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Advice for getting started with pharma serialization

The first thing manufacturers should do is: Hurry! But there's more...

 

If there's one issue driving pharmaceutical manufacturers and packagers to ramp-up their educational efforts, it's the need for compliance with item-level serialization. Requirements such as the California State Board of Pharmacy's E-Pedigree Law--if there are no further delays--will take effect on a staggered basis from January 1, 2015 through July 1, 2017 with the following schedule:
  • 50 percent of a manufacturer's products by 2015;
  • The remaining 50 percent of the manufacturer’s products by 2016;
  • Wholesalers and repackagers must accept and forward products with the e-pedigree by July 1, 2016; and
  • Pharmacy and pharmacy warehouses must accept and pass e-pedigrees by July 1, 2017.
At 2012 Pack Expo in Chicago, D. Bruce Cohen, principal, PackTechPlus, Raleigh-Durham, NC, presented some fundamental bits of advice from his industry consulting experience, including: "Hurry!" This is because only a call minority of companies have lines in compliance and there will be intense competition, and possibly something of a shortage for the outside consultants manufacturers will have to "rent.” And change doesn't come easy to manufacturing personnel when a "temporary" expert is brought in; these things take time.
 
Beyond "Hurry!" Cohen's fundamental advice is that "communication within your company is critical. Also, the effort "must be driven top-down" and involve all levels of personnel. This includes not just inside the manufacturing organization, but across suppliers, contract manufacturing organization (CMO) partners, wholesaler-distributors and retail distributors. 
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