Lecture 6

Question 1

traditional NP

Answer 1

low energy or SPECT practice
primarily deals with gamma emitting diagnostic isotopes and alpha/beta therapy
preparation and dispensing functions
majority are Tc-99m based
may dispense high energy PET drugs but only after FDA approval

Question 2

PET manufacturing

Answer 2

not considered practice of pharmacy
cyclotron production of position emitting isotopes, followed by synthesis into a final radiolabeled compound
for manufacturing only; final products are dispensed to pharmacies

Question 3

PET dispensing

Answer 3

some PET manufacturing facilities also are directly associated with a dispensing nuclear pharmacy
two facilities are not under the same license

Question 4

RP manufacturing

Answer 4

commercial production of RP
longer half-life products

Question 5

FDA approval process

Answer 5

laboratory development
investigational new drug (IND) application
clinical trials
new drug application

Question 6

NRC regulatory areas

Answer 6

licensing
training requirements
proper use and calibration of instruments
ALARA program
bioassay
shipment and receipt of material
labeling of radioactive material
recordkeeping
contamination control

Question 7

agreement state

Answer 7

part of the atomic energy act of 1954 and following amendments
NRC relinquish part of its regulatory authority to state regulatory bodies
must have adequate regulatory framework in place to uphold and enforce NRC requirements

Question 8

Part 20

Answer 8

standards for protection against radiation
general radiation safety chapter with most of the basic radiation safety requirements found here

Question 9

ICRP

Answer 9

international commission for radiation protection
standards that are used internationally which are in many cases more stringent than what is used in the United States