What does USP Chapter 797 standards do not apply to?

October 17, 2025 •

2 min read

According to the American Society of Clinical Oncology (ASCO), many routine oncology practice activities are not subject to USP Chapter <797> standards, clarifying common misconceptions. Knowing what does USP Chapter 797 standards do not apply to is crucial for healthcare practitioners to correctly implement regulations and focus resources on qualifying sterile compounding activities. This article explores the specific exceptions and non-applicable scenarios outlined by the United States Pharmacopeia.

Quick Summary

This article details the specific exclusions and exceptions from USP Chapter 797, including the administration of medications, preparations made per manufacturer's labeling, non-sterile compounding, and immediate-use sterile preparations, as well as guidance on radiopharmaceuticals.

Key Points

Administration is Excluded: Giving a sterile medication to a patient is outside the scope of USP Chapter <797>.
Manufacturer Instructions Prevail: Preparations made exactly according to a manufacturer's FDA-approved labeling for a single patient dose are not considered compounding under this chapter.
Immediate-Use Exception: An exception exists for immediate-use CSPs, which must be administered within four hours and involve a limited number of ingredients.
Non-Sterile Compounding is Separate: USP Chapter <797> does not apply to non-sterile compounding activities, which are regulated by USP Chapter <795>.
Radiopharmaceuticals are Governed by <825>: The preparation of radiopharmaceuticals is subject to USP Chapter <825>.
Spiking an IV is Not Compounding: Withdrawing a dose from a vial or spiking an IV bag without further manipulation is considered administration and is exempt.
Hazardous Drugs Refer to USP <800>: Handling hazardous drugs involves compliance with USP Chapter <800>.

Understanding the Core Scope of USP Chapter 797

USP Chapter <797> provides standards for preparing compounded sterile preparations (CSPs) to prevent contamination and patient harm. These standards apply to healthcare professionals preparing CSPs in various settings. However, some activities fall outside this scope.

Activities Excluded from USP <797>

Several common practices are not considered sterile compounding under USP <797> and are exempt from its requirements. This includes administration of medications, preparations made according to FDA-approved manufacturer's labeling for a single patient dose, and non-sterile compounding, which is covered under USP <795>. Immediate-use CSPs have different rules if specific conditions are met, and compounding radiopharmaceuticals may follow USP Chapter <825> requirements.

Comparison of Compounding Scenarios

The table below highlights the differences between activities covered by USP <797> and those that are excluded.


Feature	Compounding Under USP <797>	Excluded from USP <797>
Activity Type	Altering a drug to create a sterile preparation.	Administering medications to a patient.
Preparation per Labeling	Deviating from manufacturer's labeling.	Preparing a single dose according to manufacturer's instructions.
Product Type	Compounded sterile preparations (CSPs).	Non-sterile compounded preparations (under USP <795>).
Environment	Controlled environments required.	Immediate-use can be in uncontrolled environments under specific conditions.
Batch Size	Can involve multiple doses.	Single doses for one patient.
Hazardous Drugs	Special procedures typically covered by USP <800> and incorporated into <797>.	Administration of hazardous drugs is excluded (handling covered by USP <800>).

Immediate-Use Preparations: A Closer Look

The immediate-use exemption allows sterile preparations to be made outside a cleanroom for direct administration. To qualify, administration must start within about four hours, and the preparation can use no more than three different sterile products. These rules aim to minimize contamination risk in uncontrolled settings. Personnel must be trained in aseptic technique.

The Role of Other USP Chapters

Activities excluded from USP <797> are often regulated by other USP chapters. Non-sterile compounding is under USP <795>, while handling hazardous drugs is primarily addressed in USP <800>. Understanding these chapters is crucial for comprehensive compliance.

Conclusion

USP Chapter <797> provides vital standards for preparing CSPs, but it doesn't cover all pharmaceutical activities. Recognizing what does USP Chapter 797 standards do not apply to—such as medication administration, preparations following manufacturer instructions, and non-sterile compounding—is essential for correct application of regulations and ensuring patient safety. Consulting other relevant chapters like <795> and <800> is also important. More information can be found on {Link: AANA https://www.aana.com/practice/clinical-practice/clinical-practice-resources/usp-general-chapter/}.

Frequently Asked Questions

The main purpose of USP Chapter <797> is to set standards for preparing compounded sterile preparations (CSPs) to prevent harm to patients from contamination.

No, if the reconstitution follows the manufacturer's approved labeling for a single dose and immediate use, it's exempt.

The act of administering an injection is not subject to USP <797>; the standards apply to the preparation of sterile drugs.

USP <797> regulates sterile compounded products, while USP <795> covers non-sterile compounded preparations.

For an immediate-use preparation to be exempt, it must be administered within four hours, involve no more than three sterile products, and personnel must be trained in aseptic technique.

Yes, withdrawing a dose from a commercially manufactured sterile product for immediate administration is considered administration and is outside the scope of USP <797>.

The USP itself doesn't enforce standards; compliance is enforced by regulatory bodies like the FDA and state pharmacy boards.