In sterile compounding, what does it mean for a dosage form to be sterile?

A dosage form classified as sterile means that it is devoid of viable microorganisms. Sterility is a critical requirement for certain pharmaceutical preparations, especially those administered via routes that bypass the body's natural barriers, such as injections, ophthalmic solutions, or implantable devices. The absence of viable microorganisms ensures that the product is free from any potential pathogens that could cause infection or complications in a patient.

While some dosage forms may contain beneficial microorganisms, such as in certain probiotic products, this does not pertain to sterile compounds. The concept of "effective against pathogens" relates more to antimicrobial activity rather than sterility itself and does not guarantee that the product is without bacteria or spores. Moreover, chemical sterilization is one method employed to achieve sterility, but it is important to note that sterilization alone does not imply a product is sterile; the end product must be tested for sterility. Thus, stating that a dosage form is devoid of viable microorganisms captures the fundamental essence of what sterility entails in compounding practices.