NABP launched VDIP Accreditation for diagnostic over-the-counter (OTC) medical devices on 9/23/16.
VDIP Accreditation comes on the heels of the recent OptumRX policy change that requires prescription drug distributors to hold VAWD Accreditation. OptumRX claims the policy change was made to reduce “Fraud, Waste and Abuse” (FWA) in the prescription supply chain.
In a move to encompass OTC suppliers under VAWD Accreditation, the NABP added VDIP Accreditation. The new VDIP Accreditation will include criteria, an application, and SOP Assessments specific to the OTC category.
Criteria will examine all entire operational activities include sourcing, facility requirements, personnel, record-keeping and more. Highlights below:
- Sourcing: VDIP Accredited suppliers must only purchase from manufacturers or distributors that purchase directly from the manufacturer.
- Licensing: VDIP Accredited suppliers must have proper licensing. For example, if selling into California, the supplier must hold a valid OTC wholesale license.
- Facility: VDIP Accredited suppliers must proper temperature & humidity controls, quarantine area, and inventory controls.
- Personnel: VDIP Accredited suppliers must ensure qualified personnel are employed at the facility.
- Record-keeping & Authentication/Verification: VDIP Accredited suppliers must keep all records and have them readily available for inspection.
- Policies & Procedures: VDIP Accredited suppliers must have proper P&Ps that govern all operational activities.
For VDIP services, click here.
Five Rivers RX provides Compliance Solutions to all members of the prescription drug and device supply chain, from manufacturer to provider. Leverage the expertise, experience, and finesse that Five Rivers RX brings to the table by reaching out today. We look forward to serving you.