Tag Archives: DQSA

3 DSCSA Requirements You Can Totally Ignore

The Drug Quality and Security Act (DQSA) was constructed back in 2013 by Congressional staff, with input from the FDA, members of the industry and who knows who else.  There was one bill in the House of Representatives and a different bill in the Senate.  Once these bills passed their respective houses, they formed a conference committee who merged the two bills into the final text that we know today as the DQSA (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”).  Chapter 2 of that act is the Drug Supply Chain Security Act (DSCSA).  Most readers of RxTrace haven’t forgotten that history but it is important to look back at that history to explain why most companies can ignore certain requirements in the law.  That’s right.  There are requirements in the law that you can ignore because they will not be enforced by anyone.  They are the result of the disjoint way the DQSA was written.  Let me explain. Continue reading 3 DSCSA Requirements You Can Totally Ignore

FDA Publishes DSCSA Grandfathering Guidance Exactly 2 Years Late

Today is November 27, 2017, the four year anniversary of President Obama signing the Drug Quality and Security Act (DQSA) into law (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), and it is the two year anniversary of the due date for the FDA to publish four guidance documents—one of the four on grandfathering (see “FDA DSCSA Deadline Passes Quietly”).  And today they have finally met that requirement, for grandfathering at least.  One overdue Drug Supply Chain Security Act (DSCSA) guidance down, three to go (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”, “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?“, and “”).  (The DSCSA is Part 2 of the DQSA.) Continue reading FDA Publishes DSCSA Grandfathering Guidance Exactly 2 Years Late

DSCSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure, Again

iStock_000021010135XSmallA 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

DSCSA Verification and Suspect Product

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

New Must-Read DSCSA Resource

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

Can Anyone Buy Non-Serialized Drugs After 11-27-2019?

Image of a package of non-serialized drugsWell 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?

Sponsored: How To Properly Define GTINs For Your NDCs

Image showing relationships of define GTINs
Packaging Hierarchy. Drawing by Omega Design

RxTrace readers are well aware that the deadline is this November 27 for applying unique serial numbers within GS1 DataMatrix 2D barcodes to prescription drugs distributed in the United States under the Drug Supply Chain Security Act (DSCSA).  Once that happens, most prescription drugs entering the U.S. supply chain will be identified by 14-digit GS1 Global Trade Item Numbers (GTIN-14) for the first time (see “Anatomy of a GTIN”).  That’s because, you can’t fit the drug’s National Drug Code (NDC) along with the serial number, lot number and expiration date into a data matrix barcode, as required by the law, without first encoding it into a GTIN-14 (see “Anatomy Of The National Drug Code”, and “Depicting An NDC Within A GTIN”).  This fact forces companies to encode their NDCs into GTIN-14s, many for the first time. Continue reading Sponsored: How To Properly Define GTINs For Your NDCs

DSCSA Serialization: What Wholesalers Expect

Image of McKesson's sign on their corporate headquarters building in San Francisco, CARecently, 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