Specifically, the organizations have asked the agency to amend its regulations to provide that the Part 11 electronic records and electronic signature requirements do not apply to Veterinary Feed Directives (VFDs) issued by veterinarians to their clients for the use of animal drugs in medicated feed that are limited to use pursuant to a VFD as a condition of drug approval and for records required to be created or maintained by feed manufacturers and distributors related to medicated feeds containing VFD drugs.
They said the requested exemption from Part 11 for all VFD-related records would be consistent with FDA’s recent decision to exempt from such compliance all documents related to new requirements under the FDA Food Safety Modernization Act (FSMA) for current good manufacturing practice, hazard analysis, and preventive controls for animal and human food.
“In 1997, the cost of developing a computerized electronic records and signature system in full compliance with Part 11 was about $150,000 per facility,” said Dave Fairfield, NGFA senior vice president of feed services. “With inflation, that cost is roughly $225,000 today.”
An exemption would also benefit the FDA, said the trade groups, in that it would enable industry to provide documents to FDA for review, and copying, if warranted, in electronic form so that site inspections could be conducted efficiently.
“The number of VFD-related documents will be a tiny fraction of the number of documents related to FDA’s new FSMA requirements for current good manufacturing practice, hazard analysis, and preventive controls for animal food and human food,” noted the AFIA and the NGFA in the petition. “Because FDA has already concluded that exempting those FSMA records from Part 11 compliance will not undercut FDA’s regulatory oversight, it follows that FDA should reach the same conclusion for the much smaller number of VFD-related records.”
The majority of veterinarians that issue VFDs to their clients are in solo or small group practices that do not have the personnel, technical or financial resources needed to implement and maintain computer systems in compliance with Part 11, they added. “To the best of AFIA’s and NGFA’s knowledge, none of their members that are in the business of manufacturing and distributing medicated feed – including those that are part of large corporations – have a computer system that is fully Part 11-compliant today.”
It likely would mean that feed manufacturers and distributers would have to raise prices to cover the cost of installing such systems, the groups said.
The FDA have 180 days to respond to the petition’s request, however the VFD requirements take effect on January 1 so both organizations are asking for a change prior to the start date.
The VFD is a portion of the FDA’s process to encourage the stewardship of antibiotics in animal production. The plan includes ending the use of medically important antibiotics for growth promotion.
It addresses requirements for the distribution and use of specific antibiotics and medicated animal feeds, said the agency. After the directive takes effect, drugs falling into the newly created category of veterinary feed directive drugs will be limited to use with professional oversight and approval of a licensed veterinarian.
Medicated feeds will only be available after an order is issued by a veterinarian who has seen or has knowledge of the animals being treated, the agency said.