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Peptide Practice Verification  (PPV)

Advancing  Quality, Transparency, and  Stakeholder  Confidence in Peptide  Compounding 

The rapid growth of peptide compounding has generated significant interest among patients, prescribers, regulators, and pharmacy professionals. Recent discussions during the FDA’s Pharmacy Compounding Advisory Committee (PCAC) meeting highlighted that many stakeholders support continued access to appropriately compounded peptides while also advocating for stronger “guardrails” to ensure patient safety and confidence. 

The Coalition for Compounding Excellence (CCE) has developed the Peptide Practice Verification (PPV) Program, a voluntary verification program designed specifically for compounding pharmacies preparing peptide medications. The PPV focuses specifically on peptide-related practices, including but not limited to those raised during the recent PCAC meeting.

The PPV Program emphasizes: 

  • API originates from manufacturers the FDA has evaluated and placed on a substance-specific Green List. Pharmacies obtain API for these peptides only through FDA-registered repackagers/resellers that provide lot-specific quality and sourcing documentation. 

  • Compounding is based on valid, patient-specific prescriptions based on a prescriber judgment(documented) –There is a real prescriber-patient-pharmacy triad. 

  • Patients receive a clear, but enhanced disclosure that the preparation is compounded and is not FDA-approved. 

  • Pharmacies report serious adverse events related to these peptides through FDA’s MedWatch system and maintain records that allow investigation, traceability, and recall where necessary. 

  • Complete lot-level traceability and chain-of-custody documentation.

  • Enhanced quality controls for sterile peptide preparations.

Supporting the Future of Responsible Peptide Compounding 

By encouraging higher standards of supplier qualification, product verification, traceability, documentation, transparency, and continuous quality improvement, the PPV Program seeks to increase confidence among patients, prescribers, regulators, and payers while supporting the continued availability of high-quality compounded peptide preparations.

Contact us to find out about adding the Peptide Practice Verification to your core CCE Accreditation.

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