serialization readiness

HDA survey finds serialization readiness is crawling along

Equipment availability is cited as a cause for delay

As of mid-August, 64.2% of pharma manufacturers expected to be delivering at least one serialized product to US wholesalers by Nov. 27, 2017 (the original date for 100% compliance, under the Drug Supply Chain Security Act, DSCSA). In the poll with 67 manufacturers participating, 62.7% have concerns with meeting the original deadline, and of those, 61.9% cited delays in equipment deliveries as a reason, followed closely by lack of resources and expertise at contract manufacturing organizations (CMOs) that they use.

Putting unique serial numbers on each unit of salable product—in order to track that product’s movement through the supply chain—is the fundamental first step to compliance with the full DSCSA mandate, which has a November 2023 deadline. The serialization readiness question was complicated this year when FDA announced “enforcement discretion” to allow manufacturers an additional year, to November 2018, to serialize their products.

This survey by the Healthcare Distribution Alliance commenced just after that announcement and concluded in mid-August. Anecdotal comments at the just-concluded Traceability Seminar (Washington, DC; Nov. 8-10), where the results were announced, indicate that preparations might have slowed down even more than the data indicate. Overall, HDA concludes that while “100% of product will not be serialized by November 27, 2017 . . . it also does not appear that all products will be serialized by November 27, 2018, when FDA’s enforcement discretion expires.” This will create an “the additional challenge of managing dual, serialized and non‐serialized systems.”

That sounds bad; however, it has been known all along that there will be a mixed environment for years to come, simply because some pharma products linger in the supply chain for years until their expiration dates pass. Among other things, the industry is waiting for guidance from FDA on how these products are to be grandfathered through the transition.

Progress report
Looking at what has been accomplished to date shows how much effort the industry has committed to the compliance mandate; it’s worth noting that some 40 other countries globally have serialization mandates of their own, with some already in place and others to fall in over the next 2-5 years. According to the survey, 38.8% of all manufacturers are currently shipping at least one serialized product—and that rises to 59.4% of manufacturers who have more than 15 packaging lines. 72.7% of companies with only branded products will be 100% by November 2018 (which implies, however, that 27.3% will not be compliant even then); and 68.7% of generics-only companies will be 100% compliant by then (the case of mixed branded/generic firms was not analyzed).

Putting the serial numbers on the packages is the first step; the next is being able to transmit the corresponding data to wholesalers or other downstream trading partners. The survey indicates that 56.7% of manufacturers expect to do that by November 2018, and that 23.9% were ready to do so by this month.

The full survey is available at HDA’s website.