On Feb 15-16, FDA held a public workshop, “Determination of System Attributes for the Tracking and Tracing of Prescription Drugs,” which was attended by manufacturers, distributors, pharmacy representatives, government groups, and suppliers of software and technology.
In February 2011, the European Parliament adopted the “Falsified Medicines Directive.” The legislation is intended to protect EU citizens from falsified medicines, which are defined as products that “may contain ingredients in the wrong dosage or no active ingredients at all.” A distinction is made between “falsified medicines” and “counterfeit medicines,” which are defined as “medicines that do not comply with EU law on intellectual and industrial property rights, such as registered trademarks or patent rights.” According to a mem
There is a growing need for creative out-of-the-box technologies that prevent a rift in patient safety while keeping a company’s investments and reputation in good standing. Counterfeiting, diversion, the resale of expired products, and complexities within the supply chain are forcing the healthcare industry to seek ahead-of-the-curve security packaging.
The generic pharmaceutical company Alvogen Inc. (Parsippany, N.J.) introduces the AB-1 rated Nitroglycerin Transdermal Delivery System, which is available in patient-ready, 30-count cartons and includes several key packaging features designed to improve care. Some of these features are RSS barcoding on each individual unit; the smallest available patch sizes of any generic nitroglycerin system; and hypoallergenic, transparent patches.
Covectra announces a new offering for Contract Service Providers (CSP) working in the pharmaceutical space. The company’s new CSP Serialization Gateway solution allows CSPs to simplify serialization and event data exchange between CSP sites and multiple brand owners. The turnkey solution offers CSPs the opportunity to serialize selective products for customers who may not already have a mass serialization program in place.
Brazil’s schedule for establishing serialized packaging has been side-tracked, as industry debates what the program should look like.
The country’s regulatory authority, ANVISA, has outlined requirements for a traceability system, following national legislation that sets out an aggressive three-year time table for a full track-and-trace solution.
If you are inspecting packages and storing the results of those inspections in an event repository to track package compliance, you may be closer to a track-and-trace model than you first thought. “It is the same basis that allows you to build up for track and trace,” explains Niall Carty, vice president of marketing & business development, Crest Solutions. “It is all about feeding data up to an ERP environment.”
In June, Victoria Espinel, Intellectual Property Enforcement Coordinator (IPEC), Office of Management and Budget, testified before Congress about drug counterfeiting. Her office is establishing an interagency committee to combat counterfeiting, and her team will take on unlicensed Internet pharmacies and counterfeit drugs both in the United States and around the globe. “And to further guard against the proliferation of counterfeit drugs, we will increase our enforcement efforts and cooperation with relevant agencies, including CBP, DEA, and FDA,” she testified.