|Is every step of the compounding process from prescribing to compounding and labeling through dispensing reviewed and verified by a licensed pharmacist?
|Do you verify the potency of finished compounds through the weight, volume and yield checks?
|Weights on formula sheets, volume on formula sheets, yield on packaging formula sheets
|Do you perform pH testing on injections and other compounds?
|Yes – results are documented on formula sheets
|Do you perform 3rd party HPLC verification on certain formulations?
|Yes, on every injection made in batches over 24, and monthly on random pulls of creams and capsules
|Are you committed to compliance with the USP guidelines for sterile compounding? Have you completed a gap analysis?
|Based on your assessment of , are you compounding preparations at the lowest risk to your doctors and patients?
|If you are compounding sterile preparations, do you conduct weekly and monthly independent lab tests of air and surface samples in your clean-room and other controlled environments?
|Weekly in-house surface tests, air tests conducted monthly in-house. These are validated bi-annually through testing from third-party labs.
|Is the air quality in your general compounding lab engineered for HEPA filtration to reduce particulates?
|All chemicals are manipulated in an area filtered directly by a HEPA system
|Do you obtain independent, routine certifications of your clean rooms and laminar airflow hoods?
|Twice each year
|Do you perform daily monitoring and documentation of your clean-room temperature?
|Is your staff properly trained and evaluated in aseptic manipulation skills, gowning technique and clean-room use?
|Yes, and they are tested and re-certified numerous times throughout the year. Follow-up tests are unannounced.
|Do you have systems in place for handling complaints and investigating sterility adverse events?
|In the event of a sterility failure, complaint or adverse event, do you have a procedure in place for determining and conducting a recall, if necessary?
|Do you filter (0.2 micron) in a Class 100 (ISO 5) laminar airflow hood contained in a Class 1000 (ISO 6) clean room, or autoclave where appropriate, to achieve sterility?
|Do you perform sterility testing on every preparation batch?
|On those over 24 in quantity, samples are sent to an independent lab and every intrathecal batch is tested with in-house media testing. We use multiple labs as a cross-check method.
|Do you perform sterility testing according to USP Sterility Tests and USP Bacterial Endotoxin (Pyrogen) Test?
|Do you purchase USP pharmaceutical-grade chemicals?
|Do you obtain Certificate of Analyses for all formula ingredients?
|Do you maintain both master formulas and lot-specific worksheets for all compounds?
|Can you immediately trace a prescription back to the original formula log sheet and the source of ingredients?
|Are your pharmacists, technical and customer-service staff dedicated exclusively to compounding?
|Yes – WE do NOT stock or fill any orders for commercially available products without assurance that there is a therapeutic preference or a supply shortage for a compounder preparation.
|Does the pharmacy have adequate liability insurance?