reglab/statecodes huggingface dataset:
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 13:39-11.19 - Stability and sterility criteria and beyond-use dating

Current through Register Vol. 56, No. 14, July 15, 2024
(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 supporting valid scientific sterility testing and stability information that is directly applicable to specific preparations, the following dates and times for storage and initiation of administration of the compounded sterile preparations shall apply, according to the assigned risk level of the preparation, unless the manufacturer's package indicates a different stability time:
1. For low-risk level compounded sterile preparations, in the absence of passing a sterility test:
i. Administration shall begin within 48 hours when the preparation is stored at controlled room temperature (20 degrees Celsius to 25 degrees Celsius);
ii. Administration shall begin within 14 days when the preparation is stored at cold temperatures (two degrees Celsius to eight degrees Celsius);
iii. Administration shall begin within 45 days when the preparation is stored in a solid frozen state (-20 degrees Celsius); and
iv. For products prepared in an airflow workbench not located in a buffer area in accordance with 13:39-11.10, administration shall begin within 12 hours or less of preparation;
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 13:39-11.20 - Documentation; audit trail

Current through Register Vol. 56, No. 14, July 15, 2024
(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 pharmacist shall be responsible for the accuracy and appropriateness of the compounded prescription. When more than one pharmacist is involved in the steps of the compounding process, the pharmacist shall be responsible for the accuracy and appropriateness of each step he or she performed or he or she approved and reviewed, and his or her unique and secure user identifier(s) shall be recorded in the audit trail.
(b) A pharmacy shall maintain an audit trail for all compounded sterile preparations consistent with the requirements of 13:39-7.6.
(c) A pharmacy shall maintain a compounding record for each compounded sterile preparation that contains the following information:
1. Selection of the drugs, container, and diluent prior to their being compounded, including documentation of lot numbers and expiration dates of the drugs, containers, and diluents, if applicable;
2. Verification that ingredients comply with the prescription or medication order;
3. Verification that the prescription or medication order label complies with the requirements of 13:39-11.21;
4. 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; and
5. Verification that the prescription or medication order is complete and ready to be dispensed, including any necessary ancillary supplies.
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 13:39-11.21 - Information required to appear on prescription label

Current through Register Vol. 56, No. 14, July 15, 2024
(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 for use;
5. The name and strength or quantity of all active ingredients, and the name and volume of the diluent, vehicle, and base solution(s), if applicable;
6. The name, address, and telephone number of the pharmacy;
7. The phrase "use by" followed by the preparation's use by date and time (if no time is stated, it is presumed to be 11:59 P.M. of the stated use by date).
8. Any ancillary and cautionary instructions as needed;
9. As pertinent, a warning, consistent with applicable Federal and State law, that antineoplastic agents and other hazardous substances are biohazardous;
10. As pertinent, the requirements for proper storage; and
11. In a retail pharmacy, for those medications not dispensed pursuant to the requirements of N.J.A.C. 13:39-9, the prescription number.
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 13:39-11.22 - Handling, packaging, and delivery

Current through Register Vol. 56, No. 14, July 15, 2024
(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-charge shall ensure that:
1. Tamper-evident packaging is utilized;
2. Delivery is made from the pharmacy to the patient or patient care location within a reasonable time; and
3. Proper in-transit storage is provided consistent with product labeling.
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 13:39-11.23 - Policy and procedures manual

Current through Register Vol. 56, No. 14, July 15, 2024
(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-management program, including, but not limited to, documentation of incidents, adverse drug reactions, and product contamination.
i. The risk-management program shall require that the pharmacist-in-charge report all confirmed incidents of product contamination to the New Jersey Board of Pharmacy within 48 hours of becoming aware of such incidents;
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 13:39-11.25 - Prohibited compounding

Current through Register Vol. 56, No. 14, July 15, 2024
(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 shall not compound any commercially available drug 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 commercially available product; or
2. The commercially available product is not available from normal distribution channels in a timely manner to meet the patient's needs, and the dispensing of the compounded product has been approved by the prescriber and the patient.
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 13:39-11.26 - Security

Current through Register Vol. 56, No. 14, July 15, 2024
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.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11A - COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11A.1 - Purpose and scope

Current through Register Vol. 56, No. 14, July 15, 2024
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, and environments associated with compounded non-sterile preparations, and for the skill and knowledge of pharmacy personnel who prepare compounded non-sterile preparations. The requirements in this subchapter establish minimum good compounding practices that will enhance a pharmacist's ability to compound non-sterile preparations that are of acceptable strength, quality, and purity.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11A - COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11A.2 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
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 based on the relationship of the practitioner or patient with the pharmacist in the course of professional practice or for the purpose of, or incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescriptions or medication orders based on routine, regularly observed, prescribing patterns.
"Compounding pharmacist" means a pharmacist who performs or supervises any part of the compounding process.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11A - COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11A.3 - Prohibited compounding

Current through Register Vol. 56, No. 14, July 15, 2024
(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 shall not compound any commercially available drug products except as provided in 13:39-11A.4.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11A - COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11A.4 - Compounding commercially available products

Current through Register Vol. 56, No. 14, July 15, 2024
(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 commercially available product; or
2. The commercially available product is not available from normal distribution channels in a timely manner to meet the patient's needs, and the dispensing of the compounded product has been approved by the prescriber and the patient.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11A - COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11A.5 - Batch preparation

Current through Register Vol. 56, No. 14, July 15, 2024
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 subsequently received shortly thereafter or medication orders that have been generated solely within an established professional prescriber-patient-pharmacist relationship, and provided the prescription or medication order is retained on file at the pharmacy, consistent with the requirements of 13:39-7.19. The pharmacist shall document the batch preparation process in accordance with the requirements of 13:39-11A.15.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11A - COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11A.6 - Compounded non-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 non-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 non-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.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11A - COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11A.7 - Preparation of pharmacy generated products (PGPs) for over-the-counter sale

Current through Register Vol. 56, No. 14, July 15, 2024
(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 product is not one for which a prescription or medication order is required.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11A - COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11A.8 - Compounding area

Current through Register Vol. 56, No. 14, July 15, 2024
(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 pharmacy that engages in occasional compounding shall prepare an area prior to each compounding activity that allows for the safe and orderly compounding of drug products. The area shall allow for the orderly placement of equipment and materials in order to minimize the potential for errors.
(c) A pharmacy engaged in compounding shall ensure that:
1. All compounding areas are well-lighted and ventilated and are maintained in a clean and sanitary condition;
2. Heating and air conditioning systems are controlled to avoid decomposition of chemicals;
3. Sewage, trash, and other refuse in and from the pharmacy and immediate drug compounding area are maintained, and disposed of, in a timely, safe, and sanitary manner; and
4. The compounding area is easily accessible to hot and cold running water, exclusive of the bathroom sink; soap or detergent; and air dryers or single source towels.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11A - COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11A.9 - Equipment and supplies

Current through Register Vol. 56, No. 14, July 15, 2024
(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, cleaning, and maintenance of the equipment.
(c) Equipment used in compounding drug products shall be of suitable composition. Equipment surfaces that contact components shall not be reactive, additive, or adsorptive, so as to alter the safety, identity, strength, quality, and purity of the compounded product.
(d) Equipment used in compounding drug products shall be thoroughly cleaned and sanitized after each use, and when necessary, prior to use, in order to prevent cross-contamination of ingredients and preparations.
(e) Equipment used in compounding drug products shall be stored in a manner to prevent cross-contamination of ingredients and preparations.
(f) Automated, mechanical, or electronic equipment may be used in compounding non-sterile preparations. All equipment utilized in compounding non-sterile preparations shall be inspected, maintained, and validated at appropriate intervals, consistent with manufacturer's recommendations, to ensure the accuracy and reliability of equipment performance.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11A - COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11A.10 - Responsibilities of the compounding pharmacist; reporting requirement

Current through Register Vol. 56, No. 14, July 15, 2024
(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 compounding process set out in 13:39-11A.15 are documented and that accurate compounding records for all compounded non-sterile preparations prepared by the pharmacy are maintained;
3. Compounding personnel are capable of performing and qualified to perform their assigned duties;
4. Ingredients used in compounding have their expected identity, quality, and purity consistent with the requirements of 13:39-11A.12;
5. Compounded preparations are of acceptable strength, quality, and purity, with appropriate packaging and labeling, and are prepared in accordance with good compounding practices, official standards, and relevant scientific data and information as set forth in USP 795, which is incorporated herein by reference, as amended and supplemented, and which is available for purchase at the United States Pharmacopeia website,
www.usp.org
;
6. Critical processes are recorded and validated to ensure that procedures will consistently result in the expected qualities in the finished preparation;
7. The compounding environment is suitable for its intended purpose;
8. Appropriate stability evaluation is performed or is determined from the literature for establishing reliable beyond-use dating to ensure that the finished preparations have their expected potency, purity, quality, and characteristics, at least until the labeled beyond-use date;
9. Compounding conditions and procedures are in place to minimize the potential for errors;
10. Adequate procedures and records exist for investigating and correcting failures or problems in compounding, testing, or in the preparation itself; and
11. The patient is advised that the product dispensed is a compounded preparation.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11A - COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11A.11 - Beyond-use dates

Current through Register Vol. 56, No. 14, July 15, 2024
(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 short-term storage, beyond-use dates may be assigned based on criteria different from those applied to assigning expiration dates to manufactured drug products.
(b) In the absence of stability information that is applicable to a specific drug product and preparation, the following are the maximum beyond-use dates for non-sterile compounded drug preparations that are packaged in tight, light-resistant containers and stored at controlled room temperature unless otherwise indicated:
1. For nonaqueous liquids and solid formulations:
i. Where the manufactured drug product is the source of the active ingredient, the beyond-use date shall not be later than 25 percent of the time remaining until the product's expiration date or six months, whichever is earlier;
ii. Where a United States Pharmacopeia-National Formulary (USP-NF), analytical reagent (AR), certified American Chemical Society (ACS), or Food Chemicals Codex (FCC) grade substance is the source of the active ingredient, the beyond-use date shall not be later than six months or the expiration date of the ingredient, whichever is earlier; and
iii. Where there is more than one ingredient, the beyond-use date shall be no longer than six months or the expiration date of the first ingredient to expire, whichever is earlier;
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11A - COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11A.12 - Ingredient selection

Current through Register Vol. 56, No. 14, July 15, 2024
(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 substance ingredient is not available, the pharmacist shall establish the purity and safety of the ingredient by reasonable means, which may include lot analysis, manufacturer reputation, or reliability of source study.
(b) A manufactured drug product may be utilized as the source of an active ingredient. Only manufactured drug products from containers labeled with a batch control number and an unexpired expiration date shall be utilized as sources of active ingredients. When compounding with manufactured drug products, the compounding pharmacist shall consider all ingredients present in the drug product relative to the intended use of the compounded non-sterile preparation.
(c) Components used in the compounding of non-sterile preparations such as aliquots, triturates, stock solutions, buffering agents, or isotonic solutions may be prepared in advance and stored as pharmacy stock. The preparation of such products shall be documented in accordance with the requirements of 13:39-11A.15(b)1  and 6 through 14.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11A - COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11A.13 - Information required to appear on prescription label

Current through Register Vol. 56, No. 14, July 15, 2024
(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 out-patient use shall include the name of the prescriber on the label, consistent with the labeling requirements for a retail pharmacy;
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11A - COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11A.14 - Pharmacy technicians, pharmacy interns, and pharmacy externs; required supervision

Current through Register Vol. 56, No. 14, July 15, 2024
(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 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 11A - COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES › Section 13:39-11A.15 - Audit trail; compounding record documentation

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A pharmacy shall maintain an audit trail for all non-sterile compounded preparation prescriptions dispensed consistent with the requirements of 13:39-7.6.
(b) Except as provided in (c) below, a pharmacy shall maintain a compounding record for each compounded non-sterile preparation that contains the following information:
1. Selection of the ingredients and documentation of source, lot numbers, and expiration dates of all ingredients used;
2. Verification that ingredients comply with the prescription or medication order;
3. Verification that the prescription or medication order label complies with the requirements of 13:39-11A.13;
4. Verification that the prescription or medication order is complete and ready to be dispensed, including any necessary ancillary supplies;
5. Strength of preparation;
6. Date of preparation;
7. Name or personal identifier of the person(s) who performed each step of the compounding process and the compounding pharmacist(s) who verified the preparation;
8. Reference(s) for formulation, if available;
9. Total quantity;
10. Detailed steps of the compounding process to ensure that the exact same compound can be duplicated at a future date;
11. Type of dispensing container used when a drug has specific storage requirements;
12. Beyond-use date of the finished product consistent with the requirements in 13:39-11A.11;
13. The assigned internal identification number for the preparation or the prescription number; and
14. Instructions for use, storage, and handling of the compounded preparation.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11B - COMPOUNDING ANTINEOPLASTIC AGENTS AND OTHER HAZARDOUS SUBSTANCES: STERILE AND NON-STERILE PREPARATIONS › Section 13:39-11B.1 - Purpose and scope

Current through Register Vol. 56, No. 14, July 15, 2024
(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 other hazardous substances. The rules in this subchapter supplement those of N.J.A.C. 13:39-11 and 11A. To the extent the requirements for compounding antineoplastic agents and other hazardous substances are not specifically addressed in this subchapter, the requirements of N.J.A.C. 13:39-11 and 11A, as applicable, shall be followed.
(b) Effective on the effective date of USP 800 (currently, December 1, 2019), the compounding of antineoplastic agents and other hazardous substances shall be consistent with the standards established in USP 800, which is incorporated herein by reference, as amended and supplemented, and which is available for purchase at the United States Pharmacopeia website,
www.usp.org
.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11B - COMPOUNDING ANTINEOPLASTIC AGENTS AND OTHER HAZARDOUS SUBSTANCES: STERILE AND NON-STERILE PREPARATIONS › Section 13:39-11B.2 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
(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: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings, Appendix A (2012 Edition). The sample list of drugs that shall be handled as hazardous (Appendix A) is incorporated herein by reference, as amended and supplemented, and can be found at the Centers for Disease Control and Prevention website,
www.cdc.gov
, specifically,
www.cdc.gov/niosh/docs/2004-165/
.
(b) Any term not defined in this section shall have the definition set forth in N.J.A.C. 13:39-11.2. 13:39-11B.3 Compounding antineoplastic agents and other hazardous products: sterile preparations
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11B - COMPOUNDING ANTINEOPLASTIC AGENTS AND OTHER HAZARDOUS SUBSTANCES: STERILE AND NON-STERILE PREPARATIONS › Section 13:39-11B.3 - Compounding antineoplastic agents and other hazardous products: sterile preparations

Current through Register Vol. 56, No. 14, July 15, 2024
(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, respectively, consistent with the following:
1. Effective up until the day before the effective date of USP 800 (currently, November 30, 2019), for compounding of antineoplastic agents and other hazardous substances in a cleanroom pursuant to N.J.A.C. 13:39-11.9, the primary engineering control shall be placed in an ISO class 7 buffer room that is physically separated from other preparation areas and has not less than 0.01 inch water column negative pressure to adjacent positive pressure ISO class 7 or better ante room, thus providing inward airflow to contain any airborne drug. Effective on the effective date of USP 800 (currently, December 1, 2019), for compounding of antineoplastic agents and other hazardous substances in a cleanroom pursuant to N.J.A.C. 13:39-11.9, the primary engineering control shall be placed consistent with the standards set forth in USP 800.
2. Effective up until the day before the effective date of USP 800 (currently, November 30, 2019), for compounding of antineoplastic agents and other hazardous substances outside of a cleanroom pursuant to N.J.A.C. 13:39-11.8, if a compounding aseptic containment isolator is used outside of a buffer area, the compounding area shall be physically separated from other areas and shall maintain a minimum negative pressure of 0.01 inch water column and have a minimum of 12 air exchanges per hour. Effective on the effective date of USP 800 (currently, December 1, 2019), for compounding of antineoplastic agents and other hazardous substances outside of a cleanroom pursuant to N.J.A.C. 13:39-11.8, if a compounding aseptic containment isolator is used outside of a buffer area, the compounding area shall meet the standards set forth in USP 800.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 11B - COMPOUNDING ANTINEOPLASTIC AGENTS AND OTHER HAZARDOUS SUBSTANCES: STERILE AND NON-STERILE PREPARATIONS › Section 13:39-11B.4 - Compounding antineoplastic agents and other hazardous products: non-sterile preparations

Current through Register Vol. 56, No. 14, July 15, 2024
When antineoplastic agents and hazardous substances are utilized in the compounding of non-sterile preparations, a pharmacy shall adhere to standards established by the Occupational Health and Safety Administration (OSHA) set forth in Section VI, Chapter 2 of OSHA's Technical Manual on Controlling Occupational Exposure to Hazardous Drugs (effective date January 20, 1999). OSHA's Technical Manual is incorporated herein by reference, as amended and supplemented, and can be found at the OSHA website,
www.osha.gov
, specifically,
www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
. Personnel shall also comply with the standards established by National Institute for Occupational Safety and Health (NIOSH) in NIOSH Publication No. 2004-165: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. The NIOSH standard is incorporated herein by reference, as amended and supplemented, and can be found at the CDC website,
www.cdc.gov
, specifically,
www.cdc.gov/niosh/docs/2004-165/
. Effective on the effective date of USP 800 (currently, December 1, 2019), personnel shall also comply with the standards set forth in USP 800.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 12 - NUCLEAR PHARMACIES › Section 13:39-12.1 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
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 any intermediate handling of any components of a radiopharmaceutical.
"Authorized practitioner" means a practitioner duly authorized by applicable Federal and State law to possess, use and administer radiopharmaceuticals.
"Designated agent" means an individual under the direct supervision of a practitioner authorized to communicate the practitioner's instructions to the nuclear pharmacy.
"Immediate personal supervision" means that the pharmacist is physically present in the compounding/dispensing area when interns, externs and pharmacy technicians are performing delegated duties, and the pharmacist conducts any necessary in-process checks and the final check in preparation and compounding of medications, including the checking of each ingredient used, the quantity of each ingredient whether weighed, measured or counted, and the finished label.
"Internal test assessment" includes, but is not limited to, conducting those tests necessary to insure the integrity of the test.
"Radiopharmaceutical" means any substance defined as a drug in Section 201(g)(1) of the Federal Food, Drug and Cosmetic Act or in the FDA's Nuclear Pharmacy Guidelines and which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any such drug which is intended to be made radioactive. This definition includes nuclide generators which are intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides.
"Radiopharmaceutical quality assurance" includes, but is not limited to, the performance of appropriate chemical, biological and physical tests on radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history and the keeping of proper records.
"Radiopharmaceutical service" includes, but is not limited to, the compounding, dispensing, labeling and delivery of radiopharmaceuticals; the participation in radiopharmaceutical utilization reviews; the proper and safe storage and distribution of radiopharmaceuticals; the maintenance of radiopharmaceutical quality assurance; and the offering of those acts, services, operations or transactions necessary in the conduct, operation, management and control of a nuclear pharmacy.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 12 - NUCLEAR PHARMACIES › Section 13:39-12.3 - General requirements for a nuclear pharmacist

Current through Register Vol. 56, No. 14, July 15, 2024
(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 the requirements of the United States Nuclear Regulatory Commission or its successor and the State of New Jersey Bureau of Radiation Protection.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 12 - NUCLEAR PHARMACIES › Section 13:39-12.4 - Minimum requirements for space, equipment, supplies, and library

Current through Register Vol. 56, No. 14, July 15, 2024
(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 square feet; and
3. The compounding and dispensing area shall be a minimum of 300 square feet.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 12 - NUCLEAR PHARMACIES › Section 13:39-12.5 - Quality control

Current through Register Vol. 56, No. 14, July 15, 2024
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 data resulting from chemical, biological and physical tests on potentially radioactive pharmaceuticals to determine the suitability for use in humans and other animals, including internal test assessment and authentication of product history.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 13 - COLLABORATIVE PRACTICE › Section 13:39-13.1 - Purpose and scope

Current through Register Vol. 56, No. 14, July 15, 2024
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, consistent with his or her scope of practice, shall be permitted.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 13 - COLLABORATIVE PRACTICE › Section 13:39-13.2 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
(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 care needs, pursuant to a collaborative practice protocol directed on a voluntary basis by a patient's physician with the patient's informed consent, by the patient's physician and a pharmacist who has signed a collaborative practice agreement with the physician.
"Collaborative practice" means that practice of pharmacy whereby one or more pharmacists have jointly agreed to work in conjunction with one or more physicians for the purpose of collaborative drug therapy management of patients, consistent with the requirements of this subchapter.
"Collaborative practice protocol" means a written document that identifies the collaborative drug therapy management actions that a pharmacist is authorized to perform for a patient and that is developed jointly by the pharmacist and the physician and meets the requirements outlined in 13:39-13.5.
"Informed consent" means the written document that is signed by a patient whereby the patient agrees to collaborative drug therapy management by the patient's physician and a pharmacist who has entered into a collaborative practice agreement with the physician.
"Therapeutic interchange" means the substitution and dispensing of a drug chemically dissimilar from the prescription drug originally prescribed.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 13 - COLLABORATIVE PRACTICE › Section 13:39-13.3 - Board approval; pharmacist qualifications; continuing education

Current through Register Vol. 56, No. 14, July 15, 2024
(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 pharmacist shall submit a collaborative practice application and documentation that establishes that he or she has successfully completed one of the following:
1. A certificate training program offered by an Accreditation Council for Pharmacy Education (ACPE)-approved provider;
2. A post-graduate residency program accredited by the American Society of Health-System Pharmacists; or
3. A certification program from the Board of Pharmacy Specialties.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 13 - COLLABORATIVE PRACTICE › Section 13:39-13.4 - Collaborative practice agreement

Current through Register Vol. 56, No. 14, July 15, 2024
(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. 13:39-13 Appendix, which is incorporated herein by reference. The written agreement shall:
1. Identify, by name and title, each physician and each pharmacist who is permitted to participate in a patient's collaborative drug therapy management, including all covering physicians and/or pharmacists. Each covering physician shall meet the requirements of 13:35-6.27(b)  and each covering pharmacist shall meet the requirements of 13:39-13.3. The agreement shall establish the means by which the physician and/or pharmacist will be notified about covering practitioners for collaborative practice purposes;
2. Specify the functions and responsibilities, including the scope of practice and authority, to be exercised by the pharmacist;
3. Indicate any restrictions placed on the use of certain types or classes of drugs or drug therapies;
4. Indicate any diagnosis or types of diseases that are specifically included or excluded;
5. Include copies of all protocols to be used in the collaborative practice;
6. Contain an effective date for the agreement; and
7. Be signed and dated by the physician(s) and pharmacist(s).
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 13 - COLLABORATIVE PRACTICE › Section 13:39-13.5 - Collaborative practice protocols

Current through Register Vol. 56, No. 14, July 15, 2024
(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 pharmacist.
(b) Each protocol shall:
1. Be jointly developed by the physician and the pharmacist, consistent with standards and practices that are deemed commonly accepted and recognized by national standard setting organizations, or national or State professional organizations of the same discipline as the treating physician, and be signed and dated by both the physician and the pharmacist;
2. Be initiated and utilized at the sole discretion of the physician for a specific patient with whom the physician has a bona fide physician-patient relationship as defined in 13:35-6.27(a);
3. Be agreed to by both the physician and the pharmacist with the written informed consent of the patient, consistent with the requirements of 13:39-13.6;
4. Be available at the practice sites of the pharmacist and physician and made available at each site to the patient;
5. Establish the means by which the patient will be advised of the right to elect to participate in and withdraw from the collaborative drug therapy management;
6. Establish when physician notification is required, the physician chart update interval, and an appropriate time frame within which the pharmacist shall notify the physician of any change in dose, duration, or frequency of medication prescribed. Written notification, by either facsimile or electronic means, shall be provided to the physician no later than eight hours after any change in prescribed medication is made by the pharmacist;
7. Identify the method and time frame for notification of the physician if an adverse event occurs; and
8. Be reviewed at least once per year by the parties to determine whether the protocol should be renewed, modified, or terminated.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 13 - COLLABORATIVE PRACTICE › Section 13:39-13.6 - Informed consent for collaborative drug therapy management

Current through Register Vol. 56, No. 14, July 15, 2024
(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 the specific patient's name;
2. Identify the risks and benefits of collaborative drug therapy management, including the fact that services provided under collaborative drug therapy management may not be covered by the patient's insurance provider;
3. Identify the fact that covering physicians and/or pharmacists may be utilized in the collaborative drug therapy management of the patient's care;
4. Identify the patient's right to elect to participate in and withdraw from the collaborative drug therapy management; and
5. Be signed and dated by the patient.