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As Kennedy himself acknowledged during the podcast, the restrictions effectively created the gray market. Products sourced through these channels carry significant risks including contamination, incorrect dosing, mislabeling, and complete absence of quality control

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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)

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