GENERAL PROVISIONS

Section 80.1 - Definitions

GENERAL PROVISIONS

Section 80.1 Definitions. Except where different meanings are expressly specified, the terms used in this Part shall have the meanings set forth in Public Health Law, section 3302.

(a) Authorized practitioner and practitioner means practitioner as such term is defined in the Public Health Law (section 3302(28), and shall include certified nurse practitioners and licensed midwives certified by the Education Department to prescribe and administer drugs. The term shall also include registered physician's assistants certified by the Education Department.

(b) GSA means the United States General Services Administration.

(c) Department means the Department of Health of the State of New York.

(d) Commissioner means the Commissioner of Health of the State of New York.

(e) Bureau of Narcotic Enforcement means the Bureau of Narcotic Enforcement of the Department of Health of the State of New York.

(f) Drug Enforcement Administration registration number means such number assigned by the Drug Enforcement Administration, United State Department of Justice, or its successor agency, to a practitioner, authorized practitioner, or any person authorized to manufacture, distribute, sell, dispense or administer controlled substances.

(g) Automated dispensing system means a system approved by the Department that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, and dispensing of controlled substances, and which collects, controls, and maintains all transaction information.

(h) Digital signature means a record created when a file is algorithmically transformed into a fixed length digest that is then encrypted using an asymmetric cryptographic private key associated with a digital certificate. The combination of the encryption and algorithm transformation ensure that the signer's identity and the integrity of the file can be confirmed.

(i) Electronic signature means the creation of an electronic identifier (i.e. an electronic sound, symbol, or process, attached to or logically associated with an electronic record and executed or adopted by a person with the intent to sign the record) in accordance with regulations of the commissioner and the commissioner of education.

(j) Written prescription, for the purposes of this Part, and issued in New York State, shall mean an official New York State prescription form.

(k) Compliance with the requirements of this Part does not alter the responsibilities of the practitioner, pharmacist or pharmacy to comply with any applicable federal law or regulation.

Effective Date: 
Wednesday, March 27, 2013
Doc Status: 
Complete

Section 80.2 - Exemptions

80.2 Exemptions.

(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 the same acting within the scope of his employment;

(2) public officers or their employees in the lawful performance of their official duties requiring possession of controlled substances;

(3) temporary incidental possession by employees or agents of persons lawfully entitled to possession or by persons whose possession is for the purpose of aiding public officers in performing their official duties;

(4) a person in the employ of the United States government, its territories, districts or insular governments by reason of his official duties;

(5) a master of a ship or a person in charge of any aircraft upon which a physician is not regularly employed; or

(6) a duly authorized agent of an incorporated society for the prevention of cruelty to animals or a municipal animal control facility for the limited purpose of purchasing, possessing and dispensing sodium pentobarbital to registered and certified personnel, to euthanize animals and ketamine hydrochloride to anesthetize animals prior to euthanasia.

(b) The provisions of article 33 with respect to the payment of fees and costs shall not apply to the State of New York or any political subdivision thereof or any agency or instrumentality of either.

(c) The following exemptions are granted to the possession and use of schedule III or IV substances as part of an industrial process or manufacture of substances other than drugs: None.
 

Effective Date: 
Wednesday, February 25, 2009
Doc Status: 
Complete

Section 80.3 - Exceptions, reclassification and exemptions of scheduled controlled substances

80.3 Exceptions, reclassification and exemptions of scheduled controlled substances. (a) Exemptions.

(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 dispensing on prescription, listed in section 1308.32 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.

(3) Those chemical preparations and mixtures listed in section 1308.24 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.

(4) The following compounds, mixtures or preparations containing a narcotic antagonist substance having no potential for abuse, and being excepted or exempted from control under the Federal Controlled Substances Act (21 USC 801 et seq.) are excepted from the application of sections 3306 and 3319 of the Public Health Law:

(i) naloxone and its salts; and

(ii) naltrexone and its salts.

(b) Reclassifications.

(1) The following drugs listed in schedule II(c) of section 3306 of the Public Health Law are hereby reclassified as schedule III substances.

 

TRADE NAME OR OTHER DESIGNATION

COMPOSITION

MANUFACTURER OR SUPPLIER

Mediatric-tablets, capsules and liquid

Tablet and capsule: Conjugated estrogens-equine (Premarin (R), 0.25 mg.; Methyltestosterone, 2.5 mg.; Ascorbic Acid (Vit. C) 100 mg. (for capsules, provided as ascorbic acid, 70 mg. and as Sodium ascorbate, 30 mg.); Cyanocobalamin, 2.5 mcg.; Thiamine mononitrate, 10.0 mg.; Riboflavin, 50 mg.; Niacin-amide, 50.0 mg.; Pyridoxine HC1,3.0 mg.; Calc. panto thenate, 20.0 mg.; Ferrous sulfate exsic., 30.0 mg.; Methamphetamine HC1,1.0 mg. Liquid: Premarin (R)(Conjugated estrogens, (U.S.P.),0.25 mg.; Methyltestosterone, 2.5 mg.; Thiamine HC1, 5.0 mg.; Cyanocobalamin, 1.5 mcg.; Methamphetamine HC1, 10 mg.; Alcohol, 15%.

Ayerst

Phelantin-Kapseals

Phenobarbital (1/2gr) 30 mg.; Dilantin (Diphenyl-hydantoin)(11/2gr) 100 mg.; Methamphetamine Hydrochloride2.5 mg.

Parke-Davis

 

 

(2) The following drug classified under schedule I of section 3306 of the Public Health Law is hereby reclassified as a schedule V substance:  a drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol (2-[1R-3-methyl-6R-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols.

 

(c) Exemptions. The following compounds, mixtures or preparations containing an anabolic steroid listed in subdivision (h) of Schedule II of Section 3306 of the Public Health Law have ingredients included therein in such combinations, quantity, proportion or concentration as to reduce substantially the potential for abuse and, therefore, are exempted from the requirements of Public Health Law Article 33:

 

TRADE NAME

COMPOSITION

MANUFACTURER OF SUPPLIER

Estratest

Esterified estrogens (1.25mg); Methyl- testosterone (2.5mg)

Solvay Pharmaceuticals

Marietta, GA

Estratest HS

Esterified estrogens (0.625mg); Methyl-testosterone (1.25mg)

Solvay Pharmaceuticals

Marietta, GA

Premarin with Methyltestosterone

Conjugated estrogens (0.625 mg); Methyl-testosterone (5.0mg)

Wyeth-Ayerst Laboratories

Philadelphia, PA

Premarin with Methyltestosterone

Conjugated estrogens (1.25mg); Methyl-testosterone (10mg)

Wyeth-Ayerst Laboratories

Philadelphia, PA

 

Effective Date: 
Wednesday, May 22, 2019
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 3307

Section 80.4 - Habit-forming drugs

80.4 Habit-forming drugs. 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:

CHART - PARENT SUBSTANCE--BARBITURIC ACID (refer to pages 228.2f1 H 4-30-74 through 228.2g H 4-30-77)
 

Doc Status: 
Complete

Section 80.5 - Licenses

80.5 Licenses. (a) Licenses for controlled substances privileges shall be issued by the department in the following classifications:

Class Issued to:

Manufacturers and distributors

1 Manufacturer

1a Manufacturer out-of-State

2 Distributor

2a Distributor out-of-State

Institutional dispenser

3 Institutional dispenser

3a Institutional dispenser, limited

Research and instructional

4 Researcher--II to V

4a Researcher--Special industrial II to V

5 Instructional activities--II to V

6 Treatment programs, methadone

6a Treatment programs, methadone and other substances

6b Hospital pharmacies--detoxification, temporary treatment

7 Research and instructional activities--I

8 Analytical laboratories

Importers and exporters

9 Importer

9a Importer broker

10 Exporter

10a Exporter broker

Registered Community Pharmacy

11 Registered Community Pharmacy--Automated dispensing system

(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 licensed to manufacture or import;

(2) A person licensed to manufacture any controlled substance listed in schedules II through V shall be authorized to conduct chemical analysis and preclinical research (including quality control analysis) with narcotic and non-narcotic controlled substances listed in those schedules in which he is authorized to manufacture;

(3) A person licensed to conduct research with a controlled substance listed in schedule I shall be authorized to manufacture such class if, and to the extent that, such manufacture is set forth in the research protocol filed with the application for license and to distribute such class to other persons licensed or authorized to conduct research with such class or licensed or authorized to conduct chemical analysis with controlled substances;

(4) A person licensed or authorized to conduct chemical analysis with controlled substances shall be authorized to manufacture and import such substances for analytical or instructional purposes, to distribute such substances to other persons licensed or authorized to conduct chemical analysis or instructional activities or research with such substances and to persons exempted from license pursuant to section 3305 of Public Health Law, to export such substances to persons in other countries performing chemical analysis or enforcing laws relating to controlled substances or drugs in those countries, and to conduct instructional activities with controlled substances; and

(5) A person licensed or authorized to conduct research with controlled substances listed in schedules II through V shall be authorized to conduct chemical analysis with controlled substances listed in those schedules in which he is authorized to conduct research to manufacture such substances if, and to the extent that, such manufacture is set forth in a statement filed with the application for license, and to distribute such substances to other persons licensed or authorized to conduct chemical analysis, instructional activities, or research with, such substances and to persons exempted from licensing under section 3305 of the Public Health Law, and to conduct instructional activities with controlled substances;

(6) A person licensed to dispense controlled substances listed in schedules II through V shall be authorized to conduct research and to conduct instructional activities with those substances.

(7) A single license to engage in any group of independent activities may include one or more controlled substances listed in the schedules authorized in that group of independent activities.

(8) A separate license is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed or dispensed by a person.

(9) The following locations shall be deemed not to be places where controlled substances are manufactured, distributed or dispensed:

(i) a warehouse where controlled substances are stored by or on behalf of a licensed person, unless such substances are distributed directly from such warehouse other than the licensed location from which the substances were delivered or to persons not required to be licensed in accordance with section 3305 of the Public Health Law;

(ii) an office used by agents of a licensee where sales of controlled substances are solicited, made or supervised, but which neither contains such substances nor serves as a distribution point for filling sales orders; and

(iii) an office used by a practitioner (who is registered at another location) where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office, and where no supplies of controlled substances are maintained.

(b) Holders of licenses shall register with the appropriate Federal agency or agencies in the comparable controlled substances schedule and license class provided for under Federal regulations.

(c) A controlled substances license shall be permanently displayed in the place to which it applies.

(d) No controlled substances license shall be considered valid and in good standing unless the indicated activity is conducted at the address stated therein and by the person in whose name the license has been issued and unless the license has been renewed as required.

(e) A controlled substances license shall be promptly returned to the department upon revocation or suspension, or when the activity for which the applicant is licensed has been discontinued.

(f) A registered community pharmacy licensed in class 11 and maintaining a separate registration with the Drug Enforcement Administration may install and operate automated dispensing systems in a Residential Health Care Facility (“RHCF”) which is licensed or approved by the Department.

(g) A registered community pharmacy operating an automated dispensing system as provided in paragraph (f) of this section shall provide to such system only those controlled substances obtained under the Drug Enforcement Administration registration of the registered community pharmacy and not the Drug Enforcement Administration registration of the automated dispensing system.

Effective Date: 
Wednesday, November 26, 2008
Doc Status: 
Complete

Section 80.6 - Safeguarding controlled substances

80.6 Safeguarding controlled substances.

(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 authorized officers, agents and employees of the New York State Department of Health, Bureau of Narcotic Enforcement.

(b) Access to controlled substances stocks shall be limited to the minimum number of employees actually required to efficiently handle the manufacture, distribution, custody, dispensing, administration or other handling of such substances.

(c) The administrative head of a licensee hospital, laboratory, dispensary, nursing home and health-related facility and the supervisor of a manufacturer or distributor is responsible for the proper safeguarding and handling of controlled substances within the hospital or other facility. An administrative head or supervisor is not relieved of his responsibility to detect and correct any diversion or mishandling of controlled substances by a delegation of responsibility.

(d) Persons operating pharmacies and supervising pharmacists of such pharmacies are responsible for the proper safeguarding and handling of controlled substances within the pharmacy. Persons operating pharmacies and supervising pharmacists are not relieved of their responsibility to detect and correct any diversion of mishandling of controlled substances by a delegation of responsibility.
 

Effective Date: 
Wednesday, November 26, 2008
Doc Status: 
Complete