Daniel McChesney, Director, Office of Surveillance and Compliance, CVM | Slides
CVM: 2013 Priorities and Activities
• Compounding and unapproved animal drugs
– Human drug compounding and animal drug
compounding
• Legislation
• Applicability of similar approaches
• CPG for animal drug compounding
– Are different approaches for animals intended for food and
those not intended for food
– Compounding from bulk drug
– Positive and negative lists
CVM: 2014 Priorities
• Eliminate FOIA backlog
• Address current lawsuits
• Process/staff to address FOIA in real-time
• Avoid future lawsuit’s due to response time
• Implements guidance 213 and VFD regulations
• Improve Section 105 data reporting and
transparency
• Support drug approval process by addressing
competing unapproved and/or compounded
products
found here
CVM: 2013 Priorities and Activities
• Compounding and unapproved animal drugs
– Human drug compounding and animal drug
compounding
• Legislation
• Applicability of similar approaches
• CPG for animal drug compounding
– Are different approaches for animals intended for food and
those not intended for food
– Compounding from bulk drug
– Positive and negative lists
CVM: 2014 Priorities
• Eliminate FOIA backlog
• Address current lawsuits
• Process/staff to address FOIA in real-time
• Avoid future lawsuit’s due to response time
• Implements guidance 213 and VFD regulations
• Improve Section 105 data reporting and
transparency
• Support drug approval process by addressing
competing unapproved and/or compounded
products
found here
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