New Jersey Administrative Code

(a) Prior to use for the first time of an automated medication system, the pharmacy shall conduct and submit to the Board a self-inspection of the automated medication system documented on a form provided by the Board. After receipt of the self-inspection, the Board shall conduct…

(a) When an automated medication system is used to fill prescriptions or medication orders, it shall be operated according to written policies and procedures of operation. The policies and procedures of operation shall: 1. Include a table of contents; 2. Include a description of …

The pharmacist-in-charge shall be responsible for ensuring that, prior to performing any services in connection with an automated medication system, all pharmacists and pharmacy technicians, interns and externs are trained in the pharmacy's standard operating procedures with rega…

(a) A pharmacy which uses an automated medication system to fill prescriptions or medication orders shall operate according to a written program for quality assurance of the automated medication system which: 1. Requires continuous monitoring of the automated medication system; 2…

(a) A pharmacy which uses an automated medication system to fill prescriptions or medication orders shall maintain a written plan for recovery from a disaster which interrupts the ability of the pharmacy to provide services. The written plan for recovery shall include: 1. Plannin…

A pharmacy which uses an automated medication system to fill prescriptions or medication orders shall maintain a written program for preventative maintenance of the system. Notes N.J. Admin. Code § 13:39-10.8

The rules in this subchapter regulate the practice of sterile compounding and shall apply to all retail and institutional pharmacies that compound and dispense sterile preparations. This subchapter establishes standards for the quality and control of processes, components, and en…

A pharmacy holding an institutional pharmacy permit may utilize ISO class 5 laminar airflow workbenches not located in a buffer area to prepare low-risk level compounded sterile preparations provided that the administration of such preparations commences within 12 hours of the pr…

A pharmacy holding an institutional pharmacy permit may prepare non-hazardous immediate use compounded sterile preparations outside of an ISO class 5 laminar airflow workbench when the delay resulting from the use of the workbench would harm the patient, including situations in w…

(a) The pharmacist-in-charge shall supervise all sterile compounding performed by pharmacy personnel. The pharmacist-in-charge shall be trained in aseptic manipulation skills. (b) The pharmacist-in-charge shall be responsible for, at a minimum, the following: 1. Determining the p…

(a) Pharmacists shall provide immediate personal supervision to pharmacy technicians, pharmacy interns, or pharmacy externs who are performing sterile compounding. The ratio of pharmacists to pharmacy technicians shall not exceed 1:2 at any given time unless all of the requiremen…

(a) All personnel who engage in compounding sterile preparations shall comply with the following requirements before entering the buffer area: 1. Personnel shall remove personal outer garments (for example, bandanas, coats, hats, jackets, scarves, sweaters, vests), all cosmetics,…

(a) The cleanroom, buffer area, and ante area shall be cleaned and disinfected consistent with the following requirements: 1. All surfaces in laminar airflow workbenches, biological safety cabinets, compounding aseptic isolators, and compounding aseptic containment isolators shal…

(a) The pharmacist-in-charge and all pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs involved in compounding sterile preparations shall have didactic and practical training in sterile preparation compounding, including proper personnel cleansing and garb…

(a) Pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs, consistent with N.J.A.C. 13:39-11.13, may compound sterile preparations in a quantity that is supported by prior valid prescriptions or medication orders before receiving a valid written prescription o…

In the absence of a valid patient-specific prescription or medication order, pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs shall not prepare compounded sterile preparations for human use for a licensed prescriber to use in his or her practice, except t…

(a) For purposes of this section, stability means the extent to which a preparation retains, within specified limits and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding. (b) In the absence of supportin…

The following words and terms, when used in this subchapter, shall have the following meanings: "Ante area" means an ISO class 8 or better area where personnel hand hygiene and garbing procedures, staging of components, order entry, labeling, and other high-particulate-generating…

(a) The pharmacist shall ensure that compounded sterile preparations have been properly prepared, consistent with the assigned risk level of the preparation, labeled, controlled, stored, dispensed, and distributed in accordance with the provisions of this subchapter. The pharmaci…

(a) The dispensed container for any compounded sterile preparation shall bear a permanently affixed label with at least the following information: 1. The date and time prepared; 2. In the retail pharmacy only, the name of the prescriber; 3. The name of the patient; 4. Directions …

(a) The pharmacy shall be responsible for the proper handling and packaging of compounded sterile preparations for delivery from the pharmacy to the patient in order to assure and maintain the integrity, efficacy, stability, and sterility of these preparations. The pharmacist-in-…

(a) The pharmacy's policy and procedures manual shall set forth in detail the pharmacy's standard operating procedures with regard to compounded sterile preparations. (b) The policy and procedures manual shall include policies and procedures governing the following: 1. A risk-man…

(a) The pharmacy's quality assurance program shall require, at a minimum, that: 1. A reasonable effort shall be made by the pharmacist to assure that compounded sterile preparations shall be kept under appropriate controlled conditions at the location of use by providing adequate…

(a) A pharmacist shall not compound preparations that contain drug products that appear on the Federal Food and Drug Administration's List of Drug Products Withdrawn or Removed from the Market for Reasons of Safety or Effectiveness, codified at 21 CFR 216.24. (b) A pharmacist sha…

The compounding area and its contents and other areas where compounded preparations are present shall be secured, so as to prevent access by unauthorized personnel. Notes N.J. Admin. Code § 13:39-11.26 New Rule, R.1998 d.297, effective 6/15/1998. See: 29 N.J.R. 2246(a), 30 N.J.R.…

Notes N.J. Admin. Code § 13:39-11.27 Recodified to N.J.A.C. 13:39-11.26 by R.2005 d.25, effective 1/18/2005. See: 36 New Jersey Register 3345(a), 37 New Jersey Register 295(a). Section was "Security".

(a) An applicant for a new pharmacy who wishes to compound sterile preparations shall satisfy all pharmacy permit application requirements set forth in N.J.A.C. 13:39-4.1. As part of the permit application, the applicant shall submit plans detailing the physical arrangements nece…

(a) The pharmacy shall have a designated area for sterile preparation compounding, known as the "cleanroom." A cleanroom shall be physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites. Critical sites are locations tha…

(a) The surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the cleanroom shall be smooth, impervious, free from cracks and crevices, and nonshedding, thereby minimizing spaces in which microorganisms and other contaminants may accumulate. (b) Work …

(a) The ante area shall have appropriate environmental control devices capable of maintaining ISO class 8 air quality conditions for non-hazardous drug compounding activities. (b) The ante area shall contain the following equipment:1. A sink with hot and cold running water with a…

(a) The buffer area shall have appropriate environmental control devices capable of maintaining ISO class 7 air quality conditions during normal activity consistent with the requirements of N.J.A.C. 13:39-11.4(d). (b) The buffer area shall contain only the following: 1. Items suc…

A pharmacy may utilize compounding aseptic isolators and compounding aseptic containment isolators not located in a cleanroom to prepare compounded sterile preparations, provided the compounding aseptic isolators and compounding aseptic containment isolators can provide isolation…

Notes N.J. Admin. Code § 13:39-11.9 Repealed by 49 N.J.R. 3761(a), effective 12/4/2017

The following words and terms when used in this subchapter shall have the following meanings, unless the context clearly indicates otherwise. "Authentication of product history" includes, but is not limited to, identifying the purchase source, the ultimate use or disposition and …

(a) The application for a specialized retail permit to operate a pharmacy providing radiopharmaceutical services shall only be issued to a site employing a qualified nuclear pharmacist. All personnel performing tasks in the preparing and distribution of drugs shall be under the i…

(a) A qualified nuclear pharmacist shall meet the following requirements: 1. He or she is a pharmacist licensed to practice in the State of New Jersey; and 2. He or she meets minimal standards of training and experience in the handling of radioactive materials in accordance with …

(a) Each nuclear pharmacy must meet the following requirements for space: 1. The area for the storage, compounding and dispensing of radioactive drugs shall be completely separate from pharmacy areas for non-radioactive drugs; 2. Hot lab and storage area shall be a minimum of 120…

The holder of a nuclear pharmacy permit shall be responsible for the radioactive quality control of all drugs, including biologicals, dispensed or manufactured. Radioactive pharmaceutical quality controls include, but are not limited to, the carrying out and interpretation of dat…

The rules in this subchapter establish standards applicable to all pharmacists who seek to engage in collaborative practice with one or more physicians licensed by the Board of Medical Examiners. Only those activities that have been approved by the collaborating physician, consis…

(a) The following words and terms, as used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise: "Collaborative drug therapy management" means the cooperative management of a patient's drug, biological, and device-related health ca…

(a) In order to enter into an agreement to engage in the collaborative drug therapy management of a patient with a physician licensed in this State, a licensed pharmacist shall be pre-approved by the Board to engage in such activity. In order to obtain Board approval, a pharmacis…

(a) A pharmacist who engages in collaborative practice with one or more physicians shall provide the Board, upon request, with a signed copy of a collaborative practice agreement. The collaborative practice agreement shall be consistent with the example contained in N.J.A.C. 13:3…

(a) A collaborative practice protocol shall be developed for each different type of collaborative drug therapy management authorized by the physician under the collaborative practice agreement and shall identify those activities that may be performed by the collaborating pharmaci…

(a) Written informed consent shall be obtained from each individual patient participating in collaborative drug therapy management. Both the physician and the pharmacist shall retain a copy of the patient's written informed consent. The written informed consent shall:1. Contain t…

(a) Collaborative drug therapy management shall be between a single patient with whom the physician has a bona fide physician-patient relationship, the physician, and the patient's collaborative practice pharmacist(s) and shall address that patient's specific condition, disease o…

(a) Participation in, or withdrawal from, a collaborative practice agreement shall be voluntary on the part of a physician and a pharmacist. (b) Participation in, or withdrawal from, collaborative drug therapy management shall be voluntary on the part of the individual patient. N…

Any violation of the collaborative practice agreement or protocols on the part of the pharmacist may be deemed professional misconduct and may subject the pharmacist to discipline consistent with N.J.S.A. 45:1-21. Notes N.J. Admin. Code § 13:39-13.9

(a) A pharmacist shall be authorized to furnish self-administered hormonal contraceptives to a patient, in accordance with standardized procedures and protocols jointly developed and approved by the Board and the State Board of Medical Examiners as set forth at N.J.A.C. 13:39 App…

(a) In order for a pharmacist to be authorized to furnish self-administered hormonal contraceptives pursuant to the Protocol, the pharmacist shall: 1. Complete a training program compliant with N.J.A.C. 13:39-14.7; 2. Affirm, in writing, that the pharmacist has completed a traini…

(a) Pharmacists may furnish the following self-administered hormonal contraceptives pursuant to the Protocol: 1. Combined oral contraceptive pill; 2. Progestin-only oral contraceptive pill; 3. Patch; 4. Ring; and 5. Injectable hormonal contraceptive. (b) A pharmacist may not furn…