The HDA (Healthcare Distribution Alliance), submitted a recommendation to the FDA
to achieve traceability in the pharmaceutical supply chain under the DSCSA. This
stepwise approach would allow trading partners to continue current business
practices.
The DSCSA requires that all trading partners in the drug supply chain meet its final requirements by November 27, 2023. The FDA has stated that providing and receiving these data in an EPCIS event file satisfies this requirement.
Manufacturers and wholesale distributors provide EPCIS event files to their purchasing customers that include the Product Identifier of each package that is sold. This allows
tracing at the package level, which does not exist today in the U.S.
pharmaceutical supply chain.
HDA’s wholesale distributor members and their trading partners continue to make progress to meet the final DSCSA deadlines, but many manufacturers will not be completely ready by
November 27. This poses enormous problems for wholesale distributors and real
risks to continued access to needed medicines for dispensers, healthcare providers, and patients.
HDA recommends that FDA enable the supply chain to reach the DSCSA’s final requirements in phases, relying on a combination of FDA-granted exemption requests, limited enforcement discretion for defined time periods, and defined trading partner actions that
are phased in over time.
The phased approach described in the HDA document dated June 2, 2023 is not
intended to alter the existing requirements regarding the verification systems
and processes trading partners must have to identify, investigate, and
quarantine suspect products and to make illegitimate product notifications.
Iptor
Pharmaceutical distribution challenges the operational and logistics resources of any company.
With Iptor you can benefit from a fully integrated business platform that ensures compliance with industry specific regulations and reporting requirements, while synchronizing your entire supply chain. For over 40 years, Iptor has worked alongside pharma industry leaders to map their evolving needs into our product road map. The result, a true vertical offering that matches a staggering number of pharmaceutical wholesalers’ specific requirements.
Smart products and functionalities well designed down to the last detail is what Iptor can provide:
- Serialization
- Fast and intuitive order entry
- Micro-service platform
- EDI transactions
- ARCOS reporting
- Instant state and federal license verification
- DSCSA transaction statement (T3)
- Suspicious order monitoring
- CSOS (controlled substance ordering system)
- Rebates and chargebacks management
No matter what size your business is, Iptor can provide solutions for the single-tenant user as well as small businesses and start-ups.
Iptor Pharma is the package that grows with your needs.
We are taking the combination of modern cloud technology and leading functionality one step further. Providing a package in a multitenant model for the smaller business and start-ups that is pre-configured and ready to use.
