What are the concerns about custom-compounded "bioidentical" hormone therapy?

@article{Pinkerton2014WhatAT,
  title={What are the concerns about custom-compounded "bioidentical" hormone therapy?},
  author={JoAnn V. Pinkerton},
  journal={Menopause},
  year={2014},
  volume={21 12},
  pages={1298-300}
}
Unsubstantiated claims, lack of scientific safety and efficacy data, and lack of quality control surround custom-compounded bioidentical hormone products. FDA-approved hormone therapy provides tested and regulated therapy without the risks of unregulated and untested custom preparations.