Pedigree Laws Overview - References

  
     References 21 U.S.C. 353(e)(1)(A). 21. U.S.C. 353(e)(3)(A); 21 C.F.R. 203.3(u). “The Secretary shall by regulation issue guidelines establishing minimum standards, terms, and conditions for the licensing of persons to make wholesale distributions in interstate commerce of drugs subject to subsection (b) of this section. Such guidelines shall prescribe requirements for the storage and handling of such drugs and for the establishment and maintenance of records of the distributions of such drugs.” 21 U.S.C. 353(e)(2)(B). 21 C.F.R. 203.50. FDA, Addendum to FDA’s Guidance for Industry: PDMA Pedigree Requirements – Questions and Answers Related to the Preliminary Injunction ordered 12/5/06 in RXUSA Wholesalers, Inc. v. HHS (Dec. 15, 2006), available at http://www.fda.gov/cder/regulatory/PDMA/pdma_addendum.pdf. 69 FR 8105, 8106 (Feb 23, 2004). FDA Counterfeit Drug Task Force Report: Update (2004), available at... Email Med-eHUB at info@Med-eHUB.com for additional information or to ask related questions.