N.J. Admin. Code § 8:21-4.1

Current through Register Vol. 56, No. 12, June 17, 2024

Section 8:21-4.1 - Statement of policy

(a) The following "new drug" regulations as adopted by the Department of Health (Department) are to provide guidance in the administration of the provisions of N.J.S.A. 24:6A-1 et seq.

(b) To ensure that a complete and comprehensive review for safety is provided to a new drug application submitted pursuant to the State act, it has been deemed proper and expeditious to adopt by reference such procedures, records, reports, sampling, toxicology, pathology, and clinical testing measures afforded to new drugs by the United States Food and Drug Administration as provided in 21 C.F.R. 300, 310, 312, and 314.

(c) It is the intent and policy of the Department to implement and administer those provisions of the Federal new drug regulations adopted by this Department that pertain to or are concerned with the safety of the product subject of a State new drug application.

N.J. Admin. Code § 8:21-4.1

Amended by 53 N.J.R. 2191(a), effective 12/20/2021