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|The requirements of the Drug Supply Chain Security Act (DSCSA) will take effect for distributors in November 2019 and will phase in fully by November 2023.|
|The purpose of the DSCSA is to improve the security of the pharmaceutical supply chain by reducing the risk of counterfeit, stolen, contaminated or otherwise harmful drugs from reaching patients and consumers.|
|The DSCSA directs the Food and Drug Administration (FDA) to establish national licensure standards for wholesale providers and requires them to report licensure annually to FDA.|
|The DSCSA will affect how McKesson Medical-Surgical distributes low unit of measure prescription drugs and return of prescription drugs, beginning in November 2019.|
Under the DSCSA, the saleable units of measure of all prescription drugs must contain a serial number. Unfortunately, numerous manufacturers have elected to limit serialization to the case or carton level – and not put serial numbers on individual boxes or vials. As a result, the typical low unit of measure that you have purchased in the past will no longer be available from distributors.
Beginning in November 2019, McKesson Medical-Surgical will stop selling low unit of measure quantities of prescription drugs, such as vials and eaches, unless they have been serialized by the applicable manufacturer. Instead, McKesson will work with repackagers to provide you the low unit of measure services that you have come to expect from McKesson. Our repackagers will create low unit of measure packaging for you that will comply with the DSCSA and address your prescription drug needs.
The DSCSA requires wholesaler distributors to perform a verification for returned prescription drug products. In order for McKesson Medical-Surgical to associate the returned prescription drug product with its DSCSA transactional data (Transaction Information & Transaction Statement): Customers will need to provide an invoice reference or other related information (e.g.: sales order number, customer PO, order date, etc.) so that we are able to associate the drug product was originally purchased from McKesson Medical-Surgical. This information will be gathered during the Return Authorization generation process when you contact our Customer Service Center.
Due to the increased expense related to repackaging, relabeling, handling and transportation, you will see an increase in price for prescription drugs sold by the vial or each.
Additionally, low unit of measure prescription drugs will be drop-shipped to meet timing guidelines for the new serialization requirements. Non-refrigerated items have a drop-ship fee of $5, while refrigerated items have a drop-ship fee of $25.
See our frequently asked questions to learn more.
Download the complete list of affected items to find out when they will be available for drop-ship in low units of measure. Download
November 27, 2013
Congress enacts the Drug Quality and Security Act (DQSA), which includes Title II, the Drug Supply Chain Security Act (DSCSA)
DSCSA requirements begin phasing in
All pharmaceutical suppliers are required to send to McKesson Medical-Surgical the DSCSA transaction data: Transaction Information, Transaction Statement & Transaction History for prescription drugs. McKesson Medical-Surgical must provide the DSCSA transaction records to its customers
McKesson Medical-Surgical will retain customer’s DSCSA transaction data for prescription drugs purchases from McKesson Medical-Surgical Distribution Centers for a period of six years (from the invoice date)
All manufacturers and repackagers serialize product for all prescription drugs by affixing a product identifier (2d) bar code to each individual package and homogenous case
Distributors must sell serialized units of measure for prescription drugs. In response, McKesson Medical-Surgical begins sourcing repackaged low unit of measure prescription drugs
McKesson Medical-Surgical will only accept prescription drug returns if our customer purchased the prescription drug from McKesson Medical-Surgical
Now through 2023
Product tracing requirements continue to phase in under DSCSA
Why is the price increasing for products sold by the each?
The higher price reflects additional expenses related to repackaging, relabeling, handling and transportation.
Why is the product being drop-shipped?
This is the most efficient way for the supply chain to accommodate the serialization requirements by the November 2019 deadline.
How much is the fee to drop-ship?
Drop-ship fees vary on if the item is refrigerated or not. Non-refrigerated items have a drop-ship fee of $5. Refrigerated items have a drop-ship fee of $25.
Are there GPO contracts on these items?
No. GPO contracts do not include low unit of measure items and all will be non-contract.
Will there be a separate customer invoice for these drop-shipped low unit of measure prescription drugs?
How will I see this on my statements?
On statements or invoices, you will see the item price and a separate line for the drop-ship fee.
Are the new drop-shipped items returnable?
No. The new drop-shipped low unit of measure prescription drugs are NOT returnable.
What is the lead time with drop-ship vendors?
Drop-shipped prescription drugs will be sent UPS ground. Shipment time varies based on location but expected within 5 – 7 days.
When will low unit of measure prescription drugs transition to this new repackaging serialization process?
We will be releasing waves of the transition items from August – November 2019.
What is required to return prescription drugs to McKesson Medical-Surgical?
Any prescription drugs returned to McKesson Medical-Surgical will require that you originally purchased the product from McKesson Medical-Surgical by providing a valid invoice number and the product is in saleable condition.
What is considered a valid invoice reference?
Customer will need to provide an invoice reference or other related information (e.g.: sales order number, customer PO, order date, etc.) so that we are able to associate the drug product was originally purchased from McKesson Medical-Surgical.
To be a valid invoice reference, the prescription drug needs to have been purchased on that account and invoice and there needs to be an available return quantity meaning that a return has not already been made against that reference exhausting the quantity purchased.
Are controlled (CRx) substances returnable to McKesson Medical-Surgical?
No, controlled substances are not returnable.
What happens if I am unable to provide a valid invoice reference?
A customer who provides an invalid invoice reference will be denied the saleable return request. No credit will be given without a valid invoice reference.
Be advised that information contained in this update is intended to serve as a useful reference for informational purposes only and is not complete clinical information. This information is intended for use only by competent healthcare professionals exercising judgment in providing care. McKesson cannot be held responsible for the continued currency of or for any errors or omissions in the information.
©2019 McKesson Medical-Surgical Inc.