Which information must be included on a generic substitution label?

The inclusion of the name of the manufacturer or distributor of the substituted drug on a generic substitution label is crucial for several reasons. First, it ensures transparency for the patient and healthcare providers regarding the source of the medication being dispensed. This is particularly important in the context of generic drugs, as there may be variations in quality and efficacy between different manufacturers. By providing the name of the manufacturer, patients can make informed choices and report any adverse effects or concerns about a specific product to the correct source.

Additionally, knowing the manufacturer can help pharmacists and healthcare providers track recalls or quality issues that may arise with specific generic drugs. This information supports patient safety by allowing for better monitoring of medications that may be associated with particular brands or distributors.

Including the name of the original brand drug, the date of manufacture, or the prescription refill number might provide useful information but does not fulfill the regulatory requirements for labeling generic substitutions as clearly as the manufacturer's name does. In summary, highlighting the manufacturer's name on the label is essential in promoting informed patient care and ensuring accountability within the pharmaceutical distribution process.