21 CFR 165.3

§ 165.3 Definitions.

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

Cite this

Citation: 21 CFR 165.3, § 165.3 Definitions, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84834
Permanent ID: ys:prov:84834@1
SHA-256: fa97cf1581ae27e5fc5e5154179757d9e047e6e9c03f21ce11ae155aa472eaf3

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Full text

(a) A lot is: (1) For purposes of determining quality factors related to manufacture, processing, or packing, a collection of primary containers or units of the same size, type, and style produced under conditions as nearly uniform as possible and usually designated by a common container code or marking, or in the absence of any common container code or marking, a day's production. (2) For purposes of determining quality factors related to distribution and storage, a collection of primary containers or units transported, stored, or held under conditions as nearly uniform as possible. (b) A sample consists of 10 subsamples (consumer units), one taken from each of 10 different randomly chosen shipping cases to be representative of a given lot, unless otherwise specified in a specific standard in this part. (c) An analytical unit is the portion(s) of food taken from a subsample of a sample for the purpose of analysis.

Legislative history

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