What is the Origin of Potency Variation?

This term originates from pharmaceutical quality assurance and regulatory oversight, where 'potency' defines the strength or effectiveness of a drug. The problem of variation is particularly highlighted in non-FDA-approved compounded hormone preparations, where the lack of rigorous, standardized manufacturing and testing processes can lead to inconsistencies. Studies have repeatedly documented that the labeled potency of compounded products may not match the actual content.

What is the Mechanism of Potency Variation?

The underlying mechanism for potency variation stems from inconsistencies in raw material purity, inadequate mixing or blending during the compounding process, or poor chemical stability of the final formulation over time. When a patient receives a dose significantly higher or lower than prescribed, the endocrine system's delicate balance is disrupted. This unpredictability results in inconsistent clinical outcomes, making precise dose titration and safety monitoring challenging for the prescribing clinician.

Potency Variation

Meaning

Potency Variation refers to the measurable difference between the actual concentration or biological activity of the active pharmaceutical ingredient (API) contained within a drug product and the amount stated on its label. This quality control issue is a serious concern in clinical practice because it directly compromises the predictability and safety of the patient’s therapeutic regimen. It represents a deviation from the expected dose, leading to either sub-therapeutic or toxic effects.