25 Jun USP 797 vs 800: What’s the Difference?

The line between a safe and effective medication and a dangerous one is often razor-thin. To prevent crossing this line, the United States Pharmacopeia (USP) established guidelines, such as USP 797 and USP 800. In short, these standards aim to improve the overall safety and handling of medications. In this article, we’ll explore what USP 797 and USP 800 are, and then delve into the similarities and differences of USP 797 vs USP 800.

What is USP 797?

USP Chapter 797 is a set of guidelines or standards that focuses on sterile compounding. (Compounding is the process of combining, mixing, or altering ingredients to create a medication suited to the needs of individual patients.) In other words, USP 797 sets rules for healthcare facilities on how to prepare contaminant-free medications, known as compounded sterile preparations (CSPs).

These rules can apply to facilities such as hospitals, pharmacies, clinics, or any other locations where sterile medications are compounded. First introduced in 2004, USP 797 has undergone several updates to improve these guidelines.

What is USP 800?

USP Chapter 800, on the other hand, is a set of guidelines that focuses on the safe handling of hazardous drugs. These rules are similarly applied in healthcare settings to protect staff, patients, and the environment. They apply to many stages, including delivery, storage, preparation, dispensing, and administration. USP 800 was first introduced in 2016.

USP 797 vs 800: What are the Main Differences?

In this section, we’ll go over some of the differences of USP 797 vs 800. Below is a quick chart of the differences, followed by more detailed explanations for each aspect.

Purpose

The primary difference between USP 797 and USP 800 is in what they focus on. USP 797 is centered on the compounding of sterile preparations (CSPs). USP 800, however, focuses on the safe handling of hazardous drugs to protect healthcare personnel, patients, and the environment from exposure, regardless of whether the drugs are sterile or non-sterile.

Types of Drugs and Compounding Practices

USP 797 covers all sterile compounding, including both hazardous and non-hazardous drugs. However, USP 800 specifically addresses hazardous drugs, including those that require sterile and non-sterile compounding.

Engineering Controls

In the context of USP 797 and USP 800, primary engineering controls (PECs) and secondary engineering controls (SECs) are important in making sure that medicines are both sterile and safe.

To make things easier to understand, let’s first go over what PECs and SECs are before explaining the differences in engineering controls of USP 797 vs USP 800.

PECs are devices, such as laminar airflow workbenches or biological safety cabinets (BSCs), that provide a clean space for preparing or containing medications, specifically at an ISO Class 5 level.

SECs, on the other hand, are the rooms or areas where PECs are located. They are considered a kind of “buffer” area, which help control the environment around PECs.

USP 797 requires SECs, such as cleanrooms and segregated compounding areas (SCAs), to keep a sterile environment. They must have HEPA (high-efficiency particulate air) filtration, meet ISO Class 7 or better for the buffer area, and ISO Class 8 or better for the anteroom.

They also must have positive pressure so that contaminants cannot enter the space in case of a breach. USP 797 spaces use PECs, as we mentioned above, such as laminar airflow workbenches or BSCs, to keep medications sterile during compounding.

Similarly, all surfaces should be easy to clean, smooth, and non-porous.

USP 800 also requires proper ventilation with HEPA filtration, but to protect spaces from hazardous drugs. It recommends primary engineering controls (C-PECs), like BSCs or compounding aseptic containment isolators (CACIs) for compounding, and containment secondary engineering controls (C-SECs), the rooms where C-PECs are located. These spaces need external venting, negative pressure, and at least 12 air changes per hour (ACPH).

Similar to USP 797, USP 800 recommends that surfaces should be easy to clean, smooth, and strong enough to handle frequent cleaning.

Personal Protective Equipment (PPE)

USP 797 requires PPE such as gowns, gloves, masks, shoe covers, and more to keep the areas around the medication sterile. However, USP 800 requires additional PPE, like respirators, to protect personnel from drug exposure.

Environmental Monitoring

USP 797 requires regular checks of air and surfaces with air sampling, surface sampling, and particle counting to keep the compounding area clean. USP 800, using similar methods, emphasizes monitoring for hazardous drug contamination.

Documentation Requirements

USP 797 and USP 800 both require detailed documentation. USP 797 focuses on records processes, including logs of air and surface sampling, compounding records, and cleaning procedures. USP 800 is similar, but focuses more on documentation of hazardous drug handling, including storage logs, decontamination procedures, and incident reports.

Personnel Training and Protocol

Personnel training and protocol are both extremely important under both USP 797 and USP 800. USP 797 requires training in aseptic techniques, use of PPE, and how to maintain a clean environment. USP 800, on the other hand, adds specialized training for handling hazardous drugs, including the use of additional protective equipment and safety procedures to prevent exposure.

The Bottom Line

Though USP 797 and USP 800 have many similarities and may use similar engineering controls, their main focuses are different. USP 797 is fundamentally about preventing the contamination of medicines, while USP 800 is about protecting personnel and the environment from hazardous drugs. Facilities can and often do comply with both sets of standards, as they are not mutually exclusive. Together, these guidelines ensure the highest standards of safety, protecting both patients and healthcare workers.

Need help meeting USP 797 or USP 800 standards? Contact Allied Cleanrooms today to get a free quote and learn how we can assist you in creating safe, compliant spaces.