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):

  • 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 are 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.