Whatever else may be at issue in a Warning Letter FDA recently released to a 503A pharmacy, dated September 18, the lesson for pharmacies is straightforward: Prescriber judgment — and properly documenting that judgment — matters to FDA.
APC does not ordinarily comment on FDA enforcement actions, and we have no comment on Empower Pharmacy or the facts of the Warning Letter. But one point in that letter deserves clarification because it could easily be misread.
Volume itself is not the violation. Federal law does not impose a numerical limit on how much a 503A pharmacy may compound when that volume is supported by valid prescriptions for individually identified patients.
Nor does the letter declare that combination GLP-1 formulations are automatically “essentially copies.” Read through page three. FDA’s stated concern is that the pharmacy, in FDA’s judgment, lacked sufficient documentation that prescribers had determined the compounded combinations produced a significant difference for their individual patients.
Without that documentation, FDA says, the products are essentially copies. That is an important distinction.