Commercial Distribution [Food and Drugs] Law and Legal Definition
Pursuant to 21 CFR 207.3 (5) [Title 21 Food and Drugs; Chapter I Food and Drug Administration, Department of Health and Human Services; Subchapter C Drugs: General; Part 207 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution; Subpart A General], Commercial Distribution means “any distribution of a human drug except for investigational use under part 312 of this chapter, and any distribution of an animal drug or animal feed bearing or containing an animal drug for noninvestigational uses, but the term does not include internal or interplant transfer of a bulk drug substance between registered establishments within the same parent, subsidiary, and/or affiliate company. For foreign establishments, the term "commercial distribution" shall have the same meaning except that the term shall not include distribution of any drug that is neither imported nor offered for import into the United States.”
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