When inpatient pharmacies repackage unit-dose medications, which records must they keep?

When inpatient pharmacies repackage unit-dose medications, it is essential to maintain comprehensive records that include all relevant packaging information. This is crucial for ensuring patient safety and for regulatory compliance. The records need to cover several critical elements, such as the manufacturer's lot number, expiration date, drug name, strength, dosage form, and specific packaging details.

Maintaining this full set of information allows the pharmacy to track and trace medications effectively, which is especially important in the event of a recall or adverse reaction. It also aids in ensuring that medications dispensed to patients are safe, effective, and properly labeled.

Having only selective information, like just the manufacturer's lot number and expiration date, or limited details like the drug name and strength, would not provide adequate safety measures or legal compliance. Complete records are a fundamental requirement to ensure the pharmacy can provide high-quality care and adhere to regulatory obligations.