Today’s foremost challenge is complying with Title II of the Drug Quality and Security Act – the Drug Supply Chain Security Act (DSCSA). Passed into law on November 27, 2013, the enforcement of the DSCSA will impact our distributor customers this year (a year later than our manufacturing customers). We have been following the developments quite closely and have participated in seminars in Washington, DC for the last three years so we could provide our customers with the latest information and the software solutions that will allow them to ease into compliance.
The DSCSA Requirements
The law requires that trading partners exchange product tracing information for certain types of products but does not dictate how to do so. For most prescription drugs, trading partners must exchange transaction information (TI), transaction history (TH) and a transaction statement (TS) at a unit level. Methods of information exchange could include, but are not limited to:
* Paper or electronic versions of invoices
* Paper versions of packing slips
* Electronic Data Interchange (EDI) standards, such as the Advance Ship Notice (ASN)
* EPCIS (Electronic Product Code Information Services)
Furthermore, the distributor must be able to identify, quarantine and report “suspect products.”
The requirements for wholesale distributors go into effect on November 27 of this year.
Our DSCSA Approach
While many software and systems providers have defined and recommend a specific solution. TurningPoint is committed to developing a flexible system that meets all regulatory and industry requirements, automates data capture and reporting, yet is maximumly adaptable to our customers’ workflow needs. Compliance without the constraints.
Other RX Distribution Developments
Pharmaceutical distribution is an everchanging business and at no time has the change been faster than the past 5-years. Some of the change has been imposed by the demands of your customers and some by the passage of new regulations on the industry. The effect on the distributor is eroding profits. In many cases, the profitability and viability of the distributor lies in the automation of business systems through technology.
About TurningPoint Systems
TurningPoint Systems, a pharmaceutical distribution sector specialist, has been adapting the latest technologies to our fully integrated systems to respond to these challenges. Vendor relations automation of contract management, chargebacks and order processing has been realized through expanded use of HDMA format EDI. Substantial efficiencies were achieved with warehouse management technologies like scanning and automated materials handling, perpetual inventory management and purchasing algorithms. And, that means more profit to you – profitability through technology.