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In the prepared briefing documents for the meeting, FDA experts note that there is a lack of evidence on efficacy and safety to justify manufacturing these peptides by pharmacies, and thus they propose not to include them on the 503A Bulks List

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Manufacturing Standards Solidphase peptide synthesis (SPPS) is the standard method for producing research peptides

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Over days and weeks, these micro-stresses accumulate and can reduce potency faster than the BUD suggests

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