American Embryo Transfer Association (AETA)

Congratulations to the 2019 AETA Student Scholarship Winners!

Josh Brown, University of Minnesota
David Hardesty, University of Wisconsin-Madison
Sarah Harp, The Ohio State University
Makayla Hawbaker, University of Wisconsin
Russell Johnson, Tuskegee University
Kaitlin Karl, Michigan State University
Mariah Markle, Louisiana State University
Hilary Seals, Auburn University
Nicholas Shen, Lincoln Memorial University
Michael Topper, University of Pennsylvania

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:

AMDUCA only allows for extralabel drug use when the health of an animal is threatened. There is no production allowance, particularly for compounding; therefore, one cannot use human-approved drugs (i.e., ECP, Pfizer) or a different form of an animal-approved drug (i.e., growth-promoting implants) for production purposes.
Compounding from a bulk product is specifically prohibited in the AMDUCA regulations.
The safety, potency, efficacy, stability, sterility, and disposition of compounded products is unknown. Compounded products do not undergo FDA inspection, potency testing, or efficacy testing. Veterinary compounding pharmacies that also compound for humans are under federal regulation and FDA inspected; however, this only applies to the human side of the compounding operation. Veterinary compounding pharmacies do not have this level of oversight. There is no guarantee of the safety or efficacy of compounded products and the liability for the use of such products falls on the veterinarian in the event of an adverse reaction or violative residue.
Because the safety, efficacy, potency, and disposition of the compounded product is not known, it is impossible to assign a withdrawal interval for compounded products.
The use of compounded products in food animals places a veterinarian at a risk of professional liability.

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 fred@aabp.org with any questions.