Why Should You Attend:
FDA is concerned about the use of animal drugs compounded from bulk drug substances, especially when approved alternatives exist that can be used as labeled or in an extra label manner consistent with the requirements of FDA’s extra label provisions.
Compounded drugs have not undergone premarket FDA review of safety, effectiveness, or manufacturing quality. The unrestricted compounding of animal drugs from bulk drug substances has the potential to compromise food safety, place animals or humans at undue risk from unsafe or ineffective treatment, and undermine the incentives to develop and submit new animal drug applications to FDA containing data and information to demonstrate that the product is safe, effective, properly manufactured, and accurately labeled.
This webinar will discuss FDA’s decision not to take enforcement action depends on its ability to evaluate whether the compounding of animal drugs is in accordance with each of the following conditions:
If the animal drug is compounded in a state-licensed pharmacy.
If the animal drug is compounded by a licensed veterinarian
If the animal drug is compounded by an outsourcing facility
Areas Covered in the Webinar:
Laws, Regulations, and Litigation with the Drug Enforcement Administration
How to document record keeping of controlled drugs?
References needed for pharmacist to practice in a pharmacy dispensing veterinary medications
Handling extra-labels prescriptions
Review species differences in drugs
FDA is concerned about the use of animal drugs compounded from bulk drug substances, especially when approved alternatives exist that can be used as labeled or in an extra label manner consistent with the requirements of FDA’s extra label provisions.
Compounded drugs have not undergone premarket FDA review of safety, effectiveness, or manufacturing quality. The unrestricted compounding of animal drugs from bulk drug substances has the potential to compromise food safety, place animals or humans at undue risk from unsafe or ineffective treatment, and undermine the incentives to develop and submit new animal drug applications to FDA containing data and information to demonstrate that the product is safe, effective, properly manufactured, and accurately labeled.
This webinar will discuss FDA’s decision not to take enforcement action depends on its ability to evaluate whether the compounding of animal drugs is in accordance with each of the following conditions:
If the animal drug is compounded in a state-licensed pharmacy.
If the animal drug is compounded by a licensed veterinarian
If the animal drug is compounded by an outsourcing facility
Areas Covered in the Webinar:
Laws, Regulations, and Litigation with the Drug Enforcement Administration
How to document record keeping of controlled drugs?
References needed for pharmacist to practice in a pharmacy dispensing veterinary medications
Handling extra-labels prescriptions
Review species differences in drugs
Speakers
Dr. Bernadette Alisantosa completed her MPVM degree from University of CA, Davis, School of Veterinary Medicine in 1996. She is ACLAM Diplomate since 2009. Currently she is working as the Attending Veterinarian for George Mason University in Fairfax, VA.Her interests are focused on food producing animals and their health related to human health and zoonoses impact in public health. She is the first and co authors on several papers on scientific journals on Pathogenicity of environmental origin salmonella in specific pathogen free and broiler chicks.
Dr. Alisantosa has been serving as a Veterinary reviewer for JoVE Scientific Video journal since 2010.
