Physician’s Due Diligence Check List for Quality Sterile Compounded Prescriptions

Ask These Questions of your Compounding Pharmacy

Do you have a long established reputation as an expert in the field of compounding and well respected by your peers?	We Do
Are you in compliance with USP-797 guidelines for sterile compounding?	We Are
Have you or any of your staff ever been under suspicion of, or had charges brought against you, for questionable practices?	No
Do you filter (0.2 micron) in a ISO Class 5 Laminar airflow hood contained in a ISO Class 6 cleanroom, or autoclave where appropriate, to achieve sterility?	We Do
Do you perform sterility testing on every product batch?	We Do
Do you perform post-filtration filter-integrity testing?	We Do
Is the air quality in your general compounding lab engineered for HEPA filtration to reduce particulates?	Yes
Are you recognized as a fellow in any professional associations such as the American College of Apothecaries or the International Academy of Compounding Pharmacists?	Yes
Are you an active member in professional organizations such as the American Pharmaceutical Association, Michigan Pharmacists Association, National Association of Retail Druggists, or the American College of Apothecaries?	Yes
Is your staff trained and validated in proper aseptic technique, cleanroom regulations and USP guidelines?	Yes
Do you purchase only pharmaceutical-grade chemicals (USP, NF equivalent) from FDA registered suppliers?	Yes
Do you perform pH testing on injections, ophthalmic preparations and other compounds?	Yes
Do you verify the potency of finished compounds through weight, volume, and yield checks? Do you perform HPLC validation on selected formulations?	Yes
Is every step of the compounding process reviewed and authorized by a licensed trained compounding pharmacist?	Always
As per Michigan law, is a pharmacist on site during all pharmacy business hours?	Absolutely
Do you maintain master formulas and lot-specific worksheets for all compounds?	Yes
Can you trace prescriptions back to the original formula log sheet and source of ingredients?	Yes
Does your pharmacy maintain adequate liability insurance?	Absolutely

To Better Serve Our Patients, we are now Billing Several Major Insurances! For more information, call 989-791-1691.

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