EXAM 3 Rules of the Board 1140-06

Question 1

Who makes the rules in Nuclear Pharmacy in TN?

Answer 1

Nuclear Regulatory Commission (federal) (or state equivalent)

in TN: Division of Radiological Health

-also need to apply to the rules of the Department of Transportation (since radioactive material is transported from the pharmacy hospitals)

Question 2

Who regulates PET drugs?

Answer 2

FDA

Question 3

General Requirements

Answer 3

-Adequate space
-Separate radioactive from non
-Adequate storage and decay areas (radioactive material needs to decay)
-Allowed to transfer to authorized persons not intended for drug use (e.g., disposal)
-allowed to “furnish” for office use

Question 4

What needs to be on the label of radioactive drugs?

!!! ***

Answer 4

-in addition to the requirements of non-radioactive drugs
-labeled on the immediate outer container

-Standard radiation symbol
-“Caution – Radioactive Material”
-Radionuclide
-Chemical Form
-Amount of radioactive material, in millicuries or microcuries
-Volume, if liquid
-Calibration time (the time when the drug was calibrated)
-Expiration time (usual short half-lives)
-Pharmacy name, address, telephone number

Question 5

What should be on the label of the immediate container of a radioactive drug?

!!! ***

Answer 5

-the immediate container may be the syringe that is kept in the lead shield

-Standard radiation symbol
-“Caution – Radioactive Material”
-Drug name
-Rx order number

Question 6

Other General Requirements in Nuclear Pharmacy

Answer 6

-Proper” record-keeping requirements
-Sterility testing required

-Cradle to grave tracking: track the time of arrival to the pharmacy -> made radioactive -> no longer radioactive

Question 7

What reference library should be available in the Nuclear Pharmacy?

Answer 7

-Adequate reference library (may be specific to Nuclear pharmacy)
-Tennessee Pharmacy Laws current edition

Question 8

What equipment is required in a nuclear pharmacy?

Answer 8

-Vertical laminar flow hood
-Dose calibrator
-Refrigerator
-Room Monitor
-Portable survey monitor (measures radioactivity in the room)
-Scintillation counter (measures radioactivity)
-Microscope
-Other BRH required equipment

Question 9

Where to find NRC regulations

FYI

Answer 9

10 CFR part 20

TN is an agreement state: they agree to abide by the Nuclear Radiology Commission through the Board of Radiological Health