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.
| Is every step of the compounding process from prescribing to compounding and labeling through dispensing reviewed and verified by a licensed pharmacist? | Yes |
| 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? | Yes |
| Based on your assessment of , are you compounding preparations at the lowest risk to your doctors and patients? | Yes |
| 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? | Yes |
| 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? | Yes |
| 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? | Yes |
| 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? | Yes |
| 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? | Yes |
| Do you purchase USP pharmaceutical-grade chemicals? | Yes |
| Do you obtain Certificate of Analyses for all formula ingredients? | Yes |
| Do you maintain both master formulas and lot-specific worksheets for all compounds? | Yes |
| Can you immediately trace a prescription back to the original formula log sheet and the source of ingredients? | Yes |
| 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? | Yes |