This years TRAX Conference Pharmaceutical Supply Chain Integrity, August 7-9, 2006 at the Ritz Carlton Tyson's Corner in McLean,VA produced two clear and significant themes - the tone of which can be summed up in the opening remarks from Leonardo DeCandia, Senior Vice President, Supply Chain Management for AmerisourceBergen Corporation.

"If you are not 100% committed to responsibly provide the delivery of drugs and therapies to the patients who need them, then get out of my industry."

The event began with a one-day symposium on cold-chain: delivering new guidelines on the proper handling of temperature sensitive goods, an interactive session that featured presentations on USP Guidelines, the evolving distribution model for temperature sensitive products, understanding bottom line costs in thermal packaging and case studies on methods for qualifying refrigerated trucks.

Among the messages gleaned from the conference by my colleagues and other delegates are:

- Changes in "cold chain" guidelines and regulations are eminent and are predicted to have a significant impact on the supply matrix of pharmaceutical wholesalers and distributors.

- Pharmaceutical manufacturers are expanding their acceptance of responsibility and accountability of their products through the supply chain. They are tightening their "terms of sale" to include thermal packaging compliance in an effort to mitigate their liability and exposure to a changing environment.

- Pharmaceutical manufacturers scope of concern is forcing them to "re-qualify" their distribution partner’s logistics practices, establishing exclusive sourcing agreements for sustained business or potentially "interrupted/discontinued" representation for non-compliance.

- Some distributors continue to openly admit that they are "guessing" at their cold chain packaging practices. That they "do not know how to pack out" or "validate" their packaging and that audits by drug manufacturers note this as a serious and significant deficiency.

- One pharmaceutical company (name removed) has undergone two separate FDA audits this year specifically targeting temperature sensitive distribution practices. No 483's were issued. However, recommendations were made by the agency requiring a corrective action response. The document the agency used as reference to identify the deficiencies was <USP 1079>.