The FDA has released a draft Memorandum of Understanding
(MOU) on the interstate distribution of compounded medications by traditional
pharmacies. Currently, no more than 5% of their total interstate sales can be
from compounded drugs; this new MOU allows them to ship up to 30%, if their
state agrees to bear the burden for any adverse events or quality issues, and
to police the 30% rule in its pharmacies. Many states will be unwilling to take
on such responsibilities, which will leave the 5% limit in place.
Administratively, it will be next to impossible for
compounding pharmacies to predict if they are exceeding 30% (or even 5%) until
the end of the year, when it’s too late to do anything about it. The FDA has
offered no rationale yet as to how it reached that 30% number. If 30% is as
safe as 5%, then clearly safety is not the FDA’s concern and any restriction is
Tell the FDA and Congress that any limit on interstate sales
Please personalize and add your own comments if you have time!
Protect Interstate Commerce for Compounders!
Dear [Decision Maker],
Sincerely,[Your Name] [Your Address] [City, State ZIP]