Two years into the 2010-2015 committee cycle, and the United States Pharmacopeia (USP) Expert Committee on Packaging, Storage & Distribution has already held 10 meetings. The committee began with reviewing all 27 chapters related to packaging, storage and distribution, and after deleting and combining a couple of chapters, skinnied the menu down to 24, with two new chapters on the way. The committee has initiated work on 75% of these chapters and to date have completed a third of them. Additionally, several smaller sub-groups within the Expert Committee have coordinated their individual activities and, as of this writing, are actively working on eight General Chapters concurrently. While diverse in their scope and content, with a broad range of topics like sterile product packaging integrity and evaluation to determining leachable thresholds of plastic primary packaging, three specific chapters are of great interest to those involved in the transport of temperature-sensitive products:

• Good Storage and Distribution Practices for Drug Products
• Monitoring Devices – Time, Temperature and Humidity
• Good Distribution Practices – Supply Chain Integrity

The first two chapters listed are revisions to existing guidance; the third , is a brand new chapter.

The long awaited revision to General Chapter has undergone a major rewrite during the past few years and received more than 160 comments from industry last summer when it was posted in Pharmacopeia Forum (PF) 37(4). The last of those comments were reviewed by the nine-member workgroup within the Expert Committee (EC) by late January in order to prepare the document for ballot in February. The chapter will appear in the USP 35-NF 30 Second Supplement and become official December 1, 2012.

Significant changes are also in store for as temperature and humidity monitoring technologies and devices have dramatically evolved and new ones have emerged since the chapter was last updated. A draft of the document appears in PF 38(3) released earlier this month, and public comments will be accepted until July 31, 2012. If approval is granted on the USP ballot in October, the revised chapter is expected to become official August 1, 2013.

In April, the FDA issued warnings to healthcare professionals that an adulterated version of the cancer drug Altuzan was introduced into the U.S. drug supply chain. A month earlier, fake vials of another cancer drug, Avastin, surfaced in three states. In both instances their pedigree proved dubious, complements of convoluted wholesale re-importation practices and lack of controls, which resulted in an easy back-door entre into the legitimate drug supply chain by those with little or no moral conscience. And while the debate over whether the re-importation of what are thought to be American-made drugs back into the U.S. is a threat to national security, degenerate profiteers continue to exploit the system. The FDA’s stance has been that imported and reimported drugs can’t be guaranteed to be safe. Studies have shown that a significant percentage of drugs thought to be made in America and reimported are actually counterfeit, ineffective or even toxic. In one sting operation in 2003, for example, FDA and Customs officials found that 88% of the imported drug packages they inspected did not meet FDA safety standards.

It is timely then, that as the media highlights that fact that the pharmaceutical supply chain is growing increasingly complex, so are the risks to drug quality and safety. More attention and resources need to be focused on securing drug products to assure their authenticity and integrity as they make their way through the supply chain. 

To that end, the USP Expert Committee on Packaging, Storage & Distribution has developed a new general chapter Good Distribution Practices – Supply Chain Integrity, which was recently published in PF 38 (2), March-April, 2012. The document is posted on the USP website and is available for public comment until May 31, 2012. This new chapter offers best practices for industry to help ensure the integrity within key areas of the supply chain, ultimately providing greater protection to consumers from poor-quality and counterfeit medicines.

In conjunction with the development of the new general chapter, the USP is hosting a Supply Integrity Workshop at USP Headquarters in Rockville, Maryland on May 22-23, 2012. Participation in the workshop is intended for any and all stakeholders interested in securing the pharmaceutical supply chain. This includes: raw material and ingredient suppliers, manufacturers, wholesalers/distributors, re-packagers, physicians, pharmacists and Regulatory Agencies). By fostering conversation among stakeholders, the USP hopes to gain further industry insight and perspectives, make improvements to the chapter and focus on future USP initiatives.

Additional work by the Expert Committee extended to General Chapter on Good Distribution Practices for Bulk Pharmaceutical Excipients which appeared in Pharmacopeia Forum 37(6). And in their effort to extend their focus on expanding global cooperation, participation and influence, the USP also co-led a supply chain conference in Mumbai, India where a joint IPC-USP Scientific Conclave was held in February in conjunction with the 11th Science & Standards Symposium on Global Quality Standards for Biologicals and Supply Chain Management.

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Kevin O’Donnell is a senior partner at Exelsius Cold Chain Management – U.S. He serves as chair for the International Air Transport Association (IATA) Time & Temperature Task Force, is a member of the USP Expert Committee on Packaging, Storage and Distribution, and is a temporary advisor to the WHO. He blogs at www.clutchcargo.us. He can be reached at kevin.odonnell@exelsius.us.