New Jersey Administrative Code

A pharmacist shall be responsible for the processing, accuracy, appropriateness, and dispensing of the filled prescription. Notes N.J. Admin. Code § 13:39-7.22 Adopted by 49 N.J.R. 3761(a), effective 12/4/2017

(a) A pharmacist may substitute a biological product for a prescribed biological product, provided that the following conditions are met: 1. The authorized prescriber has not indicated that there shall be no substitution as set forth in N.J.S.A. 24:6E-7; and 2. The biological pro…

(a) A prescription for medication or devices, which pursuant to State or Federal law may be sold, dispensed or furnished only upon prescription, shall not be renewed without specific authorization of the practitioner or the practitioner's authorized agent, and the prescription ma…

(a) Except as provided in (b) below, in the absence of a current, valid prescription, a pharmacist may dispense an emergency supply (no more than a 72-hour quantity) of a chronic maintenance drug or device if, in his or her professional judgment, refusal would endanger the health…

(a) No drug or medicine other than a compounded prescription order, consistent with (c) below, shall be sold or dispensed in any pharmacy within the State of New Jersey until such drug or medicine has received New Drug Application (NDA), Abbreviated New Drug Application (ANDA), I…

(a) A pharmacy shall maintain an audit trail that records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s), or extern(s) performing the component functions of intake, processing, fulfillment, and dispensing of prescrip…

(a) A pharmacy shall immediately comply with the patient's request for copies of prescriptions and/or patient profile. Copies of prescriptions issued directly to the patient shall state in letters at least equal in size to those describing the medication dispensed, the underlined…

(a) When a patient, the patient's caregiver, or a pharmacy acting on behalf of a patient or caregiver requests the transfer of a valid prescription between pharmacies, a pharmacy, the registered pharmacist-in-charge, and the pharmacist who receives the request for transfer shall …

(a) Prescriptions for all controlled substances listed in Schedule II shall be maintained in a separate prescription file. (b) Prescriptions for all controlled substances listed in Schedules III, IV and V shall be maintained in a separate prescription file for such controlled sub…

(a) The rules in this subchapter shall apply to all retail pharmacies which contract to provide pharmaceutical services for healthcare facilities and to all institutional pharmacies which provide pharmaceutical services for their own health care system. (b) An institutional pharm…

(a) The pharmacist-in-charge shall be responsible for determining the specifications for drugs and pharmaceutical preparations used in the treatment of patients of the facility as to quality, quantity and source of supply. An authorized purchasing agent and/or materials manager a…

(a) The pharmacist shall review the practitioner's original order or a copy of the original order generated by any media that facilitates the reproduction of the original order before any initial dose of medication is dispensed, except as provided for in N.J.A.C. 13:39-9.13. (b) …

(a) The provisions of this section shall be implemented in accordance with the policies and procedures of, and protocols of the Pharmacy and Therapeutics Committee. (b) A pharmacist shall receive oral orders only from an authorized practitioner. Such orders shall be immediately r…

(a) The pharmacist shall be responsible for monitoring drug therapy of patients in the facility. This shall include, but is not limited to, maintaining and reviewing the patient medication profile prior to the dispensing of medications. (b) In instances involving the issuance and…

The pharmacist shall be responsible for providing medication in a form that requires little or no further alterations, preparation, reconstitution, dilution or labeling by other licensed personnel. The pharmacist shall provide adequate instructions for those products that are not…

Labeling of medications, other than intravenous solutions, shall be in conformance with written policies and procedures controlling the drug distribution system in use within the facility and in accord with current acceptable standards of pharmaceutical practice. Labeling of intr…

(a) No drugs shall be administered to a patient except those provided through the pharmacy or as provided by written policies and procedures developed by the pharmacist-in-charge or, where applicable, the director of pharmaceutical services and approved by the Pharmacy and Therap…

(a) Where the use of a drug-dispensing device is approved as an integral part of the drug distribution system by the facility, the pharmacist-in-charge and the Pharmacy and Ther-apeutics Committee, the device may be used when the pharmacist is not on duty (absent during either th…

(a) Written policies and procedures governing unused medications shall be established and implemented by the pharmacist-in-charge and shall comply with the following requirements: 1. All medications where the drug source, lot or control number, or expiration or use by date are mi…

(a) Records of the pharmaceutical services of the provider pharmacy for the facility shall be the responsibility of the pharmacist-in-charge. A pharmacy shall maintain an audit trail that records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmac…

The following words and terms, as used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise. "Drug administration" means a procedure in which a prescribed drug is given to a patient by an authorized person in accordance with all la…

(a) The pharmacist-in-charge shall be responsible for maintaining drug standards, references and sources of drug information current and adequate to meet the needs of the pharmacists, physicians, nurses, other health care personnel, and patients of the facility. Reference texts s…

(a) Only a pharmacist shall have access to the pharmacy stock of controlled dangerous substances in Schedules II through V. (b) Only a pharmacist shall have access to the institutional pharmacy except that in a pharmacist's absence from an institution, a registered nurse designat…

(a) Adequate facilities (space, lighting, equipment, temperature control and supplies) shall be provided for the control of the professional, technical and administrative functions of the institutional pharmacy as needed for the effective and efficient assurance of patient safety…

(a) Provisions shall be made for adequate safe storage of drugs wherever they are stored in the health care facility. 1. All drugs shall be secured for safe use and protected against illicit diversion. Controlled dangerous substances in the institutional pharmacy and throughout t…

Adequate equipment shall be provided for the compounding, packaging, labeling, refrigeration, sterilization, testing and safe distribution of drugs and other functions. Notes N.J. Admin. Code § 13:39-9.24 Recodified from N.J.A.C. 13:39-9.17 by R.1994 d.351, effective 7/18/1994. S…

(a) An institutional decentralized pharmacy or a "satellite pharmacy", means an area within a health care system that has been issued an institutional permit and is in a location other than the original permitted location, where the preparation or dispensing or compounding of med…

(a) Only medication orders issued by a practitioner licensed to write medication orders in the United States or any territory of the United States shall be considered valid medication orders and such medication orders shall be filled pursuant to New Jersey law. (b) Medication ord…

(a) A pharmacist may, subject to the conditions set forth in this section, accept for dispensing a prescription or a medication order transmitted by a facsimile (FAX) machine or other technological device as approved by the Board. (b) A pharmacist filling prescriptions under an i…

(a) Any institutional pharmacy as defined under N.J.A.C. 13:39-9.2 shall be registered with and possess an institutional permit issued by the Board. The permit shall be conspicuously displayed in the facility's pharmacy. The institutional pharmacy is subject to and shall be condu…

An institutional permit is required for any area within an institution serviced by an outside vendor that performs on-site pharmaceutical services as defined in N.J.A.C. 13:39-1.2. Notes N.J. Admin. Code § 13:39-9.4 Amended by R.1994 d.351, effective 7/18/1994. See: 26 New Jersey…

The pharmacist-in-charge, or designee, shall be an actively participating member on any committees of the facility that may be concerned with drugs and their utilization. Notes N.J. Admin. Code § 13:39-9.5 Recodified from N.J.A.C. 13:39-9.10 by R.1994 d.351, effective 7/18/1994. …

(a) In all health care facilities providing pharmaceutical services to patients, an active standing committee of the institution entitled the Pharmacy and Therapeutics Committee or other appropriate name shall be established if required pursuant to Department of Health rules. A P…

Notes N.J. Admin. Code § 13:39-9.7 Recodified from N.J.A.C. 13:39-9.12 by R.1994 d.351, effective 7/18/1994. See: 26 N.J.R. 1596(a), 26 N.J.R. 2905(b). Recodified from N.J.A.C. 13:39-9.21 and amended by R.2005 d.25, effective 1/18/2005. See: 36 N.J.R. 3345(a), 37 N.J.R. 295(a). I…

(a) The pharmaceutical services of the health care facility shall be the responsibility of and under the control, supervision, and direction of the pharmacist-in-charge of the provider pharmacy. (b) If a health care facility does not have an institutional pharmacy on its premises…

Notes N.J. Admin. Code § 13:39-9.9 Amended by R.1994 d.351, effective 7/18/1994. See: 26 N.J.R. 1596(a), 26 N.J.R. 2905(b). Recodified from N.J.A.C. 13:39-9.4 by R.2005 d.25, effective 1/18/2005. See: 36 N.J.R. 3345(a), 37 N.J.R. 295(a). Former N.J.A.C. 13:39-9.9, Monitoring of p…

The following provisions shall constitute the practice and procedure of, and shall govern all proceedings, in the Division on Civil Rights. When a case is transmitted to the Office of Administrative Law, or the Director elects to hear the contested case, the Uniform Administrativ…

(a) These provisions shall be liberally construed by the Director to permit the Division on Civil Rights to discharge its statutory functions and to secure just and expeditious determinations of all matters before the Division on Civil Rights. (b) The Director may, upon notice to…

(a) The Director may rescind, amend, or expand this chapter from time to time, as necessary, to comply with the Law Against Discrimination, N.J.S.A. 10:5-1 et seq., or the Family Leave Act, N.J.S.A. 34:11B-1 et seq., and such new rules shall be filed with the Office of Administra…

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise. "Administrative law judge" means any person appointed pursuant to N.J.S.A. 52:14F-4 or 52:14F-5(m) and assigned by the Director of the Offi…

If any rule, sentence, paragraph or section of these rules, or the application thereof to any persons or circumstances, shall be adjudged by a court of competent jurisdiction to be invalid, or if by legislative action any rule shall lose its force and effect, such judgment or act…

(a) An attorney may appear on behalf of a party by completing a Division Notice of Appearance form electronically or by providing all of the information requested on such form in a letter or similar document. The Notice of Appearance form is available from the Division's offices …

(a) Any employer, housing provider, or place of public accommodation may register with the Division electronically and identify an individual to electronically accept service in connection with any complaint filed with the Division by providing the name, email address, and phone …

Unless otherwise provided in a specific rule, in computing any period of time fixed by this chapter, the day of the act or event from which the designated period begins to run is not to be included. The last day of the period so computed is to be included, unless it is a Saturday…

At any time during the course of the proceedings, the Director may enter such orders, including protective orders and orders of dismissal, as may be necessary to effectuate the processing and determination of a case as they may deem appropriate to further the intent and purposes …

(a) Following the completion of an investigation of a verified complaint filed with the Division, the Director shall determine whether or not probable cause exists to credit the allegations of the verified complaint. (b) If the Director determines based upon a review of the inves…

All orders of the Director, including findings of probable cause and no probable cause, shall be promptly served on all parties. Notes N.J. Admin. Code § 13:4-10.3

(a) The Director shall determine when a hearing shall be necessary in any matter. (b) When the Director has determined pursuant to N.J.A.C. 13:4-10.2(b) or (d), that probable cause exists to credit the allegations of a verified complaint and conciliation has failed to eliminate t…

The procedure for conducting hearings, issuing initial decisions and issuing final orders shall be governed by the Uniform Administrative Procedure Rules, N.J.A.C. 1:1. Notes N.J. Admin. Code § 13:4-11.2

If the Director determines that the interests of the complainant may be irreparably damaged by the lapse of time before a hearing could be scheduled or between the scheduling of a hearing and the ultimate disposition of the matter in the Division, he or she shall instruct the att…