The FDA updated their website this morning with new guidance that indicates they intend to use enforcement discretion by not enforcing the dispenser requirements to accept and capture Transaction Information (TI),Transaction History (TH) and a Transaction Statement (TS) until November 1, 2015, a four month delay in enforcement. The document indicates that the FDA’s decision to take this action was based on the fact that “…some dispensers have expressed concern that electronic systems used to exchange, capture, and maintain product tracing information will not be operational by this effective date.” Continue reading FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015
Monthly Archives: June 2015
Dispensers Make Last Minute Appeal for Delay in DSCSA Deadline
Less than a week before the July 1, 2015 Drug Supply Chain Security Act (DSCSA) deadline for dispensers to begin receiving, storing a being able to retrieve Transaction Information (TI),Transaction History (TH) and a Transaction Statement (TS) for every incoming shipment of prescription drugs, a group of pharmacy associations have asked the FDA for enforcement discretion for an unspecified time to avoid “…the possible outcome of disruptions to the supply chain”. Continue reading Dispensers Make Last Minute Appeal for Delay in DSCSA Deadline
India’s Pharma Export Serialization Deadlines: April Fools!
On May 22nd, 2015, India’s Directorate General of Foreign Trade (DGFT) quietly published Public Notice #13 with the subject “Implementation of the Track and Trace system export of drug formulations”. It was an amended version of Public Notice #4, dated April 1, 2015 with a similar subject. Get it? April Fools!
I have to admit, I fell for it. Did you? Continue reading India’s Pharma Export Serialization Deadlines: April Fools!
FDA DSCSA Deliverables Are Bunching Up In Second Half of 2015
I was poking around on the FDA website yesterday to find out if any new DSCSA documents had been released recently. I just returned from a near three-week trip to Western Europe and wanted to see if perhaps I missed something. No. Nothing released recently. You can find a list of DSCSA documents released by the FDA on their website and the most recent one was published on December 31, 2014.
Back in January of this year the FDA published their annual list of guidance titles that they think they will publish in the coming year (updated in April). That list included six titles of guidance documents related to the DSCSA that they expect to either publish in draft form, or finalize. These include: Continue reading FDA DSCSA Deliverables Are Bunching Up In Second Half of 2015
InBrief: ‘The Smallest Individual Saleable Unit’ In The DSCSA
The U.S. Drug Supply Chain Security Act (DSCSA) requires manufacturers and repackagers to place DSCSA-specific “product identifiers” on all drug packages and homogeneous cases by November 27, 2017 (2018 for repackagers). These product identifiers must include a Standardized Numeric Identifier (SNI), which is composed of the drugs National Drug Code (NDC) and a unique serial number (for more on DSCSA “product identifiers”, see “The DSCSA Product Identifier On Drug Packages“, for more on the SNI, see “FDA Aligns with GS1 SGTIN For SNDC“, and for more on the NDC, see “Anatomy Of The National Drug Code“).
A common question is, what is the smallest level of packaging that must be serialized?. The DSCSA text provides the answer. Continue reading InBrief: ‘The Smallest Individual Saleable Unit’ In The DSCSA
3PL Operation Under The DSCSA
Another type of business affected by the U.S. Drug Supply Chain Security Act (DSCSA) is the third party logistics provider (3PL) business.
I wrote an RxTrace essay about the impact of the California pedigree law on 3PLs back in 2013 (see “3PL Operation Under California ePedigree“). This is an update of that essay to address the impacts of the new DSCSA on 3PLs since the California pedigree law is now obsolete.
There are a number of important differences between wholesale distributors and 3PLs as defined in the DSCSA. Continue reading 3PL Operation Under The DSCSA