Global Drug Supply - Strategize Traceability Now!

I have to admit that I put on my California 'blinders' every now and then. This is one case where I got surprised to see what is going on in the global setting of drug traceability. I read this superb IndustryWeek article that frames, yet again, the pain induced when there is a general lack of harmonization, Global Drug Traceability Mandates: Why Act Now? - Should pharmaceutical companies sit back and wait for someone else to blaze the drug traceability trail? Author Brian Daleiden taps into my Californa (CA) blindspot by stating, "California decided to go one step further and include an item-level drug serialization requirement in their state mandates. Given the significant incremental investment this would require, it was no surprise when the start date for CA compliance was pushed back to 2015, giving the industry a sigh of relief. But should it? A closer look at the current domestic landscape should give pause to anyone feeling too comfortable." In a nutshell, the article's conclusion challenges us to think about whether companies are making the right decisions, "The myriad of business and regulatory issues confronting most companies along the global pharmaceutical supply chain can be daunting. Against such uncertainty, it is understandable that the temptation is to take the path of least resistance and isolate and tackle each issue as it comes. Unfortunately, it is becoming clearly apparent that the industry has reached a tipping point where this approach will no longer work. The operational costs and business risks are just too high." Global Drug Traceability Mandates: Why Act Now? - Should pharmaceutical companies sit back and wait for someone else to blaze the drug traceability trail? (displayed on one page) 

Related Posts: FDA Draft Guidance - Drug Supply Chain and SNIs FDA - Global Drug Supply Chain Needs Better Oversight CA Gov Delays e-Pedigree Mandate to 2015 CA E-Pedigree - Pedigree and Serialization FDA Draft Guidance On Good Importer Practices 

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FDA - Global Drug Supply Chain Needs Better Oversight

Updated August 3, 2024

The original link broke.

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Office of Global Policy and Strategy - FDA.gov

---  the original post follows below  ---

We're still reeling from the tainted heparin situation, and I suspect that it's only the tip of the iceberg. A rising percentage of drugs are coming from China and India, reports this ASHP News article, "World's Drug Supply Chain Needs Better Oversight, FDA Says." The associate commissioner for policy and planning at FDA is quoted, and here's a small sample of highlights . . .

• "where there are economic incentives and/or there is lax regulatory oversight, there is going to be greater opportunity for risky or criminal behavior"
• "If we have good behavior, we want to facilitate compliance. If we have risky behavior, we want to provide deterrence. And with criminal behavior, we need rapid detection and aggressive enforcement. And electronic track and trace can play an important role in it."

Previous Posts:
Gambling With Life - Counterfeit Drugs - Like ED Drugs (Viagra)
Counterfeiters Can Get Life In Jail

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CA Gov Delays e-Pedigree Mandate to 2015

Here's the latest update on the CA e-Pedigree situation, as reported in this The MQN Weekly Bulletin news brief, "Schwarzenegger Terminates 2009 ePedigree Deadline." Here are the main points . . .

• Under the new law, a manufacturer must have an epedigree by 2015 for 50 percent of its drugs sold in California. Unit volumes, SKUs or drug product families may define the 50 percent figure.
• California Gov. Arnold Schwarzenegger has signed legislation that delays the state’s 2009 electronic pedigree mandate for prescription drugs until 2015.

Previous Posts: The Health, Drug, Prescription, and GMP Supersite: CA E-Pedigree - Pedigree and Serialization

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CA E-Pedigree - Pedigree and Serialization

In Why California (Still) Matters, a podcast interview of Adam Fein offers a quick overview of key issues regarding supply chain security, compliance costs, state versus federal legislation, and data ownership issues. This podcast nicely frames the issues before you dive deeper into the specifics surrounding California's e-Pedigree legislation.

The CA e-Pedigree situation is getting complicated as the state's serialized e-pedigree law implementation deadline is shifting from 2011 to 2015 in order to give folks affected by the law some additional time to implement electronic technology to track the distribution of drugs within the state.

Additional Resources:

1. CA State Board of Pharmacy - California E-Pedigree Law
2. CA E-Pedigree: Hasta La Vista, 2011 - a blog post by Fein

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