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OTHER
COMPOUNDING
PHARMACY |
Are you committed to compliance with the new USP 797-guidelines for sterile compounding?
Where are you in the implementation? |
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Do you filter (0.2 micron) in a Class 100 laminar airflow hood contained in a Class 1000 cleanroom, or autoclave where appropriate, to achieve sterility? |
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Do you obtain independent, semi-annual certifications of your cleanrooms and laminar airflow hoods? |
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Do you perform sterility testing on every product batch? |
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Do you perform post-filtration filter-integrity testing? |
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Do you conduct monthly independent lab tests of air and surface samples in your cleanrooms? |
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Do you have a dedicated Quality Assurance Department? |
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Is the air quality in your general compounding lab engineered for HEPA filtration to reduce particulates? |
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Are your pharmacists and technical staff dedicated exclusively to compounding? |
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Are you active members of the American College of Apothecaries the American College of Veterinary Medicine and the International Academy of Compounding Pharmacists? |
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Is your staff trained and validated in proper gowning and aseptic techniques, cleanroom regulations and USP Guidelines? |
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Do you purchase pharmaceutical-grade chemicals (USP, NF equivalent) from FDA-registered suppliers? |
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Do you perform pH testing on injections, ophthalmic preparations and other compounds? |
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Do you verify the potency of finished compounds through weight, volume and yield checks? |
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Do you perform HPLC validation on selected formulations? |
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Is every step of the compounding process from prescribing to compounding and labeling through dispensing reviewed and authorized by a licensed pharmacist? |
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Do you maintain both master formulas and lot-specific worksheets for all compounds? (Do they include the manufacturer and lot number of each ingredient and quality-control test result?) |
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Can you trace a prescription back to the original formula log sheet and the source of ingredients? |
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Does the pharmacy have adequate liability insurance? |
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Do you test your staff on a regular basis to ensure competency? |
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Are your sterile compounds certified by an independent agency such as American College of Apothecaries? |
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