Nuclear Pharmacy

Question 1

“Authentication of product history” includes, but is not limited to:

Answer 1

identifying the purchase source, the ultimate use or disposition and any intermediate handling of any components of a radiopharmaceutical.

Question 2

“Authorized practitioner” means:

Answer 2

a practitioner duly authorized by applicable Federal and State law to possess, use and administer radiopharmaceuticals.

Question 3

“Designated agent” means:

Answer 3

an individual under the direct supervision of a practitioner authorized to communicate the practitioner’s instructions to the nuclear pharmacy.

Question 4

“Immediate personal supervision” means:

Answer 4

pharmacist is physically present in the compounding/dispensing area when interns, externs and pharmacy technicians are performing
delegated duties, and the pharmacist conducts any necessary in-process checks and the final check-in preparation and compounding of medications, including the checking of each ingredient used, the quantity of each ingredient whether weighed, measured or counted, and the finished label.

Question 5

“Internal test assessment” includes, but is not limited to:

Answer 5

conducting those tests necessary to insure the integrity of the test.

Question 6

“Immediate personal supervision” means:

Answer 6

that the pharmacist is physically present in the compounding/dispensing area when interns, externs and pharmacy technicians are performing
delegated duties, and the pharmacist conducts any necessary in-process checks and the final
check in preparation and compounding of medications, including the checking of each ingredient
used, the quantity of each ingredient whether weighed, measured or counted, and the finished label

Question 7

“Internal test assessment” includes, but is not limited to:

Answer 7

conducting those tests necessary to insure the integrity of the test.

Question 8

“Radiopharmaceutical” means

Answer 8

any substance defined as a drug in Section 201(g)(1) of the Federal Food, Drug and Cosmetic Act or in the FDA’s Nuclear Pharmacy Guidelines and which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any such drug which is intended to be made radioactive.

Question 9

Radiopharmaceutical quality assurance” includes, but is not limited to:

Answer 9

the performance of appropriate chemical, biological and physical tests on radiopharmaceuticals and the
interpretation of the resulting data to determine their suitability for use in humans and animals,
including internal test assessment, authentication of product history and the keeping of proper
records.

Question 10

“Radiopharmaceutical service” includes, but is not limited to:

Answer 10

the compounding, dispensing, labeling and delivery of radiopharmaceuticals; the participation in radiopharmaceutical utilization reviews; the proper and safe storage and distribution of radiopharmaceuticals; the maintenance
of radiopharmaceutical quality assurance; and the offering of those acts, services, operations or
transactions necessary in the conduct, operation, management and control of a nuclear pharmacy.

Question 11

The application for a specialized retail permit to operate a pharmacy providing radiopharmaceutical services shall only be issued to:

Answer 11

a site employing a qualified nuclear

pharmacist.

Question 12

All personnel performing tasks in the preparing and distribution of drugs shall be:

Answer 12

under the immediate personal supervision of the nuclear pharmacist who shall be responsible for all nuclear operations of the licensed area and shall be in personal attendance at all times when the nuclear pharmacy is open for business. Nuclear pharmacies shall maintain an audit trail that records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s) or
extern(s) performing the radiopharmaceutical services, which are required to be performed by a pharmacist, pharmacy technician, intern or extern pursuant to the
requirements of this chapter. The collection of demographic information for the patient
profile as provided for in N.J.A.C. 13:39-6.15(a)2i is not required to be, but may be, recorded in the audit trail.

Question 13

Nuclear pharmacies shall have:

Answer 13

adequate space, commensurate with the scope of
services required and provided, meeting minimal United States Nuclear Regulatory Commission or its successor’s requirements and the requirements established by the State of NJ Bureau of Radiation Protection.

Question 14

The nuclear pharmacy shall be separate from the pharmacy areas for non-radioactive drugs and shall be:

Answer 14

inaccessible to all unauthorized personnel.

Question 15

All pharmacies handling radiopharmaceuticals shall be:

Answer 15

provided with a radioactive storage and decay area. A nuclear pharmacy dispensing radioactive drugs may be exempted from the general space requirements for pharmacies.

Question 16

The process used for handling radioactive materials by any license holder must involve:

Answer 16

appropriate procedures for the purchase, receipt, storage, manipulation, compounding, distribution, and disposal of radioactive materials

Question 17

In order to ensure the public health,

safety, and welfare, a nuclear pharmacy shall first meet the following general requirements:

Answer 17

1) The environment where the handling of radioactive materials takes place shall be
properly ventilated so that radioactive materials cannot be airborne from that
environment to other non-occupationally unrestricted areas;
2) The environment shall be properly located so that the receipt and dispersal of radioactive materials does not result in inadvertent and undesired contamination of other non-occupationally labeled areas;
3) The area shall be designed in such a manner that radioactive materials can be contained in given areas to ensure adequate safety and protection to personnel
working in or near them and to insure proper operation of the corresponding assay
equipment; and
4) Those engaged in the compounding of radiopharmaceuticals for injection shall
comply with N.J.A.C. 13:39-11, 11A, and 11B, as applicable

Question 18

Nuclear pharmacies shall maintain:

Answer 18

records of acquisition and disposition of all

radioactive drugs in accordance with rules and regulations of the United States Nuclear Regulatory Commission

Question 19

The immediate outer container of a radioactive drug to be dispensed shall be labeled
with the following:

Answer 19

1) The standard radiation symbol;
2) The words, “CAUTION—RADIOACTIVE MATERIAL”;
3) The radionuclide;
4) The chemical form;
5) The amount of radioactive material contained in millicuries or microcuries;
6) If a liquid, the volume in milliliters;
7) The requested calibration time for the radioactivity contained;
8) The name, address, and telephone number of the nuclear pharmacy;
9) The prescription number; and
10) The date and patient’s name, if available.

Question 20

The immediate container shall be labeled with the following:

Answer 20

1) The standard radiation symbol;
2) The words, “CAUTION—RADIOACTIVE MATERIAL”;
3) The name of the radiopharmaceutical.
g) Nuclear pharmacies shall only dispense radiopharmaceuticals which comply with acceptable professional standards of radiopharmaceutical quality assurance.
h) A nuclear pharmacist may transfer to authorized persons and United States Nuclear Regulatory Commission licensed medical practitioners radioactive materials not intended for drug use, in accordance with the regulations of the United States Nuclear Regulatory
Commission or its successor. A nuclear pharmacy may furnish radiopharmaceuticals to these practitioners for patient use.
i) Nuclear pharmacies shall comply with all applicable laws and regulations of Federal and State agencies including those laws and regulations governing non-radioactive drugs. For nuclear pharmacies handling radiopharmaceuticals exclusively, the Board of
Pharmacy may waive rules pertaining to pharmacy permits for nonradiopharmaceuticals
which requirements do not pertain to the practice of nuclear pharmacy.
j) Radioactive drugs are to be dispensed only upon a non-refillable prescription order from
a United States Nuclear Regulatory Commission licensed medical practitioner (or the
designated agent) authorized to possess, use and administer radiopharmaceuticals.
k) Prescription orders for delivery of radioactive drugs for use in the medical practice of a United States Nuclear Regulatory Commission licensed medical practitioner may be placed on a telephone answering and recording device, only if the practitioner (or the
designated agent) is identified in such a manner that is clearly recognized by the nuclear pharmacist dispensing the radioactive drug.
l) A qualified nuclear pharmacist shall have the authority to delegate to any qualified and properly trained person or persons, acting under his or her immediate personal
supervision, any nuclear pharmacy act which a reasonable and prudent pharmacist would find is within the scope of sound pharmaceutical judgment to delegate. Such delegation may only occur if, in the professional opinion of the qualified nuclear
pharmacist, the act may be properly and safely performed by the person to whom the
pharmacy act is delegated. The delegated act may only be performed in its customary manner, not in violation of other statutes. The person to whom a nuclear pharmacy act is delegated shall not hold himself or herself out to the public as being authorized to
practice pharmacy.

Question 21

A qualified nuclear pharmacist shall meet the following requirements:

Answer 21

1) He or she is a pharmacist licensed to practice in the State of New Jersey; and
2) He or she meets minimal standards of training and experience in the handling of radioactive materials in accordance with the requirements of the United States
Nuclear Regulatory Commission or its successor and the State of New Jersey Bureau of Radiation Protection.

Question 22

Each nuclear pharmacy must meet the following requirements for space:

Answer 22

1) The area for the storage, compounding and dispensing of radioactive drugs shall be completely separate from pharmacy areas for non-radioactive drugs;
2) Hot lab and storage area shall be a minimum of 120 square feet; and
3) The compounding and dispensing area shall be a minimum of 300 square feet

Question 23

Each nuclear pharmacy shall be equipped with at least the following items of equipment:

Answer 23

1) Dose calibrator;
2) Refrigerator;
3) Drawing station;
4) Well scintillation counter;
5) Microscope;
6) Chromatographic apparatus or comparable means of effectively assuring tagging efficiency;
7) Radiation survey equipment of the appropriate type and calibration to detect quantities of radioactive materials as prescribed in the appropriate radioactive
material licenses; and
8) Other equipment deemed necessary for radiopharmaceutical quality control for products compounded or dispensed as may be determined by the United States Nuclear Regulatory Commission or its successor and the State of New Jersey Bureau
of Radiation Protection.

Question 24

Each nuclear pharmacy shall have on the premises the following, up-to-date reference
books:

Answer 24

1) An up-to-date, comprehensive pharmaceutical reference text(s) and suitable reference texts encompassing the general practice of pharmacy, drug interactions, drug product composition and patient counseling. Unabridged computerized versions
of these reference texts shall be acceptable;
2) State statutes and rules relating to pharmacy;
3) State and Federal regulations governing the use of applicable radioactive materials;
and
4) Text relating to the practice of nuclear pharmacy and radiation safety

Question 25

The holder of a nuclear pharmacy permit shall be:

Answer 25

responsible for the radioactive quality control of all drugs, including biologicals, dispensed or manufactured.

Question 26

Radioactive pharmaceutical quality controls include, but are not limited to:

Answer 26

the carrying out and interpretation of data resulting from chemical, biological and physical tests on potentially radioactive pharmaceuticals to determine the suitability for use in humans and other animals, including internal test assessment and authentication of product history