N.J. Admin. Code § 13:39-11.10
A pharmacy holding an institutional pharmacy permit may utilize ISO class 5 laminar airflow workbenches not located in a buffer area to prepare low-risk level compounded sterile preparations provided that the administration of such preparations commences within 12 hours of the preparation or as recommended by the manufacturer, whichever is less. Such workbenches shall be located in an area which is maintained under sanitary conditions and which is traveled only by persons engaging in the compounding of sterile preparations. Such workbenches shall not be in a location that has unsealed windows or doors that connect to the outdoors or high traffic flow, or that is adjacent to areas including, but not limited to, construction sites, warehouses, or food preparation. Sinks may not be located adjacent to the ISO class 5 workbench environments and must be separated from the immediate area of ISO class 5 workbenches. Personnel engaged in sterile compounding in such areas shall follow the procedures relating to cleansing and garbing set forth in 13:39-11.14.
N.J. Admin. Code § 13:39-11.10
See: 29 N.J.R. 2246(a), 30 N.J.R. 2255(a).
Recodified from N.J.A.C. 13:39-11.23 and amended by R.2005 d.25, effective 1/18/2005.
See: 36 N.J.R. 3345(a), 37 N.J.R. 295(a).
Substituted "ISO class 5" for "class 100" and "engaging in the compounding of sterile preparations" for "engaging in sterile product preparation". Former N.J.A.C. 13:39-11.22, Vertical air laminar flow hoods, recodified to N.J.A.C. 13:39-11.21.
Recodified from N.J.A.C. 13:39-11.22 and amended by R.2013 d.084, effective 6/3/2013.
See: 45 N.J.R. 439(a), 45 N.J.R. 1400(b).
Section was "Laminar air flow hoods not in a clean room for compounded sterile preparations". Rewrote the section. Former N.J.A.C. 13:39-11.10, Information required to appear on prescription label, recodified to N.J.A.C. 13:39-11.21.