Protect Interstate Commerce for Compounders!

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 utterly arbitrary. 

Tell the FDA and Congress that any limit on interstate sales is unacceptable.

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

Recipients

  • Your Senators
  • Your Representative
  • Stephen Ostroff

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Message

Protect Interstate Commerce for Compounders!

Dear [Decision Maker],

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