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While Pure Indulgence responded to FDA's Form 483 before the warning letter was issued, stating that it was taking corrective actions, the agency said it was insufficient because the response lacked sufficient details and documentation

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Medicare and most payers require clear documentation of the dose administered, the week preceding the first dose (if applicable), and related CPT codes for injection administration

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Copper supplementation (usually around 2 mg) should be added to any regimen that includes more than 50 mg supplemental zinc daily for more than four weeks

Sermorelin: A Better Approach to Management of Adult-Onset Growth Hormone Insufficiency