DSCSA Update: Breaking Case Packs & Adoption Increases
When initially signed by President Obama in 2013, industry was well aware of the sweeping changes it would cause in the supply chain. With full implementation officially less than three years away, industry has taken huge strides in the implementation of the law – and many questions are finally being answered.
Answered Questions: Pfizer Moratorium on Breaking Case Packs
Over the last few months, Pfizer has advised wholesale distributor customers that breaking case packs is not an acceptable activity. Pfizer is made aware of the activity via sales report they receive from those customers.
Interestingly enough, per our article from January 2019, it was our thinking that Pfizer would not include a serial number, and would therefore not a be a saleable unit under the DSCSA regulations.
Of note is that Pfizer is taking a proactive approach to the DSCSA requirement in that they are analyzing their sales reports to identify non-compliance from customer activities. This aligns closely with other situations where manufacturers are held accountable for a customer’s customer activity – for example, Mallinckrodt was previously disciplined for not looking at sales data to identify suspicious controlled substance orders.
According to a recent report by GS1 Healthcare US®, in conjunction with the Big 3 wholesalers, AmerisourceBergen, Cardinal Health and McKesson, adoption increased by 19% year-over-year to an impressive 87% adoption of DSCSA requirements. Specifically, the adoption rate was calculated by looking at the proportion of packs and cases bearing the four DSCSA application identifiers: the Global Trade Identification Number (GTIN) including a National Drug Code (NDC), serial number, lot number and expiration date.