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!
Dear [Decision Maker],
Sincerely,[Your Name] [Your Address] [City, State ZIP]