N.J. Admin. Code § 8:21-3A.5

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

Section 8:21-3A.5 - Evaluation criteria

(a) In considering any application for registration, the Department shall consider, at a minimum, the following factors in reviewing the qualifications of those persons applying for registration as a wholesale drug distributor:

1. Any convictions of the applicant under any Federal, state, or local laws relating to drug samples, wholesale or retail drug distribution, or distribution of a controlled substance;

2. Any felony conviction under Federal laws, or the equivalent (under whatever statutory term) conviction under state or local laws;

3. The applicant's past experience in the manufacturing or distribution of drugs or controlled substances;

4. The furnishing of false or fraudulent material in any application made in connection with drug or device manufacturing or distribution;

5. Suspension or revocation by Federal, state or local government of any registration currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances;

6. Compliance with license and/or registration requirements under any previously granted license or registration, if any;

7. Compliance with requirements to maintain and/or make available to the Department or Federal or local law enforcement officials those records required by this subchapter; and

8. Any other factors or qualifications the Department considers relevant to and consistent with the public health and safety.

(b) Wholesale drug distributors shall operate in compliance with applicable Federal, State and local laws and regulations and where the wholesale drug distributor also deals in controlled dangerous substances, it shall also register with the Department and Drug Enforcement Administration (DEA) and also comply with all applicable State rules and DEA regulations.

(c) A retail pharmacy wishing to conduct a wholesale business shall operate the wholesale business under a separate name and at a separate location, other than that of the pharmacy name and address and the wholesale business will be subject to all of the requirements of a wholesale distributor.

N.J. Admin. Code § 8:21-3A.5

Amended by R.2006 d.391, effective 11/20/2006.
See: 37 N.J.R. 3899(a), 38 N.J.R. 4857(b).
In introductory paragraph of (a), deleted "prescription" preceding "drug"; and in (a)3, deleted "prescription" preceding "drugs".