The California Board of Pharmacy has posted the agenda for the upcoming 3/14 meeting of the Enforcement Committee and Public Meeting on E-Pedigree.

E-Pedigree Agenda Topics

• SNI: Update on proposed regulations to implement serialized numeric identifiers
• Grandfathering: Update on proposed regulations for identifying drugs which may be shipped into CA after the Jan 1, 2015 deadline without serialization and ePedigree
• 50 percent calculations: Proposed regulations on calculating the 50 percent of products each manufacturer must serialize and ePedigree by Jan 1, 2015
• Inference: Update from the Board on their proposal for regulations concerning the use of inference. Read our notes from the Feb. 2013 BoP meeting on Inference.
• Drop Ship: Discussion on the use of drop shipments in the supply chain and their ePedigree requirements
• Implementation Timelines: Presentations and questions from pharma supply chain participants on their readiness to meet the staggered implementation timeline as laid out in California state law
• Certification Process: Discussion on the certification process to comply with the ePedigree law

TraceLink will be there capturing the discussion and providing a summary for our industry friends. Here is the link to the official PDF of the meeting and agenda.

NOTE: Our CA Board of Pharmacy LIVE Q&A webinar (3/20) will bring out many of the answers and discussions which went on at the meeting. So join us!

Posted by Brian Daleiden | Comments (0) | Trackback (0) | Permalink

In the last five years we have seen a very rapid growth in recalls and drug shortages. The ramifications are not only a lack of life saving drugs for patients but also a rise in drug prices and counterfeiting. The recent issues with Avastin counterfeits and Doxil supply shortages clearly indicate the problem is growing and becoming more life-threatening. The situation keeps getting worse and the root causes need to be understood and addressed.

In parallel, we have seen the biopharmaceutical supply chain undergo massive changes based upon a fundamental change in the business model and organizational structure. Historically, biopharmaceutical companies were predominantly vertically integrated where they owned their own active pharmaceutical ingredient and bulk product manufacturing plants as well as their own packaging plants. In recent years, however, supply has become globalized and production virtualized. This has rapidly created a significant increase in the inherent risk in the supply chain. Products can now be manufactured in stages from all over the world and through a network of complex relationships. While the manufacturing network has grown in complexity the global distribution network has substantially grown in volume. China, India, Brazil and Turkey are all major growth markets, however their distribution networks are inherently vulnerable to diversion and counterfeiting. The US and EU markets are also threatened by the larger global distribution market with the diversion of counterfeits through importation or distributors engaged in illegal practices.

In order to address the growing risks in the supply chain, biopharmaceutical companies need to maintain the oversight of and collaboration with manufacturing partner companies as if they were their own plants. Many urge even greater visibility and tracking since partner companies have to manage the needs of multiple customers simultaneously. Coordination and visibility across the entire production lifecycle, including visibility into production status, quality reviews, material availability and current inventory levels, are essential to maintain the supply of quality products to the market. From a distribution perspective, China, India, Brazil and Turkey are now requiring both serialization and track and trace of products. The goal is to empower the pharmacist, the clinician and even the patient with the tools to verify the authenticity of the product before dispensation or administration. The US and EU are also moving towards comprehensive adoption of serialization, track and trace with authentication.

At TraceLink, we are working with major biopharmaceutical companies to address the need for superior collaboration, visibility, track and trace in order to achieve the supply quality, capacity and integrity required by the industry. Our approach is to create tight collaboration between supply planning, quality, logistics and manufacturing across companies in order to deliver quality products on-time and in-full. Our track and trace solutions use emerging GS1 standards being adopted by almost all countries for ePedigree and authentication delivered either through enterprise integration or mobile solutions available to patients via iPhone, Android or SMS phones.

With rapid adoption of the solutions that the industry has been developing, we can eliminate drug shortages and counterfeits from our global supply chain.

Posted by Shabbir Dahod | Comments (5) | Trackback (0) | Permalink