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Have you heard the old saying, “Speak now or forever hold your peace”? Well, for us, it is “Speak now or forever follow some of the ‘over-the-top’ regulations that are in USP 825.”
The United States Pharmacopeia (USP) has developed a new regulation for sterile preparation and compounding just for us. It is called USP<825>, and it is out for public comment RIGHT NOW!!!
USP<825> applies only to preparing and compounding radiopharmaceuticals, NOT cold drugs or adjunctive medications; for those medications, we still need to abide by USP<797> regulations. To make things even more complicated, the latest revision of USP<797> is also out now for public comment.
The USP<825> document is long and detailed, but it WILL IMPACT YOUR PRACTICE, so we are asking/begging all of you to PLEASE READ IT and SUBMIT COMMENTS AND CONCERNS TO THE USP BY November 30 so the USP 825 committee can address our concerns prior to enacting this regulation.
Leadership has reviewed the document and lists just a few areas of concern below:
If you fail any of the required testing, including media fill and gloved fingertip testing, then you CANNOT prepare any radiopharmaceuticals until you pass. It can take approximately 2 weeks to read the media fill and gloved fingertip testing media.
Personnel who have not performed radiopharmaceutical processing in more than 6 months must be re-qualified in all core competencies before resuming duties. If you have per diem personnel, this might be a problem.
Any time a pressure differential is required, a pressure monitoring device is required. Are you able to maintain negative pressure between your hot lab and unrestricted area or negative pressure between your department and the rest of your institution?
If you use a Generator, it must be eluted in an ISO Class 8 environment; not in regular room air.
Syringes that have been used in a patient care area must not be brought back into the classified room (e.g., buffer or ante-room) or SRPA for re-assaying or disposal. Do you have 2 dose calibrators in your department?
A record for preparation with minor deviation or compounding must include the name of vendor or manufacturer, lot numbers, and expiration dates of all ingredients and components. This includes saline.
Areas intended for non-sterile compounding must be separated from areas intended for sterile radiopharmaceuticals. This means that you cannot use your hot lab for sterile preparation or compounding other than immediate use.
As stated at the beginning of this email, these are only a few of the areas of concern. Please take time to review the document and provide your comments to the USP. To do this, select: http://www.usp.org/chemical-medicines/general-chapter-825.
The above text was derived from an Uptake article by Michele Panichi-Egberts, CNMT.
If you have any questions, please contact one of the following Technologist Advocacy Group leaders in your state:
Art Maune MEd, CNMT
University of Arkansas for Medical Sciences
Ph: (501) 686-6848 | firstname.lastname@example.org
Shannon Youngblood, MSRS, CNMT
State of Louisiana [L.R.T. (N)]
Ph: (225) 333-6027 | email@example.com
Alison T. Kleven, CNMT
Lovelace Medical Center
Ph: (505) 550-4284 | firstname.lastname@example.org
Mark Marshall, CNMT
Ph: (918) 724-5549 | email@example.com
Julie Lentz-Koehn, CNMT
Ph: (405) 456-4453/(405) 684-0484 | Julie.Lentz-Koehn@Va.gov
Vesper Grantham, MEd, CNMT, RT(N)
University of Oklahoma, Allied Health Building
Ph: (405) 271-6477 | firstname.lastname@example.org
Lucrecia Pantarotto, CNMT
North Texas Health Care System
Ph: (214) 208-4179/ (214) 857-0130 | email@example.com
Adam Fairbourn, CNMT
UTSW Medical Center
Ph: (214) 793-8816 | firstname.lastname@example.org
CALLING FOR VOLUNTEERS! To help with registration-related tasks just before and during our Chapter meeting in Arlington (March 22-24, 2019), please contact our executive director Charles Metzger. Email cmetzger(at)swc-snmmi.org or call 830.370.6554.