21 CFR 203.23
§ 203.23 Returns.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 203.23, § 203.23 Returns, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/85846
- Permanent ID
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Full text
The return of a prescription drug purchased by a hospital or health care entity or acquired at a reduced price by or donated to a charitable institution is exempt from the prohibitions in § 203.20, provided that:
(a) The hospital, health care entity, or charitable institution documents the return by filling out a credit memo specifying:
(1) The name and address of the hospital, health care entity, or charitable institution;
(2) The name and address of the manufacturer or wholesale distributor from which it was acquired;
(3) The product name and lot or control number;
(4) The quantity returned; and
(5) The date of the return.
(b) The hospital, health care entity, or charitable institution forwards a copy of each credit memo to the manufacturer and retains a copy of each credit memo for its records;
(c) Any drugs returned to a manufacturer or wholesale distributor are kept under proper conditions for storage, handling, and shipping, and written documentation showing that proper conditions were maintained is provided to the manufacturer or wholesale distributor to which the drugs are returned.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.