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A Quality Checklist |
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Because of the strict USP guidelines for compounding, it's more important than ever for prescribers to choose a compounding pharmacy they can trust. When you are choosing a compounding pharmacy to work with you, be sure to ask questions like those listed below. We are known for providing its clients with the safest products on the market.
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Is every step of the compounding process from prescribing to compounding and labeling through dispensing reviewed and verified by a licensed pharmacist?
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Yes
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Do you verify the potency of finished compounds through the weight, volume and yield checks?
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Weights on formula sheets, volume on formula sheets, yield on packaging formula sheets
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Do you perform pH testing on injections and other compounds?
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Yes - results are documented on formula sheets
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Do you perform 3rd party HPLC verification on certain formulations?
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Yes, on every injection made in batches over 24, and monthly on random pulls of creams and capsules
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Are you committed to compliance with the USP <797> guidelines for sterile compounding? Have you completed a <797> gap analysis?
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Yes
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Based on your assessment of <797>, are you compounding preparations at the lowest risk to your doctors and patients?
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Yes
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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?
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Weekly in-house surface tests, air tests conducted monthly in-house. These are validated bi-annually through testing from third-party labs.
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Is the air quality in your general compounding lab engineered for HEPA filtration to reduce particulates?
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All chemicals are manipulated in an area filtered directly by a HEPA system
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Do you obtain independent, routine certifications of your clean rooms and laminar airflow hoods?
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Twice each year
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Do you perform daily monitoring and documentation of your clean-room temperature?
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Yes
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Is your staff properly trained and evaluated in aseptic manipulation skills, gowning technique and clean-room use?
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Yes, and they are tested and re-certified numerous times throughout the year. Follow-up tests are unannounced.
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Do you have systems in place for handling complaints and investigating sterility adverse events?
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Yes
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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?
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Yes
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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?
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Yes
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Do you perform sterility testing on every preparation batch?
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On those over 24 in quantity, samples are sent to an independent lab and each intrathecal batch is tested with in-house media testing
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Do you perform sterility testing according to USP <71> Sterility Tests and USP <85> Bacterial Endotoxin (Pyrogen) Test?
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Yes
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Do you purchase USP pharmaceutical-grade chemicals?
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Yes
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Do you obtain Certificate of Analyses for all formula ingredients?
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Yes
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Do you maintain both master formulas and lot-specific worksheets for all compounds?
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Yes
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Can you immediately trace a prescription back to the original formula log sheet and the source of ingredients?
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Yes
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Are your pharmacists, technical and customer-service staff dedicated exclusively to compounding?
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Yes - WE do NOT stock or fill any orders for commercially available products.
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Does the pharmacy have adequate liability insurance?
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Yes
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Do you belong to trade and professional organizations?
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International Academy of Compounding Pharmacists, Professional Compounding Centers of America, Illinois Pharmacists Association, American Pharmacists Association, American Society of Health-System Pharmacists, The Better Business Bureau
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