The big three wholesale distributors have sent at least one DSCSA communication letter to the manufacturers per year for the last three years. Last week, AmerisourceBergen (ABC) issued the 2018…
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The FDA starts serialization enforcement for manufacturers and repackagers on November 2018— just 4 months away. The rate of serialization adoption by November 2018 is anyone’s guess. Serialization Readiness According…
This year at the Healthcare Distribution Alliance (HDA)’s PCSC Educational Seminar in East Hanover, New Jersey, I had the pleasure of meeting Tony Orosz, assistant director of the Pharmaceutical, Health…
There’s been a lot of confusion about product identifiers in the pharmaceutical industry since the DSCSA was passed. In my own work with clients I get these kinds of questions…
The Falsified Medicines Directive – the overseas cousin of our Drug Supply Chain Security Act (DSCSA) that protects the European public from counterfeit, stolen, expired, and recalled drugs – became…
The good news: The worldwide pharmaceutical industry has agreed that improved patient safety and drug supply-chain integrity are vitally important goals, and serialization regulations are necessary to achieve them. The…
In year 2018, we’ll look back at 2015 and reminisce about the simplicity of lot controlled manufacturing. Under today’s lot control standards, when a lot of 50,000 is produced and…
Last week, I wrote about commissioned serial numbers and questioned whether getting only commission serial numbers from the CMO is sufficient. Before I can answer that question, let us first take…
Upcoming Webinar Global Serialization 3 of 3: A Closer Look at EU Falsified Medicines Directive (Thu, Dec 3, 2015, 11 am Eastern Time) EU Falsified Medicines Directive (FMD) became effective…
When it comes to event data for serialized products, many individuals are confused about both the events and the data. Take commissioned serial numbers for example: commissioning is the event,…