Label of the Drug Product

1. Label of the Drug Product • Retail drug product • Legal rules for what is to appear on the label on a retail dispensed drug product comes from the FDCA on the federal level and also from the state. The USP in 2012 has also published guidelines as well • Name, address and phone of pharmacy • Initials of Rah • Rx number • Date of filling • Patient’s name • Directions for use • Doctor’s name • Quantity • Depending on the state the following may be needed • Drug name and strength • Drug expiration • Number of refills left • Original date of the Rx written

2. Compounded Products • Extemporaneous Compounded Products • Made for a specific patient “out of the moment” with no specific recipe. • Compounded by the pharmacist only • Bulk Compounding • Involves a recipe for compounding • Technicians can be called to compound these with the permission of the pharmacist • Made to meet needs of the entire course of tax for a single patient • Bulk Manufacturing • Bulk Compounding for several patients • PTCE makes this distinction

3. Unit Dose System • A system that individually packages a manufacturer’s medication into smaller use blister seals or containers • Can be used on any patient for which it is ordered • Labeling requirement are state governed • Includes the following • Generic (Brand) name of drug • Manufacturer • Lot number /Exp date * • Strength of drug *= an institutional lot number is often generated in which a log book is keep to reference that lot number to the manufacturer’s lot number and Expiration date Institutional date follows the 50% rule Is done by a technician and checked by a pharmacist

4. Intravenous Medication Labeling • Labeling rules are governed by the state, non governmental agencies guidelines (JCAOH, USP797) • Include the following: • Patient’s name, location in institution, MRN • Drug and strength • Base fluid • Name of other additives and quantities of • The intended time of administration of drug • Rate of administration if LVP (or hang time if SVP) • Prep by field and Verified by field • Product expiration field • In addition a nursing label may be attached detailing: • When product was “hung” (i.e. started) • By whom the product was hung

5. IV products that require special handling • Some IV products require special handling and precautions • These drugs are loved to be tested by PTCE • Paclitaxel (Taxol®) requires non PVC IV tubing • Nitroglycerin Injection requires glass container for IV and non PVC IV tubing • Nitroprusside Injections requires the same as nitroglycerin and the IV tube must be covered by a light resistant material to prevent from light degradation • IVIG products must never be shaken