tirzepatide shortage list FDA confirms is still over, gives compounders a grace period FDA reinstates tirzepatide on drug

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there's no federal mandate for batch-level potency, sterility, or endotoxin testing Limited batch size: Generally produce smaller quantities for individual patients No FDA inspections: Not subject to routine FDA inspections (though the FDA can inspect in response to reported problems) 503B Outsourcing Facilities Section 503B outsourcing facilities represent a higher regulatory standard for compounding operations

But studies like STEP-1 and SURMOUNT-1 show that 10-15% of people on these meds dont reach that benchmark

Jul-Aug 2019;40(4):594-597