CFD recently sent information on requirements for FDA notification and supplier acknowledgements. There are a number of information sessions being conducted by various organizations. When members have attended those they have provided additional information to CFD and we appreciate that… The following is noteworthy…
- Documentation required for a VFD can only be stored electronically when in compliance with Federal Rules known as Part 11. This is essentially a secured server environment. CFD recommends that all documentation be maintained on paper initially. AFIA is working with the FDA to eliminate this mandate and we will keep you posted.
- VFD cannot provide for automatic refills. The time period is limited to 6 months.
- Pulsing regiments are not permitted.
- To use Bovatec in conjunction with a VFD drug the VFD must include that direction.
- Record retention requirements for documentation vary by state. Federal requirements are 2 years.