N.J. Admin. Code § 13:39-12.4

Current through Register Vol. 56, No. 11, June 3, 2024

Section 13:39-12.4 - Minimum requirements for space, equipment, supplies, and library

(a) Each nuclear pharmacy must meet the following requirements for space:

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.

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

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.

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

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.

N.J. Admin. Code § 13:39-12.4

Amended by R.1999 d.214, effective 7/19/1999.
See: 31 New Jersey Register 1151(a), 31 New Jersey Register 1932(a).
In (c), rewrote the introductory paragraph and 1.