The United States Pharmacopeia (USP) stands as an independent scientific organization, dedicated to establishing and disseminating standards governing the identity, quality, strength, and purity of medicinal drugs, dietary supplements, and food ingredients.
These standards, widely recognized and employed by regulatory bodies, manufacturers, and healthcare professionals, play a crucial role in ensuring the safety and efficacy of pharmaceuticals and related products.
In this regard, the introduction of USP 797 and USP 800 has prompted healthcare organizations, medication manufacturers, and compounding pharmacies to reassess their policies regarding the sterile compounding of hazardous drugs.
Let’s delve into a detailed comparison of USP 797 vs. 800 and explore some recent updates in these standards.
What is USP 797?
The USP 797 Pharmaceutical Compounding – Sterile Preparations standard was established in 2014 to ensure the quality and safety of compounded sterile products. It covers various factors such as HVAC systems, cleanroom requirements, temperature and pressure factors, personnel training, and additional lab equipment requirements.
The primary objective of USP 797 is to mitigate the risks of harm and fatality resulting from microbial contamination (non-sterility), excessive bacterial endotoxins, and substantial errors in the strength or composition of ingredients in sterile preparations. Proper adherence to USP 797 is instrumental in ensuring that patients receive uncontaminated drugs.
What is USP 800?
While the USP 797 standard related to sterile compounding places the patient at the center of protection, the USP 800 shifts its focus to safeguarding healthcare workers who handle hazardous drugs.
USP 800 outlines comprehensive requirements for various aspects, including spill control, cleaning, decontamination, facility controls, personnel training, medical surveillance, and protocols to be followed in case of contact with hazardous drugs.
These hazardous drugs encompass substances used in cancer chemotherapy, antiviral drugs, hormones, certain bioengineered drugs, and various other pharmaceuticals.
Primary Differences Between USP 797 and USP 800
Here are the key differences between USP 797 and USP 800:
|Sterile compounding of medications
|Handling of hazardous drugs
|Pertains to the compounding of sterile preparations, including both hazardous and non-hazardous drugs.
|Specifically deals with the handling of hazardous drugs.
|Deals with facility design, environmental controls, personnel training, and aseptic techniques
|Focuses on ventilation systems, facility control, PPE use, and handling guidelines for hazardous drugs
|Emphasizes the training and competency of personnel involved in sterile compounding, including the use of aseptic technique, proper garbing, and understanding the principles of cleanroom behavior.
|Requires training programs for personnel handling hazardous drugs, covering topics such as risk assessment, use of personal protective equipment (PPE), and spill response.
|Defines standards for sterile compounding environments, including requirements for cleanrooms and other controlled areas where compounding occurs.
|Defines guidelines for the use of containment primary engineering controls (C-PECs) and containment secondary engineering controls (C-SECs) to minimize exposure.
USP 797 vs. USP 800 Compliance: A Dilemma
USP 797 holds significant importance for various crucial reasons, including patient safety, standardization, legal and regulatory compliance, and quality assurance.
Adhering to USP 797 is paramount for healthcare and pharmaceutical entities, especially those undergoing expansion and aiming to steer clear of compliance-related challenges.
According to American Cleanroom Systems, achieving USP 797 compliance requires pharmacies to conduct sterile drug compounding within an ISO 5 (Class 100) environment. This space should be installed inside a broader compounding “Buffer Zone” characterized by an ISO 7 (Class 10,000) positive pressure controlled-air environment (cleanroom).
However, some USP 800 rules propose changes that affect cleanrooms handling hazardous drugs:
- Negative pressure rooms to prevent cross-contamination of areas adjacent to cleanrooms
- Signs and demarcation lines warning of hazards are required
- Labeling requirements of hazardous drugs that require special handling, administration, and disposal.
- Storage requirements of hazardous drugs that require negative or neutral pressure, external ventilation, and at least 12 air changes per hour. Storage containment also has to be considered so that any spills, falls, or breaks remain locally isolated.
- Pass-through requirements that involve the use of pass-through rooms between the cleanroom and an adjacent room. This minimizes the risk of contamination among healthcare personnel as well as patients.
Thus, it is quite clear that upgrading a cleanroom for USP 800 compliance requires infrastructural modifications. Small changes may include modification of equipment, while more extensive upgrades may include retrofitting cleanrooms with new and updated airflow systems.
While USP 800 became official on December 1, 2019, it was informational only, and the guidelines were not applicable. After that, several changes have been made to the USP to ensure that the revamped standard of practice aids in the protection of personnel who handle hazardous drugs.
Now, with the recent updates to USP 797 in November 2022, USP 800 has also been made effective as of November 1, 2023.
If you are involved in handling hazardous drugs within a healthcare setting, it is crucial to assess whether your facility needs to adhere to USP 800 and take the necessary steps to achieve compliance.