N.Y. Public Health Law 3315 – Applications for renewal of licenses to manufacture or distribute controlled substances
§ 3315. Applications for renewal of licenses to manufacture or distribute controlled substances. 1. An application for the renewal of any license issued pursuant to this title shall be filed with the department not more than six months nor less than four months prior to the expiration thereof.
Terms Used In N.Y. Public Health Law 3315
- Commissioner: means commissioner of health of the state of New York. 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
- 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
- Federal controlled substances act: means the Comprehensive Drug Abuse Prevention and Control Act of 1970, Public Law 91-513, and any act or acts amendatory or supplemental thereto or regulations promulgated thereunder. 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. The application for renewal shall include such information prepared in such manner and detail as the commissioner may require, including but not limited to:
(a) any material change in the circumstances or factors listed in section thirty-three hundred twelve of this article;
(b) every known charge or investigation, pending or concluded during the period of the license, by any governmental agency with respect to:
(i) each incident or alleged incident involving the theft, loss, or possible diversion of controlled substances manufactured or distributed by the applicant; and
(ii) compliance by the applicant with the requirements of the federal controlled substances act, or the laws of any state with respect to any substance listed in section thirty-three hundred six of this article.
3. An applicant for renewal shall be under a continuing duty to report to the department any change in facts or circumstances reflected in the application or any newly discovered or occurring fact or circumstance which is required to be included in the application.
4. If the commissioner is not satisfied that the applicant is entitled to a renewal of such license, he shall within forty-five days after the filing of the application serve upon the applicant or his attorney of record in person or by registered or certified mail an order directing the applicant to show cause why his application for renewal should not be denied. Such order shall specify in detail the respects in which the applicant has not satisfied the commissioner that the license should be renewed.
5. Within thirty days of service of such order, the applicant may either submit additional material to the commissioner or demand a hearing or both. If a hearing is demanded the commissioner shall fix a date for hearing not sooner than fifteen days nor later than thirty days after receipt of the demand, unless such time limitation is waived by the applicant.