Fight FDA Restrictions on Hormone Pellets
Channel: BioBalance Healthcast
Date: 2015-06-15

I ask my bioidentical hormone pellet patients to take immediate action that could affect your ability to receive hormone pellets in the future. There is a rule before the FDA that, if adopted, would prohibit compounding pharmacies from sending hormones across state lines. This includes the hormone pellets BioBalance Health uses for your treatment!

It is my strong opinion that the FDA does not like compounded medicines, including hormones, because they have less control over them than regular pharmaceuticals.

BioBalance Health has been getting our pellets from a pharmacy in Colorado for over 13 years, and my mentor, Gino Tutera, used the same compounding pharmacies for over ten years before I did. I have tried pellets compounded in my state and have found them to be inconsistent in dose and quality, and they had additional side effects. For the sake of my practice, and the treatment I provide, I am unwilling to take risks, so WE MUST BE ABLE TO ORDER PELLETS FROM OUT OF STATE! The FDA wants to take this away from us.

I have written a letter to the FDA stating my position (see link below), and I ask you to write your own letter, telling them what hormone pellets have meant to you.

I believe that this action by the FDA is the first chip away at the compounding  pharmacy industry, and if adopted, will be followed by more laws, paperwork and controls until it will not be affordable to practice medicine with bioidentical hormones.

If Biobalance Health pellets have made a difference in your health and well-being, please click here to go to the Federal Register website. That page includes the memorandum with details of the rule that concerns us. In the upper right corner of that page is a green button titled, SUBMIT A FORMAL COMMENT. Click it to access the comment form. I suggest you begin with something like, “I do not agree with the proposed rule to prevent interstate commerce of compounded medications.” Continue by describing the difference bioidentical hormone pellets have made in your life. Be concise — short is better than long — and tell them how losing access to compounded hormone pellets would adversely affect your life.  

BioBalance Health currently has no trusted compounding pharmacies in Missouri. Please help me and yourself by making your voice heard!

Dr. Maupin's rebuttal: https://biobalancehealth.com/Compounding-Pharmacies-Rebuttal-of-Proposed-Rule-Maupin.pdf

Form on which you can submit your comment for the FDA: https://www.federalregister.gov/articles/2015/02/19/2015-03420/memorandum-of-understanding-addressing-certain-distributions-of-compounded-human-drug-products