REVISED NUCLEAR REGULATORY COMMISSION REGULATIONS FOR RELEASE OF PATIENTS ADMINISTERED RADIOACTIVE MATERIALS - OUTPATIENT I-131 ANTI-B1 THERAPY

The Nuclear Regulatory Commission regulations for the release of patie nts administered radioactive material have been revised to include dos e-based or activity-based criteria. Methods: The revised 10 CFR 35.75 regulations and the formula that can be used to determine when an indi vidual patient administered radioactivity is releasable are reviewed. The implications of these new regulations on patient release after I-1 31 anti-B1 therapy for the treatment of non-Hodgkin's lymphoma are als o discussed. Results: A licensee may now release patients if the total effective dose equivalent to another individual from exposure to a re leased patient is <500 mrem, Compliance with this dose limit is demons trated by licensees either by using a default table for activity or do se rate provided in Regulatory Guide 8.39 or by performing a patient-s pecific dose calculation. Licensees may also demonstrate compliance by basing patient release on the patient-specific measured dose rate at 1 m instead of administered activity. Data on more than 50 patients re ceiving I-131 anti-B1 therapy, an investigational therapy for non-Hodg kin's lymphoma, indicate that all patients would have been releasable under the new regulations. Conclusion: The new regulations will permit I-131 anti-B1 therapy to be conducted on an outpatient basis.