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Volume 31 Issue 3
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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2013  >  31(3): 238-239

LIANG Jian-jun, LUAN Zhi-peng, CHENG Shen-xin. Puzzles and revelations produced in process of U.S. local drug administration implement drug e-pedigree[J]. Journal of Pharmaceutical Practice and Service, 2013, 31(3): 238-239. doi: 10.3969/j.issn.1006-0111.2013.03.023
Citation: LIANG Jian-jun, LUAN Zhi-peng, CHENG Shen-xin. Puzzles and revelations produced in process of U.S. local drug administration implement drug e-pedigree[J]. Journal of Pharmaceutical Practice and Service, 2013, 31(3): 238-239. doi: 10.3969/j.issn.1006-0111.2013.03.023
shu

Puzzles and revelations produced in process of U.S. local drug administration implement drug e-pedigree

doi: 10.3969/j.issn.1006-0111.2013.03.023
  • 1.

    Beijing Medical Materials Supply Station, General Hospital of Beijing Military Region, Beijing 100700, China

  • 2.

    School of Pharmacy, Second Military Medical University, Shanghai 200433, China

  • Received Date: 2013-01-08
  • Rev Recd Date: 2013-03-15
  • Objective To provide a reference for drug electronic supervision being implemented in China. Methods the problems and the reasons for US drug administration to implement of drug e-pedigree were analyzed by induction the bills, reports and literatures. Results There were differences between states board of pharmacy and FDA of technical solutions, technical standards, expected results, and implementation period. Pharmaceutical enterprises had doubts about program in the practical application, increasing costs, information sharing, and policy risks of drug e-pedigree. Conclusion Revising standards, definite of information transmission rules, suspension of holding accountable, and eliminating panic in the pharmacy industry, which should be valued and addressed as matter of priority in the process of implement drug electronic supervision by Chinese drug administration agencies.
  • [1] U.S. FDA. FDA 2006 Compliance Policy Guide for the Prescription Drug Marketing Act [EB/OL]. http://www.fda.gov/OHRMS/DOCKETS/98fr/06-9211.htm. 2006-11-15.
    [2] Board of Pharmacy, State of California. Background and Summary of the California ePedigree Law[EB/OL]. http://www.pharmacy.ca.gov/laws_regs/e_pedigree_laws_summary.pdf.
    [3] U.S. FDA. Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs[EB/OL]. http://www.fda.gov/oc/initiatives/counterfeit/rfid_cpg.html.2004-11-01.
    [4] U.S. FDA. Compliance Policy Guide[EB/OL]. http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074357.htm.2004-11-01.
    [5] Board of Pharmacy, State of California. California E——Pedigree Law[EB/OL]. http://www.pharmacy.ca.gov/about/e_pedigree_laws.shtml.
    [6] Claire Swedberg. GS1 Group Completes Early Phase of E-Pedigree Model[EB/OL]. http://www.rfidjournal.com/articles/view?7605. 2010-05-19.
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Puzzles and revelations produced in process of U.S. local drug administration implement drug e-pedigree

doi: 10.3969/j.issn.1006-0111.2013.03.023
  • 1. Beijing Medical Materials Supply Station, General Hospital of Beijing Military Region, Beijing 100700, China
  • 2. School of Pharmacy, Second Military Medical University, Shanghai 200433, China
  • Received Date: 2013-01-08
  • Rev Recd Date: 2013-03-15

Abstract: Objective To provide a reference for drug electronic supervision being implemented in China. Methods the problems and the reasons for US drug administration to implement of drug e-pedigree were analyzed by induction the bills, reports and literatures. Results There were differences between states board of pharmacy and FDA of technical solutions, technical standards, expected results, and implementation period. Pharmaceutical enterprises had doubts about program in the practical application, increasing costs, information sharing, and policy risks of drug e-pedigree. Conclusion Revising standards, definite of information transmission rules, suspension of holding accountable, and eliminating panic in the pharmacy industry, which should be valued and addressed as matter of priority in the process of implement drug electronic supervision by Chinese drug administration agencies.

LIANG Jian-jun, LUAN Zhi-peng, CHENG Shen-xin. Puzzles and revelations produced in process of U.S. local drug administration implement drug e-pedigree[J]. Journal of Pharmaceutical Practice and Service, 2013, 31(3): 238-239. doi: 10.3969/j.issn.1006-0111.2013.03.023
Citation: LIANG Jian-jun, LUAN Zhi-peng, CHENG Shen-xin. Puzzles and revelations produced in process of U.S. local drug administration implement drug e-pedigree[J]. Journal of Pharmaceutical Practice and Service, 2013, 31(3): 238-239. doi: 10.3969/j.issn.1006-0111.2013.03.023
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