H-Source and DSCSA Compliance
The Implementation of DSCSA in the H-Source Marketplace
“As of 7/1/2015, dispensers (hospital and surgery center pharmacies) in the pharmacy supply chain must exchange information about a drug and who handled the drug each time it was sold in the U.S. market.
Per every transaction, “product tracing information” should be exchanged. Product tracing information consists of:
- Transaction History (TH)
- Transaction Statement (TS)
- Transaction Information (TI)
- Includes the lot number of product (except for certain wholesale drug distributor transactions
Transacting Information (TI)
To be compliant with DSCSA requirements, H-Source requires the following information regarding Transaction Information (TI):
- Proprietary or established name or names of the product
- Strength and dosage form of product
- National Drug Code (NDC) number of the product
- Container size
- Number of containers
- Lot number of product
- Date of transaction
- Date of shipment
- Business name and address of the person from whom and to whom is being transferred
Transaction History (TH)
- The transaction history for products purchased or sold prior to listing on the H-Source platform must be accounted for and documented by the selling hospital.
- On all sales, H-Source will provide an email contact and an alert that all transaction history prior to H-Source should be included with product shipment, or emailed within the 24/48 hour FDA guidelines.
Transacting Statement (TS)
All H-Source members are required to register key information that is attached to all transactions documents. These registration requirements include but are not limited to:
- Name of person conducting transaction
- Name and address of the facility
- License number of the facility, including state license number
When products sold on H-Source, members are provided printable documentation of both (TI) and (TS) information that should be included in both the shipment of the products and for record keeping.
Benefits of H-Source and DSCSA
- All transaction history is stored within H-Source in case a member requests the information.
- Aggregated data is available for systems under common control.
- GS-1/UDI barcoding and QR data bases are being implemented
- Administrative ability for IDN’s or groups under common management to control current users from a central location external from H-Source.