Which items are required on the label of a sterile pharmaceutical product prepared in an institution?

The requirement for labeling sterile pharmaceutical products prepared in an institution is critical to ensuring both safety and compliance with regulations. The inclusion of the date of preparation, patient name, and expiration date on the label is essential for several reasons.

The date of preparation is important because it provides information on when the product was compounded, which is crucial for assessing its stability and ensuring it is used within its designated shelf life. The expiration date indicates the time frame in which the product is guaranteed to be effective and safe for use. Both dates help in preventing the administration of outdated medications, reducing the risk of adverse effects.

Including the patient's name on the label ensures that the medication can be accurately associated with the individual for whom it was prepared. This personal identifier is fundamental in preventing medication errors and ensuring that the right patient receives the correct therapy.

While other options contain certain relevant details, they do not encompass the essential elements required by regulations for sterile pharmaceutical products. Some may lack critical information needed for patient safety and regulatory compliance, such as the necessity of indicating both the preparation and expiration dates clearly.