N.J. Admin. Code § 8:21-4.4

Current through Register Vol. 56, No. 23, December 2, 2024

Section 8:21-4.4 - Exemptions from section 505(a)

(a)21 C.F.R. 312.1 (Conditions for exemption of new drugs for investigational use), 21 C.F.R. 312.5 (Confidentiality of data and information in an investigational new drug notice, IND), and 21 C.F.R. 312.9 (New drugs for investigational use in laboratory research animals or in vitro tests) are hereby adopted by reference.

(b) Regarding subpart B (Controlled substances), 21 C.F.R. 312.10, Availability of records, is hereby adopted by reference.

(c) Regarding subpart C (International research), 21 C.F.R. 312.20, Clinical data generated outside the United States and not subject to a "Notice of Claimed Investigational Exemption of a New Drug", is hereby adopted by reference.

N.J. Admin. Code § 8:21-4.4

Amended by R.1990 d.563, effective 11/19/1990.
See: 22 New Jersey Register 2465(a), 22 New Jersey Register 3559(a).
Stylistic changes.