act. The guidance suggests that either the manufacturer or distributor "verify by written receipt the delivery of a drug sample by a detail person to a licensed practitioner or to the pharmacy of a hospital or health care entity receiving samples at the requests of a licensed practitioner." The agency further recommends that a medical practitioner "who is sent a sample but fails to execute a receipt be barred from receiving additional samples." FDA will accept comments on the guidance letter and the implementation of the Act up until 60 days following publication of the notice of the guidance's availability in the Federal Register. The publication date is expected to be Aug. 8. The agency plans to propose rules for the development of regulations for implementation of the law. FDA said it is asking companies and wholesalers to remove practitioners that do not supply receipts from their list of eligible sample recipients. The agency noted that it is looking for some acknowledgement that samples were received, and if practitioners do not cooperate they may be suspected of drug diversion. Manufacturers and distributors can also send samples through the mail or common carrier pursuant to a written request of a licensed practitioner and provided a written receipt is supplied to the manufacturer or distributor, the guidance says. The agency asks "that separate written requests be made for each sample or group of samples, and that open-ended or 'standing' requests not be used to order drug samples." Whether the samples are delivered by mail, common carrier, or detail person the information required in the written request form is the same: the name, address, professional title, and signature of the practitioner; the identity of the drug sample; the quantity; the name of the manufacturer or distributor of the drug sample, and the date of the request. Manufacturers and distributors must maintain all sample request forms and receipts for three years, and they must also keep a sample distribution record, the guidance says. Notification of sample loss or theft is also requested by FDA. The agency asked that it "be notified within five working days when a manufacturer or distributor becomes aware of a significant loss or theft of drug samples." The guidance states that manufacturers and distributors "shall conduct, at least annually, complete and accurate inventories of all drug samples in the possession of [their] representatives." FDA requests that the inventories be conducted by "independent personnel." PMA has proposed an industry-wide auditing system to monitor the activities and inventories of representatives. Sandoz recently revised its sample accountability system and has been looking for outside auditors to monitor its salespeople. A person or company that reports information that leads to the conviction of a representative may be entitled to a reward or "one-half the criminal fee imposed and collected, not to exceed $ 125,000." The Drug Diversion Act's requirements for the distribution of drug samples will become effective on Oct. 20, 1988, the guidance states. Requests for copies of the guidance or for further information about the Act should be directed to FDA's Division of Regulatory Affairs, Center for Drug Evaluation & Research, 5600 Fishers Lane, Rockville, Md. 20857, telephone: (301) 295-8038.

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