What Your Business Needs to Know About USP 797 Compliance

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Doctors and patients rely on compounding pharmacies to provide safe, sterile medications that cannot be obtained by other means. Living up to such responsibilities requires huge amounts of diligence and attention, as even a single mistake can be tragic.

The U.S. Pharmacopeia (USP) maintains and promulgates standards that help keep pharmacies on track even when they’re facing unexpected developments and formidable complexities. General Chapter 797 of that group’s standards details the precautions compounding pharmacies to need to take to deliver sterile preparations to patients. A quick look at some of USP 797’s most significant requirements should make it clear these are rules that always need to be observed.

The Importance of Staying Up to Date

As with standards that apply to other industries, USP 797 receives frequent updates. As such, even someone who is comfortable with and well-informed about one version of the standard can end up falling behind quite easily.

Fortunately, it is to easily find help at airquestinc.com and from other sources when revisions to the standard need to be understood and accounted for. In fact, that will often be the best way to ensure an organization remains in compliance with the latest and most fully developed form of this important standard.

Familiarity With Core Principles Pays Off

There are also a number of enduring concepts that have informed or motivated all versions of USP 797 and will almost certainly continue to do so for future ones. With the demand for compounded preparations and prescriptions rising so sharply in many recent years, pharmacists and managers need to be intimately familiar with these ideas.

Fortunately, most of the fundamental issues encompassed and addressed by USP 797 are fairly straightforward to comprehend. Some of those that most often need to be accounted for in practice are:

Container type.

Compounded preparations can be provided in containers that include a single dose or in others that include many. Different precautions have to be taken to establish and maintain sterility in each case, and recent revisions to USP 797 have modified these significantly.

Risk levels.

 It will rarely be practical to employ every potentially useful means of ensuring sterilization. Instead, pharmacists are tasked under USP 797 with assigning one of a number of established, carefully defined risk levels to each compounding project. This makes it possible to then employ an appropriate set of sterilization procedures without straying into redundancy or other forms of waste, which is an issue of increasing importance to the $7-plus-billion-dollar compounding industry.

Environmental control.

 Many experienced pharmacists are skilled at a wide variety of sterility-supporting procedures. In some cases, though, a simple lack of attention to the environment can negatively impact a preparation. USP 797 covers a wide range of topics relevant to environmental assessment and management.


Systems like hoods and vents help keep compounded preparations from succumbing to contamination. To function properly, these controls need to be placed, maintained, and operated appropriately. USP 797 includes detailed instructions regarding such matters.

Help is Always Available

While USP 797 is undeniably complex, help with coming into compliance with it is readily available. In many cases, it will also make sense to seek assistance when revisions to the standard make things even more complicated. While keeping up with USP 797 compliance can take some effort, the benefits that result help keep patients all across the country safe and healthy.