reglab/housing_qa huggingface dataset:
NJ Rev Stat § 24:6B-18 (2021)
2021 New Jersey Revised Statutes|Title 24 - Food and Drugs|Section 24:6B-18 - Determination of eligibility for licensure renewal.

24:6B-18 Determination of eligibility for licensure renewal.  9. The department shall determine eligibility for licensure and renewal thereof, of persons engaged in the wholesale distribution of prescription drugs. In addition to any additional factors that the commissioner may deem relevant to protecting the public health and safety, the following shall be considered in determining an applicant's eligibility: a. any suspension, sanction or revocation by a federal, state or local government of any license currently or previously held by the applicant or any of its owners for violations of laws regarding drugs; b. the results of the applicant's criminal history record background check pursuant to section 7 of this act and information regarding the applicant's business provided pursuant to section 6 of this act; c. the applicant's past experience in the manufacturing or distribution of drugs; d. whether the applicant furnished false or fraudulent material in any application related to drug manufacturing or distribution; e. compliance with previously granted licenses related to drug distribution or any health care professional or occupational licenses; and f. a driver's license and Social Security number verification for all company officers, key management, principals and owners, provided that the review does not conflict with State confidentiality laws. L.2005,c.206,s.9.
NJ Rev Stat § 24:6B-19 (2021)
2021 New Jersey Revised Statutes|Title 24 - Food and Drugs|Section 24:6B-19 - Additional requirements for designated representatives.

24:6B-19 Additional requirements for designated representatives.  10. In addition to satisfying any requirements that the commissioner may establish by regulation, a designated representative shall:  a. submit an application that includes the following information:  (1) the person's date and place of birth; (2) the person's occupations, positions of employment and offices held during the past seven years, and the principal business addresses; (3) whether the person has been temporarily or permanently enjoined by a court of competent jurisdiction during the past four years for violating any federal or state law regulating drugs, along with the details of those events; (4) a description of any involvement by the person with any business that manufactured, administered, prescribed, distributed or stored prescription drugs and was named as a party in a lawsuit; (5) a photograph of the person taken within the previous 30 days;  (6) the name, business address, occupation, date and place of birth for each member of the person's immediate family who is employed by the wholesale distributor in a management or operations position or has ownership in the wholesale distribution business. As used in this paragraph, the term "member of the person's immediate family" includes the person's spouse, children, parents and siblings, and the spouses of the person's children and the person's siblings; and (7) such other information as the commissioner deems relevant. b. have a minimum of two years of verifiable, full-time managerial, supervisory, auditing or compliance experience with: (1) a pharmacy, wholesale distributor or drug manufacturer licensed, permitted or registered in this or another state, territory of the United States or the District of Columbia; (2) a nationally recognized drug trade association; or (3) a state or federal agency, where the person's responsibilities included record keeping, storage and shipment of prescription drugs; c. serve as the designated representative for only one wholesale distributor location at any one time; and d. be actively involved in and aware of the actual daily operations of the wholesale distributor. As used in this subsection, "actively involved" means being: employed full-time in a managerial position; physically present at the facility during normal business hours; and knowledgeable about all policies and procedures pertaining to the wholesale distributor's operations. A designated representative may seek assistance from qualified individuals to help ensure compliance with the provisions of this subsection. L.2005,c.206,s.10.
NJ Rev Stat § 24:6B-20 (2021)
2021 New Jersey Revised Statutes|Title 24 - Food and Drugs|Section 24:6B-20 - Requirements for facilities used for wholesale prescription drug distribution.

24:6B-20 Requirements for facilities used for wholesale prescription drug distribution.  11. All facilities used for wholesale prescription drug distribution shall: a. be of suitable construction to ensure that all prescription drugs in the facilities are maintained in accordance with their labeling or official compendium standards; b. be of suitable size and construction to facilitate cleaning, maintenance and proper wholesale distribution operations; c. have adequate storage, lighting, ventilation, temperature, sanitation, humidity, space, equipment and security conditions; d. have a quarantine area for prescription drugs that are adulterated, counterfeit or suspected of being counterfeit, or otherwise unfit for distribution;  e. be maintained in a clean and orderly condition and free from infestation; f. be secure from unauthorized entry, with the outside perimeter of the premises well-lighted and entry into areas where prescription drugs are held limited to authorized personnel; g. be equipped with security and inventory management and control systems that provide suitable protection against theft, diversion or counterfeiting, and can readily provide data to the department; and h. be a commercial location and not a personal dwelling or residence. L.2005,c.206,s.11.
NJ Rev Stat § 24:6B-21 (2021)
2021 New Jersey Revised Statutes|Title 24 - Food and Drugs|Section 24:6B-21 - Provision of pedigree, certification prior to sale, return of prescription drug.

24:6B-21 Provision of pedigree, certification prior to sale, return of prescription drug.  12. a. Before the sale or return of a prescription drug to another wholesale distributor, a selling wholesale distributor shall provide a pedigree or a certification in accordance with the following specifications: (1) if the seller is an authorized distributor of record, a pedigree for each prescription drug that is included on the specified list of susceptible products and was not purchased directly from the manufacturer; or (2) if the seller is neither the prescription drug manufacturer nor an authorized distributor of record, a pedigree for each prescription drug that is distributed. b. A wholesale distributor shall provide for the secure and confidential storage of information with restricted access and policies and procedures to protect the integrity and confidentiality of the information.  c. A wholesale distributor shall conduct business in a commercial location, and not a personal dwelling or residence. d. A wholesale distributor shall provide and maintain appropriate inventory controls in order to detect and document any theft, counterfeiting or diversion of prescription drugs. L.2005,c.206,s.12.
NJ Rev Stat § 24:6B-22 (2021)
2021 New Jersey Revised Statutes|Title 24 - Food and Drugs|Section 24:6B-22 - Annual report to the Legislature on tracking system.

24:6B-22 Annual report to the Legislature on tracking system.  13. The commissioner shall report annually to the Legislature on the availability of an effective standardized electronic product identification tracking system for prescription drugs in this State. The report shall address whether such a system can be feasibly implemented by manufacturers, wholesale distributors and pharmacies for purposes of authentication, and deterrence and detection of counterfeit drugs. If the commissioner determines that implementation of such a system is feasible, he shall make recommendations regarding the timing and method of implementing the system.  L.2005,c.206,s.13.
NJ Rev Stat § 24:6B-23 (2021)
2021 New Jersey Revised Statutes|Title 24 - Food and Drugs|Section 24:6B-23 - Authentication of distribution of prescription drug.

24:6B-23 Authentication of distribution of prescription drug.  14. a. (1) A wholesale distributor shall authenticate every distribution of a prescription drug back to the manufacturer if the wholesale distributor has reason to believe that a prescription drug purchased from another wholesale distributor is adulterated, misbranded or counterfeit. (2) A wholesale distributor who distributed a prescription drug that is the subject of an authentication pursuant to this section shall provide, upon request, information regarding the distribution of the prescription drug, including: date of purchase; sales invoice number; and contact information for the wholesale distributor who sold the prescription drug, including the name, address, telephone number and e-mail address, if available. (3) If a wholesale distributor is unable to authenticate each transfer, the wholesale distributor shall quarantine the prescription drug and report this to the department within 14 days after completing the attempted authentication. (4) If the wholesale distributor satisfactorily completes the authentication, the wholesale distributor shall maintain records of the authentication for two years, and produce them to the department and the Department of Law and Public Safety, upon request.  b. (1) A wholesale distributor shall conduct annual random authentications on at least 10% of pedigrees as required by this act.  (2) A wholesale distributor shall conduct annual random authentications on at least 90% of the pedigrees of prescription drugs designated on the specified list of susceptible products for which a pedigree is required. (3) A wholesale distributor and a manufacturer from whom other wholesale distributors have purchased prescription drugs shall cooperate with random authentications of pedigrees and provide requested information in a timely manner. L.2005,c.206,s.14.
NJ Rev Stat § 24:6B-24 (2021)
2021 New Jersey Revised Statutes|Title 24 - Food and Drugs|Section 24:6B-24 - Examination of shipping container.

24:6B-24 Examination of shipping container.  15. a. A wholesale distributor shall visually examine each shipping container upon receipt to ensure its identity and to determine if it contains prescription drugs that are adulterated, contraband, counterfeit, suspected of being contraband or counterfeit, or otherwise unfit. b. Containers found to be unacceptable under subsection a. of this section shall be quarantined from the rest of stock until an examination and determination are made that the contents are not adulterated, contraband, counterfeit, or otherwise unfit. c. Upon receipt of a shipping container, a wholesale distributor shall review its records for the acquisition of prescription drugs for accuracy and completeness. d. Each outgoing shipment shall be carefully inspected for identity and to ensure that it has been stored under proper conditions. e. Disposal and destruction of containers, labels and packing shall be conducted in a manner to ensure that they cannot be used in counterfeiting activities. Appropriate witnessing of the destruction and disposal shall be in accordance with federal and State requirements.  L.2005,c.206,s.15.
NJ Rev Stat § 24:6B-26 (2021)
2021 New Jersey Revised Statutes|Title 24 - Food and Drugs|Section 24:6B-26 - Requirements for wholesale distributor.

24:6B-26 Requirements for wholesale distributor.  17. A wholesale distributor shall exercise due diligence in accordance with the following requirements, unless the commissioner waives any requirement. Prior to the first purchase of prescription drugs for distribution in this State from another wholesale distributor that is not licensed in this State pursuant to this act, the purchasing wholesale distributor shall obtain the following information from the selling wholesale distributor: a. verification of the wholesale distributor's status as an authorized distributor of record, if applicable, for which purpose inclusion of the wholesale distributor's business name on the manufacturer's list of authorized distributors of record, as required in section 8 of this act, shall be deemed acceptable for verification purposes; b. a list of the state in which the wholesale distributor is domiciled and the states into which it ships prescription drugs; c. the wholesale distributor's most recent facility inspection reports; d. copies of relevant general and product liability insurance coverage;  e. a list of any other names under which the wholesale distributor does business or was formerly known; f. names of corporate officers and managerial employees; g. a list of all disciplinary actions by state and federal agencies involving wholesale distribution of drugs for the last four years, if the selling wholesale distributor supplies it upon request by the purchasing wholesale distributor; and h. a description, including the address, dimensions and other relevant information, of each facility used for prescription drug storage and distribution. L.2005,c.206,s.17.
NJ Rev Stat § 24:6B-27 (2021)
2021 New Jersey Revised Statutes|Title 24 - Food and Drugs|Section 24:6B-27 - Maintenance of document, record relative to pedigree, certification.

24:6B-27 Maintenance of document, record relative to pedigree, certification.  18. a. A person who receives or passes a pedigree or certification pursuant to this act shall maintain the document or record for three years from receipt or passing of the document or record. b. A wholesale distributor shall: (1) establish and maintain records of all transactions regarding the receipt, distribution or other disposition of all prescription drugs, including the dates of receipt and distribution or other disposition of the prescription drugs; and (2) make its inventories and other records available for inspection and copying by an authorized official of any local, State or federal governmental agency for a period of three years following the creation of those records.  c. A wholesale distributor shall ensure that its records as described in this section: (1) if kept at the inspection site or immediately retrievable by computer or other electronic means, are readily available for authorized inspection during the retention period; and (2) if kept at a central location apart from the inspection site and not electronically retrievable, are made available for inspection within two business days of a request by an authorized official of any State or federal governmental agency charged with enforcement of the provisions of this act. d. A wholesale distributor shall maintain an ongoing list of persons with whom it does business related to prescription drugs. e. A wholesale distributor shall establish and maintain procedures for reporting counterfeit or suspected counterfeit prescription drugs, or counterfeiting or suspected counterfeiting activities to the department. f. A wholesale distributor shall maintain a system for mandatory reporting to the department of significant shortages or losses of prescription drugs when diversion of prescription drugs is known or suspected. L.2005,c.206,s.18.
NJ Rev Stat § 24:6B-28 (2021)
2021 New Jersey Revised Statutes|Title 24 - Food and Drugs|Section 24:6B-28 - Adherence to written policies, procedures by wholesale distributors.

24:6B-28 Adherence to written policies, procedures by wholesale distributors.  19. a. A wholesale distributor shall establish, maintain and adhere to written policies and procedures for the receipt, security, storage, inventory, transport, shipping and distribution of prescription drugs, including policies and procedures for: identifying, recording and reporting losses or thefts; correcting all errors and inaccuracies in inventories; and implementing and maintaining a continuous quality improvement system. b. Pursuant to subsection a. of this section, a wholesale distributor shall establish procedures:  (1) for handling recalls and withdrawals of prescription drugs; (2) to prepare for and protect against any crisis that affects the security or operation of any facility; (3) for segregating, returning and destroying prescription drugs, and providing all necessary documentation; (4) for disposal and destruction of containers, labels and packaging to ensure that they cannot be used in counterfeiting activities, which procedures shall require retention of all necessary documentation for at least three years, and appropriate witnessing of the destruction of any labels, packaging, immediate containers or containers in accordance with federal and State requirements; (5) for investigating and reporting significant inventory discrepancies to the department;  (6) for reporting criminal or suspected criminal activities involving the inventory of prescription drugs to the department within five business days of discovery and for reporting suspected criminal activities involving prescription drugs that are also controlled substances to the department; and (7) for satisfying authentication requirements required by section 14 of this act. L.2005,c.206,s.19.
NJ Rev Stat § 24:6B-30 (2021)
2021 New Jersey Revised Statutes|Title 24 - Food and Drugs|Section 24:6B-30 - Noncompliance with orders, penalties.

24:6B-30 Noncompliance with orders, penalties.  21. a. Any person who does not comply with an order of the commissioner within the time specified shall be liable to a penalty, to be established by the commissioner as follows: for the first offense, not less than $200 nor more than $5,000; and, for the second and each succeeding offense, not less than $1,000 nor more than $20,000. The penalties shall be enforced by the department as plaintiff in a summary proceeding in accordance with the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.). b. Nothing in this act shall be construed to prevent or limit the commissioner, the Division of Consumer Affairs in the Department of Law and Public Safety or any appropriate board under the purview of the Division of Consumer Affairs, or the Attorney General from taking any other action permitted by law against a person who violates the provisions of this act.  L.2005,c.206,s.21.
NJ Rev Stat § 24:6B-31 (2021)
2021 New Jersey Revised Statutes|Title 24 - Food and Drugs|Section 24:6B-31 - Real, personal property, certain, subject to forfeiture.

24:6B-31 Real, personal property, certain, subject to forfeiture.  22. Any real or personal property which was used or intended to be used to commit, facilitate or promote the commission of the crime, or which constitutes, is derived from, or is traceable to the gross proceeds that the defendant obtained directly or indirectly as a result of the crime, shall be subject to forfeiture in accordance with the provisions of N.J.S. 2C:64-1 et seq. L.2005,c.206,s.22.
NJ Rev Stat § 24:6B-32 (2021)
2021 New Jersey Revised Statutes|Title 24 - Food and Drugs|Section 24:6B-32 - Wholesale Drug Distribution Advisory Council.

24:6B-32 Wholesale Drug Distribution Advisory Council.  23. a. There is created a Wholesale Drug Distribution Advisory Council within the department to advise the department regarding proposed rules on the distribution of prescription drugs and to recommend any practical measures that may improve the integrity of the prescription drug distribution system. b. The council shall be comprised of eight members as follows:  (1) the commissioner and the Director of the Division of Consumer Affairs in the Department of Law and Public Safety, or their designees, who shall serve ex officio; (2) three persons employed by different wholesale distributors licensed in this State, one of whom shall be appointed by the Governor, one by the President of the Senate and one by the Speaker of the General Assembly; (3) one person employed by a prescription drug manufacturer, appointed by the Governor;  (4) one pharmacist, appointed by the Speaker of the General Assembly; and (5) one representative of a chain pharmacy distribution center, appointed by the President of the Senate. c. The public members shall serve for a term of three years; but, of the members first appointed, two shall serve for a term of one year, two for a term of two years, and two for a term of three years. Members are eligible for reappointment upon the expiration of their terms. Vacancies in the membership of the council shall be filled in the same manner provided for the original appointments. d. The public members shall be appointed, and the council shall organize as soon as practicable following their appointment, but no later than 60 days after the date of enactment of this act. The members shall select a chairperson and vice-chairperson from among the membership of the council. The chairperson shall appoint a secretary, who need not be a member of the council. e. The members shall serve without compensation, but shall be reimbursed for necessary expenses incurred in performing their duties and within the limits of available funds. L.2005,c.206,s.23.
NJ Rev Stat § 24:6B-33 (2021)
2021 New Jersey Revised Statutes|Title 24 - Food and Drugs|Section 24:6B-33 - Rules, regulations.

24:6B-33 Rules, regulations.  24. In accordance with the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), the commissioner shall adopt rules and regulations to ensure the safety and sanitary conduct of pharmaceutical distribution and to carry out the provisions of this act. L.2005,c.206,s.24.
NJ Rev Stat § 24:6D-1 (2021)
2021 New Jersey Revised Statutes|Title 24 - Food and Drugs|Section 24:6D-1 - Definitions

24:6D-1. Definitions  For the purpose of this act: A. A "trademark" shall be deemed to mean a mark used to indicate the maker, owner or seller of a drug, cosmetic or device and includes, among other things, any name of a person, or corporation, or any letter, word, device, emblem, figure, seal, stamp, diagram, brand, wrapper, ticket, stopper, label or other mark, lawfully adopted by him, and usually affixed to a drug, cosmetic or device to denote that the same was imported, manufactured, produced, sold, compounded, bottled, packed, or otherwise prepared by him. B. A trademark shall be "affixed" to a drug, cosmetic or device when it is placed in any manner in or upon: 1. the drug, cosmetic or device itself; or, 2. a box, bale, barrel, bottle, case, cask, platter, or other vessel or package, or a cover, wrapper, stopper, brand, label, or other thing in, by or with which the drug, cosmetic or device is packed, enclosed or otherwise prepared for sale or disposition. C. A "drug" shall be deemed to include (1) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (4) articles intended for use as a component of any article specified in clause (1), (2), or (3); but does not include devices or their components, parts, or accessories. D. "Cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap. E. "Device" means instruments, apparatus, and contrivances, including their components, parts, and accessories, intended (1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or (2) to affect the structure or any function of the body of man or other animals. F. A "counterfeit trademark" is one which is designed to resemble a genuine trademark so as to be likely to induce the belief that it is genuine, whether by the use of words or letters, similar in appearance or in sound, or by any sign, device or other means whatsoever. L.1967, c. 311, s. 1, eff. Feb. 27, 1968.