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Outsourcing facilities should confirm whether any GLP-1 compounding relies on bulk substances, reassess whether any product is identical or nearly identical to an approved drug and document the basis for continuing any formulation in light of FDA's express statement that semaglutide and tirzepatide are not on the 503B bulks list or drug shortage list
Sarlette A, Krampfl K, Grothe C, Dengler R, Petri S
Dosage, Administration, and What to Expect Both medicines are given as once-weekly subcutaneous injections with gradual dose titration
If a provider determines a compounded GLP-1 medication is clinically appropriate and issues a prescription, the medication is compounded and shipped directly from a licensed 503A partner pharmacy to the patient
