When a patient or provider chooses a compounding pharmacy to prepare IV medications, they are trusting that the pharmacy operates under rigorous, independently enforced standards. In the United States, those standards are defined by two chapters of the United States Pharmacopeia: USP <797> for sterile compounding and USP <800> for hazardous drug handling.
Pharmko operates in full compliance with both chapters. Understanding what these standards require, and what happens when they are not met, helps patients and providers make informed decisions about which pharmacy they trust with their care.
What Is USP <797>?
USP <797> (Pharmaceutical Compounding, Sterile Preparations) is the national standard that defines the minimum requirements for compounding sterile preparations safely. It covers:
- Cleanroom environment classification, ISO Class 5 at the point of compounding, ISO Class 7 for the surrounding buffer area, ISO Class 8 for the ante-room
- Personnel training, gowning, and aseptic technique requirements
- Sterilization and filtration methods by product type
- Beyond-use dating (BUD), how long a compounded sterile preparation remains safe to use
- Environmental and personnel monitoring schedules
- Quality assurance, documentation, and deviation management
USP <797> applies to every pharmacy that prepares IV solutions, injections, eye drops, or other sterile preparations, whether they are a hospital pharmacy, ambulatory infusion center, or specialty pharmacy like Pharmko.
The 2023 Revision: What Changed
USP <797> was significantly revised in 2023 (effective November 2023). Key changes include:
- Stricter beyond-use date requirements, compounded sterile preparations must now meet more conservative dating limits unless sterility testing supports extended dating
- Enhanced environmental monitoring, more frequent air and surface sampling with defined action levels
- Clearer personnel qualification requirements, competency assessments are now required at defined intervals
- New category system, preparations are now categorized (Category 1 and Category 2) based on sterility assurance level and BUD
Pharmacies that were compliant under the previous version of USP <797> must have updated their procedures and infrastructure to meet the 2023 revision. Pharmko updated our facilities, policies, and documentation systems in alignment with the revised chapter.
What Is USP <800>?
USP <800> (Pharmaceutical Compounding, Hazardous Drugs) establishes standards for the safe handling of hazardous drugs throughout the pharmacy, from receipt and storage to preparation, dispensing, and waste disposal.
Hazardous drugs include certain chemotherapy agents, antiviral medications, hormones, and other drugs that pose risks of carcinogenicity, reproductive toxicity, or organ damage at low exposure levels. USP <800> requires:
- Negative-pressure ventilated containment primary engineering controls (C-PECs) for hazardous drug compounding
- Separate, dedicated hazardous drug storage areas
- Personal protective equipment (PPE) requirements for all staff handling hazardous drugs
- Closed-system drug transfer devices (CSTDs) for certain preparations
- Spill kits and exposure management protocols
Why These Standards Matter for Patients
The consequences of non-compliance are serious. High-profile compounding pharmacy failures, including a 2012 fungal meningitis outbreak linked to contaminated steroid injections that killed 64 patients and injured hundreds, demonstrated what happens when sterile compounding standards are not followed.
For patients receiving home IV therapy, USP <797> compliance is not a credential to check once and forget, it reflects the ongoing daily practices of the pharmacy preparing their medications. Patients and providers should verify that any pharmacy preparing their IV solutions is accredited, state-licensed, and actively compliant with current USP standards.
How Pharmko Meets These Standards
Pharmko's sterile compounding facility is designed, staffed, and operated to meet USP <797> and USP <800> requirements. We are ACHC accredited, state-licensed in 22+ states, and subject to regulatory inspection. Every batch we compound is reviewed by a licensed pharmacist, and our environmental and personnel monitoring data is reviewed on a defined schedule.
For a broader overview of what sterile compounding is and how it differs from retail pharmacy, see our guide on
what is sterile compounding for IV therapy.
For providers interested in our compounding capabilities, see our
physician services page or contact our pharmacy team directly.
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Contact Pharmko about sterile compounding:
1-877-540-2003
