Apparently, the National Agency of Sanitary Surveillance (ANVISA), Brazil’s pharma regulatory body, has passed a resolution that finally suspends all remaining serialization deadlines that were left over in their old RDC-54 regulation. Remember that they suspended the deadline for the 3-lot pilot from RDC-54 last year (see “The Official Suspension of the Three-Lot Pilot in Brazil“). I consider this news to be a “rumor” only because I have not yet seen the official word, despite having heard it from a very reliable source.
While I was preparing a DSCSA resource list to be handed out at the Systech Uniquity event in Mumbai next week I stumbled across a document that the FDA recently posted on their website. It is a template for a DSCSA-specific information sharing agreement that is aimed at state agencies, like state boards of pharmacy and probably state’s attorneys’ offices and state bureaus of investigation, etc. The DSCSA contains several clauses that imply data sharing between the FDA and “…appropriate Federal or State official[s]”.
The problem is, the data that would likely need to be shared Continue reading FDA Posts DSCSA-Specific Information Sharing Agreement Template For State Agencies
The FDA is almost 10 months behind in the release of guidance documents for the Drug Supply Chain Security Act (DSCSA) as scheduled by Congress (see “FDA DSCSA Deadline Passes Quietly”, “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”, “FDA Speaks At GS1 Connect”, and “FDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances Expected”). So far this year the FDA has held one public meeting to collect public and stakeholder input on the pilot that the law mandates (see “FDA To Hold DSCSA Pilots Workshop”, and “The 2016 FDA Pilots Workshop”). The DSCSA requires the FDA to hold at least five public meetings “…to enhance the safety and security of the pharmaceutical distribution supply chain and provide for comment.”
This morning, the FDA announced Continue reading FDA To Hold DSCSA Public Meeting
There are lots of mistakes a company can make when designing their solution to comply with pharma serialization and tracing regulations. One of these is to print the unique identifier on the outsert attached to their packaging. An “outsert” is a tightly folded piece of paper that contains very detailed prescribing information intended to inform medical professionals who prescribe, dispense and/or administer the drug. It contains Continue reading Serialization Mistake #1: Printing On Your Outsert
The government of Brazil is trying to recover from the poor design of their first attempt at a pharma serialization and tracing regulation, RDC-54/2013. That first regulation was at least partially suspended (see “Brazil Suspends Pharma Serialization And Tracing Requirements” and “The Official Suspension of the Three-Lot Pilot in Brazil”). Everyone seems to be operating under the assumption that the entire RDC-54-2013 will be replaced with a new regulation. Legislation to do exactly that has been slowly churning its way through the Legislature for the last 9 months. Word came last week that Continue reading Proposed Pharma Serialization Regulation Progresses in Brazil