September 16, 2020
Two hundred years ago, a group of physicians, concerned about medication quality and safety, published the United States Pharmacopeia (USP), a set of national, uniform guidelines for drugmakers to help protect patients from dangerous or ineffective medicines.
Now, as USP celebrates its bicentennial, these guidelines remain the pharmaceutical industry standard, ensuring medication quality for patients across the country.1 The U.S. Food and Drug Administration (FDA), as well as state boards of pharmacy and other oversight organizations, use these guidelines to evaluate safety and quality practices.2
It’s critical to have accepted, proven guidelines to regulate the production of compounded medications, particularly for targeted drug delivery (TDD) medications. Quality failures at TDD pharmacies can have devastating consequences for patients. In 2012, a Massachusetts pharmacy distributed prescriptions that were contaminated with a fungus, resulting in more than 60 patient deaths.3
In 2013, Congress passed the Drug Quality and Security Act (DQSA), giving the FDA more authority to regulate the manufacture of compounded medications.4 This act incorporates USP standards, offering robust, comprehensive guidelines for every part of the compounding process, and requiring all U.S. pharmacies to follow them.
For TDD and other sterile compounders, the relevant guidelines are found in USP <797>.5 This chapter outlines the facilities and quality processes needed to produce patient-specific prescriptions that meet safety, sterility and potency requirements.
At AIS Healthcare, we’re proud to not only meet these requirements, but in many ways, we exceed them. Throughout our state-of-the-art compounding pharmacies in Dallas, Texas, and Ridgeland, Mississippi, we take extra steps and make extra investments to go beyond these requirements and produce medications of the highest quality and sterility.
All of our compounding is done by licensed pharmacists; USP does not require the compounder to be a pharmacist. We use enhanced contamination-control procedures, including full-body sterile garb for cleanroom personnel—USP just requires sterile gloves. We also get our cleanroom independently certified twice as frequently as required, and conduct environmental monitoring far more frequently than mandated by USP standards.
Additionally, we’re able to exceed USP’s Beyond-Use Date (BUD) requirements with a proven, proprietary process. By combining aseptic processing with terminal sterilization—a pharmaceutical industry standard—we are able to achieve sterility assurance of 1:1,000,000 and BUD of 21 to 45 days at room temperature.*
“The USP standards provide an essential framework for producing quality medications, especially for TDD and other high-risk compounding,” says Jonathan Hamer, Director of Pharmacy and Pharmacist in Charge, Dallas. “But at AIS Healthcare, we’re always looking for ways to do more to keep advancing quality and doing more for the patients and providers we serve. That’s why we’ve invested time and resources into building facilities and developing processes that do more to put quality first.”