Sterile Compounding Pharmacy Services
Compounding pharmacies play an essential role within the healthcare system. The services they provide ensure patients have access to safe and reliable medications, thus providing disease management continuity.
In order to ensure the safety of patients, pharmacies in particular must comply with the exacting, stringent requirements and standards of their industry.
USP Compliance
Complying with USP Chapter regulations is a constant challenge for all pharmaceutical manufacturers, including compounding pharmacies.
Regulations under USP 797 state that compounding pharmacies must compound all sterile medications within a cleanroom utilizing a laminar flow workstation. Additionally, USP 797 rules apply not only to the physical space where the preparation takes place but also to all individuals involved in the process.
As with most pharmaceutical products, sterile compounding has different risk categories:
- Low Risk
- Medium Risk
- High Risk
USP 797 regulations vary depending on the risk category, with more stringent rules applying to high-risk materials.
USP Chapter 800, on the other hand, sets forth standards to promote patient safety, healthcare worker safety, and environmental protection from exposure to hazardous drugs.
The requirements for compounding pharmacies can be tedious and time-consuming as compounding with hazardous drugs is inherently riskier than counting, repackaging, and dispensing the drugs.
Adding to the challenges of any compounding pharmacy, USP Chapter 800 can be confusing as two sections are not harmonious with current USP 797 regulations: The Segregated Compounding Area and the “Low Volume” hazardous drug compounding.
If you are unsure if USP 800 regulations apply to your setting, choose a cleanroom certifier that has ample experience working with both USP 797 and USP 800, so they can help you determine which requirements apply to your setting.
Choosing a Cleanroom Certifier
Partnering with a well-qualified cleanroom certifier is not a luxury–it’s a necessity for sterile compounding pharmacies.
There is a lot that goes into selecting a suitable cleanroom certifier for your business: services offered, the quality of those services and cost to name just a few.
Choosing a vendor with the expertise and knowledge of USP 797 and USP 800 Chapters is imperative. Your preferred vendor needs to understand what they are testing for and why.
Aside from USP Chapter standards that require hood and cleanroom certification every six months, state regulations could also require monthly or weekly environmental sampling.
For this reason, it’s highly beneficial to choose a cleanroom certifier that provides comprehensive services such as surrogate bacterial and air sampling, and media fill-kits, and glove fingertip sampling.
Our Capabilities
If you are a sterile compounding pharmacy, don’t risk falling out of compliance with USP Chapter regulations. Contact us today to learn more about our services and how we can help you retain full compliance.
- Cleanrooms
- Clean Benches
- Barrier Isolators
- Chemical Fume Hoods
- Biological Safety Cabinets
- Powder Hoods
- Balance Enclosures
- HEPA/ULPA Filter Testing
- Viable Surface Sampling
- Viable Air Sampling
- Gowning Evaluations
- Ovens
- Thermometers
- Test Weights
- Balances
- Glove Fingertip Sampling
- Consulting on USP Chapters 795, 797, 800