N.J. Admin. Code § 13:45A-35.1

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

Section 13:45A-35.1 - Purpose and scope

(a) The rules in this subchapter implement the provisions of P.L. 2007, c. 244, as amended by P.L. 2015, c. 74 and P.L. 2017, c. 341 (N.J.S.A. 45:1-44 through 51), establishing a Prescription Monitoring Program (PMP) in the Division of Consumer Affairs.

(b) The rules in this subchapter shall apply to the following:

1. A pharmacy filling prescriptions in New Jersey in an outpatient setting for a Schedule II, III, IV, or V controlled dangerous substance, for human growth hormone, or gabapentin.

i. For purposes of this subchapter, "human growth hormone" means somatrem, somatropin, or any analogue of either of them, consistent with 21 U.S.C. § 333 (e)4;

2. An out-of-State pharmacy registered with the Board of Pharmacy pursuant to N.J.A.C. 13:39-4.20that ships, mails, distributes, or delivers a Schedule II, III, IV, or V controlled dangerous substance, human growth hormone, or gabapentin into New Jersey in an outpatient setting pursuant to a prescription;

3. A person authorized to receive PMP information from the Division under 45:1-46 and N.J.A.C. 13:45A-35.6;

4. A pharmacist employed by a current pharmacy permit holder;

5. A practitioner who has a current State Controlled Dangerous Substance (CDS) registration;

6. A licensed health care professional authorized by a practitioner to access the prescription monitoring information, subject to the limitations and requirements of this subchapter;

7. A medical resident authorized by a faculty member of a medical teaching facility to access the prescription monitoring information, subject to the limitations and requirements of this subchapter;

8. A dental resident authorized by a faculty member of a dental teaching facility to access the prescription monitoring information, subject to the limitations and requirements of this subchapter;

9. A certified medical assistant authorized by a practitioner to access the prescription monitoring information, subject to the limitations and requirements of this subchapter;

10. A registered dental assistant authorized by a licensed dentist to access the prescription monitoring information, subject to the limitations and requirements of this subchapter;

11. A licensed mental health practitioner providing treatment for substance abuse to patients at a residential or outpatient substance abuse treatment center licensed by the Department of Health, subject to the limitations and requirements of this subchapter;

12. A licensed athletic trainer authorized by a practitioner to access the prescription monitoring information, subject to the limitations and requirements of this subchapter; and

13. A medical scribe authorized by a practitioner to access the prescription monitoring information, subject to the limitations and requirements of this subchapter.

(c) The reporting requirements of this subchapter shall not apply to the direct administration of a controlled dangerous substance, human growth hormone, or gabapentin to the body of an ultimate user; or to the administration or dispensing of a controlled dangerous substance that is otherwise exempted as determined by the Secretary of Health and Human Services pursuant to the National All Schedules Prescription Electronic Reporting Act of 2005, Pub.L. 109-60.

(d) The reporting requirements of this subchapter shall not apply to any prescriptions filled by a pharmacy for a Schedule II, III, IV, or V controlled dangerous substance, for human growth hormone, or gabapentin dispensed to an inpatient at a hospital, long-term care, or other facility in which the resident is provided with 24-hour nursing care.

N.J. Admin. Code § 13:45A-35.1

Adopted by 48 N.J.R. 2374(a), effective 11/7/2016

Amended by 50 N.J.R. 1219(a), effective 5/7/2018

Amended by 50 N.J.R. 1500(a), effective 7/2/2018

Amended by 51 N.J.R. 624(a), effective 5/6/2019