Manufacturers or authorized distributors of record shall not distribute drug samples on the basis of open-ended or standing requests, but shall require separate written requests for each drug sample or group of samples. An arrangement by which a licensed practitioner requests in writing that a specified number of drug samples be delivered over a period of not more than 6 months, with the actual delivery dates for parts of the order to be set by subsequent oral communication or electronic transmission, is not considered to be a standing request.
21 CFR Part 203 · Prescription Drug Marketing
§ 203.35 Standing requests
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Amendment history
Federal Register documents that created or amended this section.
- 64 FR 67756 3 Dec 1999