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Quality Assurance

We promise to provide safe and superior quality products. Our formulations are prepared in a sterile, state-of-the-art facility that meets all federal and state regulatory standards, using pre-tested formulas and expert consultation when needed.

All chemicals used in Five Star's compounded products are purchased from FDA-approved manufacturing sites. Routine product testing by independent sources adds an extra measure of quality assurance.

Our facility. Our compounding lab features a Class 1000 cleanroom, which exceeds United States Pharmacopoeia (USP) guidelines, and provides the sterile environment necessary for compounding injectables and ophthalmic preparations. The cleanroom is inspected and recertified every six months by an independent air quality technician. Our cleanroom complies with USP 797 guidelines.

Equipment. We use precision equipment that ensures accurate dosing. Equipment is calibrated daily and monitored throughout the production process.

Our autoclave has an internal mechanism to verify temperature and pressure for each cycle and includes an automatic malfunction alert system. An interfaced printer generates a validation slip to document proper sterilization.

We monitor and record scale calibration, refrigerator, freezer and cleanroom temperatures, and cleaning logs on a daily basis.

Routine Product Testing and Sampling

Testing of injectables. We test batches of injectables for pyrogens, sterility, and potency. Testing is performed both on-site and by Pharmetric Laboratory, an independent testing lab in St. Petersburg, Florida.

Documentation and Recordkeeping

We maintain meticulous record of all prescriptions, including prescription number, formula, chemical lot numbers, and expiration date. In the event of a product recall, we can quickly identify and contact affected patients.

Five Star Pharmacy

Five Star Pharmacy