Issue



USP 797: The net effect


04/01/2004







BY DOUGLAS THEOBALD, CFM

The United States Pharmacopoeia (USP) guideline governing pharmaceutical compounding and sterile preparations has recently been under review and modification. The changes outlined in USP 797 strike at the very core of an ongoing challenge—the ability to introduce a safe, sterile, manufactured response to an organic deficiency in the human body.

According to the USP, the new guidelines took effect on January 1. The revision of the previous standard, USP 1206, applies to "health care institutions, pharmacies, physicians practice facilities and facilities in which compounded sterile preparations (CSPs) are prepared, stored and dispensed."

As an industry professional, this statement is particularly intriguing to me, as previously the guidelines pertained primarily to the home health care industry. The first thought that comes to mind is: "What is the impact of a change of this magnitude?" For a number of years, I have been concerned with the lack of more defined and stringent standards for the cleanliness of the environment, behavior of the personnel and validation of compounding rooms, hospital rooms and even "out-patient" clinics. Although the events that have brought about the changes were unfortunate, I applaud the USP for addressing the issues head on and encourage professionals in the potentially affected industries to give careful consideration to the new guidelines.

Why the change?

News becomes news when it is controversial. In recent years, we have heard the stories of several people receiving contaminated "sterile" injections in northern California; patients became sick, and some died. Or, there was the story of the compounding pharmacy in North Carolina that distributed "sterile" preparations contaminated with a fungus. The source pharmacist was unable to assure a recall of the contaminated product from the several locations to which it had been distributed, and the Food and Drug Administration (FDA) intervened and ultimately initiated an alert to all of the locations that had received the contaminated injectables.

The bigger story is that before now, unless you were manufacturing a sterile compounded drug for large distribution, the FDA would not get involved in the oversight of the quality of the compounded sterile preparation. USP 797 appears to be changing all of that. Truth be known, professionals, medical practitioners and pharmacists have all had, to greater or lesser degrees, interest in safe practices.

Two words come to mind: viability and liability.

The effect

The guidelines, as delineated in USP 797, will require more stringent controls on the environment in which compounding activities occur. Compound and finished product handling will be key components. Similar to anything that comes under the scrutiny of the FDA, requirements for documented environmental testing will be critical. Another aspect that needs to be addressed is the training of personnel handling the process, and components utilized in the compounding procedure.

Dennis Saadeh of Park Pharmacy (Irvine, Calif.) narrows it down to a few basics: "It's really a move towards quality, efficacy of potency and verification of sterility. Sterile compounding has formerly been a gray area in regards to regulation. The state boards had the authority but lacked the infrastructure to inspect and enforce; the FDA has the capability of doing both."

California, as with many other states, is expected to adopt USP 797 as the standard rather than "re-invent the wheel." In addition to complying with USP 797, Dennis has received the Sterile Product License from the State of California. As physicians and medical practitioners begin to see the value, these will be critical steps in the success of any sterile compounding business.

Time to review the business plan?

Due to the potential changes to the way that compounded sterile preparations are "prepared, stored and dispensed," a few other things must be taken into consideration, such as: "What is the long-term effect of moving in the direction of more defined guidelines and requirements to comply?" Sterile compounding is performed in many different kinds of environments (i.e., hospitals, clinics, pharmacies, etc.). There is a cost to compliance.

The first decision to make is whether the volume or the value will allow for sustainability and growth in the business, while still obtaining and maintaining compliance.

We need to look at the physical capabilities of the facility where the compounding is being performed and evaluate its ability to accommodate the changes required for equipment and environmental controls. Training will be required, not only for the purposes of working within the controlled environment but also in developing and handling process and testing documentation. We need to determine which tests are appropriate for the environments and materials being manipulated.

Depending on the activity, and the potential for exposure of sterile product to contamination, protective clothing and procedures for entering and exiting the controlled areas will need to be addressed.

In essence, there are some variables in each environment that are unique. The best practice is to perform a comprehensive assessment before making any changes or incurring significant expense.

The right direction

In the past several years, significant discoveries have been made in the pharmaceutical and biotech industries. Every day, we read or hear about new technologies and advanced means of treating disorders, disease and illness: drug-delivering medical devices, such as drug eluting stents, and platinum-based drug dispensing chips, whereby medications can be implanted in the human body and deployed by way of electrical pulses. Plus, artificial cornea implants, methods of repairing damaged nerves... and the list goes on. Some technologies are capable of projecting images from inside the body at high resolutions.

The USP 797 guidelines are a step in the right direction. The purpose of the practice of sterile compounding is to maintain and improve life. If we take the steps now to implement concise and well-planned practices and procedures, obtaining this goal to a greater degree is inevitable.

View of the future

With what we have discussed in mind, the next step will be to work through the process of the design and composition of a sterile environment. In fuure issues, I will address important information on proper room layout and airflow, the types and sources of contamination, and how we can re-mediate contamination. The focus will be on the critical elements of developing documentation, achieving and maintaining compliance, appropriate training and critical cleaning practices.

There are, of course, many cost-effective solutions to compliance with the new standards, and our company has already developed and implemented them for several customers. I will discuss some of these solutions in the next topic: "Sterile compounding and room design."

DOUGLAS THEOBALD is a certified facilities manager and is the Orange County-Los Angeles general manager of Controlled Contamination Services, LLC (Anaheim, Calif.). He can be reached at: dtheobald@cleanroomcleaning.com