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Off-label means a drug is prescribed for a purpose other than those it is approved to treat
This typically happens when tirzepatide has been exposed to elevated temperatures for an extended period, has been stored outside the refrigerator for longer than the recommended timeframe , or has been exposed to direct light
If the agency ultimately issues a final determination against listing, compounders would lose any viable legal pathway though substances can be re-nominated in future PCAC cycles or challenged in federal court
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