In 2022, the FDA placed BPC-157 on its list of bulk drug substances that may not be used in compounding under Section 503A, though enforcement actions have varied by jurisdiction [5]
SC: Max 10mg/day, 30mg/week
Many peptides are cleared from the bloodstream shortly after administration resulting in limited exposure to the brain capillaries, reducing their ability to penetrate the BBB
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Common applications include the reconstitution of compatible research materials, laboratory dilution workflows, formulation studies, stability investigations, and general laboratory preparation procedures where a preserved aqueous medium is required
Additionally, FDA should create a green list of authorized FDA-registered manufacturers of these substances, Brunner said