Several major pharmaceutical companies lead the development and production of GLP-1 (glucagon-like peptide-1) medications, which are widely used for managing type 2 diabetes and weight loss. The primary players are Novo Nordisk and Eli Lilly.
Understanding the distinctions between regulatory frameworks is essential in drug development and production. Good Laboratory Practices (GLP) primarily govern the conduct of nonclinical laboratory studies. These practices ensure the integrity, reliability, and reproducibility of safety data collected during preclinical testing. Laboratories conducting these studies must adhere to GLP standards, which cover aspects like personnel qualification, study protocols, facility management, and data integrity.
When it comes to the production of GLP-1 medications, maintaining rigorous regulatory compliance is vital for ensuring safety and efficacy. The entire process involves adherence to specific standards set by authoritative bodies like the FDA. While nonclinical studies supporting these drugs are conducted in laboratories that comply with Good Laboratory Practice (GLP), the manufacturing process itself follows Good Manufacturing Practice (GMP) standards.
Pharmko is based in New York and provides home infusion therapy statewide — IV antibiotics, IVIG, TPN, IDPN, and specialty medications. Licensed, ACHC accredited, and available 24/7.
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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. → Contact Pharmko about sterile compounding: 1-877-540-2003
