The final report of the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz is now available. Download the full free report here. With this year’s survey we attempted to get a glimpse of the progress toward the next deadlines of the Drug Supply Chain Security Act (DSCSA) from drug manufacturers, repackagers, wholesale distributors, 3PLs and dispensers. Each of those different types of respondents were asked a different set of questions that were pertinent to their segment and their regulatory requirements under the DSCSA.
This is a “sponsored” essay, which simply means it is free to everyone and does not count against their one free essay per month for those who are not full subscribers. The reason for that is to maximize the number of people who have the opportunity to tell the FDA how they are progressing toward the DSCSA serialization deadline, and do so anonymously. Continue reading Sponsored: Tell The FDA About Your Progress Toward The DSCSA Serialization Deadline, Anonymously
This year’s results were very interesting because most of the responses came in during the critical time just before the 2015 DSCSA requirements were to go into effect. The questions asked were designed to elicit opinions on a wide range of topics, including the respondent company’s ability to meet the regulations on time, their technology choices and practices. This year Continue reading 2015 RxTrace U.S. Pharma Traceability Survey Results, Sponsored by Frequentz Now Available!
For the second year in a row RxTrace is partnering with Frequentz to conduct a survey about U.S. Pharma Traceability. This year the survey has been improved with separate sets of questions for each segment of the supply chain and also for companies who are not actual supply chain members. The survey asks questions about the readiness of companies for the 2015 requirements of the DSCSA as well as preparations for the 2017 serialization requirements. A few of the questions are the same as last year so we can track any change in thinking.
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 bundles are contained within which serialized cases and then which cases are contained on which serialized pallet, etc.
You can’t expect to give a couple of workers a handheld barcode reader and expect them to produce six sigma aggregation data. It is possible to collected highly accurate aggregation data (see “Pharma Aggregation: How Companies Are Achieving Perfection Today”), but it requires systems specifically designed to do so. The now obsolete California pedigree law did not Continue reading Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says…
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 the serial numbers and pedigrees. Of course, everyone should be aware by now that the U.S. Drug Quality and Security Act (DQSA) preempted that law and all State and Federal pharma serialization and pedigree laws, and replaced them with new Federal requirements that have a different rollout timeline.
The track and trace provisions of the DQSA are defined within Title II of that act, known as the Drug Supply Chain Security Act (DSCSA). Some of its provisions begin next January. Some start in November of 2017 and some start in 2023. Continue reading DQSA: Did The Authors Get The Timeline Right?
With the enactment of the Drug Supply Chain Security Act of 2013 (DSCSA) last week (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“) I have decided to conduct an annual survey of U.S. pharma traceability preparedness. You can fill out the survey by clicking on this link: Take the 2014 RxTrace U.S. Pharma Traceability Survey Now.
The answers you provide anonymously will be aggregated to provide a view of the thinking of the industry, solution providers, regulators, academics and more, in addition to a view of the preparedness of the industry to meet the new federal pharmaceutical traceability law. Please make sure your company is represented in the data that is collected. The survey is Continue reading Announcing The 2014 RxTrace U.S. Pharma Traceability Survey