reglab/statecodes huggingface dataset:
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.6 - Pharmacy and Therapeutics Committee; applicability; policies and procedures

Current through Register Vol. 56, No. 14, July 15, 2024
(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 Pharmacy and Therapeutics Committee shall be multidisciplinary and include a pharmacist.
(b) In all health care facilities providing pharmaceutical services to patients that are not required to maintain a Pharmacy and Therapeutics Committee pursuant to Department of Health rules, the pharmacist-in-charge of the provider pharmacy, in cooperation with the health care facility, shall create policies and procedures as needed to provide pharmaceutical services to the health care facility. Copies of the policies and procedures shall be made available to the Board upon request.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.8 - Control of health care pharmaceutical services; responsibilities of the pharmacist-in-charge of the provider pharmacy

Current through Register Vol. 56, No. 14, July 15, 2024
(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 or chooses to utilize the services of a pharmacy outside the health care system, it may enter into an agreement with a retail pharmacy licensed by the Board. The pharmacist-in-charge of the retail pharmacy shall direct, control, supervise and be responsible for the pharmaceutical services provided to the facility.
(c) The pharmacist-in-charge of the provider pharmacy, with the cooperation of the Pharmacy and Therapeutics Committee, shall develop written policies and procedures as needed to provide pharmaceutical services to the facility. The written policies and procedures shall be available to the Board.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.10 - Pharmaceuticals; drug supply; investigational drugs; controlled dangerous substances

Current through Register Vol. 56, No. 14, July 15, 2024
(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 and/or pharmacy buyer of the facility may perform the actual procurement. All purchases shall be reviewed by the pharmacist-in-charge or his or her designee, who shall be a pharmacist.
(b) Written policies and procedures for the maintenance, content, control and accountability of drugs supplied and located throughout the facility shall be developed by the pharmacist-in-charge and approved by the Pharmacy and Therapeutics Committee.
(c) Written policies and procedures for the control, use, and accountability of Investigational New Drugs shall be developed by the pharmacist-in-charge and the Pharmacy and Therapeutics Committee. The storage, labeling, and dispensing of all Investigational New Drugs shall be a pharmaceutical service provided in cooperation with, and in support of the principal investigator. Under these parameters, the dispensing of these drugs shall not be construed to be a violation of N.J.A.C. 13:39-7.5(a). A facility participating in experimental research involving residents shall comply with Federal Department of Health and Human Services regulations, set forth at 45 CFR Part 46, Protection of Human Subjects of Research, which is incorporated by reference herein, as amended and supplemented and with the Rowan University Guidance on Human Subjects Research, which is incorporated herein by reference, as amended and supplemented, and which is available at
http://www.rowan.edu/som/hsp/guidance/index.html
.
(d) Written policies and procedures for the control, use and accountability of controlled dangerous substances shall be developed by the pharmacist-in-charge and the Pharmacy and Therapeutics Committee. Controlled dangerous substances shall be purchased, received, stored, dispensed, administered, recorded and controlled in accordance with State and Federal laws and regulations.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.11 - Drug disbursement; written orders

Current through Register Vol. 56, No. 14, July 15, 2024
(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 13:39-9.13.
(b) Drugs not specifically limited as to time or number of doses when ordered shall be controlled by the automatic stop order procedure or other methods in accordance with written policies of the facility.
(c) The Pharmacy and Therapeutics Committee shall develop a list of unapproved or unacceptable abbreviations and symbols which shall not be used in the facility. Orders involving symbols or abbreviations shall only be dispensed consistent with this list.
(d) When appropriate, the pharmacist shall make necessary entries into the patient medical record relative to drug use in accordance with health care facility policies and, where applicable, pursuant to regulations of the Department of Health and/or Centers for Medicare and Medicaid Services.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.12 - Drug disbursement; oral orders

Current through Register Vol. 56, No. 14, July 15, 2024
(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 recorded and signed by the person receiving the order on the medication order sheet or into the electronic data processing system.
(c) Oral orders for Schedule II controlled substances shall be permitted only in the case of a bona fide emergency situation.
(d) Oral orders received consistent with the requirements of (b) and (c) above shall be countersigned by the practitioner.
(e) The pharmacist may release to the patient at discharge any remaining medication in a multiple dose container (for example, inhalers, multiple dose injectable medications, such as insulin, topical preparation, drops, ointments and topical irrigation solutions), and a limited supply of other medications, provided that the pharmacist:
1. Labels the medications for out-patient use pursuant to labeling requirements set forth in 13:39-7.12;
2. Counsels the patient prior to discharge from the hospital or medical facility pursuant to 13:39-7.21; and
3. Ensures that discharge orders contain the attending physician's authorizations to dispense the remaining doses of the prescription or the limited supply of other medications to the patient or guardian.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.13 - Monitoring of patient drug therapy

Current through Register Vol. 56, No. 14, July 15, 2024
(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 administration of STAT orders (orders requiring immediate attention) these drugs shall be documented on the patient's medication profile immediately after dispensing.
(c) When the pharmacy is closed, these drugs shall be documented on the patient's medication profile immediately after the pharmacy is reopened.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.14 - Medication not dispensed in finished form

Current through Register Vol. 56, No. 14, July 15, 2024
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 dispensed in finished form.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.15 - Drug labeling

Current through Register Vol. 56, No. 14, July 15, 2024
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 intravenous solutions shall be consistent with the labeling requirements set forth in N.J.A.C. 13:39-11.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.16 - Use of patient's own medication

Current through Register Vol. 56, No. 14, July 15, 2024
(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 Therapeutics Committee.
(b) Although the use of patient's own medications may be warranted in certain situations, it should be discouraged as a general or routine practice. If a patient's previously acquired medication is to be used, a written order to this effect shall be signed and dated by the patient's physician. Such medications shall be identified by the pharmacist as to contents and dispensing origin. Also, these medications shall be documented as part of the pharmacy's patient profile record system.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.17 - Drug-dispensing devices

Current through Register Vol. 56, No. 14, July 15, 2024
(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 the day or night), provided that any absence of the pharmacist does not exceed 24 hours, or when the pharmacist is on duty, provided that proper review of the use of the drug-dispensing device can be ascertained. The supervision of any drug dispensing device so utilized shall be the responsibility of the pharmacist-in-charge servicing the health care facility. The drug-dispensing device data shall be checked for accuracy every 24 hours by a pharmacist and so documented.
(b) Packaging and labeling of medication for drug-dispensing devices, when done by the pharmacy, shall be performed under the immediate personal supervision of a pharmacist in the employ of or under contract to the facility.
(c) Stocking of the drug-dispensing devices with prepackaged medications shall be performed by or under the supervision of a pharmacist.
(d) The cleanliness of the drug dispensing devices shall be maintained by a pharmacist or by a person under the supervision of a pharmacist.
(e) Controlled substances and other medications to which, in the professional judgment of the pharmacist-in-charge, access should be limited, shall be secured within the drug dispensing device to limit access to single medications only and shall be checked and documented by the pharmacist or his or her designee who shall be a licensed health care professional, every 24 hours. Other than a pharmacist, only authorized registered nurses, licensed practical nurses, practitioners, pharmacy technicians, interns and externs shall have access to the medication in each drug-dispensing device. The activity regarding all medication, including the identity of the person accessing the medication, shall be recorded and available to the pharmacist.
(f) All medications withdrawn from a drug dispensing device require a medication order by an authorized practitioner. All such medication orders shall be checked by the pharmacist within 24 hours from the time of the original order and so noted on the pharmacy's patient medication profile.
(g) When there is no pharmacy on the premises and when the drug-dispensing devices are an integral part of the approved drug distribution system of the facility, the devices shall be controlled by the pharmacist-in-charge who is responsible for the pharmaceutical services of the institution. Under these circumstances, the time between medication order checks shall not exceed 24 hours.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.18 - Disposal of unused medications

Current through Register Vol. 56, No. 14, July 15, 2024
(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 missing, shall be sent to the pharmacy for final disposition, or shall be disposed of by the health care facility according to its written protocol.
2. If a unit dose packaged medication has been stored in a medication room or secure area in the institution and the medication seal and control number are intact, the medication may be recycled and redispensed.
3. Any and all medication returned by out-patients of the facility shall not be redispensed.
4. The record of disposal of unused or nonadministered dispensed controlled dangerous substances expended or wasted either by accident or intent shall be signed and cosigned and witnessed by a licensed nurse, physician, or pharmacist, or where allowed by Department of Health rules an administrator of the health care facility, and disposed of by the health care facility according to its written protocol and consistent with all local, State, and Federal laws and regulations.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.20 - Drug information and education

Current through Register Vol. 56, No. 14, July 15, 2024
(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 shall include, but not be limited to, those required by the Board under 13:39-5.8.
(b) On each patient care unit, the pharmacist shall maintain the following:
1. A copy of the current institutional formulary;
2. A reference drug compendium which will give basic information concerning drugs approved by the Pharmacy and Therapeutics Committee; and
3. The telephone number of either the local or regional poison control center.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.21 - After hours access to the institutional pharmacy

Current through Register Vol. 56, No. 14, July 15, 2024
(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 designated by the registered pharmacist-in-charge may obtain medication from the hospital pharmacy as needed in an emergency and not available as floor stock.
(c) A designated registered nurse shall remove only those medication doses which shall be administered prior to the opening of the pharmacy. The designated registered nurse may remove the following from the pharmacy stock of drugs or automated dispensing device:
1. A drug in its original container or a drug pre-packaged by the pharmacy for use in the institution;
2. The required dose(s) of a drug from the original container for a specific patient.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.22 - Pharmacy facilities; space

Current through Register Vol. 56, No. 14, July 15, 2024
(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 through proper purchasing, receipt, storage, dispensing, administration and control of drugs.
(b) The facilities shall include, but are not limited to, those requirements provided in N.J.A.C. 13:39-5.4 through 5.8 and 5.11.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.23 - Storage and security

Current through Register Vol. 56, No. 14, July 15, 2024
(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 the facility shall be stored and protected in conformance with State and Federal laws and regulations.
2. Supplies of external preparations stored in patient care areas shall be kept separate from internal medications.
3. The pharmacist-in-charge or, where provided for in Department of Health rules, the director of pharmaceutical services shall be responsible for all the medications in the facility.
4. The drugs throughout the facility shall be maintained under adequate storage conditions including proper lighting, ventilation and temperature control as required by N.J.A.C. 13:39-5.7(b).
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.24 - Equipment

Current through Register Vol. 56, No. 14, July 15, 2024
Adequate equipment shall be provided for the compounding, packaging, labeling, refrigeration, sterilization, testing and safe distribution of drugs and other functions.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.25 - Institutional decentralized pharmacies

Current through Register Vol. 56, No. 14, July 15, 2024
(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 medications is performed.
(b) Medication shall not be dispensed from a decentralized pharmacy without a pharmacist present, except that, when the decentralized pharmacy is closed, a licensed nurse may dispense medication in accordance with the written policies and procedures of the institution.
(c) Institutions operating decentralized pharmacies shall notify the Board, in writing, of the existence of, and the discontinuation of, each decentralized pharmacy location.
(d) Institutional decentralized pharmacies shall be subject to normal Board inspections.
(e) Inspections of all medications in a decentralized institutional pharmacy shall be performed consistent with the requirements of 13:39-9.23.
(f) Institutional decentralized pharmacies shall comply with all requirements in this subchapter applicable to the pharmaceutical services provided by the decentralized pharmacy, as determined by the pharmacist-in-charge.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.26 - Valid medication orders; out-of-State medication orders

Current through Register Vol. 56, No. 14, July 15, 2024
(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 orders, other than those listed in (a) above, shall not be filled by a pharmacy in New Jersey.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 9 - PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES › Section 13:39-9.27 - Prescriptions and medication orders transmitted by technological devices in an institution

Current through Register Vol. 56, No. 14, July 15, 2024
(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 institutional permit for employees of the institution and their dependents and for eligible outpatients may accept for dispensing prescriptions for all substances consistent with the requirements of 13:39-7.10 and 7.11.
(c) A pharmacist who is authorized to fill inpatient medication orders, as defined in 13:39-9.2, in an institutional pharmacy may accept all inpatient medication orders, including orders for Schedule II substances, which have been transmitted by technological device.
(d) Whenever a pharmacist has reason to question the accuracy or authenticity of a prescription or medication order transmitted by technological device, the pharmacist shall verify the transmission directly with the prescribing practitioner.
(e) It shall be deemed professional misconduct for a pharmacist to use a technological device in order to circumvent his or her responsibilities with regard to documenting, authenticating and verifying medication orders and prescriptions or in order to circumvent other standards of pharmacy practice.
(f) No licensee or permit holder registered under 45:14-40 et seq. shall under any circumstances provide a technological device to, or accept a technological device from, any practitioner licensed to write prescriptions.
(g) No licensee or permit holder shall enter into any agreement with an authorized practitioner which denies the patient the right to have his or her prescription transmitted by technological device to a pharmacy of the patient's choice.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 10 - AUTOMATED MEDICATION SYSTEMS › Section 13:39-10.1 - Purpose and scope

Current through Register Vol. 56, No. 14, July 15, 2024
The rules in this subchapter establish standards applicable to all pharmacies and/or facilities that utilize automated medication systems to store, package, dispense and distribute prescriptions or medication orders.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 10 - AUTOMATED MEDICATION SYSTEMS › Section 13:39-10.2 - "Automated medication system" definition

Current through Register Vol. 56, No. 14, July 15, 2024
As used in this subchapter, "automated medication system" means any process that performs operations or activities, other than compounding or administration, relative to the storage, packaging, dispensing, and distribution of medications, and which collects, controls, and maintains all transaction information. "Automated medication system" does not mean an automatic counting device operated pursuant to N.J.A.C. 13:39-5.9 or a drug dispensing device operated pursuant to N.J.A.C. 13:39-9.17.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 10 - AUTOMATED MEDICATION SYSTEMS › Section 13:39-10.3 - Authority to use automated medication system

Current through Register Vol. 56, No. 14, July 15, 2024
(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 an inspection of the automated medication system. The pharmacy shall not use the system until it receives Board approval.
(b) A pharmacy may use an automated medication system to fill prescriptions or medication orders provided that the pharmacy:
1. Conducts an annual self-inspection of the automated medication system documented on a form provided by the Board. The pharmacy shall make the self-inspection available to the Board upon request;
2. Tests the automated medication system consistent with N.J.A.C. 13:39-10.6. The pharmacy shall make the results of such testing available to the Board upon request; and
3. Makes the automated medication system available to the Board for the purpose of inspection, whereby the Board may validate the accuracy of the self-inspection and/or of the system.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 10 - AUTOMATED MEDICATION SYSTEMS › Section 13:39-10.4 - Written policies and procedures of operation

Current through Register Vol. 56, No. 14, July 15, 2024
(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 all procedures of operation;
3. Set forth methods that shall ensure retention of each amendment, addition, deletion or other change to the policies and procedures of operation for at least two years after the change is made. Each such change shall be signed or initialed by the pharmacist-in-charge and shall include the date on which the pharmacist-in-charge approved the change;
4. Set forth methods that shall ensure that a pharmacist currently licensed in the transmitting jurisdiction reviews and approves the transmission of each original or new prescription or medication order to the automated medication system before the transmission is made;
5. Set forth methods to identify the quality control measures in place to ensure the accuracy of the final dispensed product;
6. Set forth methods that shall ensure that access to the records of medications and other medical information of the patients maintained by the pharmacy is limited to licensed practitioners or personnel approved to have access to the records, for the purpose of complying with 13:39-7.19;
7. Set forth methods that shall ensure that access to the automated medication system for stocking and retrieval of medications is limited to licensed practitioners or qualified pharmacy technicians, interns and externs under the supervision of a pharmacist. An accountability record, which documents all transactions relative to stocking and removing medications from the automated medication system shall be maintained; and
8. Identify the circumstances under which medications may be removed from the automated medication system by a licensed practitioner for distribution to a patient without prior order review by a pharmacist.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 10 - AUTOMATED MEDICATION SYSTEMS › Section 13:39-10.5 - Personnel training requirements

Current through Register Vol. 56, No. 14, July 15, 2024
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 regard to automated medication systems as set forth in the written policies and procedures of operation maintained pursuant to 13:39-10.4.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 10 - AUTOMATED MEDICATION SYSTEMS › Section 13:39-10.6 - Written program for quality assurance

Current through Register Vol. 56, No. 14, July 15, 2024
(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. Establishes mechanisms and procedures to test the accuracy of the automated medication system at least every six months and whenever any upgrade or change is made to the system;
3. Establishes a protocol for measuring the effectiveness of the automated medication system;
4. Requires the pharmacy to report to the Board each recurring error of the automated medication system. A "recurring error," for purposes of this section, means any specific type of inaccuracy within the automated medication system that occurs more than twice within a 14 day period; and
5. Requires the pharmacy to maintain all documentation relating to the written program for quality assurance for at least two years.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 10 - AUTOMATED MEDICATION SYSTEMS › Section 13:39-10.7 - Written plan for recovery

Current through Register Vol. 56, No. 14, July 15, 2024
(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. Planning and preparation for a disaster;
2. Procedures for response to a disaster;
3. Procedures for the maintenance and testing of the written plan for recovery; and
4. A procedure to notify the Board, each organization which has contracted with the pharmacy, each patient of the pharmacy, and other appropriate agencies, of a disaster and the date on which the pharmacy expects to recommence the provision of service.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 10 - AUTOMATED MEDICATION SYSTEMS › Section 13:39-10.8 - Written program for preventative maintenance of automated medication system

Current through Register Vol. 56, No. 14, July 15, 2024
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.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11 - COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11.1 - Purpose and scope

Current through Register Vol. 56, No. 14, July 15, 2024
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 environments associated with compounded sterile preparations and for the skill and knowledge of pharmacy personnel who prepare compounded sterile preparations.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11 - COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11.4 - Cleanroom: use, access, location; temperature; air pressure

Current through Register Vol. 56, No. 14, July 15, 2024
(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 that include any component or fluid pathway surfaces (for example, vial septa, injection ports, beakers), openings (for example, opened ampules, needle hubs), exposed and at risk of direct contact with air (for example, ambient room or HEPA-filtered), moisture (for example, oral and mucosal secretions), or touch contamination. A cleanroom shall include a buffer area and an ante area. The buffer area shall contain an ISO class 5 or better primary engineering control, such as a laminar airflow workbench, biological safety cabinet, compounding aseptic isolator, and/or compounding aseptic containment isolator, unless the buffer area has ISO class 5 or better air quality.
(b) All sterile compounding shall take place within the confines of the buffer area, except for the following:
1. Compounding in a compounding aseptic isolator or a compounding aseptic containment isolator pursuant to 13:39-11.8;
2. Compounding in a laminar airflow workbench in an institutional pharmacy pursuant to 13:39-11.10; and
3. Compounding immediate use compounded sterile preparations in an institutional pharmacy pursuant to 13:39-11.11.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11 - COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11.5 - Cleanroom requirements

Current through Register Vol. 56, No. 14, July 15, 2024
(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 surfaces shall be constructed of smooth, impervious materials, such as stainless steel or molded plastic, so that the work surfaces may be readily cleaned and sanitized. All work surfaces shall be resistant to damage from cleaning and sanitizing agents.
(c) Junctures where ceilings meet walls shall be covered, caulked, or sealed to avoid cracks and crevices in which microorganisms and other contaminates can accumulate. All areas in ceilings and walls where the surface has been penetrated shall be sealed.
(d) Ceilings that consist of inlaid panels shall be impregnated with a polymer to render them impervious and hydrophobic and shall either be caulked or weighted and clipped.
(e) Walls shall be constructed of flexible material (for example, heavy gauge polymer), panels locked together and sealed, or of epoxy-coated gypsum board.
(f) Floors shall have a covering that shall be seamless or have heat-welded seams and coving to the sidewall. There shall be no floor drains.
(g) There shall be no dust-collection overhangs (such as ceiling utility pipes) and ledges (such as window sills) shall be avoided. All sprinkler heads shall be flush with the ceiling.
(h) Ceiling lighting fixtures shall have exterior lens surfaces which are smooth, mounted flush, and air tight.
(i) Carts shall be of stainless steel wire, nonporous plastic, or sheet metal construction with good quality, cleanable casters to promote mobility.
(j) Refrigerators shall be within, or reasonably accessible to, the cleanroom in order to ensure the integrity of the compounded sterile preparations, consistent with the requirements of 13:39-11.12(b)3.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11 - COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11.6 - Ante area requirements

Current through Register Vol. 56, No. 14, July 15, 2024
(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 an integrated and closed plumbing system;
2. Waste containers for all personal protective equipment;
3. An eyewash station; and
4. A hazardous waste spill kit.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11 - COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11.7 - Buffer area requirements

Current through Register Vol. 56, No. 14, July 15, 2024
(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 13:39-11.4(d).
(b) The buffer area shall contain only the following:
1. Items such as furniture, equipment, supplies, and other materials that are required for the tasks to be performed there;
2. Items that are nonpermeable, nonshedding, cleanable, and resistant to damage from disinfectants; and
3. Items that have been cleaned and disinfected immediately prior to their being placed in the buffer area.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11 - COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11.8 - Use of compounding aseptic isolators and compounding aseptic containment isolators located outside of a cleanroom

Current through Register Vol. 56, No. 14, July 15, 2024
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 from the room and maintain ISO class 5 air quality during dynamic operating conditions, including transferring ingredients, components, and devices into and out of the isolator and during preparation of compounded sterile preparations. Particle counts sampled approximately six to 12 inches upstream of the critical exposure site must maintain ISO class 5 air quality levels during compounding operations. Compounding personnel shall obtain documentation from the manufacturer that the compounding aseptic isolator or compounding aseptic containment isolator will meet this standard when located in worse than ISO class 7 environments. A compounding aseptic isolator and compounding aseptic containment isolator not located in a buffer area shall be located in an area that is maintained under sanitary conditions and such area shall only be traveled by persons engaging in the compounding of sterile preparations.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11 - COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11.9 - Compounding of antineoplastic agents and other hazardous substances (Repealed)

Current through Register Vol. 56, No. 14, July 15, 2024
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11 - COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11.10 - Institutional pharmacy use of airflow workbenches not in a buffer area for low-risk level compounded sterile preparations

Current through Register Vol. 56, No. 14, July 15, 2024
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 preparation or as recommended by the manufacturer, whichever is less. Such workbenches shall be located in an area which is maintained under sanitary conditions and which is traveled only by persons engaging in the compounding of sterile preparations. Such workbenches shall not be in a location that has unsealed windows or doors that connect to the outdoors or high traffic flow, or that is adjacent to areas including, but not limited to, construction sites, warehouses, or food preparation. Sinks may not be located adjacent to the ISO class 5 workbench environments and must be separated from the immediate area of ISO class 5 workbenches. Personnel engaged in sterile compounding in such areas shall follow the procedures relating to cleansing and garbing set forth in 13:39-11.14.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11 - COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11.11 - Compounding immediate use compounded sterile preparations in an institutional pharmacy

Current through Register Vol. 56, No. 14, July 15, 2024
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 which the patient experiences a sudden change in clinical status.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11 - COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11.13 - Pharmacy technicians, pharmacy interns, and pharmacy externs; required supervision

Current through Register Vol. 56, No. 14, July 15, 2024
(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 requirements of 13:39-6.15 are met.
1. Supervision shall include, but is not limited to, the checking of each ingredient used, the quantity of each ingredient whether weighed, measured or counted, and the finished label.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11 - COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11.14 - Personnel cleansing and garbing requirements

Current through Register Vol. 56, No. 14, July 15, 2024
(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, and hand, wrist, and other visible jewelry or piercings (for example, earrings, or lip or eyebrow piercings);
2. The wearing of artificial nails or extenders is prohibited while working in the compounding area. Natural nails shall be kept neat and trimmed;
3. Personnel protective equipment shall be donned in the following order:
i. Dedicated shoes or shoe covers;
ii. Head and facial hair covers (for example, beard covers in addition to face masks);
iii. Face masks; and
iv. Eye shields, if required;
4. A hand and forearm cleansing procedure shall be performed. Personnel shall remove debris from underneath fingernails using a nail cleaner under running warm water followed by vigorous hand washing for at least 30 seconds. Hands and forearms to the elbows shall be completely dried using either lint-free disposable towels or an electric hand dryer; and
5. Personnel shall wear non-shedding gowns with sleeves that fit snugly around the wrists and enclosed at the neck, that are designed for buffer area use.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11 - COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11.15 - Cleaning and disinfection requirements for cleanroom, buffer area, and ante area

Current through Register Vol. 56, No. 14, July 15, 2024
(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 shall be cleaned and disinfected at the beginning of each work shift, before each batch preparation is started, after spills, and when surface contamination is known or suspected;
2. All counters, work surfaces, and floors shall be cleaned and disinfected daily; and
3. All walls, ceilings, and storage shelving shall be cleaned monthly.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11 - COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11.17 - Batch preparation

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs, consistent with 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 or medication order, provided the pharmacist:
1. Documents a history of valid prescriptions or medication orders subsequently received, within the beyond-use dating time of each product, which have been generated solely within an established professional prescriber-patient-pharmacist relationship;
2. Maintains the prescription or medication order on file for all such products dispensed at the pharmacy;
3. Documents the batch preparation process, including selection of the drugs, containers, and diluents, lot numbers and expiration dates of the drugs, containers, and diluents, if any, and verification that the compounded sterile preparation has been visually inspected to ensure the absence of particulate matter in solutions, the absence of leakage from vials and bags, and the accuracy and thoroughness of labeling. Each batch shall be given a unique batch number to identify the specific batch; and
4. Ensures that the labeling requirements set forth at 13:39-11.21(a)1, 5, 7, 9, and 10 are satisfied.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11 - COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11.18 - Compounded sterile preparations for prescriber practice use

Current through Register Vol. 56, No. 14, July 15, 2024
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 to the extent permitted by Federal law. A pharmacy may prepare compounded sterile preparations for a licensed prescriber for non-human use in the prescriber's practice without a prescription consistent with State and Federal laws pertinent to the prescriber's health care practice.