There are a number of misconceptions floating around the industry right now about what will happen in November of 2023, when the Enhanced Drug Distribution Security (EDDS) phase mandated by the Drug Supply Chain Security Act (DSCSA) begins. It is surprising where you hear some of these, but they are all based on mis-reads of the DSCSA law itself. I’ll explain the myths, and then I will try to provide extracts from the DSCSA that expose them as myths. Continue reading 5 Myths About The DSCSA In 2023
China once had one of the most aggressive pharma serialization mandates of any market. Their compliance timeline began in 2007 with a list of “essential drugs” and ended in January of this year when, effectively, all drug packages were required to carry a unique serial number. Shortly after that milestone the government suspended that requirement, pending a new regulation. Since that time the China Food and Drug Administration (CFDA) has posted several documents related to their new plans (see “China Adds Traceability Requirement To CFDA Drug Quality Management Specification”). Last month a new notice from the CFDA Continue reading China’s Retreat From Pharma Serialization: Will This Become A Global Trend?
Last week I wrote about the recent FDA DSCSA Public Meeting where the FDA asked for reports on the progress of the industry toward meeting the November 27, 2017 serialization requirements contained in the Drug Supply Chain Security Act (DSCSA) (see “FDA Forfeits Opportunity To Guide Industry”). In that essay I expressed a view that the FDA has squandered too much of the time necessary for the industry to meet whatever guidance they might offer about grandfathering and exceptions for products that are too small to accommodate a DSCSA product identifier. These guidance documents are now 11 months late.
What if the delay in publishing these guidance documents is intentional? Continue reading Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?
I hope you were able to attend last Friday’s FDA DSCSA Public Meeting at FDA’s White Oak, Maryland campus (see “FDA To Hold DSCSA Public Meeting”). If you missed it, make sure you listen in on the recording that the FDA will provide on the event webpage. You can also submit written comments through that page as well. The event was called “Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act (DSCSA)” and it consisted of very brief introductory comments by the FDA followed by presentations made by attendees who applied for a speaking slot. Presentations covering progress toward the November 27, 2017 DSCSA serialization requirements were made by: Continue reading FDA Forfeits Opportunity To Guide Industry
The 4th Pharmaceutical Traceability Forum will occur on November 30 through December 2 in Philadelphia. Two of the top speakers will be Matt Sample, Senior Director, Secure Supply Chain from AmerisouceBergen, one of the “Big-3” wholesale distributors in the United States, and Christopher Howell, Senior Director, Global Engineering and Technology from Patheon, one of the largest pharma contract manufacturers in the U.S.. Recently, IQPC conducted an interview of both of these supply chain thought leaders. Get a copy of the interviews here. Continue reading Sponsored: Interview With Two Pharma Supply Chain Thought Leaders
I am writing this from Mumbai India where I am scheduled to speak at the Systech Uniquity Conference, but I will be home by the time you read this. I just won’t have time to publish a new essay this week due to the incredibly long flights I need to get home. So, here is a re-posting of a great essay from May 9, 2016.
Medical convenience kits are exempt from the Drug Supply Chain Security Act (DSCSA). But be careful. Continue reading DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?…Again
Most RxTrace readers are at least aware of GS1 standards. GS1 is an international non-profit membership organization that facilitates the development and maintenance of technical standards that are intended for use within supply chain operations and interactions. GS1 standards are used in many supply chains including pharma. GS1 standards are playing an indispensable role in the implementation of pharma serialization, including their GTIN, GLN, SSCC, Datamatrix, application identifier and EPCIS standards. I have written frequently about GS1 and these specific standards (see “GS1”).
But today I want to draw your attention to a different standards development organization Continue reading The Open Serialization Communication Standard (Open-SCS)
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.