Campaign to Protect Access to Compounded Medications Scores Major Victory!
What’s happening?

The Pharmacy Compounding Advisory Committee (PCAC) - the committee that advises FDA on matters related to drug compounding - met today to discuss whether to continue allowing four crucial ingredients to be compounded (choline chloride, melatonin, methylcobalamin, and oxitriptan).

PCAC listened to testimonies, reviewed patient stories, and took into consideration the FDA staff's recommendations before voting for each compounded ingredient. Their votes determined if each ingredient can or cannot continue to be compounded.

The AANP, along with many coalition partners, has spent several years submitting information and testifying to defend the use of compounded ingredients. Our grateful thanks to Dr. Paul Anderson, who spoke on behalf of the AANP this afternoon and in past PCAC sessions.

Important: Please note, PCAC reviewed the compounded form of these ingredients, not just the ingredient itself.

Ingredients & the status of their ability to compound are below.
Compounded Ingredient
Meeting Result
Choline Chloride
  • UNABLE to compound
Melatonin
for oral administration
  • ABLE to compound
Methylcobalamin
  • ABLE to compound
Oxitriptan (5-HTP)
for oral administration
  • ABLE to compound
This is a major victory for patients and providers in a process that has been stacked against natural ingredients.

But we must continue to fight! FDA will be reviewing another 6 ingredients, including glutathione and capsaicin palmitate, and may still decide to make these illegal for compounding. They have already denied another 301 ingredients which will become illegal to compound when this process is completed unless we keep fighting. 

How can you help?

1. Donate. We need donations to be able to continue to protect compounded medications. Your donation will support the legal actions we are taking to protect patient access to compounded medications, including legal counsel and expert witnesses to prepare nominations and testimony to defend medications for review by the FDA.

2. Share this news. Let colleagues, patients, friends, know that these crucial compounded ingredients have been protected!
Curious about other AANP advocacy initiatives? Learn more here.