N.Y. Public Health Law 3312 – Application for initial license
§ 3312. Application for initial license. 1. An applicant for an initial license to manufacture or distribute controlled substances shall furnish to the department such information as it shall require and evidence that the applicant:
Terms Used In N.Y. Public Health Law 3312
- Affidavit: A written statement of facts confirmed by the oath of the party making it, before a notary or officer having authority to administer oaths.
- Department: means the department of health of the state of New York. See N.Y. Public Health Law 3302
- Distribute: means to deliver a controlled substance, including by means of the internet, other than by administering or dispensing. 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
- Equitable: Pertaining to civil suits in "equity" rather than in "law." In English legal history, the courts of "law" could order the payment of damages and could afford no other remedy. See damages. A separate court of "equity" could order someone to do something or to cease to do something. See, e.g., injunction. In American jurisprudence, the federal courts have both legal and equitable power, but the distinction is still an important one. For example, a trial by jury is normally available in "law" cases but not in "equity" cases. Source: U.S. Courts
- 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.
- 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
(a) and its managing officers are of good moral character;
(b) possesses sufficient land, buildings and equipment to properly carry on the activity described in 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 manufacture or distribution of the controlled substances for which the license is sought.
2. The application shall include the name, residence address and title of each of the officers and directors and the name and residence address of any person having a ten percentum or greater proprietary, beneficial, equitable or credit interest in the applicant. Each such person, if an individual, or lawful representative if a legal entity, shall submit an affidavit with the application setting forth:
(a) any position of management or ownership during the preceding ten years of a ten percentum or greater interest in any other business, located in or outside this state, manufacturing or distributing drugs; and
(b) whether such person or any such business has been convicted, fined, censured or had a license suspended or revoked in any administrative or judicial proceeding relating to or arising out of the manufacture or distribution of drugs; and
(c) such other information as the commisisoner may require.
3. The applicant shall be under a continuing duty to report to the department any change in facts or circumstances reflected in the application on any newly discovered or occurring fact or circumstance which is required to be included in the application.