Part 80 Rules and Regulations on Controlled Substances

The following chemical derivatives of barbituric acid, a substance named in section 502(d) of the Federal Food, Drug and Cosmetic Act, are hereby designated as habit-forming:

(a) No person shall act as an institutional dispenser or institutional dispenser limited of controlled substances in this State without first having obtained a license from the department. (b) Licensees shall register with the appropriate Federal agency or agencies in the compara…

(a) Hospitals, veterinary hospitals, mental hospitals, or similar facilities qualified for controlled substances privileges shall first obtain a class 3 license from the department and thereafter, a registration from the Drug Enforcement Administration, United States Department o…

(a) Nursing homes, convalescent homes, health-related facilities, adult care facilities subject to the provisions of 18 NYCRR Parts 487, 488 and 490, dispensaries or clinics not qualifying as institutional dispensers in license class 3 shall apply for an institutional dispenser, …

(a) Hospitals and other facilities licensed and authorized by the department to purchase, possess and use controlled substances shall keep the following records: (1) An order, signed by a person authorized to prescribe under the provisions of this Part, specifying the controlled …

(a) All nursing homes, convalescent homes, health-related facilities, homes for the aged and other facilities licensed and authorized by the department as institutional dispensers limited and authorized to possess and distribute controlled substances prescribed for individual pat…

(a) Licenses for controlled substances privileges shall be issued by the department in the following classifications: (1) A person licensed to manufacture or import any controlled substance shall be authorized to distribute that substance, but no other substance which he is not l…

(a) Reserve or main stocks of controlled substances shall be securely kept as follows: (1) Schedule I and II controlled substances shall be kept in one of the following secure storage areas: (i) A GSA class 5 rated steel cabinet or equivalent safe approved by the Bureau of Narcot…

(a) As described in this section, the destruction of controlled substances shall mean that the substances have been rendered totally unrecoverable and beyond reclamation. (b) Single-unit doses or partial doses remaining after the administration or attempted administration of a po…

Any person holding a Federal registration number who is in possession of a controlled substance listed in any schedule may, without being licensed as a distributor, return that substance to either the distributor from whom he obtained it or to the manufacturer of the substance pr…

(a) Controlled substances shall at all times be properly safeguarded and securely kept at the address on file with the Drug Enforcement Administration and which is used in the ordering of the controlled substances, where they will be available for inspection by properly authorize…

No practitioner shall obtain schedule II controlled substances except by means of his or her official Federal written order forms. Schedules II, III, IV and V controlled substances shall be obtained from manufacturers or distributors licensed under article 33 of the Public Health…

A person authorized by law to obtain controlled substances for professional use shall not use such drugs for the treatment of his own addiction, or habitual use.

(a) Physicians and other authorized practitioners in the course of their professional practice, may dispense, administer or prescribe controlled substances for legitimate medical purposes or treatment, other than treatment for addiction to controlled substances, when the practiti…

(a) A prescription as defined by the Public Health Law means: (1) an official New York State prescription; (2) an electronic prescription; (3) an oral prescription; or (4) an out-of-state prescription, which means a prescription issued in lieu of an official prescription by a pra…

(a) A prescription for a controlled substance may be issued only by a practitioner who is: (1) authorized to prescribe controlled substances pursuant to his licensed professional practice; and (2) either registered under the Federal Controlled Substances Act and in possession of …

A prescription, in order to be effective in legalizing the possession of controlled substances, shall be issued for legitimate medical purposes only. The responsibility for the proper prescribing and dispensing of controlled substances shall be on the physician, dentist, podiatri…

No prescriptions shall be made or filled for controlled substances in schedule I.

(a) Prescriptions shall not be refilled for schedule II substances and: Alprazolam Bromazepam Camazepam Chlordiazepoxide Clobazam Clonazepam Clorazepate Clotiazepam Cloxazolam Delorazepam Diazepam Estazolam Ethyl Loflazepate Fludiazepam Flunitrazepam Flurazepam Halazepam Haloxazo…

(a) In an emergency, a practitioner may orally prescribe and a pharmacist may dispense, to an ultimate user, controlled substances in schedule II and those controlled substances listed in section 80.67 of this Part; provided, however, the pharmacist shall: (1) contemporaneously r…

(a) In addition to the requirements set forth in sections 80.67 and 80.70 of this Part, substances in schedule III, IV or V shall be prescribed by a practitioner on an official New York State prescription or, subject to the following, an electronic prescription, in good faith, an…

(a) Except as provided in sections 80.67 and 80.68 of this Part, a practitioner may orally prescribe and a pharmacist may dispense, to an ultimate user, controlled substances in schedule III, IV or V; provided, however, the pharmacist shall: (1) contemporaneously reduce such pres…

(a) Practitioners, in good faith and in the course of their professional practice only, and as limited in this Part may dispense controlled substances. (b) Except as provided in subdivision (c) of this section, the quantity of substances dispensed may not exceed a 30-day supply i…

(a) A practitioner shall register with the department to be issued official New York State prescription forms. The registration application shall include, but not be limited to, the requesting practitioner's name, specialty, primary address and other practice site address(s), num…

(a) A licensed, registered pharmacist, or a pharmacy intern acting in conformity with the provisions of section 6806 of the Education Law and regulations thereunder in a registered pharmacy, may, in good faith and in the course of his/her professional practice, sell and dispense …

(a) Except as provided in sections 80.67 and 80.73 of this Part, a licensed, registered pharmacist, or a pharmacy intern acting in conformity with the provisions of section 6808 of the Education Law, and regulations thereunder, in a registered pharmacy may, in good faith and in t…

(a) Institutional dispensers licensed by the department may cause controlled substances to be administered or dispensed for use on the premises only pursuant to a written order by a practitioner for such medication. A prescription is not required for inpatient use. In an emergenc…

Controlled substances shall not be prescribed for, administered or dispensed to addicts or habitual users of controlled substances except as provided by the Public Health Law or this Part.

(a) Adequate safeguards and security measures shall be undertaken by practitioners holding official New York State prescription forms to assure against the loss, destruction, theft or unauthorized use of the forms. Practitioners shall maintain a record of the disposition of all f…

(a) A licensed, registered pharmacist, or a pharmacy intern acting in conformity with the provisions of section 6808 of the Education Law, and regulations thereunder, in a registered pharmacy may, in good faith and in the course of his/her professional practice, dispense to an ul…

Pursuant to the provisions of the Federal Drug Addiction Treatment Act of 2000 (DATA 2000) (106 P.L. 310, div. B, title XXXV, section 3502[a]), an authorized practitioner may prescribe, administer or dispense an approved controlled substance, and a licensed registered pharmacist …

(a) The administration of controlled substances to narcotic addicts or habitual users of controlled substances is prohibited except as provided for in this Part. (b) Controlled substances may be administered to narcotic addicts or habitual users of controlled substances upon the …

(a) All persons approved pursuant to article 32 of the Mental Hygiene Law to operate a chemical dependence program, other than authorized physicians and pharmacists as defined in section 80.84 of this Part who are registered with the department to prescribe, administer or dispens…