Does a ‘one-size-fits-all’ pharmacy compounding regulation really work?


Accepting USP <797>as a robust quality and patient safety regulation is the first step to enforcing it

By Eric S. Kastango, MBA, RPh, FASHP

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 with allergies
  • A floor nurse who compounds medications to be given to patients in critical care
  • A homecare 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

Unlike pharmaceutical manufacturing, where companies are more similar than dissimilar (though some would strongly disagree), the standards of sterile compounding must be applied to all of the situations listed above and others that were not described.

In the introduction of USP Chapter <797>, it is stated that the standards are intended to apply to all persons who prepare compounded sterile preparations (CSPs) and all places where CSPs are prepared, e.g., hospitals and other health care institutions, patient treatment clinics, retail pharmacies, physicians’ practice facilities, and any place where CSPs are prepared, stored, and transported. Persons who perform sterile compounding include pharmacists, nurses, pharmacy technicians, and physicians, and all are required to comply with this chapter.

USP Chapter <797> first appeared in the pharmacy lexicon on January 1, 2004, spawned by patient incidents starting in the 1970s. It was the genesis of years of voluntary practice standards attempting to prevent future errors. The process started with the National Coordinating Committee on Large Volume Parenterals (NCCLVP), which led to the American Society of Health-System Pharmacists Guidelines on Quality Assurance for Pharmacy Prepared Products in 1993, USP Chapter <1206>: Sterile Drugs for Home Use in 1995, and to the present day chapter, which is considered enforceable by the FDA.

Now that we are into this enforceable chapter for more than three years, how did the USP Council of Experts, Sterile Compounding Committee do? Well, if you ask the hundreds of stakeholders who submitted thousands of comments including several prominent organizations like the Centers for Disease Control (CDC), the American Society of Microbiology (ASM), Association for Professionals in Infection Control and Epidemiology, Inc. (APIC), and the FDA, there was opportunity for improvement. Since the USP process is a dynamic one and relies on stakeholder feedback, a revised chapter is scheduled for release in 2007.

The revised chapter was written to consider all of the perspectives of the various groups, some of which are at odds with the standards of practice expected of pharmaceutical manufacturers and by the FDA.

Some of the principles, concepts, and requirements within the revised USP Chapter <797> have been challenged by the question “Where is the science behind the requirements?” Many pharmacists and other stakeholders believe that the requirements are too stringent and have questioned their need especially in the areas of facilities, environmental monitoring, personnel garbing, and cleaning and disinfection. These sections involve spending money in areas that have historically been misunderstood, overlooked, ignored, or routinely de-funded. In the pharmaceutical industry, many of the thought leaders and even the editor of this publication have stated that they believe the chapter is not stringent enough. Aseptic processing in the practice of pharmacy is, most of the time, not the same as manufacturing. However, there are parallels with many of the same practices, processes, and procedures. There are several factors that make this chapter as a “one-size-fits-all” regulation tenuous. They include:

  • Many pharmacists by choice or by necessity have to handle and compound patient-specific sterile preparations using bulk non-sterile active pharmaceutical ingredients in order to meet the patient’s therapeutic needs because no commercial drugs are available. When does the pharmacy cross the line and become a manufacturer?
  • Patients won’t be able to access care because the cost of compliance will discourage practitioners in rural areas 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 non-patient-specific sterile preparations for office use (bulk vials), making some pharmacies appear more like manufacturers. 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, compounders, and state boards of pharmacy in identifying the point at which a compounding pharmacy becomes a manufacturer spurred the FDA to post on May 31, 2007 a document titled “The Special Risks of Pharmacy Compounding” ( on its Consumer Health Information Page.

Some would argue that these situations don’t make the matter of compliance very easy or clear. However, with all of that being said, is there an easy answer to the “one-size-fits-all” regulation? I think so. As the new revisions get assimilated into practice, and everyone starts believing that the moving target known as USP Chapter <797> isn’t moving any more, the excuses as to why people can’t comply will go away. It is a robust document with the express purpose of building quality into compounded sterile preparations and ensuring patient safety. This chapter will continue to spark the scientific research that will, in turn, generate the scientific evidence needed in the area of sterile compounding.

The bottom line is that USP Chapter <797> is a regulation that is not going away and compliance is required. Unlike registered manufacturers who have the FDA to enforce the cGMPs, not all state boards of pharmacy are on board with this regulation yet. It is my hope that the state boards will rise to the challenge and take responsibility for this chapter and start enforcing it in order to ensure patient safety and keep the FDA out of the practice of pharmacy.

Eric S. Kastango is 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. He also serves on the CleanRooms Editorial Advisory Board.