N.Y. Public Health Law 3321 – Exempt distribution
§ 3321. Exempt distribution. 1. The commissioner by regulation or ruling may exempt from the licensing requirements of this title:
Terms Used In N.Y. Public Health Law 3321
- Commissioner: means commissioner of health of the state of New York. See N.Y. Public Health Law 3302
- Distributor: means a person who distributes a controlled substance. See N.Y. Public Health Law 3302
- Outsourcing facility: means a facility that:
(a) is engaged in the compounding of sterile drugs as defined in § 6802 of the education law;
(b) is currently registered as an outsourcing facility pursuant to Article one hundred thirty-seven of the education law; and
(c) complies with all applicable requirements of federal and state law, including the Federal Food, Drug and Cosmetic Act. 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
- Pharmacy: means any place registered as such by the New York state board of pharmacy and registered with the Federal agency pursuant to the federal controlled substances act. See N.Y. Public Health Law 3302
- Practitioner: means :
A physician, dentist, podiatrist, veterinarian, scientific investigator, or other person licensed, or otherwise permitted to dispense, administer or conduct research with respect to a controlled substance in the course of a licensed professional practice or research licensed pursuant to this article. See N.Y. Public Health Law 3302
(a) the return of controlled substances to a manufacturer, registered outsourcing facility or distributor by a practitioner or pharmacy;
(b) the sale of controlled substances by a pharmacy or practitioner to a pharmacy or practitioner for the immediate needs of the pharmacy or practitioner receiving such substances; and
(c) the disposition of controlled substances by a person in lawful possession thereof who, not in the ordinary course of business, wishes to discontinue such possession.
2. Records of such transactions shall be prepared and maintained and reports filed in such manner as the commissioner shall require.