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”.
The request was signed by representatives from the National Community Pharmacists Association (NCPA), the American Pharmacists Association (APhA) and the National Alliance of State Pharmacy Associations (NASPA).
This new request is reminiscent of a message sent to the FDA by the Healthcare Distribution Management Association (HDMA) last November expressing concern over the January 1, 2015 deadline for manufacturers, repackagers and wholesale distributors to exchange the same data (see “HDMA Expresses Concerns About Industry Readiness for DSCSA”). That message resulted directly in a delay in enforcement by the FDA until May 1, 2015 (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).
The pharmacy letter makes the point that, with the delay in enforcement of the manufacturer’s and wholesale distributor’s deadline to May 1, 2015, the “…implementation timetable has been compressed.” They are
“…concerned that despite the extensive efforts by pharmacy and wholesale distributor associations to educate dispensers, some trading partners will encounter challenges beyond their control, with the possible outcome of disruptions in the supply chain.
In order to forestall potential disruptions in the pharmaceutical supply chain, the undersigned organizations respectfully request that FDA utilize its enforcement discretion to delay the July 1 product tracing deadline for dispensers.”
When the HDMA expressed their concerns about their approaching deadline they gave the FDA a little more than a month to react. It will be interesting to see of the FDA can develop, sign-off and publish a new guidance document delaying enforcement of some of the dispenser requirements with a notice of less than one week.
[See also ASHP’s request for a delay dated June 16, 2015.]
It makes sense that the July 1st deadline should be postponed the same 4 month duration as the earlier deadline and the FDA has probably debated an automatic postponement internally, independent of this latest request. It is possible that the FDA had already planned an announcement of delay, but it only makes sense to publish a delay like that at the last minute so no one slows their preparations for meeting the regulation. If a delay in enforcement is announced, we will know sooner rather than later.