CHPPC Module 4, Section 1: Fundamentals of USP <797> & <800>
MODULE 4: STERILE COMPOUNDING & IV ROOM OPERATIONS

Section 1: Fundamentals of USP <797> & <800>

This section is the rulebook for the cleanroom. United States Pharmacopeia (USP) Chapters <797> and <800> are not just guidelines; they are the enforceable standards that govern every aspect of sterile compounding. Mastering them is the first and most critical step to ensuring the safety of every IV medication you prepare.

Part 1: USP Chapter <797> – Non-Hazardous Sterile Compounding

The Blueprint for Sterility

USP <797> provides the minimum practice and quality standards for all Compounded Sterile Preparations (CSPs). Its sole purpose is to prevent patient harm from microbial contamination, excessive endotoxins, and other impurities. We will break down its core components: the environment, the personnel, and the process.

Retail Pharmacist Analogy: From Local Health Code to FDA Manufacturing Plant

In your retail pharmacy, you follow best practices for compounding, much like a local restaurant follows the health code—important, but focused on basic safety and hygiene. USP <797> elevates this to the level of an FDA-regulated manufacturing plant. Every variable—the air, the surfaces, your clothing, your movements—is controlled, monitored, and documented to create a state of absolute sterility. The focus shifts from “clean” to “microbiologically inert.”

CSP Categories & Beyond-Use Dating (BUD): The Core of <797>

The latest version of USP <797> classifies CSPs into three categories based on the compounding environment and starting ingredients. This category determines the maximum allowable Beyond-Use Date (BUD).

CategoryCompounding ConditionsMax BUD (Room Temp)Max BUD (Refrigerator)
Category 1 Made in an unclassified Segregated Compounding Area (SCA). ≤ 12 hours ≤ 24 hours
Category 2 Made from sterile ingredients in a full cleanroom suite (ISO 7/8). This covers most hospital compounding. Varies by preparation. Up to 4 days. Varies. Up to 10 days.
Category 3 Made under the same conditions as Category 2 but with additional sterility requirements. Allows for extended BUDs. > 4 days > 10 days
Masterclass: The Garbing and Hand Hygiene Process (A Zero-Shortcut Ritual)

This is a step-by-step, rigorously enforced procedure. Humans are the single greatest source of contamination in a cleanroom. This process is designed to contain you.

  1. Step 1 (Ante-Room): Don shoe covers, a hair net, and a face mask.
  2. Step 2 (Ante-Room): Perform a thorough hand and forearm washing with soap and water for at least 30 seconds.
  3. Step 3 (Ante-Room): Don a non-shedding gown.
  4. Step 4 (Buffer Room): Apply an alcohol-based hand rub and allow to dry completely.
  5. Step 5 (Buffer Room): Don sterile gloves, which must be routinely disinfected with sterile 70% IPA during compounding.

Part 2: USP Chapter <800> – Hazardous Drug Handling

Protecting the Preparer, Not Just the Product

USP <800> provides standards for the safe handling of hazardous drugs (HDs) to minimize the risk of exposure to healthcare personnel, patients, and the environment. It covers the entire lifecycle of an HD, from receipt to disposal.

Retail Pharmacist Analogy: From Dusting Pills to Handling Radioactive Material

In retail, your biggest contamination concern might be the cross-contamination of sulfa dust on a counting tray. You clean it to protect the next patient. USP <800> is about handling drugs that are toxic to you. Think of it like handling radioactive material. The goal is no longer just sterility; it is containment. Every step is designed to prevent any molecules of the drug from escaping and exposing you and your colleagues.

The NIOSH List: What Makes a Drug Hazardous?

The list of hazardous drugs is maintained by NIOSH. Drugs are included if they are carcinogenic, teratogenic, cause reproductive toxicity, or have other organ toxicity at low doses.

  • Group 1: Antineoplastic drugs (i.e., chemotherapy).
  • Group 2: Non-antineoplastic drugs that are hazardous (e.g., immunosuppressants, some antivirals).
  • Group 3: Drugs that primarily pose a reproductive risk.
The Core Tenets of Hazardous Drug Handling
  • 1. Negative Pressure Environment: The hazardous drug room must be under negative pressure, ensuring air flows into the room, containing any aerosolized drug particles.
  • 2. Enhanced PPE: Garbing for HDs is more stringent, requiring two pairs of chemotherapy-rated gloves and an impermeable chemotherapy gown.
  • 3. Containment Hood (C-PEC): You must use a Class II Biological Safety Cabinet (BSC) or a Compounding Aseptic Containment Isolator (CACI), which protect both you and the product.
  • 4. Closed System Transfer Devices (CSTDs): These are needle-free systems that mechanically prevent the escape of drug or vapor during compounding and administration, dramatically reducing exposure risk.
Masterclass: Hazardous Drug Spill Management

Your ability to respond correctly is a critical safety competency. Every pharmacy has a dedicated HD spill kit.

  1. Secure the Area: Immediately restrict access to prevent others from being exposed.
  2. Don Appropriate PPE: This includes two pairs of chemo gloves, a resistant gown, eye protection, and often a respirator.
  3. Contain the Spill: Use absorbent pads from the spill kit to gently cover and contain the liquid.
  4. Deactivate and Clean: Use a multi-step process (e.g., deactivation with bleach, cleaning with germicidal detergent, disinfection with alcohol) as per your institution’s policy.
  5. Dispose and Document: All contaminated materials must be placed in clearly labeled hazardous waste bags. The spill must be fully documented.