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FDA-2025-N-6895 Public Docket 503A Compounding Bulk Drug Substances List Nominations (comments due July 22, 2026)

Examples include: Right knee Left shoulder Hip joint Subacromial bursa Precise anatomical documentation supports accurate coding

In September 2023, the FDA added BPC-157 to its Category 2 list of bulk drug substances under its Interim Policy on Compounding, meaning 503A compounding pharmacies and 503B outsourcing facilities are barred from using it in compounded preparations

Thymosin beta-4 in an experimental rat TBI model

Glutathione is capable of preventing damage to important cellular components caused by sources such as reactive oxygen species, free radicals, peroxides, lipid peroxides, and heavy metals