What is the Origin of Substandard Products?

This terminology is used by organizations like the World Health Organization (WHO) to categorize medicines that are legally manufactured but are of poor quality, distinguishing them from outright counterfeit products. The concept is rooted in the regulatory imperative to ensure drug efficacy and patient safety across global supply chains.

What is the Mechanism of Substandard Products?

A product may be substandard if the active hormone is not uniformly distributed throughout the dosage form, leading to inconsistent absorption and variable clinical effects. Similarly, poor dissolution properties can prevent the intended systemic bioavailability of the drug. The failure of these products to deliver the expected pharmacological action compromises the precision of hormonal therapy and the integrity of the treatment plan, necessitating a robust supply chain vetting process.

Substandard Products ∞ Area

Substandard Products

Meaning

Pharmaceutical or nutraceutical products that fail to meet the established quality standards, specifications, or legal requirements set by regulatory bodies, often containing insufficient active ingredients, being improperly formulated, or having excessive levels of impurities. These products present a risk of therapeutic failure or unpredictable adverse events. They undermine the integrity of the prescribed treatment plan and can lead to significant clinical harm.