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A large molecule such as a peptide is primarily localized within the central compartment, and thus a small volume of distribution is expected

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doi: 10.1093/jac/dkz277 388 SpellbergB

What has not happened yet (the compliance reality) The most important caution from the FDA Law Blog post is procedural: PCAC recommendations are non-binding , and even if the committee recommends adding these peptides to the 503A bulks list, the FDA still has to go through notice-and-comment rulemaking , which the authors say can take more than a year. That timeline matters because many clinics and patients are asking a simple question: Can my pharmacy legally compound this peptide now? Based on the regulatory framing above, the answer may still be not as a routine, bulk-compounded drug substance under 503A, until a formal bulks-list outcome is finalized (and potentially implemented via interim policy)