USP Releases Proposed Standard on Supply Chain Integrity and Counterfeits

Posted 05 January 2012 | By Alexander Gaffney, RAC 

The US Pharmacopeia (USP) released new proposed standards last week that are aimed at securing global supply chains and preventing counterfeit medicines from propagating.

The standards-composed of a series of best practices-would ensure that:

  • products are traceable to their original manufacturers;
  • product integrity is ensured in both substance and identity; and
  • product quality is maintained from manufacturer to consumer

Further, the best practices would ensure these goals by addressing four principle areas:

  • the importation of products, including the management of supply chain risk, and development of supplier partnerships and supply chain quality systems;
  • counterfeit products and the scope of the problem;
  • best practices to confront the counterfeiting of drugs and devices through packaging, pedigrees, intelligent tagging, security, and other international best practices; and
  • risk reduction, prevention, and response

Comments on the proposal, General Chapter 1083, Good Distribution practices-Supply Chain integrity, are due on 31 May, 2012.

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