DSCSA Receiving and Returns preparation focuses on verifying incoming and returned products to ensure they meet DSCSA compliance requirements. Proper checks and documentation help maintain supply chain integrity and protect patients from counterfeit or unauthorized products.
Following U.S. Food and Drug Administration (FDA) guidance, customers must confirm that the physical product received has DSCSA transaction data. The regulation does not define the word “confirm.” Customers should establish a standard operating procedure (SOP) as to how they intend to confirm the existence of their DSCSA transaction data. You should follow the process as outlined in your pharmacy SOPs.
The law requires DSCSA in-scope drugs to be traced as they move through the supply chain, and pharmacies should:
If a DSCSA in-scope item is missing from a delivery tote, this should be processed as a serialized shortage. Follow the steps outlined in question eight to process a serialized shortage.
If the serial number does not match, this should be processed as a mispick. Follow the steps outlined in question nine to process a mispick.
Case quantity items can be scanned and the DSCSA data contains all DSCSA in-scope items.
Note: Following FDA guidance, customers should confirm that the physical in-scope product received has DSCSA transaction data. The regulation does not define the word “confirm.” Customers should establish an SOP as to how they intend to confirm the existence of their DSCSA transaction data. You should follow the process as outlined in your pharmacy SOPs.
FedEx and UPS shipping labels utilize their own proprietary bar codes and do not contain SSCCs, which would enable you to receive DSCSA data by scanning the tote. A packing label including a Masters SSCC is inside each shipping container for your orders, and DSCSA product identifier barcodes are on each unit/product.
DSCSA in-scope product is not indicated on invoices. Some ordering portals will identify DSCSA in-scope product.
If a product was omitted and you see this message on your invoice, you should reorder the omitted product if still desired.
For Masters customers, simply email your return information to MastersReturnsTeam@McKesson.com.
To process a serialized shortage, overage or mispick with Masters, customers should be prepared to work with their dedicated sales representative and have the following information ready:
Note: Masters will request the serial number, lot number and expiration date for any overage to investigate whether the product was previously picked and assigned to another customer, allowing for direct follow-up with that customer if necessary.
Masters can only accept returns from the customer it originally sold the specific product identifier to, and all saleable return items must have a readable and scannable product identifier barcode.
DSCSA creates additional obligations on distributors, including Masters, for saleable returns of DSCSA in-scope products. After the DSCSA serialization compliance date on Aug. 27, 2025, this process will go into effect:
The DSCSA requires that a purchaser only return DSCSA in-scope product to the immediate trading partner from which they purchased the product. As of Aug. 27, 2025, Masters distributors are expected to associate the serial number of the returned package with the purchaser’s DSCSA transaction information and only accept saleable returns where the serial number of the returned package matches with the purchaser’s DSCSA transaction information.
For 340B replenishment programs, only the covered entity and not the contract pharmacy has this return right.
Only the Sold-To GLN needs to match. As part of Masters’ DSCSA association requirements for saleable returns, Masters must confirm that the Sold-To GLN returning the product is the Sold-To GLN that has purchased the product.
Drop ship product is nonreturnable to Masters. Only the selling entity – the manufacturer or other supplier for drop ships – can accept saleable returns.
No. You will need to contact your sales representative.
Effective Aug. 27, 2025, 340B contract pharmacies are no longer eligible to return products purchased by a covered entity from the wholesale distributor. This change is due to the DSCSA requirement of validating saleable returns to the original purchasing party. To support affected customers, Masters’ 340B Solutions team is developing a Virtual Return and Replenishment (VRR) model. For more information, please contact the 340B DSCSA team.
If your returned product is unable to be processed, an explanation letter that includes the explanation code will be included with the returned product. Below is a list of reasons your return may be unable to be processed:
Please note: Unsolicited or unassociated controlled room temperature product will be returned to you. If a returned product requires cold chain storage or is a controlled substance, it will be processed as an unsaleable return, and the product will be destroyed. Additionally, product(s) may only be returned by the purchasing party. This impacts 340B products, as only the covered entity that purchased the product may receive returned credit for 340B replenishment purchases.
For questions regarding DSCSA, reach out to Masters Customer Support or contact us via email.
Masters customers can call their account manager at 800.982.7922 or email info@MastersRX.com.
What do I do if I do not receive a response on an inquiry? Please allow 24 hours for a reply to any inquiry sent to one of the DSCSA mailboxes. If you do not receive a follow-up, please contact Customer Support directly via your tollfree number.
Explore our Acronym List & Definitions to quickly understand key industry terms—clear, simple, and easy to reference.
