21 CFR 601.15 - Foreign establishments and products: samples for each importation.

Beta! The text on the eCFR tab represents the unofficial eCFR text at ecfr.gov.
§ 601.15 Foreign establishments and products: samples for each importation.

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.

[70 FR 14983, Mar. 24, 2005, as amended at 80 FR 18092, Apr. 3, 2015]

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 601 after this date.

  • 2015-07-02; vol. 80 # 127 - Thursday, July 2, 2015
    1. 80 FR 37971 - Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective August 3, 2015.
      21 CFR Parts 601, 610, and 680
The section you are viewing is cited by the following CFR sections.