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PMCID: PMC10934151

They play a critical role in maintaining wellness, especially for those with deficiencies

doi: 10.1021/acs.chemrev.1c00024

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Theres been no groundswell from our members about challenging these items, perhaps because they dont meet the criteria under 503A. Under Section 503A of the Food, Drug & Cosmetic Act, an eligible bulk drug substance for compounding must be a component of an FDA-approved drug, must have a USP or NF monograph, or must appear on FDAs 503A Bulks List or Interim Bulks List Category 1

Humira alone was a major contributor often cited as the single biggest drug expenditure for insurers year after year and was recently removed from BCBS of MA formulary for a biosimilar