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Updated 8/23/21

The Secretary may: Direct agency priorities Encourage enforcement discretion Appoint or replace FDA leadership Order internal review of regulatory positions Support re-evaluation of prior safety determinations The Secretary may not: Bypass statutory requirements Ignore the Administrative Procedure Act Unilaterally legalize peptide compounding Regulatory change must follow defined legal pathways

Bacteriostatic water is generally considered safe if handled correctly and used within its expiration date

Effectiveness loss Subjective but important indicator: Peptide stopped working as well Need higher doses for same effect Complete loss of expected benefits Example: BPC-157 was reducing pain, but suddenly stops helping

E.OfverstedtL.-G.et al (2006)

doi: 10.1016/j.phymed.2021.153558, 26