Search Results for: DSCSA

DQSA of 2013

DQSA: How Should Transaction Data Be Exchanged?

The U.S. FDA just published a docket asking for public input into standards for the interoperable exchange of information for tracing of human, finished, prescription drugs in paper or electronic format.  Ironically, they will accept responses to the docket in either paper or electronic format.  Comments should be submitted to the FDA within 60 days.  … Continue reading DQSA: How Should Transaction Data Be Exchanged? →

DQSA of 2013

DQSA: Dancing Around The Returns Problem

There is an interesting dialog going on in the Food and Drug Serialization Professionals group in LinkedIn that was kicked off by a recent RxTrace essay.  Click here to see the conversation.  It got real interesting when Marc Rosenblatt, Director of Sales at Veracity Network, related an experience his company had in a recent pilot.  … Continue reading DQSA: Dancing Around The Returns Problem →

RxTrace Traceability Survey

Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says…

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One of the most intense questions about any serialization mandate is whether or not manufacturers would be required to pass “aggregation data” to their customers.  “Aggregation data” is the serial number-based packaging hierarchy of the shipment.  That is, a list of the package-level serial numbers that are contained in each serialized bundle, and then which … Continue reading Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says… →

RxTrace Traceability Survey

DQSA: Did The Authors Get The Timeline Right?

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In the last update by the California Legislature, the timeline for the rollout of the California pedigree law was spread out so that it was to take 2 ½ years from the first manufacturer deadline for serialization of 50% of their product until everything was serialized, pedigreed and wholesalers and pharmacies were making use of … Continue reading DQSA: Did The Authors Get The Timeline Right? →

DQSA of 2013

How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2

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Last week I published an overly long essay about how the supply chain provisions of the new U.S. Federal DQSA will and won’t protect the pharma supply chain.  Believe it or not, I had more to say on the subject, but because that essay was already too long, I withheld my additional thoughts until now.  … Continue reading How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2 →

DQSA of 2013

How the DQSA Will–And Won’t–Protect The Supply Chain, Part 1

The supply chain provisions contained within the Drug Quality and Security Act (DQSA)—themselves known as the Drug Supply Chain Security Act (DSCSA)—mark a significant achievement by Congress and the industry to protect the U.S. pharmaceutical supply chain from criminals.  It is the first completed attempt since 1987 when the Prescription Drug Marketing Act (PDMA) was … Continue reading How the DQSA Will–And Won’t–Protect The Supply Chain, Part 1 →

DQSA of 2013

Don’t Skip The DQSA Definition of Terms Section

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Lots of people across the U.S. pharma supply chain are spending their spare time these days trying to read and understand the U.S. Federal Drug Quality and Security Act (DQSA) that was enacted in November and begins to take effect in a significant way next January (see “It’s Official, President Obama Signs H.R. 3204, DQSA, … Continue reading Don’t Skip The DQSA Definition of Terms Section →