N.J. Admin. Code § 13:39-9.10

Current through Register Vol. 56, No. 21, November 4, 2024

Section 13:39-9.10 - Pharmaceuticals; drug supply; investigational drugs; controlled dangerous substances

(a) The pharmacist-in-charge shall be responsible for determining the specifications for drugs and pharmaceutical preparations used in the treatment of patients of the facility as to quality, quantity and source of supply. An authorized purchasing agent and/or materials manager and/or pharmacy buyer of the facility may perform the actual procurement. All purchases shall be reviewed by the pharmacist-in-charge or his or her designee, who shall be a pharmacist.

(b) Written policies and procedures for the maintenance, content, control and accountability of drugs supplied and located throughout the facility shall be developed by the pharmacist-in-charge and approved by the Pharmacy and Therapeutics Committee.

(c) Written policies and procedures for the control, use, and accountability of Investigational New Drugs shall be developed by the pharmacist-in-charge and the Pharmacy and Therapeutics Committee. The storage, labeling, and dispensing of all Investigational New Drugs shall be a pharmaceutical service provided in cooperation with, and in support of the principal investigator. Under these parameters, the dispensing of these drugs shall not be construed to be a violation of N.J.A.C. 13:39-7.5(a). A facility participating in experimental research involving residents shall comply with Federal Department of Health and Human Services regulations, set forth at 45 CFR Part 46, Protection of Human Subjects of Research, which is incorporated by reference herein, as amended and supplemented and with the Rowan University Guidance on Human Subjects Research, which is incorporated herein by reference, as amended and supplemented, and which is available at http://www.rowan.edu/som/hsp/guidance/index.html.

(d) Written policies and procedures for the control, use and accountability of controlled dangerous substances shall be developed by the pharmacist-in-charge and the Pharmacy and Therapeutics Committee. Controlled dangerous substances shall be purchased, received, stored, dispensed, administered, recorded and controlled in accordance with State and Federal laws and regulations.

N.J. Admin. Code § 13:39-9.10

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