GroundRules
21 CFR 528.2001: pPL657 recombinant deoxyribonucleic acid construct.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
- PART 528—INTENTIONAL GENOMIC ALTERATIONS IN ANIMALS
(a) Specifications. pPL657 in the glycoprotein galactosyltransferase alpha-1,3 (GGTA1) gene in domestic pigs.
(b) Sponsor. See No. 086134 in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Intended use. pPL657 rDNA construct in the glycoprotein galactosyltransferase alpha-1,3 gene (GGTA1) in the lineage of domestic pigs (Sus scrofa domesticus) hemizygous and homozygous for the intentional genomic alteration resulting in undetectable endogenous galactose alpha-1,3-galactose sugar residues on biological derivatives of domestic pigs homozygous for the intentional genomic alteration lineage that are intended to be used as sources of food or human therapeutics including excipients, devices, drugs, or biological products.
(2) Limitations. Pigs of this lineage (possessing the intentional genomic alteration (pPL657 rDNA construct)) should not be treated with aminoglycoside drugs and must only be housed in physically contained facilities specified in the approved application.
Collected 2026-08-27T02:24:47Z. Source file · JSON