FDA investigators, state inspectors, compliance officers attend training on animal compounding

Reminder (as previously posted on blog) that training was taking place this week (ends today at noon) by FDA investigators, state inspectors, compliance officers, and supervisors who are actively engaged in inspections of animal drug compounding pharmacies and veterinarians’ extra label drug use in food producing animals or review or take compliance action on these inspection reports.


COURSE DESCRIPTION / OBJECTIVES:                              
This course is intended to instruct field investigators on the laws, regulations and policies pertaining to compounding of animal drugs and the Animal Drug Use Clarification Act related to the extra-label drug use in animals. Compounding of animal drugs has increased exponentially in the last few years.  Certain compounding practices undermine the animal drug approval process, and present unknown and potentially hazardous risk to animal and human health.  Animal drug compounding is addressed in various laws, regulations, and policies.  In order to adequately assess violations of concern, investigators need to understand the laws, regulations and policy that distinguish animal from human drug compounding. Extralabel drug use practices may especially result in violative food animal tissue residues.  Investigators need to understand under what circumstances extra-label drug use can or cannot be utilized in veterinary medicine.

For Source see here.