Last week, Connie Jung, RPh, PhD, Acting Associate Director for Policy and Communications, Office of Drug Security, Integrity, & Recalls, U.S. Food and Drug Administration, spoke about the Drug Supply Chain Security Act (DSCSA) at the GS1 US Connect event in Washington DC. This was our latest opportunity to get a glimpse of what the FDA is thinking and what they are doing. Dr. Jung spoke for about 50 minutes and then answered questions from the audience. Continue reading FDA Speaks At GS1 Connect
Yearly Archives: 2016
How RxTrace Became The Target Of A Counterfeiter
The term “counterfeit” is usually defined as an unauthorized copy of a physical thing. Here is how Dictionary.com defines it:
“[koun-ter-fit]
…
noun
3. an imitation intended to be passed off fraudulently or deceptively as genuine; forgery.”
Counterfeiters seek to expropriate the good reputation, good will and trust in a recognized brand by deceit to carve out undeserved profit or other gain. Their goal is to Continue reading How RxTrace Became The Target Of A Counterfeiter
HDMA Responds To FDA Pilots RFC
A few months ago the FDA opened two “dockets”, or Requests for Comments (RFC) to collect ideas and experiences about technology pilots related to the Drug Supply Chain Security Act (DSCSA). The first docket was associated with the FDA Public Meeting held on April 5 and 6 (see “The 2016 FDA Pilots Workshop”). The second docket was opened shortly after the Public Meeting to continue collecting the same kind of information from anyone who had already conducted their own pilots or was planning future pilots. Both dockets are now closed so here is a look at the responses. Continue reading HDMA Responds To FDA Pilots RFC
More Concerns With The FMD/EUDR Big Bang Start
The key part of Article 50 of the European Union Delegated Regulation (EUDR) says: “This Regulation…shall apply from 9 February 2019.” That’s the date of the “big bang”—the date everything takes effect. On that date, all drugs entering E.U. markets (except in Italy, Belgium and Greece) must contain the two safety features called out by the regulation on their packaging, including an anti-tamper device and a compliant Unique Identifier (see “The ‘Unique Identifier’ in the EU Delegated Act”). It is the date by which “National Competent Authorities” in each of the EU member states (except the three listed above) must offer a data repository for the covered drug products that are targeted at their local market. And it is the date on which dispensers (called “persons authorised or entitled to supply medicinal products to the public” in the text) must begin using the system of repositories to “…verify the safety features and decommission the unique identifier of any medicinal product bearing the safety features they supply to the public…”. All on the same day. The day of the “big bang”.
This “big bang” start will result in some problems. Continue reading More Concerns With The FMD/EUDR Big Bang Start
DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?
Medical convenience kits are exempt from the Drug Supply Chain Security Act (DSCSA). But be careful. Just because you and your customers have called your product “a kit” for years doesn’t mean that Congress and the FDA call it that under the DSCSA. In fact, many products that have historically been referred to as “medical convenience kits” will be treated under the DSCSA as a repackaged drug, a combination product, or worse, just a collection of device(s) and drug(s). Let’s take a closer look. Continue reading DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?
Important HDMA Webinar On Barcoding for DSCSA
RxTrace followers will want to register and listen in on the Healthcare Distribution Management Association’s (HDMA) upcoming important webinar on May 19, 2016 from 1:00 to 2:00pm EDT. The webinar will cover the new changes to their “Bar Coding Quick Start Guide” for compliance with the U.S. Drug Supply Chain Security Act. HDMA originally published this document back in 2014 (see the HDMA’s website) but they are expected to publish an updated version of it any day now. I checked the HDMA website last night and did not see the new version, but with the scheduling of this webinar, odds are it will be made available to the public between now and May 19.
When that document becomes available Continue reading Important HDMA Webinar On Barcoding for DSCSA
Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 2
Part 1 of this essay provided a wealth of hyperlinks into the Code of Federal Regulations (CFR) and FDA guidance documents with content related to placing the National Drug Code in human- and machine-readable form onto drug packages prior to November 27, 2017 (see “Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 1”). In Part 2, we will look at how the Drug Supply Chain Security Act (DSCSA) will change, or add-to, the requirements found in those earlier specifications. And finally, we will be able to answer the question in the essay title.
HOW THE DSCSA CHANGES THE NDC AND BARCODE REQUIREMENTS FOR DRUG PACKAGES
First of all, the DSCSA does not change anything Continue reading Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 2
Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 1
After November 27, 2017 the U.S. Drug Supply Chain Security Act (DSCSA) requires drug manufacturers (2018 for repackagers) to affix a DSCSA “product identifier” to all drug packages entering the supply chain (see “The DSCSA Product Identifier On Drug Packages”). According to the DSCSA, that product identifier must be present in both human-readable and 2D Data Matrix barcode forms. Part of that product identifier is what is known as a Standardized Numerical Identifier (SNI). The SNI is composed of the drug’s National Drug Code (NDC) and a serial number (see “DSCSA ‘Serial Numbers’”) that is unique on every individual package of that drug (see “FDA Aligns with GS1 SGTIN For SNDC” and “Anatomy Of An FDA SNI”).
Lately, I’ve heard people in the industry claim that it is acceptable to use a GS1 Global Trade Item Number (GTIN) that encapsulates an NDC (see “Depicting An NDC Within A GTIN”) to satisfy the NDC part of this DSCSA requirement to affix the product identifier on a drug package. I’m not so sure about that. Let me explain. Continue reading Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 1
