USP <797>: The First Step to Compliance

July 2007 - Vol. 4 No. 7

By Eric S. Kastango, MBA, RPh, FASHP

THE TIME IS UPON US TO ENTER THE NEXT PHASE OF OUR JOURNEY IN aseptic compliance. After two years of work from the members of 2005-2010 USP Council of Experts’ Sterile Compounding Committee and thousands of comments from hundreds of stakeholders, the next iteration of USP Chapter <797> is scheduled to be released. The purpose of this article is not to discuss the details of those changes, but rather to provide the reader with a perspective of the challenges of writing a “one-size-fits-all” regulation. When you think about the number and variety of places where compounded sterile preparations (CSPs) are prepared, it becomes daunting. What do all these situations have in common?

  • A 25 bed critical-access hospital in rural Minnesota
  • A physician’s office where intramuscular antibiotics are given to children with pneumonia
  • An allergist who manages the care of 200 patients
  • A floor nurse who compounds medications to be given to patients in critical care
  • A home care company with 72 pharmacies in 44 states, delivering home infusion therapy to more than 10,000 patients daily
  • A national outsourcing company that is both licensed as a pharmacy and registered with the FDA as a manufacturer

In all of these settings, USP Chapter <797> requirements need to be incorporated into compounding practices to ensure patient safety. The introduction to <797> states that the standards are intended to apply to all persons who prepare compounded sterile preparations (CSPs) and all places where CSPs are prepared.

USP Chapter <797> first appeared in the pharmacy lexicon on January 1, 2004. Now, three years later, non-pharmacy stakeholders have weighed in on this chapter, including several prominent organizations like the CDC, the American Society of Microbiology (ASM), Association for Professionals in Infection Control and Epidemiology, Inc. (APIC), and of course, the FDA. You might be aware of a bill that is being kicked around the United States Senate known as the “Safe Drug Compounding Act of 2007”. Basically, it would give the FDA authority over regulating compounded medications. I strongly urge you to read more about it, because pharmacy’s last chance to keep more onerous regulations at bay depends on our acceptance and implementation of USP Chapter <797>.

Evidence-Based Science
Some of the principles, concepts, and requirements within the revised USP Chapter <797> have been challenged by the following question: “Where is the science to support this?” One area of great debate has been the evidence, or lack thereof, that cleanrooms (ISO Class 7 environments) are even necessary. At this point in time, the standard of practice throughout the world is that cleanrooms are necessary, and there is evidence from other professions (i.e., semi-conductor and pharmaceutical manufacturing) that cleanrooms are needed in order to maintain a state of control. Cleanrooms cannot nor should not be looked at as independent variables, since any robust quality system depends on several factors (i.e., employee garbing habits and work practices) all working together to achieve the desired outcome. Furthermore, the FDA wants and expects cleanrooms – end of story – until we have compelling evidence to the contrary.

While no one disputes the significant cost of building a cleanroom, many hospitals are finding the money to give pharmacy directors what they should have had long ago: adequate climate-controlled facilities where employees can work comfortably in order to prepare quality CSPs. But once the cleanroom is built, what’s next? The key to making a cleanroom work is proper staff practices. Reams of evidence support the necessity of proper hand hygiene in preventing infections. In fact, the CDC’s Guideline for Hand Hygiene in Health-Care Settings (2002) is the definitive work on the subject and provides some 50-plus pages of guidance on proper hand washing. How well do your employees wash their hands before compounding? Have they been trained? How is the training reinforced? Are you enforcing compliance? Hospital infection control personnel are great resources in assisting pharmacists and technicians in education and training.
In addition, evidence-based science shows that gravimetric air sampling (using settling plates) is inferior and leads to false results, when compared to volumetric air sampling with an electronic air sampler. Because volumetric air samplers require a significant one-time capital expense ($3,000-$10,000), there has been an uproar over the expense of these collection devices, despite their scientifically proven superiority. It would appear that when something is not convenient, is expensive, or takes too much time to perform or supervise, we don’t or won’t do what’s right, despite the science behind the activity.
The Challenges of a One-Size-Fits-All Regulation
It is reported that there are about 800 to 900 high-volume compounding pharmacies with reported sales in excess of $2 billion annually. These operations should be regulated differently than the average compounding pharmacy. But it begs the question: Is it possible to write a compounding regulation that is applicable to all facilities? There are several factors that make a “one-size-fitsall” regulation tenuous, including the following scenarios:

  • Many pharmacists, by choice or necessity, compound patient-specific sterile preparations using bulk non-sterile active pharmaceutical ingredients in order to meet the patient’s therapeutic needs when no commercial drugs are available. When does the pharmacy cross the line and become a manufacturer?
  • Patients will not be able to access care because the cost of compliance will discourage rural practitioners who only compound a few CSPs per week. At what point does a practitioner have to comply with the regulations?
  • Some state boards of pharmacy permit pharmacists to compound nonpatient-specific sterile preparations for office use (bulk vials), making some pharmacies seem more like manufacturers, but this flies in the face of federal regulations. Do these pharmacies have to comply with different standards?
  • The ongoing tug of war between the FDA, compounding facilities, and state boards of pharmacy over the point at which a compounding pharmacy becomes a manufacturer has spurred the FDA to post on May 31, 2007 a document titled “The Special Risks of Pharmacy Compounding” (available at

The practices, processes, and procedures found in the next, soon-to-bereleased version of USP Chapter <797> need to be embraced by all pharmacies. And as the revisions to <797> are incorporated into practice, and everyone starts believing that the moving target known as USP Chapter <797> isn’t moving any more, the excuses for not complying will go away. It is a robust document with the express purpose of building quality into compounded sterile preparations and ensuring patient safety. Evidence-based science exists for many of the practices that need to be managed, monitored, and measured and many of these are based on best practice; the answer is: Put patient safety first and embrace <797>. This chapter will continue to spark additional research that will, in turn, generate the scientific evidence needed to address the gray areas of sterile compounding and answer the questions surrounding best practices.

The bottom line is that USP Chapter <797> is not going away, and compliance is required. Not all state boards of pharmacy are yet on board with this regulation, but it is my hope that the state boards will rise to the challenge and start enforcing it in order to ensure patient safety and keep the FDA out of the practice of pharmacy.

Eric S. Kastango is the president, CEO, and owner of Clinical IQ LLC, a provider of customized process and educational strategies for the pharmaceutical, medical device, and health care industries. A member of USP’s Sterile Compounding Committee, he has practiced in the field of both hospital and home care
pharmacy since 1980.


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