What’s So Hard About Unique Identifier Verification?
Verification is arguably the most important concept in drug serialization and tracing regulations. What makes it so hard to get right?
Search Results for: wholesaler verification
A US Medicines Verification Organization (USMVO)? Again
Should the US pharma supply chain stakeholders create a National Medicines Verification Organization like the EMVO?
A US Medicines Verification Organization (USMVO)?
Should the pharma industry create a US Medicines Verification Organization (USMVO) to help expedite the development of the electronic, interoperable systems that will be necessary by 2023?
DSCSA Verification and Suspect Product
Does a failed verification automatically force a product into the suspect product category? The answer might surprise you.
DSCSA Red Light Green Light: Verification Responses
There is an important debate going on over the last 9 months regarding exactly how many different answers companies should prepare to provide in response to a DSCSA verification request. Some say two: “Red light” or “Green light”. And others say three: “Yes”, “No”, or “It’s Complicated”. This might seem like a minor question, but … Continue reading DSCSA Red Light Green Light: Verification Responses
DSCSA Serialization: What Wholesalers Expect
Recently, several of the larger U.S. wholesale distributors have sent letters to their suppliers to review what they expect from them relative to the Drug Supply Chain Security Act (DSCSA). You may recall that these companies have provided requirements in advance of earlier DSCSA deadlines (see “U.S. Drug Wholesale Distributors Provide Direction To Manufacturers“). These expectations … Continue reading DSCSA Serialization: What Wholesalers Expect
DSCSA: Saleable Returns Verification
The Healthcare Distribution Alliance (HDA) Traceability Seminar that was held back in early November was so packed with valuable information that I still have a number of topics queued up from that event for RxTrace essays in the future. Today I want to take a closer look at the results of the Saleable Returns Pilots … Continue reading DSCSA: Saleable Returns Verification
Drug Verification: EU Vs US
Drug verification is at the heart of most pharma serialization regulations. It is the point at which someone in the supply chain or a patient uses the unique identifier on the drug package to determine that the drug is probably authentic, or definitely is not. We can tell a lot about the intent of a … Continue reading Drug Verification: EU Vs US
