21 CFR 601.21 - Products under development.

§ 601.21 Products under development.

A biological product undergoing development, but not yet ready for a biologics license, may be shipped or otherwise delivered from one State or possession into another State or possession provided such shipment or delivery is not for introduction or delivery for introduction into interstate commerce, except as provided in sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as amended, and the regulations thereunder ( 21 CFR parts 312 and 812).

[ 64 FR 56451, Oct. 20, 1999]

Title 21 published on 10-May-2017 03:43

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

  • 2016-12-13; vol. 81 # 239 - Tuesday, December 13, 2016
    1. 81 FR 89848 - Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Correction
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; correction.
      Effective December 13, 2016.
      21 CFR Parts 20, 201, 207, 314, 514, 515, 601, 607, and 1271
The section you are viewing is cited by the following CFR sections.