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Manufacturing costs for injectable GLP-1 medications involve specialized equipment, sterile production facilities, quality assurance testing, and cold-chain logistics to maintain stability from factory to patient

The FAERS database has recorded 62,000 adverse reactions to these drugs, with 10,000 classified as serious

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For 503B outsourcing facilities, no equivalent safe harbor appears to apply, and enforcement grace periods that had been in place through early 2026 are expiring, leaving bulk compounders of GLP-1s in a substantially more precarious legal position

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