N.J. Admin. Code § 13:39-11.19

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

Section 13:39-11.19 - Stability and sterility criteria and beyond-use dating

(a) For purposes of this section, stability means the extent to which a preparation retains, within specified limits and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding.

(b) In the absence of supporting valid scientific sterility testing and stability information that is directly applicable to specific preparations, the following dates and times for storage and initiation of administration of the compounded sterile preparations shall apply, according to the assigned risk level of the preparation, unless the manufacturer's package indicates a different stability time:

1. For low-risk level compounded sterile preparations, in the absence of passing a sterility test:

i. Administration shall begin within 48 hours when the preparation is stored at controlled room temperature (20 degrees Celsius to 25 degrees Celsius);

ii. Administration shall begin within 14 days when the preparation is stored at cold temperatures (two degrees Celsius to eight degrees Celsius);

iii. Administration shall begin within 45 days when the preparation is stored in a solid frozen state (-20 degrees Celsius); and

iv. For products prepared in an airflow workbench not located in a buffer area in accordance with 13:39-11.10, administration shall begin within 12 hours or less of preparation;

2. For medium-risk level compounded sterile preparations, in the absence of passing a sterility test:

i. Administration shall begin within 30 hours when the preparation is stored at controlled room temperature (20 degrees Celsius to 25 degrees Celsius);

ii. Administration shall begin within nine days when the preparation is stored at cold temperatures (two degrees Celsius to eight degrees Celsius); and

iii. Administration shall begin within 45 days when the preparation is stored in a solid frozen state (-20 degrees Celsius);

3. For high-risk level compounded sterile preparations, in the absence of passing a sterility test:

i. Administration shall begin within 24 hours when the preparation is stored at controlled room temperature (20 degrees Celsius to 25 degrees Celsius);

ii. Administration shall begin within three days when the preparation is stored at cold temperatures (two degrees Celsius to eight degrees Celsius); and

iii. Administration shall begin within 45 days when the preparation is stored in a solid frozen state (-20 degrees Celsius); and

4. For immediate use compounded sterile preparations, administration shall begin no less than one hour following the start of preparing the compounded sterile preparation.

(c) The administration dates and times established in (b) above shall not be exceeded or extended for compounded sterile preparations without verifiable supporting valid scientific sterility and stability information that is directly applicable to the specific preparation or compound.

(d) A pharmacist shall determine the beyond-use date for a compounded sterile preparation consistent with (b) above and assign an appropriate discard-after date for the compounded sterile preparation. The discard-after date shall appear on the label consistent with the requirements of 13:39-11.21.

(e) Opened or needle-punctured single-dose containers of sterile products (for example, bags, bottles, syringes, and vials) used in the compounding of sterile preparations for immediate use in an institutional pharmacy pursuant to 13:39-11.11, shall be used within one hour if opened in worse than ISO Class 5 air quality, and any remaining contents shall be discarded.

(f) Single-dose vials used in the compounding of sterile preparations exposed to ISO Class 5 or cleaner air quality may be used up to six hours after initial puncture.

(g) Opened single-dose ampules used in the compounding of sterile preparations shall not be stored for any period of time.

(h) Opened or needle-punctured multiple-dose vials used in the compounding of sterile preparations shall be used within 28 days after initially entering the vial, unless otherwise specified by the manufacturer.

N.J. Admin. Code § 13:39-11.19

Amended by 49 N.J.R. 3761(a), effective 12/4/2017