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Small personal quantities often pass through uninspected
FDA guidance permits personal importation of 90-day supplies of non-controlled substances for personal use
APC Industry Report
This patient-specific requirement creates the fundamental limitation of the 503A model: scalability
Common state enforcement actions include: License suspension for contaminated products Fines for inadequate testing documentation Cease and desist orders for out-of-state shipping violations Required remediation for failed inspections Californias Board of Pharmacy has been particularly active, issuing over 30 enforcement actions against peptide-compounding pharmacies since 2023
Practical Implications for Different Stakeholders Regulatory complexity affects each participant in the peptide ecosystem differently
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