Empower issued the following after the FDA Pharmacy Compounding Advisory Committee voted to recommend that six out of seven peptides under review receive Category 1 inclusion, which will make them eligible for pharmacy compounding when confirmed by the FDA:
“Today is a win for patient access.
The PCAC’s recommendation that six out of seven peptides receive Category 1 inclusion is an important step toward preserving a regulated pathway for licensed providers to prescribe personalized compounding medications for patients whose care does not fit a standardized protocol.
Empower’s focus has always been quality: compounding medications prescribed by licensed healthcare providers based upon individual patient needs, under rigorous compliance standards. Today’s outcome means patients and providers are one step closer to accessing peptides within the safeguards of a regulated healthcare system. Upon FDA’s approval of the PCAC’s recommendations, licensed providers can turn to Empower for responsible peptide compounding with confidence.
We anticipated this moment. We prepared for it. We are ready.”
Empower appreciates the PCAC’s thoughtful consideration of the scientific and clinical evidence presented throughout the review process. As the regulatory process continues, Empower remains committed to working with licensed healthcare providers, regulators, and the broader healthcare community to expand patient access to high-quality compounded medications while maintaining the highest standards of safety and quality.
