With state-of-the-art 503A specialty compounding pharmacies in Dallas, Texas (our headquarters), and Ridgeland, Mississippi, AIS Healthcare has a fully redundant targeted drug delivery (TDD) operation designed to produce medication of the highest quality.
At both facilities, we have made significant investments in people and processes to be able to produce prescriptions that exceed standards and expectations. We use a proven, proprietary process that combines aseptic processing with terminal sterilization—a pharmaceutical industry standard—on patient-specific formulary prescriptions to achieve unprecedented sterility assurance and extended Beyond-Use Date (BUD). This gives providers confidence in the medications they prescribe and helps to reduce medication waste.
third-party testing of all stock solutions1
1Third-party testing for pH, sterility, potency, endotoxins and particulate matter
day BUD at room temperature—average 34 days—for all formulary medications2
2All patient-specific formulary dispenses within maximum concentrations (based on AIS Healthcare in-house data for 130,000 aseptically processed and terminally sterilized patient-specific prescriptions in 2020). Note: In California, the BUD of our combination therapy prescriptions is considered to be 3 days at room temperature.
sterility assurance levels for unprecedented quality and patient safety (versus 1:1,000 sterility assurance levels with aseptic processing and filtration)
|AIS Healthcare quality standard||USP <797> guidelines|
|All stock solutions are prepared by a licensed pharmacist and tested by a third-party, independent lab for sterility, potency, particulate matter, pH and endotoxins before use in compounding||Not required|
|Compounding done only by licensed pharmacists||Compounder not required to be licensed pharmacist|
|Enhanced contamination-control procedures, including full-body sterile garb for cleanroom personnel||Only sterile gloves required for cleanroom personnel|
|Multiple 0.22-micron sterilizing-grade filtration steps, including filter integrity testing, to ensure medication sterility||Only one 0.22-micron sterilizing-grade filtration step required|
|Four independent cleanroom certifications per year||Only two required per year|
|Non-viable particle count done 12 times per year; combined viable air and surface sampling done no fewer than 50 times per year||Non-viable particle count and viable air sampling required twice per year; surface sampling required periodically|
AIS Healthcare facilities are inspected by state boards of pharmacy as well as the U.S. Drug Enforcement Administration and the U.S. Food and Drug Administration (with zero Form 483 observations on the last inspection).
We have also been recognized by the top independent pharmacy accreditors, URAC and the Accreditation Commission for Health Care (ACHC). ACHC’s compounding accreditation division, PCAB, has assessed our compliance with industry standards, and URAC inspectors have confirmed our ability to consistently produce high-quality prescriptions for our patients. These accreditations validate our commitment to higher quality standards and set our pharmacies apart.
AIS Healthcare’s state-of-the-art 503A compounding pharmacies have been designed and upgraded to support our industry-leading quality standards, and are filled with custom equipment and staffed by highly trained pharmacists and technicians.
Our quality and sterility processes have been designed in close collaboration with industry experts, and are regularly reexamined to find any areas of potential improvement. We’ve made all these investments to deliver medications of the highest possible quality to all the patients and providers we serve.
Licensed in all 50 states, we have two state-of-the-art facilities—in Dallas, Texas, (our headquarters) and in Ridgeland, Mississippi. Our fully redundant compounding operation ensures drug supply continuity to address potential shortages, providing assurance to patients, providers and payers.
Each of our pharmacies have multiple controlled rooms that exceed the required ISO standards for cleanliness and air quality. All ISO-classified environments in both of our facilities are certified by a third party every three months, twice as frequently as industry requirements, giving patients and providers even more confidence in the quality and sterility of our medications.
The internal pharmacy environments were constructed without wood or other non-cleanable surfaces. This allows every cleaning and disinfecting we complete to be on non-porous, easily cleanable surfaces, not just in the controlled cleanroom environments but in the surrounding areas as well. Even though it is not used for compounding, all water coming into the facilities goes through deionization, reverse osmosis, multiple carbon and sediment filters and UV light to achieve the highest possible purity and limit the introduction of bioburden anywhere in the pharmacy. Backup water treatment ensures a constant flow of purified water for the operation of our facilities. We also have medical-grade air systems that run air through seven different filters before it is used for terminal sterilization and filter integrity testing.
AIS Healthcare uses double-blind order entry and verification, in which all orders are reviewed by two pharmacy technicians and then by two pharmacists, before medication is compounded. Another pharmacist and technician then verify compounding as well as a final pharmacist verification. This means multiple licensed professionals have eyes on every order to reduce the chances of any human error.
In addition to faxed written prescriptions sent to the AIS Healthcare office, physicians can place orders through their EHR systems or use the e-prescribing portal on our DEA-compliant, proprietary EHR, MyAIS Connect, to print and sign prescriptions or submit them electronically. Our prescription portal is certified by Surescripts, meaning it complies with all industry standards on sending and receiving electronic prescriptions. In addition, our central data storage system keeps data safe and allows it to be retrieved at either pharmacy whenever it’s needed.
Both pharmacies have automated facility management systems that go above industry standards to help us maintain optimal internal temperature, air pressure and humidity. In the event of a power outage, both buildings have generators and redundant units to maintain temperature, water and steam generation, helping us ensure patients get the medications they need even during an emergency.
A Center of Excellence in intrathecal medication compounding, our pharmacies work to promote clinical excellence here and throughout the country. We conduct on-site training for nurses and offer preceptorships, internships and fellowships for providers or students, and we invite physicians to both locations for ongoing education programs.