As expected, the FDA has published the draft guidance on standards for paper and electronic data exchange that was mandated by the U.S. Drug Supply Chain Security Act (DSCSA). And the guidance is early–by one day–fulfilling the intent of the FDA as expressed in the DSCSA Data Exchange workshop held last spring (see “The 2014 FDA DSCSA Workshop“).
The new guidance document can be found on the FDA website at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM424895.pdf
I will provide my full analysis in Read the rest of this essay »
Until the Drug Supply Chain Security Act (DSCSA) was passed as part of the Drug Quality and Security Act (DQSA) last year (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), companies could use whatever code they wanted to refer to the prescription drug products in supply chain operations and for their own inventory management. Some probably chose the 10-digit National Drug Code (NDC), some probably chose the 11-digit reimbursement code that is based on the 10-digit NDC, and some probably chose to use a 12- or 14-digit GS1 Global Trade Item Number (GTIN) as a reference code for their inventory data. But now that the DSCSA mandates the use of the 10-digit NDC when exchanging transaction data on January 1, companies using the other codes that are based on the NDC might need to Read the rest of this essay »
Dr. Connie T. Jung, Acting Associate Director for Policy & Communications, Office of Drug Security, Integrity and Recalls, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, spoke last week at the 2014 Healthcare Distribution Management Association (HDMA) Traceability Seminar in Arlington, VA.
The presentation was similar to those given in the past except she provided an update on the progress of the next draft guidance the Agency is expected to publish on standards for data exchange (see “DSCSA: Many Questions, Few Answers”). The deadline imposed on the FDA by the Drug Supply Chain Security Act (DSCSA) is November 27, 2014 for that draft, but during the FDA DSCSA Workshop last spring (see “The 2014 FDA DSCSA Workshop”), Dr. Jung said that the Agency recognized the need to publish earlier than that. Last week she indicated that they will Read the rest of this essay »
As we near the end of 2014, several important pharma traceability deadlines around the world are approaching. Besides the U.S. Drug Supply Chain Security Act (DSCSA), these include deadlines in Brazil and South Korea. Of course, each regulation is different. Now that the initial implementation of the exchange of transaction data in the U.S. is widely being implemented in Electronic Data Exchange (EDI) Advance Ship Notices (ASNs), the next hurdle for drug manufacturers will be to deploy serialization technologies on their U.S. and Korea market packaging lines. The data exchange technology problem will shift to Brazil, and that’s where I see trouble. Read the rest of this essay »
A while back I posted an essay called “Who Is A DSCSA Dispenser?”. I don’t think many actual dispensers read it because about half of the dispensers I run into think the earliest they have to do anything is July of next year. The other half don’t think there is anything in the Drug Supply Chain Security Act (DSCSA) about them at all. Too bad. Both are wrong.
Fortunately I think repackagers know better. At least they should, because the DSCSA contains a lot of specific requirements for them. Repackagers have most of the same requirements that manufacturers do, plus they have many of the wholesale distributor requirements. A double whammy.
Most people in the industry know what a repackager is. Typically they are companies that buy drugs from a manufacturer or a wholesale distributor and then open the packages and put the drug into a new package type. This can include putting the drug into a larger or smaller quantity package, or from bottles into blister cards or even unit dose packs for use in an automated picking machine. It can also include companies who Read the rest of this essay »
A few weeks ago, GS1 Healthcare US published version 1.1 of their guidance for using the GS1 Electronic Product Code Information Services (EPCIS) standard to meet the U.S. Drug Supply Chain Security Act (DSCSA). See “GS1 Healthcare US Publishes Updated Guidance For DSCSA”. I was too busy at that time to review the document properly, but it is an important addition to the spectrum of information that companies can use to help them understand how to best meet the requirements of the DSCSA so I wanted to get back to it when I had time. That time is now.
As long term readers of RxTrace know, I did not believe EPCIS would ever be usable to meet the now obsolete California Pedigree law (see “The California Pedigree Law Is Now Officially Inoperative”), or any other State pedigree laws, and I do not believe it will be widely used to meet the Federal DSCSA before maybe 2021 or 2022, but I do believe it will take center-stage for meeting the long-term requirements of the DSCSA.
In 2023 the DSCSA transitions into Read the rest of this essay »
The 2014 Partnership for Safe Medicines (PSM) Interchange event was held on September 18 in Washington DC. This was the fifth year of the event and every year it gets better. That’s why RxTrace has been a media sponsor of the event for the last four years. This year, I found every speaker to be compelling. Next year I am elevating this event to my “highly recommended” short list.
Attendance at the event has grown each year and this time they reached the capacity of the venue and were forced to cut off registrations some time before the day of the event. A number of RxTrace readers were present at the this year’s event but more ought to attend going forward.
The PSM interchange is a different kind of event. It’s not a “how to” event. Over the years, the speaker lineup has included State and Federal pharma regulators, criminal justice professionals (investigators and prosecutors), academics, politicians, pharmaceutical industry associations, medical professionals and occasionally, victims of counterfeit drugs. The audience includes all of the above, plus Read the rest of this essay »
I am confident that GS1’s Electronic Product Code Information Services (EPCIS) standard will take center stage in 2023 when the U.S. Drug Supply Chain Security Act (DSCSA) transitions into what that law calls the “Enhanced Drug Distribution System”, or EDDS. That’s when the DSCSA mandates that supply chain changes of ownership of prescription drugs must be documented in an interoperable electronic system based on their unique serial numbers.
Each of the steps that must be implemented by the industry between now and Read the rest of this essay »