The FDA published a new draft guidance yesterday with explanations intended to dispel various kinds of confusion over the five kinds of trading partners defined in the Drug Supply Chain Security Act (DSCSA) text. They are clearly on a roll, with the combination of the recent draft compliance policy, pilot and public meeting announcements, and now this draft guidance exceeding all of the DSCSA-specific communications they produced last year. We’ll know for sure that the logjam has been cleared when we finally see one of the four mandated guidance documents that were originally due on November 27, 2015 (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?“). But what about this new one? Continue reading Identifying Trading Partners Under the DSCSA→
This week, IQPC released the final report of a very interesting survey they conducted in April through June this year. The results are fresh and they paint a picture with good news, and not so good news about the readiness of pharmaceutical manufacturers facing serialization deadlines in the United States, the European Union and elsewhere. The survey focused on serialization planning, implementation progress, traceability in operation and benefits beyond compliance. You can download the full report here, but let’s take a look at the responses to just one of the questions they asked. Continue reading Sponsored: How Long Until You Are Fully Serialized?→
Last week I wrote about the debate over the number of possible responses to verification requests in any potential solution the industry might adopt to meet the Drug Supply Chain Security Act (DSCSA) (see “DSCSA Red Light Green Light: Verification Responses”). Today I want to take a closer look at a related issue: the relationship between verification and suspect product. Most specifically, does a failed verification automatically force a product into the suspect product category? The answer might surprise you. Continue reading DSCSA Verification and Suspect Product→
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 people on each side are surprisingly passionate about their positions. Let me explain. Continue reading DSCSA Red Light Green Light: Verification Responses→
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.