FDA Conducting Training Regarding Compounding of Animal Drugs for its Inspectors and State Inspectors

DATE:  June 1, 2012
FROM:  John Shafer
              Director, Division of Human Resource Development (HFC-60)
SUBJECT:  COURSE ANNOUNCEMENT: AMDUCA/Compounding Animal Drugs (VM207)
AMDUCA/Compounding Animal Drugs (VM207)
Nashville, TN
                Begin:    Tuesday, August 21, 2012 at 8:00 AM
                End:       Thursday, August 23, 2012 at NOON  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.

Objectives:  Upon completion of this course, participants will be able to:
1.  Describe the regulations and guidance documents that address the proper use of animal drugs, the compounding of drugs for use in animals, and the extra label use of drugs in animals.
2.  Recognize appropriate investigative and data gathering techniques for conducting investigations of compounding pharmacies, veterinarians and food animal producers.  3.  Correctly complete the documentation required for the development of a successful enforcement
action.
Target Audience:  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.

To read the entire announcement to FDA employees click here