Legality of Compounded Estradiol for Embryo Transfer

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Published on: July 25, 2019

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 (APIs 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 (e.g., ECP, Pfizer) or a different form of an animal-approved drug (e.g., growth-promoting implants) for production purposes.
  • Compounding from a bulk product is specifically prohibited in 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 are 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 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 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.1 Additional references are available on the Reproduction Committee page of the website at https://aabp.org/members/Reproduction.asp. 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 Dr. Fred Gingrich at fred@aabp.org with any questions.

Submitted by the AABP Reproduction Committee and the AABP Committee on Pharmaceuticals and Biologics.

1Hinshaw, R.H. Comparison of GnRH and estradiol 17β for follicle turnover in bovine superovulation protocols. Proceedings of the American Embryo Transfer Association 2013, p. 15.

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