Personal protection equipment (PPE)
Hand Washing And Disinfecting
❑ The single most important procedure for ❑ USP Chapter 〈797〉 has established handwashing procedures
preventing the spread of infection is hand washing. using approved sterilizing agents, such as chlorhexidine, based on
❑ Many infections such as cold, flu, and infectious recommendations of the CDC.
diarrhea are spread through touch contamination. ❑ It also suggests the use of surgical scrub brushes and nail picks similar
❑ The Center for Disease Control (CDC) has to those used by surgery personnel.
published specific handwashing guidelines for the ❑ Alcohol-based hand sanitizing agents such as Purell are also recommended.
health care profession. ❑ The handwashing process should be done for 30 to 60 seconds, vigorously
scrubbing hands and forearms up to elbows.
❑ In pharmacy, (PPE) is used to protect the CSP environment ❑ All PPE should be lint free so as to minimize dust and lint
from microbial organisms, but it can also protect pharmacy particles from entering the sterile compounding area.
personnel from harmful substances within the compounding PPE used in the sterile compounding area include the following:
environment.
❑ For example, if a pharmacy technician has an allergy to
penicillin, any contact with the drug causes painful and
itchy welts to the skin. By wearing proper PPE, the
pharmacy employee can reduce the risk of exposure to the
substance that causes this reaction.
❑ Another example is pharmacy personnel involved with the ❑ Before entering the sterile compounding area and donning
sterile compounding of chemotherapy and nuclear medicines. Both shoe covers, step on a tak-mat (or sticky mat).
of these types of medications have potentially harmful ingredients ❑ Tak-mats are covered with a sticky substance that
that can cause serious, toxic effects from exposure. removes debris from the bottom of shoes.
❑ There are specific PPE guidelines to protect personnel from ❑ They are placed at the entrance to the sterile compounding
area
the effects associated with exposure to these types of products.
❑ PPE should be removed in reverse order, starting with
gloves and ending with shoe covers.
❑ If any of the items become soiled, these should be removed
and replaced.
❑ Hands should be rewashed and sanitized.
Labeling Of Compounded Sterile Product
Labeling Element Description / Requirement
Patient Name Full name of the patient to ensure correct individualized therapy and prevent errors
Strength Exact strength or concentration of active ingredient(s) (e.g., 500 mg/50 mL)
Flow Rate Prescribed infusion rate (e.g., 50 mL/hour) to guide administration accurately
Identification Number / Lot Number Unique internal ID, barcode, or lot number to track the batch
Active Ingredient(s) Name(s) of active drug(s) with strength, activity, and concentration
Beyond Use Date (BUD) Date after which the CSP should not be Used
Compounding Facility Info Name and contact details of the pharmacy or compounding site
Dosage Form Description of the preparation (e.g., solution, injection)
Route of Administration Intended route (e.g.,intravenous,intrathecal)
Total Volume or Amount Quantity in the container if not obvious
Storage Instructions Special storage conditions (e.g., refrigerate, protect from light)
Special Handling Instructions Any warnings or precautions (e.g., "Shake well", hazardous drug labels)
Single/Multi Dose Container Status Specify if applicable
Reference to Compounded Status Statement or indication that preparation is Compounded
Date of Compounding When the product was prepared
(for 503B facilities)
List of active and inactive ingredients With quantity or proportion
Warning Statements For safety and regulatory compliance
Additional Points:
1. Labels must be clear, accurate, legible, and comply with 3. Automated and standardized label formats are
applicable laws. recommended for consistency and error reduction.
2. The final label should match the prescription, master 4. For sterile products, any hazardous drug warnings must
formulation, and compounding record. be clearly included.