USP 797 How Will It Affect Your Compounding Pharmacy?

April 7th, 2009
By John Krause

To answer that question, let's consider, what is USP 797?

The USP (US Pharmacopoeia ), is a private organization that formed in 1820. Current members of this organization include many members of accredited schools of medicine and or pharmacy, state medical and pharmacy associations, government agencies, consumer organizations and other esteemed health organizations.

What is USP?

Officially it is chapter 797(1) of the USP. This chapter is a comprehensive regulation that governs a wide range of pharmacy policies and procedures. The intent is both to cut down on contamination transmitted to patients via pharmaceutical products and to better protect those who are working in pharmacies and are exposed to pharmaceuticals.

More USP 797?

USP Chapter 797 was enacted January 1, 2004 and is the first enforceable standards for sterile compounding. Sterile compounding is generally maintained by a pharmacist who is responsible to make sure every aspect of sterile compounding. This also includes the proper storage of chemical, sterility testing of the finished product according to aseptic protocol. Sterility testing is done on all sterile compounds, chosen to be risky by the United States Pharmacopoeia, before being dispensed. All testing is acknowledged and maintained on file, which can give the physician confidence in the quality of the sterile preparations.

A compounded sterile preparation (CSP) is a prescribed quantity unit that:

v Is prepared according to the manufacturer's labeled instructions

v Contains non-sterile ingredients or uses non-sterile components or devices that need to be sterilized before use

v Is a biologic, diagnostic, drug, nutrient, or pharmaceutical that matches either of these characteristics

Examples include baths and soaks for live organs and tissues, implants, inhalants, injections, powder for injection, irrigations, metered sprays, and ophthalmic and optic preparations.

How Will It Affect Compounding Pharmacies?

The Chapter's requirements are applicable in all settings where sterile preparations are compounded. For many facilities this has raised concern regarding the cost and difficulty of being compliant. These are concerns of increased cost of construction and maintenance of the extra buffer zones in the hospitals and pharmacies. Hospital design, construction and operations professionals also need to become familiar with it. As a result, USP 797 has received great attention from hospital administrative, clinical and pharmacy staff. The regulation governs any pharmacy that prepares “compounded sterile preparations” ( CSPs ). Many pharmacies fit this description. Moreover, many large hospitals have several pharmacies- a main pharmacy and several satellites that will be affected.

But USP 797 and the rumors

USP 797 does not require that sophisticated clean rooms to be installed. For some hospitals and pharmacies a clean room may be a simpler solution. What the guideline does require are environmental controls – specifically, a separate area for compounding that meets a defined level of cleanliness, and monitoring to ensure that control is maintained. Once the initial concerns over the cost and difficulty in meeting USP797's requirements have passed, patients and staff alike will be better off as a result.

How this regulation is working on the related medical and pharmacy organizations?

USP 797 has been approved and adopted by several states and is currently under review by many others (check with your state Board of Pharmacy). States have the option to adopt 797 precisely or to edit the standards into pharmacy regulations ( Missouri and Texas have sterile compounding regulations. New Jersey requires that the buffer zone be ISO 6 / Class 1,000 – clean room). Keep in mind that the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is enforcing USP Chapter 797 within their standards. JCAHO may require stricter compliance to 797 than your state Board of Pharmacy.

Chapter 797, as it applies to clean rooms (Buffer Zones), is general in nature but refers to the Intern ational Standards Organization, ISO-14644 standard for clean rooms. Sterile compounding is to be performed in an ISO 5 (class 100) environment that is surrounded by an ISO 8 (Class 100,000) Buffer Zone (clean room), ISO 7 (Class 10,000) in 2006. A barrier isolator does not have to be contained in an ISO-rated space unless recommended by the manufacturer.

Sterile compounding or the cleaning of the room or the zone to be used medically or pharmaceutically is done for the proper storage of chemicals and other serious medical and pharmaceutical procedures by sterility testing of the finished product. It is followed according to aseptic (free of disease-causing micro-organisms) protocol.

What is the Buffer zone?

A “Buffer Zone” is an environment that separates the compounding room from the surrounding ambient area and is to be constructed from low-particle-generating materials that can withstand continuous cleaning. ISO standards require that the buffer zone be maintained under positive pressure and that airborne particles be limited in compliance with ISO 8 (Class 100,000) requirements. ISO 7 (Class 10,000) will be required in 2006. You may be able to meet the specified standards with as little as a fresh coat of paint such as with a water-based epoxy and the installation of 1, 2 or 3 new additional walls.

Some hazardous process and drug compounding need to be done in a biological safety cabinet, vented and ventilated 100 percent to the outside, according to The National Institute for Occupational Safety and Health (NIOSH), as prescribed in September 2004. A clean room is the best way to create the buffer room or zone. It fundamentally consists of smooth, impermeable floor, walls and ceiling with appropriate vents and doors, to support the heart of a clean room, the HVAC with HEPA filters, which controls the air pressure, creating the ISO Class 7 during operation. It also maintains the desired temperature and humidity.

How is USP797 going to affect the pharmacies and other related organization in US?

In general, the response to various surveys indicated that; chapter 797 would negatively affect workload and pharmacy's ability to provide sterile preparations in a timely manner. On the other hand, respondents responded that the new standard would have a positive effect on the quality of care provided by the hospital. In summary of the surveys indicated that 45.3% of respondents had plans to build a clean room, and 21.7% reported plans to obtain new equipment so as to comply. In addition, 42.3% of respondents had decreased the quantity of high-risk compounding. Also reported was that pharmacy's budget had increased in order to comply with chapter 797. The most common requirements with which respondents were not willing to comply were validating the accuracy of automated compounding devices, sterilizing products and equipment before entering the clean room, rotating the type of disinfectants, and prohibiting use of cosmetics by staff. While this maybe something new to the labs technicians it has been the norm for staff that work in technical manufacturing for years to protect the product being produced, i.e., the semi-conductor industry.

Can We Sum it Up ?

USP chapter 797 standards have influenced the compounding practices of hospital pharmacies nationwide, including a decrease in the compounding of high-risk preparations, an increase in budgetary allocations, and implementation of better quality assurance practices. Larger hospitals tended to implement more changes than did smaller hospitals, and there remains room for improvement overall.

From The Publics Point of View

Recent incidents of contaminated “sterile” products causing patient harm and even in some deaths have given the profession of pharmacy a negative reputation. These incidents occurred because recommended published compounding guidelines were not followed, particularly those pertaining to guidelines that address quality assurance and personnel training. Chapter 797 was developed to eliminate the risk of patient harm due to improperly compounded sterile preparations, but it is unknown how an enforceable standard will influence the changes that FDA, JCAHO, and the public demand.

USP797 is going to increase the cost and expenditure on the pharmacy and medical care facilities. A positive note, implementation of Chapter 797 is going to ultimately benefit the public as well as private health service s and products used. So what are your thoughts? Is USP 797 a good thing, or just an inconvenience for you operation? As a future or present patient, are you happy for the implementation of USP 797? Share your thoughts at http://www.johnkrause.me/