N.Y. Public Health Law 3322 – Reports and records
§ 3322. Reports and records. 1. Persons licensed under this title or operating a registered outsourcing facility shall maintain records of all controlled substances manufactured, compounded, received, disposed of, delivered or distributed by them. The record shall show the date of receipt or delivery, the name and address, and registration number of the person from whom received or to whom delivered or distributed, the kind and quantity of substance received and delivered or distributed, the kind and quantity of substance produced or removed from the process of manufacture and the date thereof.
Terms Used In N.Y. Public Health Law 3322
- Commissioner: means commissioner of health of the state of New York. See N.Y. Public Health Law 3302
- delivery: means the actual, constructive or attempted transfer from one person to another of a controlled substance, whether or not there is an agency relationship. 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
- 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
- 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 - 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
- Prescribe: means a direction or authorization, by prescription, permitting an ultimate user lawfully to obtain controlled substances from any person authorized by law to dispense such substances. See N.Y. Public Health Law 3302
2. Any person licensed under this title or operating a registered outsourcing facility shall prepare and maintain a biennial report setting forth the current inventory of controlled substances, the quantities of controlled substances manufactured, compounded, delivered or distributed within the state during the period covered by the report and such other information as the commissioner shall by regulation prescribe. Maintaining for inspection a biennial inventory of controlled substances prepared and maintained in compliance with federal statutes and regulations shall be deemed in compliance with this section.
3. Any person licensed under this title or operating a registered outsourcing facility shall forthwith notify the department of any incident involving the theft, loss or possible diversion of controlled substances manufactured, compounded, delivered or distributed by the licensee or operator.
4. The records and reports required by this section shall be prepared, preserved, or filed in such manner and detail as the commissioner shall by regulation prescribe.