N.J. Admin. Code § 13:39-11.3

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

Section 13:39-11.3 - Application and pre-approval requirements for compounding sterile preparations

(a) An applicant for a new pharmacy who wishes to compound sterile preparations shall satisfy all pharmacy permit application requirements set forth in N.J.A.C. 13:39-4.1. As part of the permit application, the applicant shall submit plans detailing the physical arrangements necessary to ensure compliance with the requirements in this subchapter. An applicant for a pharmacy permit shall not compound sterile preparations at the site until receiving written approval from the Board to engage in such activities. Prior to issuing the written approval, the Board shall conduct an inspection of the pharmacy to ensure compliance with the requirements in this subchapter.

(b) The holder of an existing pharmacy permit who wishes to compound sterile preparations shall submit an amended pharmacy permit application to the Board. The amended permit application shall contain plans detailing the physical arrangements necessary to ensure compliance with the requirements in this subchapter. The holder of an existing pharmacy permit shall not compound sterile preparations at the site until receiving written approval from the Board to engage in such activities. Prior to issuing the written approval, the Board shall conduct an inspection of the pharmacy to ensure compliance with the requirements in this subchapter.

(c) A pharmacy permit holder who is approved to compound sterile preparations shall notify the Board at least 60 days in advance of any remodeling, change of location, or change in size of the pharmacy cleanroom, consistent with the requirements of 13:39-4.7 and 4.8. Such notification shall include the pharmacy's remodeling or relocation plans, as appropriate, the pharmacy's interim plans for the continuation of sterile compounding operations, which the Board shall review and approve, and the anticipated date of completion. The pharmacy permit holder and the pharmacist-in-charge shall ensure compliance with all requirements set forth in this subchapter while compounding operations continue during the remodeling or relocation process. The pharmacy permit holder shall notify the Board upon completion of the remodeling or relocation process, at which time the Board shall inspect the premises.

(d) A pharmacy holding an institutional permit that is approved to compound sterile preparations and that intends to compound sterile preparations using a laminar airflow workbench not located in a buffer area, as provided in 13:39-11.10, shall notify the Board at least 60 days in advance of its intention and of all locations where such equipment will be installed. The pharmacy permit holder shall notify the Board upon completion of such installation, at which time the Board shall inspect the equipment. The pharmacy shall not utilize such equipment to compound sterile preparations until receiving Board approval.

(e) A pharmacy permit holder who is approved to compound sterile preparations and who intends to utilize compounding aseptic isolators or compounding aseptic containment isolators not located in a buffer area, as provided in 13:39-11.8, shall notify the Board at least 60 days in advance of its intention and of all locations where such equipment will be installed. The pharmacy permit holder shall notify the Board upon completion of such installation, at which time the Board shall inspect the equipment. The pharmacy shall not utilize such equipment to compound sterile preparations until receiving Board approval.

(f) Notwithstanding the requirements of (a) through (e) above, a pharmacy permit holder or pharmacy applicant may compound sterile preparations for the sole purposes of process, equipment, personnel, and environmental testing. Any sterile preparations compounded for these purposes shall be destroyed.

(g) Approval by the Board to dispense compounded sterile preparations shall be contingent upon demonstration that, as is related to maintaining a sterile compounding environment, all environmental control and processes have been tested and validated, and all equipment has been certified, tested, and validated.

N.J. Admin. Code § 13:39-11.3

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