Questions and Answers on USP 797: Answers Provided by Scott Sutton, Ph.D. Senior Director, Microbiology Services Vectech Pharmaceutical Consultants:

• SS6 Question: I have a question regarding oncology offices and the practice of mixing chemotherapeutic drugs for immediate use on patients.  According to the new June updates to 797 is this still an acceptable practice or do the offices need to mix chemo in barrier isolators or a clean room?
   
• SS6 Answer:   <797> provides for compounding immediate-use CSP when compounding exclusively with sterile ingredients and components and “…only for those situations where there is a need for emergency or immediate patient administration of a CSP. Such situations may include cardiopulmonary resuscitation, emergency room treatment, preparation of diagnostic agents, or critical therapy where the preparation of the CSP under conditions described for Low-Risk Level CSPs subjects the patient to additional risk due to delays in therapy.   Immediate-use CSPs are not intended for storage for anticipated needs or batch compounding. Preparations that are medium-risk level and high-risk level CSPs shall not be prepared as immediate-use CSPs.”
  
  If the chemo drugs are of such as nature as to be emergency care then it is covered.  If the medications are being mixed in an office environment without an overwhelming benefit to the patient, then it is probably not a good idea when weighed against the potential for contamination.  In this situation they should be mixed under Class 5 conditions or as a medium-risk CSP according to <797>.  (09/14/08) 

(Answer provided as a courtesty to usp797.org, inc. by Scott Sutton, Ph.D.
Senior Director, Microbiology Services Vectech Pharmaceutical Consultants.  Please note that usp797.org, inc. is not responsible for this answer.)

• About Scott V.W. Sutton: Scott V.W. Sutton received his Ph.D. (microbiology) from the University of Rochester.   Dr. Sutton  is a Senior Director for Microbiology Services at Vectech Pharmaceutical Consultants.
  He is also the owner/operator of the following:
   
  • The Microbiology Network (http://www.microbiol.org), the Internet information service for microbiologists. This service provides information, links, mail
    lists, and web pages for individuals and user's groups in microbiology.
  • The PMFList (http://microbiol.org/Z_OldFiles/pmflist.htm), an Email list devoted to pharmaceutical microbiology.
  • The PSDGList (http://microbiol.org/Z_OldFiles/psdglist.htm), an Email list devoted to pharmaceutical stability programs.

  Dr. Sutton can be reached as follows:

  Scott Sutton, Ph.D.
  Senior Director, Microbiology Services
  Vectech Pharmaceutical Consultants
  585-594-8273
  scott.sutton@microbiol.org