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Numerous drugs are approved or indexed for use in animals. However, there are many different species of animals with different diseases and conditions for which there are no approved or indexed animal drugs. In some cases, approved human drugs can be used to treat an animal under the extra label use provisions of the FD&C Act and FDA regulations.
For example, various chemotherapeutic drugs approved for humans are used to treat cancer in dogs and cats. FDA recognizes that there are circumstances where there is no drug available to treat a particular animal with a particular condition, because either no drug is approved for a specific animal species or no drug is available under the extra label drug use provisions. In those limited circumstances, an animal drug compounded from bulk drug substances may be an appropriate treatment option.
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:
Why should you Attend?
Who will Benefit?
This webcast will be of a valuable assistance to the below audience.
Veterinary Pharmacy Law, Licensed Veterinarian, Veterinary Oversight, Animal Producers, Animal Growth, Animal Health, VFD Drugs, Animal Antimicrobial Drugs, Drug Enforcement Administration, Veterinary Medications
Dr Sue Hudson Duran is a professor at Auburn University College of Veterinary Medicine and Adjunct Clinical Professor, Harrison School of Pharmacy, Auburn, Alabama. She has experience as a GMP pharmacist in pharmaceuticals, biologicals, nutraceuticals and food. She is an active member of the Auburn Food Systems Institute. She has been the safety officer at the College of Veterinary Medicine since 2000, serving to educate medical professionals in safe handling
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