As of today, U.S. Prescribing Information (USPI) must still be distributed to prescribing healthcare professionals in printed paper format. Despite ongoing discussions around digital transformation and electronic product information, the requirement for printed labeling remains in place under current federal law.
This means pharmaceutical manufacturers are still responsible for composing FDA-approved USPI content into print-ready documents for distribution. Even if electronic distribution becomes authorized by future legislation or regulation, printed versions will continue to be required for compliance and must be promptly available upon request, though the overall demand for printed copies is expected to decline.
How LexisNexis Reed Tech Supports Manufacturers
The continued USPI print requirement underscores the importance of efficient, compliant labeling workflows.
LexisNexis Reed Tech helps manufacturers meet these obligations by:
- Accurately formatting FDA-approved USPI content into print-ready documents
- Saving time and cost through automated workflows and expert review
- Ensuring consistency and quality across labeling materials
As the industry transitions toward digital product information, LexisNexis Reed Tech Label Composition Service remains a vital solution, helping you stay compliant, maintain audit-readiness, and anticipate regulatory changes so your teams are always prepared for what’s next.