New Jersey Statutes 24:6E-6. List of interchangeable drug products
Terms Used In New Jersey Statutes 24:6E-6
- Drug: means (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. See New Jersey Statutes 24:1-1
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
- Food: means (1) articles used for food or drink for man or other animals (2) chewing gum and (3) articles used for components of any such article. See New Jersey Statutes 24:1-1
- New drug: means (1) any drug the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof, and (2) any drug the composition of which is such that such drug, as a result of investigations to determine its safety for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions. See New Jersey Statutes 24:1-1
- person: includes corporations, companies, associations, societies, firms, partnerships and joint stock companies as well as individuals, unless restricted by the context to an individual as distinguished from a corporate entity or specifically restricted to one or some of the above enumerated synonyms and, when used to designate the owner of property which may be the subject of an offense, includes this State, the United States, any other State of the United States as defined infra and any foreign country or government lawfully owning or possessing property within this State. See New Jersey Statutes 1:1-2
- State: extends to and includes any State, territory or possession of the United States, the District of Columbia and the Canal Zone. See New Jersey Statutes 1:1-2
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 department for advance notice of its public hearings and shall be published in the New Jersey Register.
c. Manufacturers shall, upon the request of the department, 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 department 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 department to evaluate its drug products for the purpose of inclusion on the list of interchangeable drug products, or to request that the department consider removal of any drug product from the list. Any such request shall be accompanied by such information as the department 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 department for inclusion on or removal from the list.
e. Prior to any drug product being approved by the department, 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 U.S.C. or in such standards relating to drug manufacturing practices as may be promulgated by the department from time to time and must show evidence of a satisfactory inspection by the Federal Food and Drug Administration or the department.
f. The department 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 department.
g. The department shall be authorized to adopt reasonable rules and regulations, in accordance with the provisions of the “Administrative Procedure Act,” P.L.1968, c.410 (C. 52:14B-1 et seq.), to carry out its functions and duties under this act and to effectuate its purposes.
L.1977, c.240, s.7; amended 2010, c.87, s.2.