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21 CFR 203.35

§ 203.35 Standing requests.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 203.35, § 203.35 Standing requests, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/85853
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Full text

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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.