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503A compounding pharmacies may work with materials which, in addition to being accompanied by a valid certificate of analysis (CoA) and manufactured in an FDA registered facility, must meet one of the below three requirements: Complies with an applicable USP or NF monograph if one exists* Is a component of an FDA-approved drug product if an applicable USP or NF monograph does not exist

The FDA cited insufficient evidence on safety for human use in the compounding context

However, its application specifically for autoimmune conditions (rather than general tissue repair) is largely extrapolated from its known mechanisms rather than directly studied

They also help the body make more glutathione, a health benefit

doi:10.1039/c0ce00278j