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Current Good Manufacturing Practices

Meaning

Current Good Manufacturing Practices, or cGMP, are a set of stringent regulations enforced by regulatory agencies to ensure that pharmaceutical products, dietary supplements, and medical devices are consistently produced and controlled according to quality standards. These practices cover all aspects of production, from the starting materials and premises to the equipment and the training of personnel. Adherence to cGMP provides clinical assurance of a product’s identity, strength, quality, and purity, which is paramount in hormonal health interventions.
Rows of uniform vials with white caps, symbolizing dosage precision for peptide therapy and bioidentical hormones. Represents controlled administration for hormone optimization, vital for metabolic health, cellular function, and endocrine regulation in clinical wellness protocols.
What Are the Regulatory Differences between Compounded and Manufactured Peptides?

What Are the Regulatory Differences between Compounded and Manufactured Peptides?

The regulatory path for peptides is defined by their purpose: manufactured drugs undergo extensive FDA trials for broad public safety, while compounded versions are personalized under pharmacy standards for specific patient needs.
∞ Active Pharmaceutical Ingredient (API)
∞ Current Good Manufacturing Practices
∞ FDA New Drug Application
HRTio
August 1, 2025