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 ).
21 CFR Part 601 · Licensing
§ 601.21 Products under development
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Warning letters citing § 601.21
1 FDA warning letters since 2017 cite this section :
- Lattice Biologics, Ltd. 27 Aug 2020
FDA guidance that cites § 601.21
- Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus: Guidance for Industry 29 Jun 2026
- Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use: Guidance for Industry and Food and Drug Administration Staff 20 Jul 2020
Amendment history
Federal Register documents that created or amended this section.
- 64 FR 56451 20 Oct 1999