N.J. Admin. Code § 13:45H-5.4 - Maintenance of records and inventories

(a) Every inventory and other record required to be kept under this subchapter shall be kept by the registrant and be available, for at least two years from the date of such inventory of records or pursuant to recordkeeping provisions of the State professional licensing board governing the registrant, whichever is longer, for inspecting and copying by authorized employees of the Drug Enforcement Administration and the Drug Control Unit, except that financial and shipping records (such as invoices and packing slips but not executed order forms subject to 21 CFR 1305.17) may be kept at a central location, rather than at the registered location in accordance with 21 CFR 1304.04, which is incorporated herein by reference.

(b) Each registered manufacturer, distributor, reverse distributor, importer, and exporter shall maintain inventories and records and controlled substances as follows:

1. Inventories and records of controlled substances listed in schedules I and II shall be maintained separately from all of the records of the registrant; and

2. Inventories and records of controlled substances listed in schedules III, IV, and V shall be maintained either separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant.

(c) Each registered individual practitioner required to keep records and institutional practitioner shall maintain inventories and records of controlled substances in the manner prescribed in (b) above.

(d) Each registered pharmacy shall maintain the inventories and records of controlled substances as follows:

1. Inventories and records of all controlled substances listed in schedules I and II shall be maintained separately from all other records of the pharmacy, and prescriptions for such substances shall be maintained in a separate prescription file; and

2. Inventories and records of controlled substances listed in schedules III, IV, and V shall be maintained either separately from all other records of the pharmacy or in such form that the information required is readily retrievable from ordinary business records of the pharmacy, and prescriptions for such substances shall be maintained either in separate prescription file for controlled substances listed in schedules III, IV, and V only or in such form that they are readily retrievable from other prescription records of the pharmacy. Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is stamped in red ink in the lower right corner with the letter "C" no less than one-inch high and filed either in the prescription file for controlled substances listed in schedules I and II or in the usual consecutively numbered prescription file for non-controlled substances.

(e) A person or duly authorized agent registered to use sodium pentobarbital for purposes of animal euthanasia and required to keep records shall maintain inventories and records of controlled substances in the manner prescribed in (b) above.

Notes

N.J. Admin. Code § 13:45H-5.4

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