New Jersey Administrative Code

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

(a) A compounding pharmacist shall be responsible for the ensuring that: 1. Compounded non-sterile preparations have been properly prepared, labeled, controlled, stored, dispensed, and distributed in accordance with the provisions of this subchapter; 2. All aspects of the compoun…

(a) The beyond-use date is the date after which a compounded non-sterile preparation shall not be used. The beyond-use date shall be determined from the date the preparation is compounded. Because compounded preparations are intended for administration immediately or following sh…

(a) All ingredients used to compound non-sterile preparations shall be United States Pharmacopeia-National Formulary (USP-NF), analytical reagent (AR), certified American Chemical Society (ACS), or Food Chemicals Codex (FCC) grade substances. If a USP-NF, AR, ACS, or FCC grade su…

(a) The dispensed container for any compounded non-sterile preparation shall bear a permanently affixed label with at least the following information: 1. In a retail pharmacy only, the name of the prescriber. i. An institutional pharmacy compounding non-sterile preparations for o…

(a) The compounding pharmacist shall provide immediate personal supervision to pharmacy technicians, pharmacy interns, or pharmacy externs who are performing non-sterile preparation compounding.1. Supervision shall include, but is not limited to, the checking of each ingredient u…

(a) A pharmacy shall maintain an audit trail for all non-sterile compounded preparation prescriptions dispensed consistent with the requirements of N.J.A.C. 13:39-7.6. (b) Except as provided in (c) below, a pharmacy shall maintain a compounding record for each compounded non-ster…

The following words and terms, when used in this subchapter, shall have the following meanings: "Compounding" means the preparation, mixing, assembling, packaging, and labeling of a drug or device as the result of a practitioner's prescription or medication order or initiative ba…

(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…

(a) A pharmacist shall not compound commercially available products unless: 1. The commercially available product is modified to produce a significant difference, in the professional judgment of the prescriber, between the compounded product for the patient and the comparable com…

A pharmacist may compound non-sterile preparations in a quantity that is supported by prior valid prescriptions or medication orders before receiving a valid written prescription or medication order, provided the pharmacist can document a history of valid prescriptions subsequent…

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

(a) A pharmacist may prepare a pharmacy generated product to be sold over-the-counter without a prescription or medication order provided that: 1. The product does not contain an ingredient that exceeds allowable strengths and doses for over-the-counter drugs; and 2. The finished…

(a) A pharmacy that regularly engages in compounding shall have an area specifically designated for the safe and orderly compounding of drug products. Such area shall allow for the orderly placement of equipment and materials in order to minimize the potential for errors. (b) A p…

(a) A pharmacy shall possess equipment appropriate to the type of compounding performed at the pharmacy. (b) Equipment used in compounding drug products shall be of appropriate design and capacity, and shall be suitably located to facilitate operations for the intended use, clean…

(a) The rules in this subchapter regulate the practice of compounding antineoplastic agents and other hazardous substances for both sterile and non-sterile preparations and shall apply to all retail and institutional pharmacies that compound and dispense antineoplastic agents and…

(a) The following words and terms, when used in this subchapter, shall have the following meanings: "Hazardous substances" shall mean those substances identified as hazardous by the National Institute for Occupational Safety and Health (NIOSH) in NIOSH Publication No. 2004-165: P…

(a) Pharmacies shall not prepare antineoplastic agents and other hazardous substances as immediate use compounded sterile preparations. (b) A pressure indicator or air velocity meter shall be installed that can be readily monitored for correct room pressurization or air velocity,…