N.J. Admin. Code § 13:39-5.11

Current through Register Vol. 56, No. 23, December 2, 2024

Section 13:39-5.11 - Control and monitoring of temperature of prescription drugs and chemicals

(a) All prescription drugs and chemicals shall be stored, filled, dispensed, transported, and/or delivered to the patient, agent of the patient, or facility or healthcare provider providing care to the patient to assure and maintain the integrity and stability of the prescription drug or chemical at temperatures as specified by the drug manufacturer. If the drug manufacturer has not specified the appropriate temperature, the prescription drug or chemical shall be maintained at a temperature maintained thermostatically between 20 and 25 degrees Celsius (68 and 77 degrees Fahrenheit).

1. A pharmacy shall monitor and record the temperature of the pharmacy permitted area and refrigerator and, if applicable, freezer, no less than twice daily with an interval of at least eight hours.

i. Appropriate manual, electromechanical, or electronic temperature recording equipment and/or logs shall be utilized to document proper storage of prescription drugs and chemicals.

ii. A pharmacy shall maintain documentation of the recorded temperatures for two years.

iii. A pharmacy shall calibrate thermometers or temperature monitoring devices at predetermined intervals according to the manufacturer specifications.

2. A pharmacy that delivers a filled prescription drug or chemical to the patient, agent of the patient, or facility or healthcare provider providing care to the patient by any method, except when picked up directly from the pharmacy by the patient or his or her authorized agent, shall, in the professional judgment of the pharmacist, and in accordance with the pharmacy's policies and procedures as set forth in (d) below, use adequate methods to ensure temperature controlled conditions are maintained during facility storage, transportation, and delivery.

i. To ensure that temperature control is maintained during delivery, the shipping processes may include the use of appropriate packaging material or devices according to information provided by the manufacturer, Chapter 1079 of USP, other learned treatises, or expert qualification analysis.

ii. When packaging material or devices are used to maintain temperature control during delivery, the contents of the package shall include instructions to the recipient how to easily detect improper storage or temperature variation, and instructions how to report the storage or temperature excursion to the pharmacy.

(b) The temperature in a refrigerator and, if applicable, freezer that are used to store prescription drugs or chemicals must be maintained according to USP standards and guidelines.

(c) The pharmacist-in-charge is responsible for ensuring proper temperature controls for all prescription drugs and chemicals in the pharmacy permitted area and all prescription drugs and chemicals that are shipped, mailed, distributed, or otherwise delivered from the pharmacy.

(d) The pharmacist-in-charge shall develop and maintain written policies and procedures to ensure the proper storage in the pharmacy permitted area of all prescription drugs and chemicals, and the proper storage when prescription drugs or chemicals are delivered from the pharmacy to the patient, agent of the patient, or facility or healthcare provider providing care. The written policies and procedures shall include, at a minimum, the following:

1. Monitoring and recording the temperature of the pharmacy permitted area and refrigerator and, if applicable, freezer consistent with the requirements of this section;

2. Maintaining documentation of the recorded temperatures consistent with the requirements of this section;

3. Actions to be taken in the event of temperature excursions include, but are not limited to: notification of appropriate personnel, investigation of all temperature excursions, inspection and disposal, as applicable, of the stock in question, and corrective actions;

i. For purposes of this paragraph, a "temperature excursion" means any deviation from the manufacturer's specifications or, in the absence of manufacturer specifications, applicable USP standards.

4. Calibrating thermometers or temperature monitoring devices consistent with the requirements of this section;

5. Actions to be taken in the event that the prescription drugs and chemicals do not arrive at their destination in a timely manner or when there is evidence that the integrity of a drug was compromised during shipment or delivery; and

6. Training of all personnel who handle, or are responsible for overseeing the handling of, prescription drugs and chemicals to ensure the appropriate storage and delivery of all prescription drugs and chemicals, including refrigerated and frozen pharmaceuticals.

(e) In the event of a temperature excursion, as defined in (d)3i above, at a permitted pharmacy practice site lasting 24 hours or more, the pharmacist-in-charge shall immediately notify the Board. Notification shall be made in a manner such that notice is received by the Board within 48 hours of becoming aware of the temperature excursion.

(f) In the event of a temperature excursion, as defined in (d)3i above, lasting 72 hours or more, a pharmacist shall not dispense any prescription drug or chemical unless the pharmacist verifies with the manufacturer of the prescription drug or chemical that as a result of the temperature excursion, the drug or chemical has not been adulterated, is safe and efficacious, and its stability has not been adversely affected.

N.J. Admin. Code § 13:39-5.11

Adopted by 49 N.J.R. 451(a), effective 3/6/2017