N.J. Admin. Code § 13:39-11.24

Current through Register Vol. 56, No. 24, December 18, 2024

Section 13:39-11.24 - Quality assurance program

(a) The pharmacy's quality assurance program shall require, at a minimum, that:

1. A reasonable effort shall be made by the pharmacist to assure that compounded sterile preparations shall be kept under appropriate controlled conditions at the location of use by providing adequate labeling and verbal or written instructions regarding proper storage and administration as set forth by the product manufacturer, with each compounded sterile preparation dispensed;

2. The quality assurance program encompasses all phases of sterile compounding for each unique type of compounded sterile preparation dispensed;

3. After the preparation of every admixture, the contents of the container are thoroughly mixed and then visually inspected to ensure the absence of particulate matter in solutions, the absence of leakage from vials and bags, or any other defects, and the accuracy and thoroughness of labeling;

4. All pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs involved in compounding sterile preparations shall have their aseptic technique tested consistent with the requirements of N.J.A.C. 13:39-11.16;

5. All high-risk level compounded sterile preparations that are prepared in groups of more than 25 identical individual single-dose packages (for example, ampules, bags, syringes, vials), or in multiple-dose vials for administration to multiple patients, or that are exposed longer than 12 hours at two degrees to eight degrees Celsius and longer than six hours at warmer than eight degrees Celsius before they are sterilized, and all compounded sterile preparations whose beyond-use date has been exceeded, shall be tested to ensure that they are sterile before they are dispensed or administered. The USP membrane filtration method shall be used where feasible. Another method may be used if verification results demonstrate that the alternative is at least as effective and reliable as the membrane filtration method or the USP direct inoculation of the culture medium method, consistent with the standards set forth in USP 797 concerning "Sterility Testing," 2012 edition, incorporated herein by reference, as amended and supplemented, and available for purchase at the United States Pharmacopeia website, http://www.usp.org.

i. When high-risk level compounded sterile preparations are dispensed before receiving the results of the sterility tests set forth in (a)5 above, the written quality assurance procedure shall require daily observation of the incubating test specimens and immediate recall of the dispensed compounded sterile preparations when there is any evidence of microbial growth in the test specimens. The patient and the physician of the patient to whom a potentially contaminated compounded sterile preparation was administered shall be notified immediately of the potential risk. Positive sterility tests shall require rapid and systematic investigation of aseptic technique, environmental control, and other sterility assurance controls in order to identify sources of contamination and to take corrective action.

ii. All high-risk level compounded sterile preparations, except those for inhalation and ophthalmic administration, shall be tested to ensure that they do not contain excessive bacterial endotoxins;

6. Air and surface sampling for microbial organisms in ISO class 5 primary engineering controls, such as laminar airflow workbenches, compounding aseptic isolators, compounding aseptic containment isolators, and biological safety cabinets, and in all other ISO classified areas shall be certified by an independent certification company once every six months and at any time when microbial contamination is suspected;

7. Pressure differential monitoring shall be conducted consistent with the requirements of N.J.A.C. 13:39-11.4(d). A pressure gauge or velocity meter shall be installed to monitor the pressure differential or airflow between the buffer area and the ante area and between the ante area and the general environment outside the cleanroom. The results shall be reviewed and documented on a log at least every work shift (minimum frequency shall be at least daily) or by a continuous recording device;

8. Laminar airflow workbenches, compounding aseptic isolators, compounding aseptic containment isolators, and biological safety cabinets shall be certified every six months, and every time they are moved, by an independent certification company to ensure that these primary engineering controls meet appropriate ISO classifications;

9. A cleanroom shall be certified by an independent certification company every six months and whenever the room or a primary engineering control in the room is relocated or altered, or whenever major service to the facility is performed, to ensure that the cleanroom meets appropriate ISO classifications. Such certifications shall be performed consistent with procedures outlined in the Controlled Environment Testing Association (CETA) Certification Guide for Sterile Compounding Facilities (CAG-003-2006) (revised December 8, 2008), incorporated herein by reference, as amended and supplemented, and which may be found at the CETA website, http://www.cetainternational.org, specifically, http://www.cetainternational.org/reference/CETAAsepticCompoundingCertificationGuide.pdf; and

10. Whenever test results indicate that the cleanroom or any primary engineering controls do not meet the standards established in this section, the pharmacy shall immediately cease using the cleanroom or primary engineering control that is out of compliance until such time that the cleanroom and/or the primary engineering control meets the requisite standards. The pharmacy shall notify the Board in writing within 48 hours of any air and/or surface sampling test results that are out of compliance. Test results indicating non-compliance with the requisite standards shall require re-evaluation of all procedures associated with the production of compounded sterile preparations in the impacted cleanroom or primary engineering control and documentation with respect to the period of time that the cleanroom and/or primary engineering control was out of compliance.

N.J. Admin. Code § 13:39-11.24

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