Tell the FDA Their New Compounding Rules Will Hurt Patients

Under new rules proposed by the FDA, there will be an approved list of “bulk ingredients” (drugs) the FDA will allow to be sold by compounders in outsourcing facilities. Anyone can nominate bulk ingredients for the list (pharmacies are expected to be the most likely to do so), but the FDA is requesting supporting data for any ingredient nominated—and the new rules for this supporting information are so broad and complex, requiring so much time and research, that smaller organizations will find it difficult or even impossible to meet the agency’s requirements.

Tell the FDA that their terms of the request for nominations for bulk substances are entirely too broad, and will greatly diminish patients’ access to important medications.

Please personalize your comments if you have the time!


  • Food and Drug Administration (FDA)


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Dear [Decision Maker],

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