Tell the FDA to Protect Compounded Medicines!

The FDA has released a list of nominations to its “Demonstrably Difficult to Compound” (DDC) list, which is supposed to identify drugs that cannot safely be compounded because of their complexity. Included on this list are certain kinds of safe, bioidentical hormones such as progesterone (including progesterone with estradiol), human chorionic gonadotropin (HCG), testosterone, and delivery systems such as time-released medicines. If these are banned, drug companies would then have a government-enforced monopoly—even though the pharmaceutical versions or their alternative products are often substandard or even dangerous.

Compounding pharmacists say these are not difficult to compound and are not dangerous. Thirty-eight percent of the nominations came from one of the largest multinational pharmaceutical companies in the world. Other nominations came from doctors with ties to Big Pharma, while some nominations seem to be from people confused about compounding.

Eliminating time-released medicines also threatens people with certain conditions, such as hypothyroidism. These patients MUST have access to compounded hypothyroid medications, especially since pharmaceutical companies are starting to put gluten in their thyroid hormone medications, which will make the majority of these patients even sicker! Many people's hypothyroidism is caused by Hashimoto's disease, an autoimmune condition that would be exacerbated by gluten.

The FDA may deny the public any input on this list. Tell the FDA to follow the rules and issue a proposed rulemaking, which allows for a period of public comment, before finalizing its Demonstrably Difficult to Compound list. Also tell them how important the survival of these compounded drugs is for you.  

Please personalize and add your own comments if you have time!


  • Food and Drug Administration


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Please Issue a Proposed Rulemaking on the DDC List

Dear [Decision Maker],

[Your Name]
[Your Address]
[City, State ZIP]