- Maximum cost of $250,000 a year for California Pedigree compliance, all costs inclusive.
- Available to branded prescription drug producers with California annual sales under $75 million, or generic drug producers with annual sales under $10 million in California.
Includes IT services, item level and case level serialization, Pedigree data, and indemnification from California Board of Pharmacy penalties for non-compliance.
There is much speculation over the pending deadline for ePedigree in California.
While the current deadline is January 2009, a delay to January 2011 is a possibility, but is not necessarily assured.
The California law does not specifically state that a delay is only to January 2011. The Board does have the discretion to delay the mandate every month if it elects to do so, until January 2011.
Regardless of one's assessment of the California Board of Pharmacy's decision for delay, RF Commerce offers a solution to branded drug producers with a fully compliant program for California serialization and pedigree.
The solution is currently only available to branded drug producers with annual prescription drug sales of under $75 million a year in California, or generic drug producers with annual sales under $10 million in California.
The program requires no modification to the drug producer's IT infrastructure, and serialization of the physical product to California can be executed at the drug producer's packaging facility, or at an outsource facility.
With the RF Commerce program, drug manufacturers require no capital investments, or advance IT investments.
Unlike any progam currently available, or in development, the RF Commerce costs only apply to drugs shipped to California, and costs are incurred only when the sale to California is executed.
The RF Commerce program does not require the drug producer to incur a cost at batch packaging.
Approximately 10% of USA consumption is in California. With RF Commerce there is no need to serialize 100% of the drug production. Only the drugs shipped to California are serialized with no disruption to the packaging line and minimal intermediation to the supply chain.
The cost is relatively simple, and can begin as low as $2.95 a case, plus an item level labeling and marking cost. The baseline architecture is as follows:
$2.95 per case
.25 per item for RFID
.15 per item for datamatrix
If a case has 24 bottles, the cost for datamatrix serialization and all the IT support is $6.55/case for only the drugs that are shipped to California.
If a case has 48 bottles, the cost for datamatrix serialization and all the IT support is $10.15/case for only the drugs that are shipped to California.
RF Commerce also offers various alternatives that are even more cost effective.
- Serialized items associated to case
If RF Commerce provides the process where the datamatrix serial number is printed along with the date and lot code at the packaging line, RF Commerce will provide the marking technology for $50,000 per packaging line.
The cost of associating the item level containers to the case level and the IT expense for producing the Pedigree data is:
$2.95 per case for 6 unit cases
$3.95 per case for 12 item cases
$4.95 per case for 24 units to a case
$5.95 per case for 48 units per case.
- Serialized attached Patient Information Sheet to case
If RF Commerce provides the process where the datamatrix serial number is printed on a Patient Information Sheet affixed directly to the item, RF Commerce will provide the marking technology at $10,000 one-time fixed cost.
The cost of associating the item level containers to the case level and the IT expense for producing the Pedigree data is:
$2.95 per case for 6 unit cases
$3.95 per case for 12 item cases
$4.95 per case for 24 units to a case
$5.95 per case for 48 units per case.
- Associating serialized 2D or RSS to item level RFID label, and associating to the case
If the customer applies datamatrix code to the item level, at the packaging line level, and RF Commerce is required to affix an RFID tag to the item that corresponds to the 2D barcode.
The cost of associating the item level 2D, applying the RFID tag and associating containers to the case level and the IT expense for producing the Pedigree data is:
$4.95 per case for 6 unit cases
$6.95 per case for 12 item cases
$9.95 per case for 24 units to a case
$14.95 per case for 48 units per case.
- Included in the service:
- Secured serial number provisioning for all prescription drugs entering California.
- Secured serial number provisioning for any selected prescription drugs that are serialized at the drug producer manufacturing site.
- Secured serial number provisioning to an approved label supplier of any drug producer.
- Association of serial number provisioning to batch level production, or batch/date lot.
- Maintain integrity of case level serial number identification. All item level drugs remain associated to the case at all times. Cases can be serialized with human readable serial numbers, bar code or RFID.
- Pedigree data is transmitted back to drug producer, transmitted forward to customer in California and/or archived for future access.
- Pedigree data of item level serialization, case level serialization, source association data and customer shipment data is archived for the lifecycle of the product.
- Secured data archiving and forensic availability to California Board of Pharmacy, on demand.
- Full compliance with California Pedigree requirements.
- Indemnification from any out-of-pocket expenses and penalties arising from non-compliance for product serialized by RF Commerce.
- Conversion and remediation of gransdfather product at California wholesalers and California retailers.
- Law enforcement support and intermediation of counterfeit drugs in California.
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