Can a dosage that differs from the prescribed dosage by more than 20% or is outside of the prescribed dosage range be used for medical purposes?
Yes. Under § 35.63, that applies to all dosages of unsealed byproduct material for medical use, an authorized user (AU) may prescribe a dosage or a dosage range. The permitted variation for an administered dose from a prescribed dose is ±20%. Refer to “Supplementary Information,” Section III, “Summary of Public Comments and Responses to Comments” for 10 CFR § 35.63, as published in the Federal Register on April 24, 2002. b) Yes. A dosage that differs from the prescribed dosage by more than 20% or is outside of the prescribed dosage range can be used for medical purposes if the AU so directs. This effectively means that before administration of the dosage, the AU modifies the prescription from one prescribed dosage or dosage range to a revised prescribed dosage or a revised prescribed dosage range that encompasses the dosage to be administered. Refer to “Supplementary Information,” Section III, “Summary of Public Comments and Responses to Comments” for 10 CFR § 35.63, as published in th
