§ 3311. Authority to issue initial licenses, amended licenses, and to renew licenses. 1. Subject to the provisions of this article the commissioner is authorized to issue licenses authorizing the manufacture or distribution of controlled substances.

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Terms Used In N.Y. Public Health Law 3311

  • 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
  • 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
  • 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

2. An application for a license, amendment of a license, or renewal of a license which, if granted, would authorize the manufacture or distribution of a controlled substance which the applicant is not then authorized to manufacture or distribute shall, with respect to any such additional authorization, be treated as an application for an initial license.

3. An application for a license which, if granted, would authorize a licensee to continue to manufacture or distribute a controlled substance shall, with respect to such continued manufacture or distribution only, be treated as an application for renewal of a license.

4. A late-filed application for the renewal of a license may, in the discretion of the commissioner, be treated as an application for an initial license.