Proposed Changes to USP Chapter <797>

April 2011 - Vol. 8 No. 4 - Page #10

Soon after USP Chapter <797> became official on June 1, 2008, members of the USP Expert Committee on Sterile Compounding (SCC) announced  there would likely be no further changes. However, as USP documents are continually evolving throughout the rigorous review process, the SCC recently proposed a few adjustments to the official standard. These changes appeared in issue 36(3) of Pharmacopeial Forum (PF); the proposed new revisions will be published in a future issue of PF. The USP will accept feedback from concerned parties for 90 days after revisions have been published.

Proposed New Definitions
Two new definitions are being considered—aseptic technique and line of demarcation. Aseptic technique is defined as: “Specific personnel practices, beginning with proper hand hygiene, which prevent the introduction of pathogenic microorganisms when preparing compounded sterile preparations.” This general definition does not explain how to perform aseptic technique but does distinguish aseptic technique from the broader scope of <797> itself.

Line of demarcation is defined as “A visible line on the floor that separates the room into areas for different purposes. For example, in the ante-area, the line separates the cleaner area from the clean area of the room. When the line of demarcation separates two different ISO classification areas, it must be accompanied by a minimum air velocity of 40 fpm from the cleaner area to the less clean area.” This definition implies that the line of demarcation is used in two different ways—in a closed cleanroom configuration (ie, physically separate ante-room and buffer room), and in an open configuration. In the first, the line of demarcation is often used to mark the line at which sterile garb must be put on. Street clothes are placed in lockers on the less clean side of the line and only sterile garb is worn on the clean side of the line. The line also shows where dirty carts must stop and where supplies must be moved to clean carts or clean shelving in the clean side of the ante-room. In the open cleanroom floor plan, the line of demarcation shows where the ante-area ends and the buffer area begins; street clothes and sterile garb may be worn on the ante-area side of this line of demarcation, but dirty carts are not allowed in the buffer area. 

Proposed Additions to the Chapter Body: Immediate-Use CSPs
The first proposed change in the body of <797> appears in the Immediate Use section. A new requirement has been proposed for addition preceeding the original requirements (see Original Requirements for Immediate-Use CSPs above) to compound a sterile preparation for immediate use (ie, administration starting within one hour after start of the preparation).

The proposed requirement states: “Before preparing Immediate-Use CSPs, compounding personnel shall apply a waterless alcohol-based hand sanitizer rub with a minimum of 60% ethanol to all surfaces of the hands, and allow to dry. Thereafter, compounding personnel shall avoid direct contact contamination (eg, from nonsterile objects, and secretions and particles shed from personnel) with sterile components of these CSPs.” This requirement is simple, but should not be taken for granted, especially in areas where sterile preparations for immediate use may be compounded.

Hazardous Drugs as CSPs
The proposed change in this section reads: “The BSC and CACI optimally should be vented to the outside air through HEPA filtration.” Currently, <797> states that biological safety cabinets (BSCs) and compounding aseptic containment isolators (CACIs) optimally should be 100% vented to the outside. Eliminating the 100% requirement would effectively allow primary engineering controls, such as BSCs and CACIs, to be only partially vented to the outside. In other words, less than 100% of the exhaust from a chemotherapy hood may be vented to the outside; part of the exhaust can be recirculated within the primary engineering control itself. The 100% exhaust requirement means that only the Class II Type B2 BSC or a CACI is acceptable for compounding hazardous drugs. This change would allow for the use of either a Class II Type A2 or Class II Types B1 or B2. 

Radiopharmaceuticals as CSPs
According to the proposed revision in this section: “If such diagnostic radiopharmaceuticals are administered within one hour of the start of compounding, they may be compounded under the ‘Immediate-Use CSPs’ provisions, if the following provisions are met:

  • The septum of the preparation vial may be entered more than two times if it is treated as a single-dose container intended for a single patient administration.
  • The preparation procedure must be completed, and start of patient administration begun not later than 1 hour following the start of preparation of the CSP, as indicated by manufacturers’ approved labeling (package insert) instructions.
  • The preparation procedure is conducted using strict aseptic technique, which includes proper hand hygiene. Proper hand hygiene consists of applying a waterless alcohol-based hand sanitizer rub with a minimum of 60% ethanol to all surfaces of the hands, and then allowing to dry. Thereafter, compounding personnel shall avoid direct contact contamination (eg, from nonsterile objects, and secretions and particles shed from personnel) with sterile components of these CSPs.
  • The preparation procedure is conducted in accordance with OSHA regulations.”
  • The purpose of this change is to allow nuclear pharmacists, technicians, and physicians to draw up radiopharmaceutical doses in a nonclassified environment—ie, no need for an ISO class 8 clean room—as long as the administration of any such dose is begun within an hour of the start of preparation. This can be an advantage in a hot lab situation, where diagnostic radiopharmaceuticals are stored and drawn up by nuclear pharmacy technicians for immediate administration to patients.

Environmental Viable Airborne Particle Testing Program
The recommended change inother  this section reads: “A general microbiological growth medium such as Soybean-Casein Digest Medium shall be used to support the growth of bacteria. Malt extract agar or some other media medium that supports the growth of fungi shall be used in high-risk level all compounding environments.” In other words, air sampling for microbial colonies must be done at least every six months, using separate bacterial and fungal growth-supporting media. This should be the case regardless of the risk level of compounding being completed in the ante-area, buffer area, or segregated compounding area.

Finally, ISO has proposed revisions to its standard that is referred to by inclusion in USP Chapter <797> (ie, 14644-1 Cleanrooms and Associated Controlled Environments, Part 1: Classification of Air Cleanliness by Particle Concentration). This proposal mainly changes the number of air sampling locations required based on clean space floor area—a concern only if a pharmacy does its own nonviable air particulate sampling.

The proposed revisions to <797> have not yet been finalized and published; they will be printed in PF for comment, perhaps by summer 2011. The SCC is considering other proposed revisions in addition to those noted here. USP will solicit feedback on these proposals, and pharmacists are encouraged to help improve patient safety by commenting on the changes (

E. Clyde Buchanan, MS, RPh, FASHP, is a pharmacy consultant and a retired director of hospital pharmacy. He received his MS in hospital pharmacy and residency training programs from The Ohio State University.


Original Requirements for Immediate-Use CSPs

Immediate-use CSPs are exempt from the requirements described for low-risk level CSPs only when all of the following criteria are met:

  • Exempt from all requirements in <797>
  • Only simple aseptic measuring and transfer are needed
  • Not more than three drug packages and no hazardous drugs
  • No delays/interruptions
  • No contact contamination of ingredients or critical sites
  • Dose must be labeled if not administered by the preparer
  • Administration must begin within one hour after the start of preparation
  • Dose must be discarded if administration has not begun within one hour after the start of preparation (No storing. No recycling.)

Reproduced with permission from Eric S. Kastango, MBA, RPh, and Konrad Crabtree. Accessed March 1, 2011.


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