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Inclusion on the 503A Bulks List means the FDA has formally determined through rulemaking that a bulk drug substance may be used in compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act

Hematol Oncol 9(2):63-78, 1991

Elevated protein carbonylation, and misfolding in sciatic nerve from db/db and Sod1(-/-) mice: plausible link between oxidative stress and demyelination