Under 35.63, does changing the needle of a unit dosage or introducing a 3-way stopcock constitute a manipulation of the unit dosage?
If a unit dosage is changed or manipulated in any way, it is no longer considered to be a unit dosage and will need to be reassayed before it is administered. However, if changing the needle of a unit dosage or introducing a 3-way stopcock does not result in modification of the supplied volume of the unit dosage or adversely impact the homogeneous distribution of the byproduct material throughout the volume of the unit dosage, then such action is not a change or manipulation of the unit dosage. Refer to Supplementary Information, Section III, Summary of Public Comments and Responses to Comments for 35.63, as published in the Federal Register on April 24, 2002.
