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Ep. 212 - What do You Need to Know about Extra Label Drug Use and Using Aspirin in Cattle?
Manage episode 445122443 series 2627083
AABP Executive Director Dr. Fred Gingrich is joined by the Dr. Alison Vander Plaats, chair of the AABP Committee on Pharmaceutical and Biologic Issues (CPBI). This podcast was created to update cattle veterinarians and farmers about extra label drug use (ELDU) and FDA’s stance on the use of aspirin in cattle. With the current HPAI H5N1 outbreak in dairy cattle, it is critical that veterinarians understand how to develop treatment protocols that are in compliance with current regulatory positions.
Veterinarians should make sure they full understand the federal Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) which outlines to criteria that must be met to incorporate ELDU in their drug treatment protocols. Vander Plaats explains that veterinarians must first utilize labeled drugs that are approved for a specific indication in that class of animals and also understand that AMDUCA allows for the ELDU of approved animal or human drugs. Aspirin is not an approved drug and does not have a New Animal Drug Approval (NADA) number, therefore it has always been illegal to use. FDA has previously stated that aspirin was of low regulatory concern, however that is no longer the position of the agency. Other unapproved drugs utilized in bovine practice, such as lidocaine, calcium solutions, and epinephrine, are not of regulatory concern due to their critical need and no alternatives that are approved. Such is not the case with aspirin and therefore veterinarians should not use aspirin in treatment protocols.
If you are an AABP member and would like to get involved with CPBI, or another committee, please go to the committee menu on the AABP website and review the committee that is of interest. On the individual committee page, you can click the email button to send an email to the committee chair and vice-chair to express your interest. Committee appointments are approved by the board and interested applicants should submit a brief biography with name, veterinary or veterinary technician school and graduation year, professional employment and your interest in the committee. AABP welcomes all volunteers to serve and guide our organization.
215 قسمت
Manage episode 445122443 series 2627083
AABP Executive Director Dr. Fred Gingrich is joined by the Dr. Alison Vander Plaats, chair of the AABP Committee on Pharmaceutical and Biologic Issues (CPBI). This podcast was created to update cattle veterinarians and farmers about extra label drug use (ELDU) and FDA’s stance on the use of aspirin in cattle. With the current HPAI H5N1 outbreak in dairy cattle, it is critical that veterinarians understand how to develop treatment protocols that are in compliance with current regulatory positions.
Veterinarians should make sure they full understand the federal Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) which outlines to criteria that must be met to incorporate ELDU in their drug treatment protocols. Vander Plaats explains that veterinarians must first utilize labeled drugs that are approved for a specific indication in that class of animals and also understand that AMDUCA allows for the ELDU of approved animal or human drugs. Aspirin is not an approved drug and does not have a New Animal Drug Approval (NADA) number, therefore it has always been illegal to use. FDA has previously stated that aspirin was of low regulatory concern, however that is no longer the position of the agency. Other unapproved drugs utilized in bovine practice, such as lidocaine, calcium solutions, and epinephrine, are not of regulatory concern due to their critical need and no alternatives that are approved. Such is not the case with aspirin and therefore veterinarians should not use aspirin in treatment protocols.
If you are an AABP member and would like to get involved with CPBI, or another committee, please go to the committee menu on the AABP website and review the committee that is of interest. On the individual committee page, you can click the email button to send an email to the committee chair and vice-chair to express your interest. Committee appointments are approved by the board and interested applicants should submit a brief biography with name, veterinary or veterinary technician school and graduation year, professional employment and your interest in the committee. AABP welcomes all volunteers to serve and guide our organization.
215 قسمت
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