N.J. Admin. Code § 13:45H-5.3

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

Section 13:45H-5.3 - Persons required to keep records and file reports

(a) Each registrant shall maintain the records and inventories and shall file the reports required by this part, except as exempted by this section. Any registrant who is authorized to conduct other activities without being registered to conduct those activities, either pursuant to 24:21-10 or pursuant to 13:45H-8.5 or 21 CFR 1301.22(b), 1307.11, or 1307.13, or Part 1317, shall maintain the records and inventories and shall file the reports required by this part for persons registered or authorized to conduct such activities (for example, when a registered manufacturer conducts chemical analysis, he or she shall maintain the records and inventories required of chemical analysts). All records of each activity may be maintained in one consolidated record system.

(b) A registered individual practitioner is not required to keep records with respect to narcotic controlled substances listed in Schedules II through V, which he or she prescribes in the lawful course of his or her professional practice; he or she shall keep records, however, with respect to such substances that he or she administers and dispenses.

(c) A registered individual practitioner is required to keep records with respect to nonnarcotic controlled substances listed in Schedules II through V, which he or she dispenses or administers.

(d) A registered person using any controlled substance in research conducted in conformity with an exemption granted under Section 505(i) or 512(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) or 360 b(j)) at a registered establishment which maintains records in accordance with either of these sections is not required to keep records if he notifies the Bureau of the name, address, and registration number of the establishment maintaining such records.

(e) A registered person using any controlled substance in preclinical research or in teaching at a registered establishment which maintains records with respect to such substances is not required to keep records if he notifies the Drug Enforcement Administration and the Drug Control Unit of the name, address, and registration number of the establishment maintaining such records.

(f) Notice required by (d) and (e) above shall be given at the time the person applies for registration or reregistration and shall be made in the form of an attachment to the application, which shall be filed with the application.

N.J. Admin. Code § 13:45H-5.3

Amended by 47 N.J.R. 2300(a), effective 9/8/2015