Let’s Get Technical For a Moment
What does it actually mean to be USP 797 compliant? First implemented in 2004, USP (United States Pharmacopeial) establishes(d) a standard of practice designed to prevent patient harm and fatality from contamination. More specifically, it’s focused on guidelines for proper sterilization of facilities and equipment. 797 “Pharmaceutical Compounding” is the first set of enforceable sterile compounding standards issued by the U.S.P.
Once you’ve become 797 compliant, there’s no turning back. It’s a commitment to both ourselves as well as our clients that we take our work seriously. And it’s a public statement that we believe in providing the safest, most comfortable environment possible for our patients—and that we’re willing to put in as much work as is necessary to make that a reality.
So, what does this all really mean for you? Our sterile compliance ensures peace of mind that all treatments, and the environment that they are administered in, are free of microbial and chemical contaminants. While our centers are at the highest levels of sterility, they are anything but cold. As a guest of Intellectual Medicine, you will be welcomed into a warm, comfortable, and relaxing space for your IV therapy. Because stress has no place at Intellectual Medicine.
- Does Intellectual Medicine have specific assignment of quality functional responsibilities as defined in a Quality Assurance plan? YES
- Does Intellectual Medicine have an independent Quality Systems Department whose responsibility is to ensure that the facility, equipment and personnel meet the demanding standards set forth by the United States Pharmacopeia? YES
Is Intellectual Medicine committed to and in compliance with USP 797 guidelines for sterile compounding? YES
- Are all significant procedures performed at Intellectual Medicine covered by Standard Operating Procedures (SOPs)? Is there documentation that Intellectual Medicine staff has been trained and understands the SOPs? YES
- Is Intellectual Medicine’s Quality Assurance plan reviewed annually and when changes are made to the plan? YES
- Does Intellectual Medicine’s facility meet or exceed U.S.P. Guidelines for compounding pharmacies? YES
- Does Intellectual Medicine have separate areas dedicated to perform sterile and non-sterile compounding, product inspections, labeling, raw material storage, and dispensing? YES
- Is the air quality in Intellectual Medicine engineered for HEPA filtration to reduce particulates? YES
- Does Intellectual Medicine conduct tests of air and surface samples of your clean-room and other controlled environments? YES
- Does Intellectual Medicine perform and document daily, weekly, and quarterly cleaning to assure a clean and safe facility? YES
- Is Intellectual Medicine’s staff properly trained to perform aseptic manipulation skills, gowning technique, clean-room use, and successfully perform media fills yearly? YES
- Does Intellectual Medicine’s staff take steps to minimize error and maximize the prescriber’s intent for the patient during the compounding process? YES
- Does Intellectual Medicine purchase pharmaceutical-grade chemicals (USP, NF equivalent) from FDA-registered suppliers? YES
- Does Intellectual Medicine perform post-filtration filter-integrity testing? YES
- Does Intellectual Medicine have systems in place for handling complaints and investigating sterility failures and adverse events? YES
Becoming USP 797 compliant is a significant distinction for Intellectual Medicine and one that we’re incredibly proud of. It’s proof of the dedication we have for the work that we do as well as the commitment we have to the people we see and treat support on a daily basis.