N.Y. Public Health Law 3325 – Authority to issue licenses; applications
§ 3325. Authority to issue licenses; applications. 1. Subject to the provisions of this title, the commissioner is authorized to license a person to manufacture, obtain and possess, dispense, and administer controlled substances for purposes of scientific research, chemical analysis or instruction.
Terms Used In N.Y. Public Health Law 3325
- Administer: means the direct application of a controlled substance, whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject. See N.Y. Public Health Law 3302
- Amendment: A proposal to alter the text of a pending bill or other measure by striking out some of it, by inserting new language, or both. Before an amendment becomes part of the measure, thelegislature must agree to it.
- Commissioner: means commissioner of health of the state of New York. See N.Y. Public Health Law 3302
- Controlled substance: means a substance or substances listed in section thirty-three hundred six of this title. See N.Y. Public Health Law 3302
- Department: means the department of health of the state of New York. See N.Y. Public Health Law 3302
- Dispense: means to deliver a controlled substance to an ultimate user or research subject by lawful means, including by means of the internet, and includes the packaging, labeling, or compounding necessary to prepare the substance for such delivery. See N.Y. Public Health Law 3302
- Diversion: means manufacture, possession, delivery or use of a controlled substance by a person or in a manner not specifically authorized by law. See N.Y. Public Health Law 3302
- Drug: means
(a) substances recognized as drugs in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them;
(b) substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; and
(c) substances (other than food) intended to affect the structure or a function of the body of man or animal. See N.Y. Public Health Law 3302 - License: means a written authorization issued by the department or the New York state department of education permitting persons to engage in a specified activity with respect to controlled substances. See N.Y. Public Health Law 3302
- Manufacture: means the production, preparation, propagation, compounding, cultivation, conversion or processing of a controlled substance, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of the substance or labeling or relabeling of its container, except that this term does not include the preparation, compounding, packaging or labeling of a controlled substance:
(a) by a practitioner as an incident to his administering or dispensing of a controlled substance in the course of his professional practice; or
(b) by a practitioner, or by his authorized agent under his supervision, for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale; or
(c) by a pharmacist as an incident to his dispensing of a controlled substance in the course of his professional practice. See N.Y. Public Health Law 3302 - Person: means individual, institution, corporation, government or governmental subdivision or agency, business trust, estate, trust, partnership or association, or any other legal entity. See N.Y. Public Health Law 3302
2. A license or amendment of a license shall be issued by the department unless the applicant therefor has failed to furnish a satisfactory protocol pursuant to subdivision three of this section, or a satisfactory statement pursuant to section 3326, and proof that the applicant:
(a) and its managing officers are of good moral character;
(b) possesses or is capable of acquiring facilities, staff and equipment sufficient to carry on properly the proposed project detailed in the protocol or statement accompanying the application;
(c) is able to maintain effective control against diversion of the controlled substances for which the license is sought;
(d) is able to comply with all applicable state and federal laws and regulations relating to the controlled substances for which the license is sought.
3. An application for a license or for an amendment to a license shall be accompanied by a detailed protocol setting forth:
(a) the nature of the proposed project;
(b) the proposed quantity or quantities of each controlled substance involved;
(c) the qualifications and competence of the applicant to engage in such project;
(d) specific provisions for the safe administration or dispensing of controlled substances to humans, if such is contemplated, and the proposed method of selecting humans;
(e) such other additional information as the commissioner may require.
4. The application for a license pursuant to this title shall include copies of all papers filed with the Bureau, the Federal Food and Drug Administration and any other governmental agency, whether state or federal, in connection with the applicant's proposed project.