21 CFR 226.42
§ 226.42 Components.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 226.42, § 226.42 Components, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86122
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Full text
(a) Drug components, including undiluted drugs and any intermediate mixes containing drugs used in the manufacture and processing of Type A medicated article(s), shall be received, examined or tested, stored, handled, and otherwise controlled in a manner to maintain the integrity and identification of such articles. Appropriate receipt and inventory records shall be maintained for 2 years, and such records shall show the origin of any drug components, the manufacturer's control number (if any), the dates and batches in which they were used, and the results of any testing of them.
(b) Nondrug components shall be stored and otherwise handled in a manner to avoid contamination, including cross-contamination from manufacturing operations.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.