Inmar CLS MedTurn Pharmaceutical Symposium October 19-20, 2009 Rodney Bias, VP Regulatory
Agenda Reverse Distribution System –Overview –Benefits “Take-back” Programs –Reverse Distributors’ Potential Role –Challenges –Program Design Options Conclusion 2 © Inmar 2009
Credit Reverse Distribution System 3 Product Distributor Third-party Policy & Pricing Applied Product Invoiced Mfr. /Agent Policy & Pricing Applied Credit/Check Distributor Destroy 2 Manufacturer Destroy Pharmacy Wholesaler Hospital © Inmar 2009
Reverse Distributor Services © Inmar Returns Management Off-Site or On-line Processing Options Controlled Substance Processing CII-V & List 1 Recall Special Handling Quality Controls- Box & Item ID One Touch Advantage Returns Management Off-Site or On-line Processing Options Controlled Substance Processing CII-V & List 1 Recall Special Handling Quality Controls- Box & Item ID One Touch Advantage Risk Prevention Hazardous Waste Disposal Regulatory Compliant Facilities Witnessed Incineration Pedigree Compliance- Lot Code & NDC Capture Recall Management Risk Prevention Hazardous Waste Disposal Regulatory Compliant Facilities Witnessed Incineration Pedigree Compliance- Lot Code & NDC Capture Recall Management Financial Recovery Electronic Invoices (Debit Memos) Reconciliation Assistance Reason Code Assignment Policy Application Financial Recovery Electronic Invoices (Debit Memos) Reconciliation Assistance Reason Code Assignment Policy Application Information Intelligence Pharmacy Level Corporate Level Recall /Withdrawals Information Intelligence Pharmacy Level Corporate Level Recall /Withdrawals
Reverse Distribution System Logical Solution for Pharmaceutical “Take-back” Programs 5 ● The Infrastructure● The Regulatory Knowledge ● The Process to Implement Quickly Credit Product Distributor Third-party Policy & Pricing Applied Product Invoiced Mfr. /Agent Policy & Pricing Applied Credit/Check Distributor Destroy 2 Manufacturer Destroy Pharmacy Wholesaler Hospital © Inmar
Challenges Facing “Take-back” Programs Absence of a Federal Standard DEA Ruling – Illegal to include Controlled Substances Retail Pharmacy - A Hazardous Waste Generator Cost Responsibility - Who Pays? 6 © Inmar 2009
Consumer “Take-back” Design Options Consumer “Take- back” Programs Mail-back In-store “Drop-box” In-store Pharmacy Assisted Community “Take-back” 7 © Inmar 2009
Conclusion The Reality: –Countless laws and regulations at both the state and federal level have the potential to impact a “Take-Back” program The Actions To Take: –Research and understand the intricacies of such a program prior to moving forward –Understand all the factors involved –Meet with your reverse logistics provider to discuss all of the options available 8 © Inmar 2009
Rodney Bias VP Regulatory © Inmar