FAQ
What are the new changes in USP 797 for 2008?
The United States Pharmacopeial Convention (USP) recently published an update to Chapter 797 Pharmaceutical compounding-sterile preparations. There are a number of changes in the updated chapter that will become effective June 1, 2008. A summary of the major changes is provided below. For a complete copy of the chapter, go to http://www.usp.org/USPNF/pf/generalChapter797.html.
The introduction clarifies that this chapter applies to any compounded sterile product (CSP) administered through application, inhalation, injection, implantation, installation, or irrigation. The initial 797 guideline did not clearly allow for the use of alternative technologies. The revision now states that any alternative technology not described that has been shown to be equal to, or superior to the guidelines listed in the chapter are acceptable. There is now a comprehensive list of definitions that was developed since some terms used in the chapter may be unfamiliar to pharmacists.
Risk Categories
There are 5 revised risk categories of CSPs:
- Immediate use
- Low risk
- Low risk with12 hours or less beyond use date (BUD)
- Medium risk
- High risk
The immediate use CSPs are exempt from 797 requirements. Immediate use is defined as a product that is compounded from < 3 non-hazardous sterile drugs, and administration is started within 1 hour of compounding. Generally this would include products prepared in the emergency department, in a code, or at the patient bedside.
Low risk with 12 hour BUD is a new category. This category is for those products that are low risk and will be administered within 12 hours of compounding. As with immediate use CSPs, this category excludes any hazardous drug (e.g. chemotherapy). This category of CSPs must be prepared in a segregated compounding area that is away from high traffic areas and includes a device that provides an ISO Class 5 air environment.
Hazardous Drugs
The section on hazardous drugs has been revised so that the agents are the same as those listed in the NIOSH guidelines (www.niosh.gov). When compounding hazardous drugs, a biologic safety cabinet (BSC) or compounding aseptic containment isolator (CACI) must be used. All hazardous drugs must be stored and prepared in a negative pressure ISO 7 with an ISO 7 ante area.
Individuals compounding hazardous drugs must use personnel protection as outlined in the chapter and must dispose of any hazardous drugs in accordance with state and federal regulations. A closed system transfer device must be used within the BSC or CACI.
Single and Multiple Use Vials
There is new information describing the use of single and multiple dose vials. Any single dose vial that is opened in an ISO 5 environment may be used for up to 6 hours. If a single dose vial is opened in worse than ISO 5 environment, it must be used within 1 hour or discarded.
Multiple dose vials with preservatives may be used with a BUD of 28 days unless otherwise recommended by the manufacturer.
Radiopharmaceuticals
All radiopharmaceuticals that require additional manipulation must be done in an ISO 5 containment device in an ISO 8 or cleaner environment. Radiopharmaceuticals are low risk if < 100 mL for a single dose or ≤ 30 mL of multiple dose.
Allergen Extracts
This is a new section in the revised chapter. All unpreserved allergen extracts must comply with USP 797. Allergen extracts with preservatives are exempt if:
- compounded by simple aseptic transfer
- properly labeled with patient name and BUD
- direct contact contamination is avoided
In addition, compounding personnel must perform hand washing using alcohol-based hand scrub and wear sterile gloves, gown, face mask and hair covering. The allergen vial stoppers and ampule necks should be disinfected with 70% isopropyl alcohol.
Environmental Cleaning and Sampling
The revised chapter specifies the minimum frequency of cleaning and disinfecting the clean room.
| Site | Minimum frequency |
| Laminar air flow hood, biologic safety cabinet, compounding aseptic isolator, compounding aseptic containment isolator | Start of each shift, start of each batch, at least every 30 minutes and after spills or when surface is contaminated |
| Counters and work surfaces | Daily |
| Floors | Daily |
| Walls, ceilings, and storage shelves | Monthly |
A new addition to environmental sampling is glove fingertip monitoring for all individuals who are compounding CSPs. Individuals must successfully complete 3 separate sampling periods prior to compounding any CSPs. Additionally, all employees must complete glovetip sampling annually for any low or medium risk CSPs and semi-annually for high risk CSPs. If individual samples demonstrate microbial contamination as outlined in the chapter, an investigation and re-evaluation of procedures shall be conducted.
Microbiological Beyond-Use Dating
Some changes have been made in the beyond-use dating of CSPs.
| Risk Category | Room Temp | Refrigerator | Freezer |
| Immediate use | 1 hour | 1 hour | N/A |
| Low risk | 48 hours | 14 days | 45 days |
| Low risk with 12 hour BUD | 12 hours or less | 12 hours or less | N/A |
| Medium risk | 30 hours | 9 days | 45 days |
| High risk | 24 hours | 3 days | 45 days |
Additional Changes
The revised chapter has outlined in Appendix I the principal competencies, practices, and quality assurance measures that are required versus those that are only recommended. The appendix is designed to help practitioners identify all necessary requirements for each section of the chapter. Please consult the full document for complete information.
Reference
U.S. Pharmacopeia. General chapter <797> pharmaceutical compounding – sterile preparations is revised and finalized. Available at: http://www.usp.org/USPNF/pf/generalChapter797.html. Accessed January 31, 2008.