From: Philip Wanek [pwanek@worldnet.att.net]
Sent: Wednesday, June 05, 2002 2:02 AM
To: fdadockets@oc.fda.gov
Cc: PWanek@easternisotopes.com
Subject: Draft Guidance and Proposed Rule

Dear Sir or Madam,

In regard to document number 99N-4063,CDER 199917 (Proposed Rule) and
document number 98D-0266, CDER 20018 (Draft Guidance), I would like the
following questions/concerns to be considered.

1.  With respect to sterility testing of PET pharmaceuticals, will the
current USP sample volume recommendations be endorsed?

2.  There is an apparent inconsistency between the USP monograph for F-18FDG
sterility requirement and the proposed rule.  The proposed rule appears to
require sterility testing of the product (a bulk solution to be further
diluted per pharmaceutical or medical practice) following the manufacturing
process, while the USP requires sterility testing of the injection itself
(the diluted product intended for patient administration).  This appears to
be a duplication of test requirements.   At what point will should the
sterility sample be taken?

Thank you.

Philip M. Wanek, R. Ph.