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Bottom line: even if the FDA eventually recommends that certain peptides can be compounded under Section 503A, many stakeholders could still be blocked by the requirement to source pharmaceutical-grade API from an FDA-registered establishment with a Certificate of Analysis and by FDAs demonstrated willingness to police marketing claims around compounded drugs

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We hypothesized that storing the gel-forming NAC eye drops under refrigeration while performing daily dosing for several weeks in rd10 mice may have led to decreased potency due to NAC dimerization in solution