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.

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  • Your Senators
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  • Stephen Ostroff


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Protect Interstate Commerce for Compounders!

Dear [Decision Maker],

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