This morning the FDA announced their intention to publish the long overdue draft guidance on Drug Supply Chain Security Act waivers, exceptions and exemptions tomorrow. The timing of the publication of this particular draft guidance is critical to the FDA holding their current enforcement deadline for serialization and verification for manufacturers and repackagers. In fact, if they had failed to meet their late May deadline for publication of this particular draft guidance Continue reading FDA To Publish Key Draft Guidance Tomorrow
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?
Back in October the FDA announced the extended use of enforcement discretion to temporarily set aside the data exchange provisions of the Drug Supply Chain Security Act (DSCSA) for dispensers until March 1, 2016 (see “FDA Extends Dispenser Delay in DSCSA Enforcement“). That was itself an additional four month extension to the four month enforcement discretion they originally announced on June 30 (see “FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015“). Many dispensers were hoping for another extension in these last few days of February. It turns out, the enforcement discretion will be extended until further notice, but apparently mostly just for first responders. Continue reading FDA Limits Ongoing Dispenser Enforcement Discretion To First Responders
Congress set the calendar for many different kinds of requirements when it adopted the Drug Supply Chain Security Act, signed by the President back on November 27, 2013. One of those dates was last November 27, 2015, two years after enactment, when the FDA was required to publish four new draft guidances. So far, none of them have appeared (see “FDA DSCSA Deadline Passes Quietly”). Continue reading Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?
Right now we are waiting for major new announcements regarding serialization and tracing requirements in the United States (4 overdue FDA guidance documents), the European Union (final publication of the Delegate Act related to the Falsified Medicines Act), Brazil (major redesign of their regulation), and Russia (first official publication of their regulation). But last week, the India Directorate General of Foreign Trade (DGFT) published a new public notice containing details of the “Implementation of the Track and Trace System for Export of Pharmaceuticals and Drug Consignments”. These details are for drugs made in India but exported to other markets. Continue reading India Posts New Deadlines (Again) For Serialization Of Drug Exports
I hope your holidays were filled with love and cheer. Mine were. It was great. So great, in fact, that I did not have time to write a brand new essay for today. Not much has happened lately since we are still awaiting publications from the FDA, the EC and ANVISA (and others), Instead, here is one of my best essays from 2015, reposted as it appeared on August 31, 2015 without modification (see “An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?“). I’m even leaving in the off-season references. If you read this essay back then, you might enjoy it again. If you did not read it back then, I recommend that you read it now. Let me know what you think.
Before we begin, if you have not yet responded to the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz, please to so now. It is open to everyone and the survey will be closed soon.
The industry is rife with rumors that Brazil’s ANVISA has made the decision to push out their serialization deadline for multiple years—and perhaps redefine the requirements. I cannot confirm any of these rumors at this point and I do not recommend acting on rumors. I suggest you continue down the path of meeting the existing, known regulation until—if ever—you get the official word from an official publication of ANVISA. Who knows when that might occur. If/when you see something official, let me know. Continue reading Sponsored: Pharma Serialization Deadlines In Flux
How are you? I’m sure your summer has been busy, just like mine. Hope you were able to get at least some time away. I’ve taken most Saturdays off, but the other days of the week have been very full with consulting, and then writing RxTrace essays every Sunday. You know, the wife is not very happy about that!
The reason I am writing directly to you at this time is to ask a question that I hope you are asking yourselves and planning ahead for. Continue reading An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?