I've had a spate of inquiries regarding USP General Chapter <1079> lately and since my flight from Chicago is delayed by more than three hours this evening, I thought now would be a good time to address them.

First, some background... the United States Pharmacopeia (USP) is an independant, science-based public health organization. They are the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States. USP sets standards for the quality of these products and works with healthcare providers to help them reach the standards. USP's standards are also recognized and used in many other countries outside the United States. In other words, they make the rules and the FDA enforces the rules.

In June, 2005, the USP published General Chapter <1079> Good Storage and Shipping Practices. It is a general information chapter "intended to provide general guidance concerning storing, distributing, and shipping of Pharmaceutical preparations." This 'general guidance' applies to warehouses, pharmacies, freight service providers, repackagers and shipping docks, in addition to manufacturers of pharmacopeial products. In essence, anyone in the cold-chain custody.

"It is meant to inform" says Claudia Okeke, Associate Director Information & Standards Development , USP and member of USP Expert Committee on Packaging, Storage and Distribution. 

It is important to note that guidance is not enforcable by law. However, with limited guidance in cold-chain storage and distribution, the FDA makes significant use of USP's guidance. Since USP sets the bar when it comes to standards, can enforcable action be far behind? On the surface, <1079> seems reasonable and thorough. But it is not without hardship and impractibility to the industry.

This is why groups like the PCCDG, the C3 and Pharma Logistics Forum, etc., are so important to industry. Who better than industry knows what are the best current practices? Or what the limitations of technology are? What's practical? What's needed?By working with USP and FDA, industry can have direct influence and impact on regulation that can affect the future of cold-chain.

More on this later. My flight will soon be boarding. With any luck, I'll make it in to Philadelphia by midnight...