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The warning alerts prescribers and patients that the drug could have serious or life-threatening risks

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The distinction matters: 503A facilities compound smaller batches under direct pharmacy oversight, while 503B facilities mass-produce for inventory distribution

This consistency helps maintain stable blood levels and reduces potential gastrointestinal side effects

However, tirzepatide has a dual mode of action, being an agonist for the GIP receptor (Gastric Inhibitory Peptide) as well as for the GLP-1 receptor