Figure 1.1
Figure 1-1 shows the distribution chain and drug pedigree for a shipment distributed from a Pharmaceutical Manufacturer through three distributors and then to a Pharmacy. On the left is a flowchart showing how this is done under Current Industry Practice; on the right is a flowchart showing how it would be done under Final Rule 21 CFR Part 203.
The Current Industry Practice Chart shows the shipment proceeding from the manufacturer to Distributor A, from Distributor A to Distributor B, from Distributor B to Distributor C, and from Distributor C to the Pharmacy. The shipment is invoiced at each step, but only the final invoice, accompanying the shipment from Distributor C to the Pharmacy, gives any pedigree information; that invoice indicates the date on which Distributor C bought the shipment from Distributor B.
The chart on the right shows how this shipment would be invoiced under Rule 21 CFR Part 203. The first two shipments, from the manufacturer to Distributor A and from Distributor A to Distributor B, are invoiced as before. The invoice accompanying the shipment from Distributor B to Distributor C gives both the date when B bought the shipment from A, and the date when A bought the shipment from the Manufacturer. The invoice sent to the Pharmacy by Distributor C includes those two dates and the date on which C obtained the shipment from B.
Notes:
Distributor A has a written distribution agreement with Manufacturer X.
Distributor B has no written distribution agreement but has at least two transactions
with Manufacturer X in any 24-month period.
Distributor C has neither a written distribution agreement nor at least 2 transactions
with Manufacturer X in any 24-month period.