USP 797 is the first enforceable standard

An overview of USP Chapter 797 prepared by pharmacist Mike Hurst, RPh, MBA, for pharmacy supplier Baxa Corp., says the chapter, which became effective Jan. 1, 2004, is the first enforceable standard for sterile compounding. Following years of patient safety recommendations and professional guidelines, the intent of USP 797 is to lay out procedural and practical requirements for safe compounding of sterile preparations. The requirements apply to all practice settings where sterile preparations are compounded, raising concerns about the cost and ease of complying.

Hurst said it's important to recognize that the goal of USP 797 is improving the compounding of sterile products. Like any change, he said, it can be misinterpreted and thus feared. He said the biggest misconception seems to be that 797 requires a sophisticated cleanroom. For the most part, it contains many procedural, training, and quality assurance requirements that Hurst said are not unreasonable for a quality IV operation.

Like other USP standards numbered below 1,000, USP 797 is enforceable by state Boards of Pharmacy or the FDA. While FDA does not routinely inspect individual pharmacies, it may intervene in the case of injuries, a death, or a complaint. In addition, USP standards often are cited as evidence of national standards in legal actions, and the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) adopted them for use after July 1, 2004. JCAHO accreditation is required for Medicare reimbursement and almost all state Medicaid programs.

Hurst exploded some of the myths about USP 797, telling both what it is and what it is not. What 797 is, he said, is long (18 pages with 13 single-spaced and in a small-text font); paperwork- and process-intensive; intended to upgrade pharmacy admixture processes to reasonable precautions; and based on three risk categories (low, medium, and high) for compounded sterile products.

But 797 isn't some of the things it's rumored to be, he maintained. Thus, it does not require sophisticated cleanrooms to be installed, instead calling for environmental controls, that is, a separate area for compounding that meets a defined level of cleanliness, and monitoring to ensure that control is maintained.

Facility baseline is first step

The first step in dealing with USP 797, according to Hurst, is to prepare a baseline on the existing facility to determine what remediation steps of facility and procedural redesign will be required to meet the environmental controls.

There are six levels of ISO (International Organization for Standardization (ISO) cleanrooms, from ISO Class 3 to ISO Class 8. The net result of the guidelines is that sterile mixing takes place in a properly maintained laminar airflow hood (ISO Class 5) situated in a relatively clean room (ISO Class 8). For most pharmacies, Hurst said, this requirement is neither difficult nor unreasonable. He expressed concern that some interpretations of the requirement have made it seem more onerous than it is.

He pointed out that USP 797 is not a radical departure from what most admixture programs are already doing. "There are basic steps in quality sterile compounding that many inpatient pharmacies have unfortunately not had the time or interest to implement. Regulatory agencies such as FDA and state Boards of Pharmacy have long recognized this need. USP 797 simply puts the requirements in a format that inspectors can check against."

Hurst cautioned that USP 797 cannot be fully met by outsourcing. USP 797 does not cover legitimate first doses, and other doses can be outsourced, he said. But almost any pharmacy will still need to make many doses such as those subject to change, short-expiration drugs, some antineoplastics, etc., that are not candidates for outsourcing. Other expensive and specialized drugs may be hard to outsource, also. Sterile compounding activities can be minimized through an outsource arrangement, Hurst said, but not entirely eliminated. Thus, nearly all hospital pharmacies have to comply with USP 797 requirements.

Can't use only isolators for compliance

Pharmacies need to be aware that isolators alone will not ensure compliance with USP 797. Hurst said that using an isolator for sterile compounding handles only part of the requirements for USP 797. Issues such as process validation, training, expiration setting, product quality maintenance after the sterile compounded product leaves the pharmacy, caregiver training, patient monitoring, and quality assurance remain the same as for products compounded in standard laminar flow hoods. Also, the special requirements for cleaning the isolator itself and for cleaning materials entering the isolator make it a demanding alternative to standard pharmacy flow hoods. Also, he said, many users find isolators physically difficult to work in and inappropriate for medium-to-large institution workloads.

Hurst said compliance with USP 797 is expected to be achieved through completion of steps on a timeline running through January 2008. The requirements allow pharmacies to plan appropriately for compliance, understanding that changes of this magnitude will not be accomplished overnight. JCAHO surveyors began surveying facilities for compliance with 797 on July 1, 2004.

The October 2004 issue of Joint Commission Perspective listed five items that the USP 797 advisory group recommended that organizations focus on for compliance: personnel training and evaluation, beyond-use dating and labeling, verification of automated compounding devices, finished preparation release checks and tests, and aseptic technique. Hurst said that list recognizes that the task of developing a comprehensive plan for USP 797 compliance is daunting. While all chapter components must be addressed for compliance, listing priority activities will allow organizations to make the most significant progress toward achieving the goal of improving the quality of sterile compounded products.

"USP 797 is a profound change for the profession of pharmacy," Hurst said. "The key is using aseptic technique with the right equipment in an environment that's appropriate."