21 CFR 601.15
§ 601.15 Foreign establishments and products: samples for each importation.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 601.15, § 601.15 Foreign establishments and products: samples for each importation, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88326
- Permanent ID
ys:prov:88326@1- SHA-256
f7ae664de83b7fb82bae331f6408a77aeeaf6bf5f85924bcf946e58622b09404
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
Random samples of each importation, obtained by the District Director of Customs and forwarded to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing addresses in § 600.2(c) of this chapter) must be at least two final containers of each lot of product. A copy of the associated documents which describe and identify the shipment must accompany the shipment for forwarding with the samples to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing addresses in § 600.2(c)). For shipments of 20 or less final containers, samples need not be forwarded, provided a copy of an official release from the Center for Biologics Evaluation and Research or Center for Drug Evaluation and Research accompanies each shipment.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.