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 |
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 |
Professional Compounding Centers of America
Michigan Pharmacists Association
International Academy of Compounding Pharmacists
Healthway Compounding Pharmacy is the first accredited in
the state of Michigan
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