Part 80 Rules and Regulations on Controlled Substances

Manufacturers, distributors, importers and exporters of controlled substances shall keep records required by article 33 of the Public Health Law, and as otherwise provided by this Part and in particular section 80.23.

Persons conducting research, instructional activities or chemical analysis of controlled substances shall keep records required by article 33 of the Public Health Law, and as otherwise provided by this Part and in particular section 80.36.

Persons acting as institutional dispensers of controlled substances shall keep records required by article 33 of the Public Health Law, and as otherwise provided by this Part and in particular section 80.48.

Persons conducting treatment programs pursuant to article 23 of the Mental Hygiene Law shall keep records required by section 3352 of the Public Health Law and submit a monthly methadone usage report on a form furnished by the department.

Every physician, dentist, podiatrist, veterinarian, or other authorized practitioner shall keep a record of all controlled substances purchased by him and a record of all such drugs dispensed or administered by him out of his own stock of such drugs. (a) Records of controlled sub…

(a) Pharmacies shall keep records of all controlled substances received and delivered or disposed of by them. (1) The records of controlled substances received by pharmacies shall include date of receipt, name and address of vendor, and kind and quantity of such drug received. A …

No person who has knowledge by virtue of his office of the identity of a particular patient or research subject, a manufacturing process, a trade secret or a formula shall disclose such knowledge, or any report or record thereof, except: (a) to another person who by virtue of his…

It shall be the duty of every attending practitioner and every consulting practitioner to report promptly to the commissioner the name and address and such other data as may be required by the commissioner with respect to any person under treatment if he finds that such person is…

For the purpose of duties arising out of article 33 of the Public Health Law and provisions of this Part, no communication made to a practitioner shall be deemed confidential within the meaning of the Civil Practice Law and Rules relating to confidential communications between su…

In addition to the requirements set forth in article 33 of the Public Health Law, holders of licenses shall comply with the following requirements: (a) A class 1 manufacturer who produces a final product that by its composition or combination with other ingredients is intended fo…

Persons licensed or certified pursuant to article 33 of the Public Health Law and persons authorized to possess controlled substances in connection with his authorized activities shall promptly notify the department of: (a) each incident or alleged incident of theft, loss or poss…

Controlled substances listed in section 3306 of the Public Health Law are designated as inventory required substances and a biennial inventory shall be prepared and maintained in accordance with the provisions of section 80.112 of this Part.

(a) All manufacturers, distributors, importers, and exporters licensed to deal in controlled substances; all institutional dispensers and persons conducting research, instructional activities, maintenance treatment programs and analytical laboratories certified for controlled sub…

(1) All persons acting as importers of controlled substances shall first obtain a class 9 license from the department and thereafter, a registration from the Drug Enforcement Administration, United States Department of Justice, or its successor agency. (2) Persons conducting acti…

The commissioner, and any representative authorized by him, shall have the power to administer oaths, compel the attendance of witnesses and the production of books, papers and records and to take proof and testimony concerning all matters within the jurisdiction of the departmen…

Rules, regulations and determinations, when made and promulgated by the commissioner, shall be the rules and regulations and determinations of the department, and, until modified or rescinded, shall have the force and effect of law.

It shall be the duty of the department to enforce all of the provisions of article 33 of the Public Health Law and all of the rules, regulations and determinations made thereunder.

The department and its representatives shall have access at all times to all orders, prescriptions or records required to be kept under article 33 of the Public Health Law and this Part.

(a) No person shall: (1) obtain or attempt to obtain a controlled substance prescription or a controlled substance, or procure or attempt to procure the administration of a controlled substance: (i) by fraud, deceit, misrepresentation or subterfuge; (ii) by the use of a forged or…

Schedule I and II raw materials, bulk materials awaiting further processing, and finished products shall be stored in one of the following secure storage areas: (a) Where small quantities permit, in a safe of GSA class 5 rated or equivalent. If the safe weighs less than 750 pound…

(a) All glue, cement or other adhesives containing one or more of the following chemical compounds are designated as glue substances containing a solvent having the property of releasing toxic vapors or fumes: acetone, cellulose acetate, benzene, butyl alcohol, ethyl alcohol, eth…

(a) For purposes of this section, prescription shall have the same meaning as provided in section 3302 of the Public Health Law, as supplemented by the meaning provided in section 3381 of the Public Health Law. It shall be unlawful for any person to sell or furnish, to any other …

(a) The following persons or classes of persons may obtain hypodermic syringes and hypodermic needles without prescription for use within the scope of their professions or activities: (1) physicians; (2) dentists; (3) veterinarians; (4) undertakers; (5) nurses; (6) podiatrists; (…

(a) The following are authorized to possess hypodermic syringes and hypodermic needles, provided they file with the commissioner a certificate of need and obtain a written authorization from the commissioner to possess and use such hypodermic syringes and needles: (1) educational…

(a) Except where different meanings are specified expressly, the terms in this section shall have the following meanings: (1) An incorporated society for the prevention of cruelty to animals (society) shall include any incorporated humane society or society for the prevention of …

(a) Employees or trained volunteers of community-based not-for-profit organizations and government entities engaged in clean hypodermic syringe and needle exchange programs designed to reduce the transmission of human immunodeficiency virus may obtain, possess and furnish hypoder…

Purchasing, possessing, delivering, administering, and safeguarding of controlled substances. (1) Ambulance service means an individual, partnership, association, corporation, municipality or any other legal entity or subdivision, thereof, engaged in providing emergency medical c…

(1) Authorized provider for the purposes of this section shall mean any of the following who have registered with the department: (i) a pharmacy licensed under article 137 of the Education Law; (ii) a health care facility licensed under article 28 of the Public Health Law; or (ii…

(1) Opioid means an opiate as defined in section 3302 of the Public Health Law. (2) Opioid antagonist means a drug approved by the Food and Drug Administration, that, when administered, negates or neutralizes in whole or in part the pharmacological effects of an opioid in the bod…

(a) Minimum security standards for storage of schedule III, IV and V controlled substances shall include the following requirements: (1) the controlled substance shall be separated from all other merchandise except that controlled substances may be stored with other pharmaceutica…

Where necessary for licensees (nonpractitioner category) to handle several classes of controlled substances separately, for example, damaged goods, returned goods and goods in process, the controlled substances may be stored apart from the main stock of controlled substances, pro…

(a) In order to minimize the possibility of internal diversion the licensee shall limit access to the storage areas for controlled substances to a minimum number of employees with a security pass system if the size, type or other factors indicate a need, as determined by the depa…

When controlled substances are distributed by nonpractitioners through agents (i.e., detailmen), the licensee is responsible for providing and requiring adequate security to guard against theft or diversion while the substances are being stored or handled by the agent.

(a) Licensees who store controlled substances in a public warehouse are responsible for utilizing a warehouse that will provide adequate security against theft or diversion. The licensee and not the warehouse is responsible for the security of the controlled substances. The depar…

All manufacturing activities, including processing, packaging, and labeling, involving controlled substances listed in any schedule shall conform to the following security controls: (a) All substances in process of manufacture shall be returned to the controlled substances storag…

(a) Pursuant to section 3305 of the Public Health Law, the provisions of this Part restricting the possession of controlled substances shall not apply to: (1) common carriers or warehousemen while engaged in lawfully transporting or storing such substances or to any employee of t…

The licensee shall promptly notify the department of any theft or loss or any controlled substance. Such theft or loss shall be reported on forms furnished by the department. Thefts shall be reported whether or not the controlled substances are subsequently recovered, the respons…

The licensee shall make a good faith inquiry either to the department or the Drug Enforcement Administration, United States Department of Justice to determine that a person is licensed to possess a controlled substance before distributing any such controlled substance to a person…

The licensee shall establish and operate a system to disclose to the licensee suspicious orders for controlled substances and inform the department of such suspicious orders. Suspicious orders shall include, but not be limited to, orders of unusual size, orders deviating substant…

Manufacturers shall keep records of all controlled substances manufactured, received, disposed of or distributed by them, which shall include date of manufacture, type and quantity of drug manufactured. (1) Records of drugs received shall indicate the date of receipt, type and qu…

(a) No controlled substances may be manufactured or delivered within this State in solid or capsule form unless it has clearly marked or printed upon each capsule or solid the national drug code number or other identifying symbol assigned to the manufacturer or distributor and th…

(a) It shall be unlawful to distribute free samples of controlled substances except by licensees licensed under this Part to persons licensed by the department for research, instructional activities or chemical analysis. (b) No such distribution shall be made without giving prior…

(1) Those nonnarcotic substances listed in section 1308.22 of title 21 of the Code of Federal Regulations, currently and as thereinafter amended, are excepted from the application of sections 3306 and 3319 of the Public Health Law. (2) Those drugs, which are restricted by law to …

(a) No person shall conduct research, instructional activities or chemical analysis of controlled substances in this State without first having obtained a license from the department. Licensees shall register with the appropriate Federal agency or agencies in the comparable contr…

(a) Persons engaged in research of controlled substances in schedules II to V shall first obtain a class 4 license from the department and thereafter a registration from the Drug Enforcement Administration, United States Department of Justice, or its successor agency. (b) Persons…