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If pregnancy occurs, the healthcare provider will likely discontinue sermorelin due to the lack of safety data

There are several specific concerns: Unknown long-term effects - Licensed medicines undergo years of trials and post-market surveillance

Supplemental folic acid therapy in pernicious anaemia: the effect on erythropoiesis and serum vitamin B12 concentrations in selected cases

We appreciate commenters' concerns about providing additional time for hospitals to adjust and for additional geometric mean data to accumulate, however given that costs that were previously packaged into CPT code 78803 are now separately paid as a result of the policy we instituted last year, we think it is appropriate to reassign CPT 78803 to an APC that better aligns with 78803's CY 2026 geometric mean cost of around $585

All orders are shipped in thermal mailers to help maintain consistent handling conditions during transit and support product integrity from our facility to delivery

The 20232026 Category 2 period created a gray market, and concern about unverified raw material quality has increased among quality managers at compounding pharmacies and research institutions alike