AANP’s Campaign to Protect Access to Compounded Glutathione Successful!
What’s happening?
The Pharmacy Compounding Advisory Committee (PCAC) – the committee that advises FDA on matters related to drug compounding – met on June 8 to discuss whether to continue allowing glutathione to be compounded.
The committee voted yes to include compounded glutathione on the “able to compound” list.
Why is this so important?
In an unusual departure for a committee that normally follows FDA recommendations, the committee voted today to include compounded glutathione on the “able to compound” list for 503A compounding pharmacies.
While PCAC ostensibly advises the FDA on matters related to drug compounding, it is exceedingly rare that they vote against FDA staff recommendations, which was to ban compounded glutathione.
One member of the PCAC committee went on to explain their “yes” vote, noting that they “found the [FDA’s] review of the efficacy [of compounded glutathione] superficial and narrow, and I found their conclusion’s [on the research available] dismissive of the positive data because the outcome wasn’t something they [FDA] were interested in looking at.”
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 our coalition partner A.J. Day, PharmD, who the coalition appointed to testify on its behalf, and to Dr. Paul Anderson, who spoke on behalf of the AANP this afternoon and in past PCAC sessions.
This is a major victory for patients and providers in a process that has been stacked against natural ingredients.
Thank you to all of those who submitted their story to the FDA! The statements and comments from providers and patients highlighted to the committee the long, safe, and essential use of glutathione and caused several PCAC members to question the exclusively negative data brought forward by FDA staff.
But we must continue to fight. The FDA will review other ingredients, and may still decide to make these illegal for compounding. They have already denied over 300 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, and friends know that this crucial compounded ingredient is on the path to being protected! Feel free to use the sample language below:
“AANP’s advocacy helps secure patient access to compounded glutathione! The FDA advisory committee just voted in favor of placing the ingredient on the approved list for compounding. This is a major victory for patients and providers in a process that has been stacked against natural ingredients!”

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