UNIVERSITY OF KENTUCKY HOSPITAL CHANDLER MEDICAL CENTER

POLICY NUMBER: PH-06-07 FIRST ISSUED: 4/94 CURRENT AS OF: 1/12

Department of Pharmacy Policy

SUBJECT: PURPOSE: Beyond-Use Dating and Labeling

This policy is designed to ensure that all pharmacy prepared sterile products bear an appropriate beyond-use date.

1.

The beyond-use date assigned to sterile products should be based on currently available drug stability information and sterility considerations. Sources of drug stability information include references (e.g., Remingtons Pharmaceutical Sciences, Extended Stability for Parenteral Drugs, The Handbook on Injectable Drugs, Micromedex), manufacturer recommendations, and reliable, published research. When interpreting published drug stability information, the pharmacist should consider all aspects of the final sterile product being prepared (e.g., drug reservoir, drug concentration, storage conditions). 1.1. In the absence of passing additional sterility test (USP 71), the beyond use dates cannot exceed the following time periods before administration. Unless specified differently by the manufacturer or references, beyond-use dates are assigned according to the risk of contamination and storage conditions as outlined in the following table: Room Temp (15-30 degrees C) 1 hour 48 hours 12 hours 30 hours 24 hours Refrigerated Temp (2-8 degrees C) 1 hour 14 days 12 hours 7 days 3 days Frozen Solid-State (< -10 degrees C) N/A 45 days N/A 45 days 45 days

Immediate-Use Low Risk Low-Risk with 12-hour BUD Medium Risk High Risk 1.2.

Immediate-use compounding will: 1.2.1. Apply to any CSP for parenteral administration (IV, inhalation, IM, SQ, etc) prepared outside of an ISO Class 5 environment without terminal sterilization. Antineoplastic agents shall not be prepared outside of pharmacy. 1.2.2. Be reserved for emergent compounded sterile products only 1.2.3. Be compounded in an uncluttered environment free of bodily fluids with low traffic flow. Ideal aseptic technique shall be used to minimize contamination including the swiping of isopropyl alcohol on critical sites and the appropriate use of filter needles for ampules

1.2.4. Be labeled with the product, diluents, date and time prepared, concentration, and initials of compounder. 1.2.5. Shall be kept on the compounder or within close proximity until administered 1.2.6. Be appropriately disposed of if not used within 1 hour. 2. 2.1. Compounded sterile products (CSPs) prepared under all of the following conditions are at a LOW RISK of contamination 2.1.1. CSPs compounded from sterile commercial drugs using commercial sterile devices. 2.1.2. The CSPs are compounded with aseptic manipulations entirely within ISO Class 5 laminar airflow workbench, hood or barrier isolator using only sterile ingredients, products, components and devices. 2.1.3. Located in a ISO Class 7 buffer room with ISO class 8 ante area. 2.1.4. The compounding involves only transfer, measuring and mixing manipulations with closed or sealed packaging systems that are performed promptly and attentively, e.g., no prolonged interruptions. 2.1.5. Examples include reconstitution of single-dose vials of antibiotics or other small-volume parenterals, preparation of hydration solutions.

2.2.

Compounded sterile products (CSPs) prepared under all of the follwing conditions are at a MEDIUM RISK of contamination 2.2.1. Admixtures compounded using multiple additives and/or small volumes 2.2.2. Batch preparations (e.g., syringes) 2.2.3. Complex manipulations (e.g., TPNs or multiple ingredient CSPs) 2.2.4. Compounding occurs over a prolonged period of time (complex procedures). 2.2.5. No bacteriostatic agents are added to the preparation and it is administered over several days (e.g., chemotherapy or pain management administered via a infusion device. 2.2.6. The CSPs are compounded with aseptic manipulations entirely within ISO Class 5 laminar airflow workbench, hood or barrier isolator using only sterile ingredients, products, components and devices.

2.2.7. Located in a ISO Class 7 buffer room with ISO Class 8 ante area. 2.2.8. Examples include pooled admixtures (CSPs made from bulk vials), parenteral nutrition solutions using automated compounders, batch compounded preparations that dont contain bacteriostatic components. 2.3. Compounded sterile products (CSPs) prepared under all of the following conditions are at a HIGH RISK of contamination 2.3.1. Prepared from non-sterile (bulk powders) ingredients 2.3.2. Open system transfers 2.3.3. Non-sterile preparations that are exposed for at least 6hrs before being sterilized. 2.3.4. Preparation from sterile ingredients but exposed to less than ISO Class 5. 2.3.5. Located in a ISO Class 7 buffer room with separate ante area or . 2.3.6. Examples include CSPs prepared from bulk, nonsterile components (e.g., neomycin irrigation, concentrated morphine, alum irrigation) or final containers that are nonsterile and must be terminally-sterilized. 3. Sterile products should be labeled with at least the following information: 3.1. For patient specific products: the patients name and any other appropriate patient identification (e.g., location, identification number); for batch-prepared products: control or lot number; All solutions and ingredient names, amounts, strength, and concentrations (when applicable); Beyond-use date and time

3.2.

3.3.

3.4.

Prescribed administration regimen, when appropriate (including rate and route of administration); Appropriate auxiliary labeling (including precautions); 3.5.1. An overfill label stating 1ml syringes have 0.05ml overfill should be placed on the outside bag containing 1ml syringe doses to alert the nurse of the overfill.

3.5.

3.6. 3.7.

Storage requirements; Identification (e.g., assigned pharmacy identification, P#/ T#/R# of the responsible pharmacists, technician or resident, respectively); Device-specific instructions (when appropriate); and Any additional information, in accordance with state or federal requirements.

3.8. 3.9. 4.

Labels should be legible and affixed to the final container in a manner enabling it to be read while the sterile product is being administered (when possible).

Approved by:

Philip Schwieterman, PharmD Infusion Center/Sterile Products Manager

Rebecca Reagan, PharmD Associate Director, Center Pharmacy Services

Gary Johnson, MBA, PharmD Enterprise Pharmacy Director