A couple of days before President Obama signed the DQSA legislation back in 2013 I published an RxTrace essay that looked at what was going to be necessary in the next year from the FDA and the industry (see “DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure“). The initial standards necessary at that time were for data exchange, and the FDA had one year to come up with them. My essay was about the need for the industry to work with the FDA to come up with the standards that would work. The FDA didn’t have the expertise or the knowledge of how the supply chain operated and so I felt it was imperative for the industry to help them out.
Fast forward to today. Rather than data exchange standards, the FDA is facing Continue reading DSCSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure, Again
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
Last week, GS1 US published a free DSCSA resource that every RxTrace reader must have. It’s called “Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA” and it can be downloaded free after registration. Do it now, then come back and finish reading this essay.
The document is 42 pages in PDF form and it Continue reading New Must-Read DSCSA Resource
Well over a year ago, my good friend Kevan MacKenzie, Director, Serialization Technology with McKesson, pointed out a really interesting discrepancy contained in the Drug Supply Chain Security Act (DSCSA) regarding the sale of non-serialized drugs. I’ve been meaning to write about it since then. The topic finally bubbled up to the top on my list.
What Kevan pointed out is that there are two sections of the DSCSA that contain slightly conflicting requirements. This leaves companies Continue reading Can Anyone Buy Non-Serialized Drugs After 11-27-2019?
Recently, several of the larger U.S. wholesale distributors have sent letters to their suppliers to review what they expect from them relative to the Drug Supply Chain Security Act (DSCSA). You may recall that these companies have provided requirements in advance of earlier DSCSA deadlines (see “U.S. Drug Wholesale Distributors Provide Direction To Manufacturers“). These expectations are aimed at the November 27, 2017 serialization requirements and beyond. Continue reading DSCSA Serialization: What Wholesalers Expect
The Healthcare Distribution Alliance (HDA) Traceability Seminar that was held back in early November was so packed with valuable information that I still have a number of topics queued up from that event for RxTrace essays in the future. Today I want to take a closer look at the results of the Saleable Returns Pilots conducted by the HDA last year to figure out the most efficient way to verify saleable returns. I discussed the overall project in my report of the Traceability Seminar (see “HDA Delivers Home Run To Record-Breaking Audience”) but today I want to focus in on just two of the approaches piloted. These are:
- Manufacturer sends to wholesale distributor product identifiers for only the units purchased by that wholesale distributor, and,
- Verification Router Service (VRS).
Continue reading DSCSA: Saleable Returns Verification
Heart Failure is a human condition that is characterized by several easily identifiable symptoms, including fatigue, difficulty breathing and in its later stages, gurgled breathing. My mother and my mother-in-law both suffered from heart failure during their decline. Analogous to heart failure in humans is a condition of an identifier system that is near the end of its useful life that we can call “identifier failure”. At the end of November, a new FDA final guidance called “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs” went into effect. Buried deep within this 200+ page document is the official announcement that signaled the National Drug Code (NDC) identifier system is now afflicted with this end-stage condition. The NDC won’t last long now, and there is no longer any excuse for inaction. The need for a replacement is now urgent. Continue reading NDC Nearing Its End, Afflicted by ‘Identifier Failure’