DSCSA Enforcement Readiness : Check
Serialization Countdown | June 2018 | by Jim Butschli
Pharmaceutical contract packager Reed-Lane works with consulting firm, machinery vendors on three key packaging lines to meet fast-approaching serialization enforcement deadline.
One can only imagine the number of calendar alerts set to trigger pharmaceutical professionals come Nov. 26, 2018.
Of course, that’s the date the Drug Supply Chain Security Act (DSCSA) serialization enforcement deadline takes effect in which manufacturers must provide unit-level product identifiers on their drug packages. The 2018 date represents a one-year delay granted by FDA in the enforcement of the requirement for manufacturers to affix or imprint product identifiers. Actual DSCSA compliance was Nov. 27, 2017.
Although studies have shown that some pharma manufacturers and contract packaging/contract manufacturing organizations have a way to go to meet the upcoming enforcement deadline, Reed-Lane is in good shape.
Headquartered in Wayne, NJ, Reed-Lane is a pharmaceutical contract packager (CP) that provides packaging to the pharmaceutical market for both prescription and over-the-counter products. FDA-audited, and Drug Enforcement Administration-licensed to package class III-V drugs, Reed-Lane specializes in blister packaging, bottling, wallet carding, pouching and convenience vial filling for solid-dose products as well as secondary packaging and kitting. With new cold storage capacity, Reed-Lane is positioned to label and package temperature-controlled products.
To help its customers meet the serialization enforcement deadline, the CP employed Vantage Solutions, a manufacturing productivity organization that works in strategic guidance, serialization, compliance and automation.
Reed-Lane first encountered Vantage at a serialization seminar where the consulting group’s Portfolio Director Frank Guthrie was speaking. At that time, Vantage was consulting with one of Reed-Lane’s customers…..read more