New Jersey Administrative Code
Title 8 - HEALTH
Chapter 21 - FOOD AND DRUGS
Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS
Section 8:21-3A.10 - Storage
Current through Register Vol. 56, No. 18, September 16, 2024
(a) All drugs shall be stored at appropriate temperature and conditions, in accordance with the requirements set forth in the labeling of such drugs or with the requirements of the current edition of an official compendium, such as the United States Pharmacopeia/National Formulary (USP/NF).
(b) If no storage requirements are established for a prescription drug, the drug may be held at controlled room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.
(c) Appropriate manual, electromechanical or electronic temperature and humidity recording equipment, devices and/or logs shall be utilized to document proper storage of drugs.
(d) For prescription drugs, a record must be maintained recording the date; time; thermometer temperature; and the initials of the person recording the data or reviewing the data if electronically monitored. This record and temperature reading must be recorded at least five days each week with the temperature readings taken between 1:00 P.M. and 5:00 P.M. E.S.T. Alternate times may be approved by the Department in writing. This record must be kept on file by the facility for at least two years.
