There is now little doubt that the Falsified Medicines Directive (FMD) will need to be delayed. The only question is, how will they do it? Let’s look at some facts and try to come up with a possible answer. Continue reading How Will They Delay The FMD?
As you are already well aware, the FDA is long overdue to publish four different guidance documents covering various aspects of the Drug Supply Chain Security Act (DSCSA), as mandated by Congress (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”). At least two of those guidance documents would affect how companies should expect to comply with the serialization deadline on November 27, 2017.
If the FDA doesn’t publish on or before that date, does that mean you don’t need to comply on time? Can you just sit back and wait for the FDA to post those guidance documents someday? I don’t think so. Here’s why. Continue reading InBrief: Why The DSCSA Will Be Enforced Even Without FDA Guidance
Last week I listened in on a Drug Supply Chain Security Act (DSCSA) call hosted by one of the Big-3 U.S. wholesale distributors. It was a well-run call that included several presentations and a Q&A session. Several times the question was discussed about whether or not the wholesale distributor would accept non-serialized product in the time between November 27, 2017 and November 27, 2019. Continue reading Who Will Enforce The DSCSA 2017 Serialization Mandate?
Drug manufacturers, contract manufacturers (CMOs) and contract packagers (CPOs) are all working hard right now preparing to meet the November 27, 2017 deadline when all prescription drugs entering the U.S. market must contain the new machine- and human-readable product identifier defined in the Drug Supply Chain Security Act (DSCSA) (see “The DSCSA Product Identifier On Drug Packages“). The date for repackagers is one year later (see “Who Is A DSCSA Repackager?”). From what I hear around the industry, some companies are going to make that date, but some will not. What will happen next for those how are not ready? I discussed this from a regulator perspective last year in one of my personal favorite essays, “An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?”, but what about from the perspective of those who will be late? Continue reading How Will The DSCSA Serialization Mandate Be Enforced After 2017?