Title 24, Title 24: FOOD AND DRUGS

24:6B-13. Appropriation There is hereby appropriated to the department so much of the revenue, not in excess of $25,000.00, derived from the registration fees as shall be required to administer this act during the fiscal year ending June 30, 1962. L.1961, c. 52, p. 532, s. 14.

24:6B-14 Definitions relative to pharmaceutical wholesale distributors. 5. As used in sections 5 through 24 of P.L.2005, c.206 (C.24:6B-14 et seq.): "Adulterated" means a prescription drug that is adulterated pursuant to R.S.24:5-10. "Authenticate" means to affirmatively verify b…

24:6B-15 Licensure required for pharmaceutical wholesale distributors. 6. a. A wholesale distributor engaged in the wholesale distribution of prescription drugs within this State, whether or not the wholesale distributor is located in this State, shall be licensed by the departme…

24:6B-16 Criminal history record background check for applicants, designated representatives, persons enumerated. 7. a. The commissioner shall require each applicant, designated representative or any person enumerated in subsection c. of section 6 of this act, in accordance with …

24:6B-17 Establishment, maintenance of list of authorized distributors. 8. a. A manufacturer that is registered with the department pursuant to P.L.1961, c.52 (C.24:6B-1 et seq.) shall establish and maintain an up-to-date list of its authorized distributors and authorized distrib…

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 de…

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…

24:6B-2 Registration statement, signature, verification; form and contents. 2. The registration statement shall be signed and verified by the individuals specified in subsection (c) hereof, shall be made on forms prescribed and furnished by the commissioner, and shall state such …

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 …

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 f…

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 ad…

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 anothe…

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 contr…

24:6B-25 Criteria for return of prescription drug to wholesale distributor. 16. a. (1) A pharmacy, chain pharmacy distribution center or pharmacy member of an affiliated group shall return to a wholesale distributor any prescription drug that is on the specified list of susceptib…

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 Stat…

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 whol…

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…

24:6B-29 Violations, gradation of offenses. 20. a. A person is guilty of a crime of the third degree if the person: (1) engages in the wholesale distribution of prescription drugs and, with intent to defraud or deceive, fails to deliver to another person a complete and accurate p…

24:6B-3. Time for filing A registration statement shall be filed prior to February 1 in each calendar year following the calendar year of original registration. L.1961, c. 52, p. 529, s. 3.

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…

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 tha…

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 …

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 provision…

24:6B-4. Fee A fee shall accompany each registration statement. It shall be $200.00 if the business has less than 2 locations in this State, and $500.00 if the business has 2 or more locations in this State; except that where the gross total annual business in drugs of a registra…

24:6B-5. Change of address; notice; fee If any location of a registered business is to be changed, the registrant shall give the department written notice prior to the change of the address of such new location and the name and address of the individual to be in charge thereof. A…

24:6B-6. Cleanliness of premises Every room in the premises or place where drugs are manufactured, packaged or stored shall be kept clean and sanitary and shall be properly lighted, drained and ventilated. The walls and floors of such rooms shall be constructed of materials which…

24:6B-7. Cleanliness of equipment and machinery Equipment and machinery used in the manufacture of drugs and any vehicles used for the transportation and delivery of such drugs shall be kept in a clean and sanitary condition. L.1961, c. 52, p. 529, s. 7.

24:6B-8. Washroom and toilet facilities Adequate washroom and toilet facilities shall be provided and maintained in the premise or place where drugs are manufactured, packaged or stored and such facilities shall be kept in a clean and sanitary condition. L.1961, c. 52, p. 529, s.…

24:6B-9. Adulteration or misbranding of drug; examination of records Whenever an officer or employee of the department finds, or has probable cause to believe, that any drug is adulterated or misbranded, he shall have the right to examine and copy any records listing the ingredie…