Sterile & Quality Assurance
Specialty Compounding is a DEA manufacturer and a Texas Drug Manufacturer. When it comes to compounding you want a provider you can trust.
All of our compounded preparations are made in a controlled clean room environment. Our sterile lab exceeds ISO class 7 standards and we are certified in non-sterile and sterile preparations by the Pharmacy Compounding Accreditation Board (PCAB). We use only USP grade ingredients from FDA-approved manufacturers and provide certificates of analysis and Material Safety Data Sheets (MSDS) on all of our chemicals. We employ the latest quality control techniques in our labs and use an independent lab to test potency on all compounds, as well as sterility and endotoxins on sterile compounds. We also conduct internal tests for sterility, particulate matter, and environmental contamination in our sterile lab.
Specialty Compounding meets or exceeds the USP 797 requirements to prepare high risk, level III sterile products. At this level there are certain quality assurance processes designated by USP that document policy and procedures to provide a foundation in order to ensure the identity, strength, purity, and quality is represented in the final product.
Our sterile products team are highly trained and qualified licensed pharmacists and technicians that products receive both didactic and experiential training and are routinely validated for proper aseptic technique. In-house rapid microbiological technology provides immediate, highly sensitive assessment of aseptic techniques.
At Specialty Compounding all aseptic manipulations are performed in our state of the art facility that is a Class 100 environment with an ISO Class 7 sterile lab.
Our Commitment to Quality
8 reasons to choose the right compounding pharmacy for you:
1. Innovative: We use various dispensing methods for medications to increase compliance and to ensure the safety of the compounded medication. Specialty Compounding also uses unit-dose pouches to protect the medication from the environment and to assure accurate dosing.
2. Knowledge: We are committed to the future of compounding. We have pledged our support to numerous issues relating to the importance of individually tailored medications. Additionally, we belong to several organizations committed to professional compounding: International Academy of Compounding Pharmacists (IACP).
3. Consistency: Compounding equipment is required in any pharmacy; however, our equipment far exceeds the minimum.
- We use a variety of pharmacy tools to assist us in ensuring the accuracy and uniformity of each compound. These include electronic balances, encapsulation devices, electronic mortar and pestles, and pipettes.
- All equipment is on a routine maintenance and cleaning schedule. Evaluation of balance accuracy is done daily by staff and regularly by an independent ISO 9002 and Guide 25 Registered Scale Company.
- Our ISO Class 7 cleanroom encloses an ISO Class 5 Laminar Air Flow Hood. Our sterile processes and quality assurance procedures meet, or exceed USP Chapter <797> standards specific to high-risk level compounded sterile products.
4. Materials: Specialty Compounding orders USP pharmaceutical grade materials from several long-standing, reputable chemical suppliers.
- Each of the active ingredients that we purchase is delivered with a Certificate of Analysis to verify the identity and the quality as per USP (United States Pharmacopoeia) guidelines.
- During the compounding process each medication is prepared in a separate powder containment hood to reduce cross contamination.
5. Safety: To ensure the high quality of our compounds and the safety of our workplace, we have established lab safety and hygiene policies. Our lab staff wears personal protective gear (scrub attire, masks and gloves), and utilizes powder containment (ventilation hoods) and sanitizing equipment. Routine cleaning procedures are in place for the preparation of all compounds and for maintaining the lab equipment.
6. Accuracy: Our compounding procedures are carefully documented and each compound goes through a comprehensive series of checks.
- Compounding pharmacists verify formula calculations, ingredients and the final compounded prescriptions.
- They also supervise the compounding technicians and verify adherence to procedures. Lot numbers and computerized records for each compound are maintained and procedures to verify final weights of dosage forms are documented.
- Our procedures enable us to track prescriptions back to the ingredients used to make each preparation.
7. Testing: The monitoring of our quality control measures (documenting of procedures, verifying recipe calculations, and ingredients) is crucial when compounding our medications and is accomplished through a variety of methods. We have staff, who meets regularly to review processes, evaluate supplies and monitor overall quality. We send finished compounds for analysis for potency and sterility by an independent laboratory to verify our procedures.
8. Ethics: Specialty Compounding follows all State Board of Pharmacy rules and guidelines suggested by IACP and Pharmacy Compounding Acceleration Board (PCAB).
Please call us with questions or to fill a prescription:
211 S. Bell Blvd. (Hwy 183 N)
Cedar Park, TX 78613
Toll Free: 877-AUSTINRX (287-8679)
Or use our contact form.
Hours of Operation
Mon-Fri: 8 AM to 6 PM
Sat: 8 AM to NOON
Specialty Compounding is now amongst the 130 pharmacies across the nation to be PCAB accredited in sterile and non-sterile compounding! PCAB Accreditation gives patients and prescribers a way to select a pharmacy that meets high quality standards.