State Codes and Statutes

Statutes > New-jersey > Title-24 > Section-24-6e > 24-6e-6

24:6E-6.  Interchangeable drug products;  list;  hearing;  duties and rights  of manufacturers;  distribution of copies;  rules and regulations for act    a.  The council shall prepare a list of interchangeable drug products. This  list shall be periodically reviewed in accordance with a schedule of and procedure for such review as shall be established by the council.  In development of the list, distinctions shall be made when:  (1) evidence of bioequivalence is considered critical and when it is not;  (2) when levels of toxicity are considered critical and when they are not.  The list may include interchangeable drug products used by the United States Government and its agencies, where the government or such agency has established the reliability of the drug products interchanged.

    b.  No drug products shall be included in such list until after a public hearing has been held thereon after at least 20 days notice.  Such notice shall  be mailed to every drug company that is authorized to do business in the State  of New Jersey and to all persons who have made a timely request of the council  for advance notice of its public hearings and shall be published in the New  Jersey Register.

    c.  Manufacturers shall, upon the request of the council, be required to submit any information in their files that relates manufacturing processes and in vivo and in vitro tests to the bioavailability of any drug product. This requirement shall also apply to technical information obtained during research related to the development of new drug products, even when such information bears only an indirect relationship to the final dosage form. The council shall not make such information public when there is a proprietary interest on the part of the manufacturer.

    d.  Any manufacturer of drug products shall have the right to request the council to evaluate its drug products for the purpose of inclusion on the list of interchangeable drug products, or to request that the council consider removal of any drug product from the list.  Any such request shall be accompanied by such information as the council shall require, and any drug product involved shall be evaluated in the same manner and shall be subject to the same procedures and requirements as all other drug products evaluated by the council for inclusion on or removal from the list.

    e.  Prior to any drug product being approved by the council, the manufacturer shall be required to demonstrate that it has complied with the standards set forth in the Current Good Manufacturing Practices of Title 21 USC  or in such standards relating to drug manufacturing practices as may be promulgated by the Department of Health from time to time and must show evidence of a satisfactory inspection by the Federal Food and Drug Administration or the Department of Health.

    f.  The council shall distribute copies of the list of interchangeable drug  products and revisions thereof and additions thereto among physicians and other  authorized prescribers and licensed pharmacists, and shall supply a copy to any  person upon request, upon payment of the price established by the council.

    g.  The council shall be authorized to adopt reasonable rules and regulations, in accordance with the provisions of the Administrative Procedure Act, P.L.1966, c. 410 (C. 54:14B-1 et seq.), to carry out its functions and duties under this act and to effectuate its purposes.

     L.1977, c. 240, s. 7, eff. Sept. 29, 1977.