Supply chain consultant Dirk Rodgers wrote recently that wholesale distributors are having issues getting in touch with suppliers in order to meet one of the first deadlines of the DSCSA, which, after Jan. 1, 2015, requires all drugs transported through the supply chain to be accompanied by transaction information, transaction history and transaction statements.
“The real problem is that, despite many attempts by wholesale distributors to contact their suppliers to find out their ability to provide that information on that date, no response has been received from a significant percentage of those suppliers,” Rodgers says.
Drugs that do not meet these transaction requirements will be quarantined, though apparently when pressed on the issue, one FDA official consented that “FDA will be practical and reasonable and recognize product flow is important.”
And for those distributors and suppliers that are just now trying to meet the requirements of the DSCSA, Rodgers is sceptical that they’ll be able to meet the requirements in less than a month.
Rodgers told In-Pharmatechnologist.com: “I have spoken to a number of larger and smaller manufacturers and wholesale distributors who have spent the last 12 months getting ready. That’s what leads me to believe the odds that anyone can start now and be ready by January 1 are very slim.”
Deadline
Most of the big companies, however, have been successful in contacting their suppliers. “That’s partly because McKesson told all of their suppliers that they had to be fully tested and corrected before November 1 or they would risk having their shipments ‘embargoed,’” Rodgers tells us, noting that McKesson has not yet “embargoed” any product, though that language “was clearly designed to get people to move sooner rather than later.”
Another option that FDA has is to push back the deadline so wholesale distributors and suppliers can meet the deadline, though Rodgers believes that would be a mistake.
“If they do, they will have an even harder time getting companies to meet the pushed back date because everyone will think it will get pushed back again. That’s what happened to California,” he said.
Costs
As far as costs are concerned, companies that have to speed up the process between now and Jan. 1 will clearly end up paying more. Rodgers adds that it “depends on where the company starts. If they are already sending EDI (electronic data interchange) ASN (advance ship notice) messages to their trading partners and they have a knowledgeable IT department who is not afraid to make changes to their EDI maps, then they might be able to pull it off. But most companies have a bureaucracy that gets in the way of making changes that fast. Then there is the testing part with each of the big three wholesalers.”
Costs will be significantly higher for companies that do not have any EDI capability today as they will need to invest in multiple software pieces and go through multiple levels of testing, he added.
“They will have a steep learning curve unless they engage a good EDI integration consultant and give that person free-reign to extract whatever they need from their existing systems. Depending on the size of the company, that might take anywhere from 3 to 12 months to accomplish. Anyone in that situation should have initiated a crash program as soon as the big-3 told them they would not accept paper. That was late last winter/early spring,” Rodgers added.