New Jersey Statutes 24:6A-1. New drugs; introduction into interstate commerce; application; effective date of application; refusal of application; application of chapter
Terms Used In New Jersey Statutes 24:6A-1
- 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
- Federal Act: means the Federal Food, Drug and Cosmetic Act (Title 21, U. See New Jersey Statutes 24:1-1
- Label: means a display of written, printed, or graphic matter upon the immediate container of any article. See New Jersey Statutes 24:1-1
- Labeling: means all labels and other written, printed or graphic matter (1) upon an article or any of its containers or wrappers, or (2) accompanying 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. Any person may file with the Department of Health of the State of New Jersey an application with respect to any new drug subject to the provisions of subsection a. Such person shall submit to the Department of Health of the State of New Jersey as a part of the application (1) full reports of investigations which have been made to show whether or not such drug is safe for use; (2) a full list of the articles used as components of such drug; (3) a full statement of the composition of such drug; (4) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing and packing of such drug; (5) such samples of such drug and of the articles used as components thereof as the Department of Health of the State of New Jersey may require; and (6) specimens of the labeling proposed to be used for such drug.
c. The application provided for in subsection b shall become effective on the sixtieth day after the filing thereof unless prior to such day the Department of Health of the State of New Jersey by notice to the applicant in writing postpones the effective date of the application to such time (not more than one hundred eighty days after the filing thereof) as the Department of Health of the State of New Jersey deems necessary to enable it to study and investigate the application.
d. If the Department of Health of the State of New Jersey finds, after due notice to the applicant and giving him an opportunity for a hearing that (1) the investigations, reports of which are required to be submitted to the Department of Health of the State of New Jersey pursuant to subsection b, do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions; (3) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug, are inadequate to preserve its identity, strength, quality, and purity; or (4) upon the basis of the information submitted to the Department of Health of the State of New Jersey as part of the application, or upon the basis of any other information before the Department of Health of the State of New Jersey with respect to such drug, the Department of Health of the State of New Jersey has insufficient information to determine whether such drug is safe for use under such conditions, the Department of Health of the State of New Jersey may, prior to the effective date of the application, issue an order refusing to permit the application to become effective.
e. This chapter shall not apply
(1) to a drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety of drugs provided the drug is plainly labeled “For investigational use only” ; or
(2) to a drug sold in this State at any time prior to the enactment of this subtitle or introduced into interstate commerce at any time prior to the enactment of the Federal Act; or
(3) to any drug which is licensed under the virus serum, and toxin Act of July 1, 1902 (U.S.C.1934 ed. title 42, Chap. 4); or
(4) to a drug dispensed on a written prescription signed by a physician, dentist, or veterinarian (except a drug dispensed in the course of conduct of a business of dispensing drugs pursuant to diagnosis by mail) if (1) such physician, dentist, or veterinarian is licensed by law to administer such drug, and (2) such drug bears a label containing the name and place of business of the dispenser, the serial number and date of such prescription, and the name of such physician, dentist, or veterinarian.
L.1939, c. 320, p. 787, s. 35, eff. Jan. 1, 1940.