|HOME||ABOUT AETA||MEMBER SERVICES||CERTIFICATION||CONVENTIONS||EDUCATIONAL MATERIALS||RESOURCES|
Congratulations to the 2019 AETA Student Scholarship Winners!
Josh Brown, University of Minnesota
Also pictured: President Matt Iager and Vice President Matt Dorshorst
Legality of Compounded Estradiol for Embryo Transfer
The AABP office has received questions from members regarding the legality of using compounded estradiol products in cattle for embryo transfer protocols. AABP has also been in discussion with the FDA about the use of compounded estradiol products in food animals. Compounding from approved drugs in animals is only permitted under the narrowly defined conditions outlined in AMDUCA (Section 21 CFR 530.13). To be permitted, extralabel use from compounding of approved animal drugs or approved human drugs must be in compliance with all relevant provisions of 21 CFR 530 (AMDUCA), including the provisions limiting extralabel use to treatment modalities when the health of an animal is threatened or suffering or death may result from failure to treat. The extralabel use regulation also does not provide for compounding from active pharmaceutical ingredients (API or bulk drugs, i.e., the raw chemical) for use in animals. Therefore, it is illegal for veterinarians to use or prescribe compounded estradiol for cattle or any form of estrogenic compounds for production purposes including embryo transfer and synchronization protocols. AABP encourages cattle veterinarians to refrain from administering or prescribing compounded estradiol for the following reasons:
The need for estradiol for successful embryo transfer protocols has not been unequivocally established. For example, data from nearly 7,000 collections did not demonstrate a difference when using GnRH in place of estradiol in the protocol. Additional references are available on the Reproduction Committee page of the website. Veterinarians who engage in federally prohibited activities put themselves at risk and also risk the profession’s reputation for appropriate and judicious oversight of pharmaceutical products in our cattle patients. This is especially of concern when using an unapproved and illegally manufactured hormone product. AABP Newsletter 5 May 2019
Please contact the Fred Gingrich at firstname.lastname@example.org with any questions.
Global Genetic Improvement Through Embryo Technology
Small Ruminant Embryo Transfer Training Video
Click the image below to watch the video (AETA members only). A DVD is available for purchase