UPDATE:FDA released a new finalized guidance document on Standards for Securing the Drug Supply Chain effective March 2010. The guidance document discusses Standardized Numerical Identification (SNI) for prescription drug packages. The new FDA guidance says in part:
“This guidance is intended to address provisions set forth in Section 505D of the Federal Food, Drug, and Cosmetic Act (the Act) regarding development of standardized numerical identifiers (SNIs) for prescription drug packages. In this guidance, FDA is identifying package-level SNIs, as an initial step in FDA’s development and implementation of additional measures to secure the drug supply chain.”
Here is a link to the guidance document:
And now here is the original post:
I think this information about the Global Drug Supply Chain is interesting. We need Good Distribution Practice if we are going to ensure drug safety. Just before the new year I paid WordPress a nominal fee to remove ads from The Blog. As I said in an early post (The Blog Reveals All) I do not receive anything from anyone for what I publish in the Blog. However, that doesn’t mean that there isn’t some good information out there from commercial sources.
A critical issue facing us is the security and integrity of the global pharmaceutical supply chain. The introduction of adulterated and counterfeit drugs is a serious issue and will take some concerted efforts to bring under control. When I was at FDA I would sometimes encounter the difficulties of maintaining the integrity of the supply chain. It is not just a question of internet pharmacies but is a serious public health problem.
I am providing a link to Pharmaceutical Technology for a discussion of this issue. Four supply chain experts from Europe and North America discuss their experiences. Also, you can look on the Blogroll under, “PharmTech Talk.” They have a wide variety of perspectives discussing different pharmaceutical issues. Oh, by the way, Happy New Year!