21 CFR 606.140
§ 606.140 Laboratory controls.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 606.140, § 606.140 Laboratory controls, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88379
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Full text
Laboratory control procedures shall include:
(a) The establishment of scientifically sound and appropriate specifications, standards and test procedures to assure that blood and blood components are safe, pure, potent and effective.
(b) Adequate provisions for monitoring the reliability, accuracy, precision and performance of laboratory test procedures and instruments.
(c) Adequate identification and handling of all test samples so that they are accurately related to the specific unit of product being tested, or to its donor, or to the specific recipient, where applicable.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.