Compounded Drug Products

This policy covers compounded drug products and individualized pharmacy compounding—including compounded BHRT (when supported by required clinical evidence), intrathecal preparations (per SUR707.008), and vaginal progesterone for reduction of preterm delivery—for patients who need customized formulations because commercially available FDA‑approved products or dosage forms are inappropriate, ineffective, or not tolerated. Coverage is limited to compounds that meet all policy criteria (e.g., include at least one non‑excluded FDA‑approved prescription ingredient, documented failure/contraindication/intolerance to FDA‑approved alternatives for the same route, and required compendia or peer‑reviewed evidence); products that are commercially available, lack required evidence, contain excluded ingredients (including items on the FDA Exemption List), or are deemed experimental/unproven are not covered and member benefit plans/state rules govern applicability.

"Coverage of FDA-approved drugs when prescribed for a use recognized as safe and effective in one or more standard medical reference compendia adopted by the U."