Pharmacy OneSource Blog

Observations in the Proposed USP 797 Revisions

There are several trends in the revisions of USP 797 that can be highlighted based on recent progress. Open comments on the chapter closed on January 31, 2016, and the expert committee is now reviewing all of the feedback.1

Aggregated Risk Levels

Previously, compounding sterile preparations (CSPs) were assigned low, medium and high-risk. Changes to USP 797 will now place CSP levels under the either Category 1 or Category 2 risk levels.

Category 1 CSPs will have shorter maximum beyond use dates (BUDs). CSPs in Category 2 will have longer maximum BUDs, but will be subject to several additional factors, including sterility considerations.

Beyond-Use Dating for Categories 1 and 2

The proposed storage conditions and BUDs for Category 1 CSPs are as follows:

  • 12 hours at room temperature
  •  24 hours in refrigeration

The proposed storage conditions and BUDs for Category 2 CSPs are as follows:

  • Room temperature: 4 days (non-sterile to sterile), 6 days (sterile to sterile), 28 days (sterility tested)
  • Refrigerated: 7 days (non-sterile to sterile), 9 days (sterile to sterile), 42 days (sterility tested)
  • Frozen: 45 days

Under the proposed changes, release sterility testing would gain an extra eight days for room temperature and 21 days for refrigerated CSPs. BUDs for terminally sterilized CSPs is limited to 45 days.

In-Use Time

The terminology, “in-use time,” is defined as the time before a manufactured sterile product must be used once it’s been opened or punctured. USP specifies that the expiration date is the time during which a conventionally manufactured drug is expected to maintain its “labeled identity, strength, quality and purity,” assuming it’s maintained in the proper storage conditions.

Reference to USP Chapter 800

The new revised edition ofUSP 797 would remove specific information pertaining to the handling of hazardous drugs. Instead, references would be made to the recently published Chapter 800: Hazardous Drugs – Handling in Healthcare Settings.

USP 800 describes the standards for the handling and administration of hazardous drugs with patient safety, worker safety and environmental protection taken into consideration. This chapter applies to all healthcare personnel who handle hazardous drugs or those who may be exposed to them.

USP Chapter 800 addresses a wide range of topics, including personnel training, labeling, packaging, environmental quality and control, and types of exposure.2

Maintaining Written Documentation

Under proposed USP 797, all facilities where CSPs are prepared would need to maintain written documentation that shows its compliance with the chapter. It will need to include Master Formulation Records (when used), compounding records, SOPs, laboratory and equipment records, prescriptions and medications orders, and all complaints.

The USP states that records may be kept electronically, but they would need to be updated regularly. Recordkeeping will also need to be compliant with federal laws and regulations.


1. Standards for Compounding Sterile Preparations to Go Under Major Revision. Published September 28, 2015:

2. Hazardous Drugs – Handling in Healthcare Settings. Published October 13, 2014:

Sterile compounding. Download the guide.

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