9 CFR 101.6
§ 101.6 Cell cultures.
United States · 9 CFR — Animals and Animal Products · Status: effective
Cite this
- Citation
- 9 CFR 101.6, § 101.6 Cell cultures, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/33853
- Permanent ID
ys:prov:33853@1- SHA-256
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Full text
When used in conjunction with or in reference to cell cultures, which may be referred to as tissue cultures, the following terms shall mean:
(a) Batches of primary cells. A pool of original cells derived from normal tissue up to and including the 10th subculture.
(b) Cell line. A pool of cells which are 11 or more subcultures from the tissue of origin.
(c) Subculture. Each flask to flask transfer or passage regardless of the number of cell replications.
(d) Master Cell Stock (MCS). The supply of cells of a specific passage level from which cells for production of biologics originate.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.