The FDA is reviewing 4 ingredients at the upcoming Pharmacy Compounding Advisory Committee (PCAC) Meeting. This committee is not made up of medical professionals that support compounding, in fact it is far from it!

Their decision could ban Methylcobalamin (the methylated form of B12) from being prepared by compounding pharmacies even with a prescription from a physician. This means that our customers may no longer be able to get methyl-B12 injections. I hope that we will still be able to get methyl-B12 in nutritional supplements, but for some people the injections are much more effective.

Methyl-B12 is the neurologically active form of B12 and for certain people it works much better than the commercially available type of B12 (cyanocobalamin). In my opinion, there are no safety risks or reasonable reasons to ban this very safe and effective treatment.

They are also looking at banning melatonin from being compounded. They aren’t banning all melatonin – just not allowing compounding pharmacies to prepare it. We compound with that much less than Methyl-B12.

If you have been using Methyl-B12 injections I especially urge you to contact the FDA with your story. Please personalize your response as much as possible because it is much easier for many copies of stock responses to be ignored. To get started, feel free to use the following as a guide for creating your own comment.

To whom it may concern,

I have been using (compounded) Methylcobalamin for _______ (years/months) to treat ________. Without Methylcobalamin, I would ______.  Methylcobalamin  has allowed me to ______________. I urge you to preserve access to compounded Methylcobalamin. I believe you create these regulations to protect patient safety, yet this decision would put my health in jeopardy.


Click here to submit your comments. On the page, choose “comment” to leave your message, and you can hit “browse” to read what other people are saying about this. It only takes a minute, and the comments need to be done asap in order to be reviewed in time. The more comments we can get the better!

Please note, these comments are published in the Federal Register, which is part of the public record of US Government business, and will be publicly available after submission. 

Please reach out to me if you have any questions Thanks for your advocacy efforts in protecting your access to compounded medications!

Jennifer Burch, PharmD

Pharmacist / CEO