Q & A on usp 797: Immediate Use Exemption

Questions and Answers on USP 797

RJLG Question 3: I work in a Nuclear Medicine Department and we use unit dose for everything but emergency scans. We have changed our policy to receive multiple separate syringes with varying activities to produce several single dose kits. During preparation aseptic techniques will be followed. The kit will be used within an hour, for only one patient and no more than two entries into any one vial. My concern is preparing an Ultra tag kit for a G.I.Bleed. If we follow the manufacturer's preparation and use the correct personal protective equipment are we covered under the immediate use exemption?

RJLG Answer 3: The Immediate use provision is intended for those situations which call the immediate administration of a compounded sterile product. The important factor here is that these items can not be prepared and stored in advance for any anticipated needs. If the compounds you are referring to are considered hazardous all hazardous materials must be manipulated within a bio safety hood or glove box. If preparation is done outside of a BSC or similar device, to meet the requirements for immediate use, preparations must: 1. Follow Aseptic technique. 2. Be limited to simple manipulations admixing no more than 3 ingredients. 3. Not exceed more than 2 entries into any 1 vial 4. Begin to be administered within 1 hour of starting preparation. 5. If the administration of the compounded product will not be completed by the person who prepared it, the compounded product must be properly labeled with patient name, all ingredient names and strengths, the initials of the preparer and the exact beyond use date (BUD) and time. 6. Be properly and safely discarded if administration does not begin within 1 hour following the start of preparation. The procedure you have outlined appears to meet these requirements and can be considered immediate use.

Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.

Royston Browne, PharmD is currently the Manager of the oncology Pharmacy at Montefiore Medical Center in the Bronx New York. He has worked in this capacity for the past 11 years and has provided leadership in complying with USP 797 policies at this institution .
Royston Browne, BS PharmDManager, Oncology PharmacyMontefiore Medical CenterHoffheimer 100 - 111 East 210 StreetBronx, NY 10467Tel: (718) 920-5778Fax: (718) 515-9529Pager: (917) 898-1918E-Mail: RBrowne@Montefiore.org

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