Personnel qualifications |
Designate one person to oversee and evaluate compounding personnel. |
Provide training and testing on principles and procedures for new staff and annual evaluation for others for sterile compounding, garbing, hygiene, gloved fingertip and thumb sampling, and media fill tests. |
Ensure that compounding personnel wear powder-free sterile gloves; non-cotton, low-lint sleeved garments that gather at the wrist and close at the neck; face mask and disposable cover for head and facial hair. |
Facilities |
Compounding must occur in either (1) an ISO Class 5 Primary Engineering Control (PEC) or (2) in a dedicated Allergenic Extracts Compounding Area (AECA), either of which must not be within 1 meter from a sink and can't be near unsealed windows, doors to the outside, or high traffic or other areas that present environmental control challenges such as bathrooms or kitchens. |
If used, a PEC must be certified every 6 months, and cleaned and disinfected before and after each compounding, and surface must be disinfected between each prescription set. |
An AECA must have a visible perimeter and meet the following conditions: - Access restricted to authorized personnel.
- No other activity permitted during compounding.
- All surfaces must be cleanable and kept clean.
- No carpet is allowed.
- No surfaces that can be damaged by cleaning and sanitizing agents.
- Surfaces must be smooth, impervious, non-shedding, and free of cracks or crevices.
- Overhangs should be avoided or must be easily cleaned.
- Well lit, and temperature and humidity controlled for comfort of compounding personnel.
- Work surface must be cleaned and disinfected before and after each compounding session, and disinfected between each new set, as well as at the time of any spill or contamination.
- Vial stoppers on packages of conventionally manufactured sterile ingredients must be disinfected with 70% isopropyl alcohol wipes before each use.
- Walls, doors, and door frames within and AECA must be disinfected monthly and when contamination is suspected.
- Ceilings in the AECA must be cleaned and disinfected when visibly soiled.
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Documentation |
Labels on prescription sets must include patient name, type, and fractional dilution with corresponding vial number, beyond use date, and required storage conditions. |
Standard Operating Procedures manuals describing required compounding process. |
Training, assessment results, evaluations, and qualification records for all compounding personnel, including any corrective actions following assessments and evaluations. |
Certification reports for PEC, if used. |
Temperature logs for refrigeration. |
Compounding records for individual extract prescription sets. |
Information on any complaints and adverse events. |
Investigations and corrective actions following any complaints and adverse events. |