New USP Chapter <1083> on Good Distribution Practices

A new general USP Chapter <1083> Good Distribution Practices - Supply Chain Integrity has been presented in the new issue of the USP Pharmacopeial Forum (volume 38, edition 2).

The main issue of the new chapter focuses on counterfeited medicines. Here are the topics which are dealt with in detail:

  • Legal definition of counterfeit medicines (laid down in an EU Directive for Europe, in FDCA, 21 USC 321 § 201 for the USA, inexistent in some countries),
  • Types of counterfeit medicines,
  • Medical consequences of counterfeit medicines (heparin, diethylene glycol),
  • Distribution (e.g. also via internet).

A paragraph entitled "Best Practices to combat Counterfeit Drugs and Medical Devices" presents a range of measures and possibilities to combat counterfeit medicines:

  • Packaging technologies (secured packaging, authentication and serialisation technologies, etc.),
  • Establishment of Pedigrees / e-Pedigress,
  • Use of 2D bar codes (ECC 200) or RFID tags,
  • Precise security guidance regarding all repackaging activities - repackagers should perform equivalent protection measures with the original ones and ensure the total destruction of the removed packaging,
  • Diversion and theft (implementation of "Good Trucking Security Practices" to check and ensure the goods during transportation through the supply chain).

Pharmaceutical manufacturers should establish a global and dedicated team to oversee product security. Furthermore, measures and steps are recommended when a counterfeit product or suspected counterfeit product is detected in the supply chain. The new chapter will be added to USP 36.

To view the document, you need to register for the Pharmacopeial Forum.

Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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