reglab/statecodes huggingface dataset:
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter J - Funeral Directing, Undertaking And Embalming › Part 79 - Price Information › Section 79.2 - Casket price list

Current through Register Vol. 46, No. 28, July 10, 2024
A funeral firm shall present for information and review a
					 printed or typewritten price list to individuals who inquire in person about
					 caskets or alternative containers. The funeral firm may neither discuss nor
					 show caskets or alternative containers until a casket price list is offered to
					 the customer. The list must contain at least the retail price of each casket
					 and alternative container offered which does not require special ordering;
					 supplier name; model name or number; species of wood, kind and gauge of metal
					 or other construction material; description of the interior; and the effective
					 date of the price list. The list must contain the true funeral firm name and
					 address as registered with the department and a caption describing the list as
					 a "Casket Price List." In lieu of a written list, other formats, such as
					 notebooks, brochures or charts may be used if they contain the same information
					 as required in a printed or typewritten list and are displayed in a clear and
					 conspicuous manner.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter J - Funeral Directing, Undertaking And Embalming › Part 79 - Price Information › Section 79.3 - Outer interment receptacle price list

Current through Register Vol. 46, No. 28, July 10, 2024
A funeral firm shall present for information and review a
					 printed or typewritten price list to individuals who inquire in person about
					 outer interment receptacles. The funeral firm may neither discuss nor show
					 outer interment receptacles until an outer interment receptacle price list is
					 offered to the customer. The list must contain at least the retail price of
					 each outer interment receptacle which does not require special ordering;
					 supplier name; model name or number; description of construction material; and
					 the effective date of the prices listed. In immediate conjunction with the
					 prices must be the following statement: "No New York State or local law
					 requires you to buy a receptacle to surround the casket in the grave. However,
					 many cemeteries require that you have such a receptacle so that the grave will
					 not sink. Either a burial vault or grave liner will satisfy these
					 requirements." The list must contain the true funeral firm name and address as
					 registered with the department and a caption describing the list as an "Outer
					 Interment Receptacle Price List." In lieu of a written list, the firm may use
					 other formats, such as notebooks, brochures or charts, if they contain the same
					 information as required in a printed or typewritten list and are displayed in a
					 clear and conspicuous manner.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter J - Funeral Directing, Undertaking And Embalming › Part 79 - Price Information › Section 79.4 - General price list

Current through Register Vol. 46, No. 28, July 10, 2024
A funeral firm shall present a printed or typewritten price
					 list for retention to the individuals who inquire in person about funeral
					 arrangements or the prices and availability of funeral services and merchandise
					 offered. When individuals inquire in person about funeral arrangements or the
					 prices of funeral services or merchandise, the funeral firm must offer them the
					 list upon beginning discussion either of funeral arrangements or of the
					 selection of any funeral services or merchandise. This list must contain at
					 least the following information:
(a)
				  The true funeral firm name, address and telephone number as registered with the
				  department;
(b) A caption
				  describing the list as a "General Price List";
(c) The effective date of the price list;
				  and
(d) Immediately above the price
				  disclosures required by this section, the list shall contain the statements:
(1) "The goods and services shown below are
				  those we can provide to our customers. You may choose only the items you
				  desire. If legal or other requirements mean you must buy any items you did not
				  specifically ask for, we will explain the reason in writing on the statement we
				  provide describing the funeral services and merchandise you
				  selected."
(2) "This list may not
				  include prices for certain items that you select, such as cemetery charges or
				  crematory services, flowers and newspaper notices. The estimated or final
				  prices for those items will be shown on the itemized statement describing the
				  funeral services and merchandise you selected."
(3) If the services of the funeral director
				  and staff cannot be declined by the purchaser, the following sentence must be
				  inserted between the second and third sentences of the required statement in
				  paragraph (1) of this subdivision: "However, any funeral arrangements you
				  select will include a charge for our services."
(4) For some items that the funeral firm buys
				  for the customer such as flowers and newspaper notices, if the firm charges
				  more than the cost or receives and retains a rebate, commission or trade or
				  volume discount, a sentence must be added at the end of the statement required
				  by paragraph (2) of this subdivision, "We charge you for our services in buying
				  certain items."
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter J - Funeral Directing, Undertaking And Embalming › Part 79 - Price Information › Section 79.5 - Alternative pricing methods

Current through Register Vol. 46, No. 28, July 10, 2024
Alternative pricing methods are not permitted except for
					 package prices which are agreed upon between the funeral firm and a
					 governmental agency, or between the funeral firm and a not-for-profit
					 corporation for members of the corporation or other persons whose interests are
					 represented by the corporation. The itemization requirements of Part 78 of this
					 Title must be complied with and if an alternative pricing method is selected by
					 the person making arrangements, the charges must be listed and provided to the
					 person on an itemization statement which complies with Part 78. Package prices
					 must be broken down and listed by their component parts on the itemization
					 statement except for the "Alternative Services" and the "Limited Services" in
					 section
					 79.4(e)(1) and
					 (10)  of this Part.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter J - Funeral Directing, Undertaking And Embalming › Part 79 - Price Information › Section 79.6 - Alternative containers

Current through Register Vol. 46, No. 28, July 10, 2024
Funeral firms must make an unfinished wooden box or
					 alternative container available for direct cremations, if they arrange direct
					 cremations.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter J - Funeral Directing, Undertaking And Embalming › Part 79 - Price Information › Section 79.7 - Retention of price lists

Current through Register Vol. 46, No. 28, July 10, 2024
Copies of all price lists shall be retained on file at the
					 funeral firm for a period of at least four years from the date of their last
					 distribution to customers and shall be available for review during normal
					 business hours by the designated representative of the
					 commissioner.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter J - Funeral Directing, Undertaking And Embalming › Part 79 - Price Information › Section 79.8 - Comprehension of disclosure

Current through Register Vol. 46, No. 28, July 10, 2024
All disclosures required by this Part shall be in a clear
					 and conspicuous manner.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › General Provisions › Section 80.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
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 States 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.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › General Provisions › Section 80.2 - Exemptions

Current through Register Vol. 46, No. 28, July 10, 2024
(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.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › General Provisions › Section 80.3 - Exceptions, reclassification and exemptions of scheduled controlled substances

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Exceptions.
(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.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › General Provisions › Section 80.6 - Safeguarding controlled substances

Current through Register Vol. 46, No. 28, July 10, 2024
(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.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Manufacturers, Distributors, Importers and Exporters › Section 80.10 - Unlicensed activity

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Except as provided for in section
					 80.5  of this
					 Part, no person shall act as a manufacturer, distributor, importer or exporter
					 of controlled substances in this State without first having obtained a license
					 from the department.
(b) Holders of
					 licenses in such categories shall register with the appropriate Federal agency
					 or agencies in the comparable controlled substances schedules and license class
					 provided for under Federal regulations.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Manufacturers, Distributors, Importers and Exporters › Section 80.11 - Additional requirements for manufacturers and distributors

Current through Register Vol. 46, No. 28, July 10, 2024
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 for human or animal consumption
					 and presents a potential for abuse, must employ a full-time pharmacist and the
					 licensed controlled substance activity must be under the personal supervision
					 of a pharmacist or a chemist. The supervisor shall not be at the same time a
					 supervisor of any other class 1 or class 2 establishment licensed by the New
					 York State Department of Health. A chemist is a person who meets the following
					 requirements:
(1) possess a bachelor of
					 science or a bachelor of arts degree in chemistry, pharmacology or equivalent
					 specialization and have had not less than four years of experience in the
					 manufacture of drug products;
(2)
					 be a citizen of the United States or an alien lawfully admitted for permanent
					 residence in the United States;
(3)
					 be of the age of 21 years or older;
(4) be of good moral character and, if the
					 person has been convicted of one or more criminal offenses, he or she must be
					 found eligible after a balancing of the factors set out in Article 23-A of
					 Correction Law. In accordance with that Article, no person shall be deemed not
					 to be a chemist on account of having been previously convicted of one or more
					 criminal offense unless (i) there is a direct relationship between one or more
					 of the previous criminal offenses and the duties required of the position or
					 (ii) deeming the person a chemist would involve an unreasonable risk to
					 property or the safety or welfare of a specific individual or the general
					 public. In addressing these questions, the Department shall evaluate all
					 factors listed under New York State Correction Law Section 753; and
(5) not be, and not have been, a habitual
					 user of narcotics or any other habit-forming drugs.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Manufacturers, Distributors, Importers and Exporters › Section 80.12 - Additional requirements for importers and exporters

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
(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 activities as importer broker of controlled substances within New
					 York State where there is no physical possession of controlled substances are
					 required to obtain a class 9a license from the department and wherever
					 necessary, proper license from the appropriate Federal agency.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Manufacturers, Distributors, Importers and Exporters › Section 80.14 - Minimum security standards for nonpractitioner handling; schedule iii, iv and v controlled substances

Current through Register Vol. 46, No. 28, July 10, 2024
(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 pharmaceuticals in a separate room or storage area within a
					 building if there is limited access to the room or storage area;
(2) during working hours the controlled
					 substances shall be kept under constant surveillance by a supervisor or
					 specific individual who has the responsibility for this duty; and
(3) an alarm system installed on the outer
					 perimeter of the building or on the safe, cabinet, vault, or inside storage
					 area, which shall be equipped to transmit, upon unauthorized entry, a signal to
					 a central station protection company, a local police agency which has a legal
					 duty to respond, or a 24-hour control station operated by the
					 registrant.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Manufacturers, Distributors, Importers and Exporters › Section 80.15 - Multiple storage area; schedule i-v controlled substances

Current through Register Vol. 46, No. 28, July 10, 2024
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, provided that
						each storage area complies with the security requirements set forth in this
						Part.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Manufacturers, Distributors, Importers and Exporters › Section 80.16 - Accessibility to storage areas; schedule i-v controlled substances

Current through Register Vol. 46, No. 28, July 10, 2024
(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 department.
(b) Where it is necessary for employee
					 maintenance or nonemployee maintenance personnel, business guests or other
					 visitors to have access to or pass through the controlled substances storage
					 area the licensee shall authorize in writing an employee to provide adequate
					 observation during the time these otherwise unauthorized persons are in the
					 storage area.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Manufacturers, Distributors, Importers and Exporters › Section 80.17 - Security standards; agents of nonpractitioners

Current through Register Vol. 46, No. 28, July 10, 2024
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.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Manufacturers, Distributors, Importers and Exporters › Section 80.18 - Security standards; public warehouse and common or contract carriers

Current through Register Vol. 46, No. 28, July 10, 2024
(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 department shall determine if the overall security
					 is adequate. The licensee shall notify the department in writing within 30 days
					 of any change in the warehouse inspected and approved by the
					 department.
(b) The licensees are
					 also responsible for utilizing a common or contract carrier that will provide
					 adequate security of the controlled substances while they are in transit. If
					 the licensee has substantial quantities of controlled substances lost or stolen
					 in transit when utilizing the facilities of a particular common or contract
					 carrier, steps shall be taken to obtain another carrier or means of
					 transportation for shipping controlled substances. Precautions such as securely
					 wrapping and sealing packages containing controlled substances or utilizing
					 unmarked or coded boxes or shipping containers are required for guarding
					 against losses in storage or in transit.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Manufacturers, Distributors, Importers and Exporters › Section 80.19 - Security controls for nonpractitioners; manufacturing areas

Current through Register Vol. 46, No. 28, July 10, 2024
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 storage area at the termination
					 of the process. If the process is not completed at the end of a workday, except
					 where a continuous process or other normal manufacturing operation should not
					 be interrupted, the processing area or tanks, vessels, bins, or bulk containers
					 containing controlled substances shall be securely locked inside an area or
					 building which affords adequate security.
(b) Manufacturing activities with controlled
					 substances shall be conducted in an area or areas with limited access and shall
					 be kept under surveillance by an employee or employees designated in writing by
					 the licensee to be responsible for the area. The designated employee or
					 employees shall be able to provide continuous surveillance of the area in order
					 that unauthorized persons may not enter or leave the area without his
					 knowledge. Limited access may be accomplished by use of physical dividers such
					 as walls or partitions, by traffic control lines or by restricted space
					 designations.
(c) During the
					 production of controlled substances, the manufacturing area shall be accessible
					 only to those employees necessary for efficient operation. If it is necessary
					 for maintenance personnel, visitors or others to be present or pass through the
					 manufacturing areas during production, the licensee shall have an employee
					 designated in writing as being responsible for providing surveillance of the
					 area.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Manufacturers, Distributors, Importers and Exporters › Section 80.20 - Theft or loss

Current through Register Vol. 46, No. 28, July 10, 2024
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 responsible parties
						identified or action taken against them.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Manufacturers, Distributors, Importers and Exporters › Section 80.21 - Good faith inquiry

Current through Register Vol. 46, No. 28, July 10, 2024
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 who the
						licensee does not know to be licensed to possess the controlled
						substance.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Manufacturers, Distributors, Importers and Exporters › Section 80.22 - Suspicious orders

Current through Register Vol. 46, No. 28, July 10, 2024
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 substantially from
						a normal pattern, and others of unusual frequency.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Manufacturers, Distributors, Importers and Exporters › Section 80.23 - Records and reports

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Manufacturers records. 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 quantity of drug received, and the name and
					 address of supplier of such drug.
(2) Records of drugs disposed of or
					 distributed shall indicate date of disposal or distribution, name and address
					 of the person receiving such drugs and type and quantity of such
					 drugs.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Manufacturers, Distributors, Importers and Exporters › Section 80.24 - Identification of controlled substances

Current through Register Vol. 46, No. 28, July 10, 2024
(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 the drug manufactured or distributed, or other set or sets of identifying
					 symbols or coding as approved by the commissioner. The commissioner may except
					 from the requirement of this subdivision controlled substances manufactured in
					 such form as to render any imprinting thereon unreasonably difficult or
					 impossible.
(b) Each manufacturer
					 or distributor of controlled substances shall furnish the department with a
					 list of all controlled substances manufactured or delivered by them within the
					 State and the national drug code number or other symbol assigned to each such
					 substance.
(c) No controlled
					 substance contained within a bottle, vial, carton or other container or package
					 for delivery to an ultimate consumer, shall be manufactured or distributed
					 within this State unless such container or package has clearly and permanently
					 marked or imprinted upon it:
(1) the national
					 drug code identification number assigned to the manufacturer or distributor, or
					 other identification number approved by the commissioner; and
(2) the national drug code number or other
					 identification number approved by the commissioner and designated for such
					 substance.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Manufacturers, Distributors, Importers and Exporters › Section 80.25 - Distribution of free samples

Current through Register Vol. 46, No. 28, July 10, 2024
(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 notice to the department regarding the proposed manner of
					 distribution and the names of those persons to whom such distribution will be
					 made. A record of all such distributions shall be made.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Research, Instructional Activities and Chemical Analysis › Section 80.35 - Unlicensed activity

Current through Register Vol. 46, No. 28, July 10, 2024
(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.
(b) Licensees.
					 Licensees shall register with the appropriate Federal agency or agencies in the
					 comparable controlled substance schedule provided for under Federal
					 regulations.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Research, Instructional Activities and Chemical Analysis › Section 80.36 - Additional requirements, research, instructional activities and chemical analysis

Current through Register Vol. 46, No. 28, July 10, 2024
(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 engaged in industrial or
					 commercial processes requiring the use of controlled, substances in schedules
					 II to V shall first obtain a class 4a license from the department and
					 thereafter a registration from the Drug Enforcement Administration, United
					 States Department of Justice, or its successor agency.
(c) Persons engaged in instructional
					 activities requiring the use of controlled substances in schedules II to V
					 shall first obtain a license from the department in class 5 and thereafter, a
					 registration from the Drug Enforcement Administration, United States Department
					 of Justice, or its successor agency.
(d) Persons conducting research with
					 controlled substances in schedule I shall apply to the department for such
					 research license in class 7 and file with the department three copies of a
					 research protocol describing the research project.
(1) The research protocol shall contain all
					 pertinent information including the objective, material, security, procedures
					 (such as species and number of animals, daily dose regimen and route of
					 administration) and investigators, if any.
(2) If the commissioner finds that the
					 applicant is qualified and competent, and has furnished a satisfactory
					 protocol, the department shall license such applicant unless he finds that the
					 application should be denied by reason of false statements in the application,
					 conviction of a felony relating to controlled substances suspension,
					 revocation, or denial of the applicant's Federal license or registration,
					 failure to provide adequate safeguards against diversion of the controlled
					 substances from legitimate medical or scientific use or other good and
					 sufficient reason.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Research, Instructional Activities and Chemical Analysis › Section 80.37 - Records; researchers

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Researchers, licensed and authorized to possess and use controlled substances,
					 shall keep a record of all such substances received and used by them.
(1) A record of all such controlled
					 substances received shall include date of receipt, name and address of vendor,
					 type and quantity of drug received. A duplicate invoice or separate itemized
					 list furnished by the vendor will be sufficient to meet this record requirement
					 providing it contains all the information required and is maintained in a
					 separate file.
(2) A record of all
					 controlled substances used shall include the name of the person authorized to
					 control and use such drugs, the date, type and quantity of drug and signature
					 of the user.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Research, Instructional Activities and Chemical Analysis › Section 80.38 - Records; instructional activities

Current through Register Vol. 46, No. 28, July 10, 2024
Persons authorized to possess and use controlled
						substances for instructional activities shall keep a record of all controlled
						substances received and used by them.
(a) The record shall include date of receipt,
					 name and address of vendor, type and quantity of drug received. A duplicate
					 invoice or separate itemized list furnished by the vendor for schedule III, IV
					 and V controlled substances will be sufficient to meet this record requirement
					 providing it contains all the information required and is maintained in a
					 separate file. Duplicate copies of Federal order forms for schedule I and II
					 substances shall also be maintained.
(b) A record of controlled substances used
					 shall include the name of the person authorized to control and use such drugs,
					 the date, type and quantity of drug and signature of the user.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Research, Instructional Activities and Chemical Analysis › Section 80.39 - Records; analytical laboratories

Current through Register Vol. 46, No. 28, July 10, 2024
Analytical laboratories authorized to possess and use
						controlled substances shall keep a record of all controlled substances received
						and used by them.
(a) The record of
					 controlled substances received shall include date of receipt, name and address
					 of vendor, type and quantity of drug received. A duplicate invoice or separate
					 itemized list furnished by the vendor will be sufficient to meet this record
					 requirement providing it contains all the information required and is
					 maintained in a separate file. In addition, duplicate copies of Federal order
					 forms for schedule II controlled substances shall be retained.
(b) A record of controlled substances used
					 shall include the name of the person authorized to control and use such drugs,
					 the date, type and quantity of drug used and signature of the user.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Institutional Dispensers › Section 80.45 - Unlicensed activity

Current through Register Vol. 46, No. 28, July 10, 2024
(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
					 comparable controlled substance schedule provided for under Federal
					 regulations.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Institutional Dispensers › Section 80.46 - Institutional dispensers; additional requirements

Current through Register Vol. 46, No. 28, July 10, 2024
(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
					 of Justice, or its successor agency.
(b) Nursing homes and other facilities having
					 the services of a physician, registered nurses and a licensed and registered
					 pharmacist may qualify for a class 3 license for controlled substances
					 privileges. Such facilities shall first obtain a class 3 license from the
					 department and thereafter, a registration from the Drug Enforcement
					 Administration, United States Department of Justice, or its successor
					 agency.
(c) Institutional
					 dispensers licensed by the department in class 3 may purchase stocks of
					 controlled substances only from authorized distributors or manufacturers
					 licensed by the department.
(d)
					 Institutional dispenser stocks of controlled substances obtained pursuant to a
					 class 3 license are for inpatient and outpatient use through a registered
					 pharmacy dispenser.
(e) Bulk stocks
					 of controlled substances may be distributed within the institution to wards,
					 floor stocks, operating rooms and emergency rooms and carried as substocks of
					 the hospital.
(1) With each substock of a
					 schedule II controlled substance, an administration sheet or other record as
					 the commissioner may approve shall be furnished.
(2) The administration sheet shall list the
					 type of controlled substance, doses and number of doses furnished to the
					 substock and shall indicate:
(i) date and
					 hour of administration;
(ii) name
					 of patient;
(iii) name of
					 prescribing practitioner;
(iv)
					 quantity administered;
(v) balance
					 on hand after each administration; and
(vi) signature of administering
					 nurse.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter K - Controlled Substances › Part 80 - Rules and Regulations on Controlled Substances › Institutional Dispensers › Section 80.47 - Institutional dispenser, limited

Current through Register Vol. 46, No. 28, July 10, 2024
(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, limited license. Such institutional dispensers qualifying for
					 controlled substances privileges shall obtain a class 3a license from the
					 department.
(b) An institutional
					 dispenser licensed in class 3a may administer controlled substances to patients
					 only pursuant to a prescription issued by an authorized physician or other
					 authorized practitioner and filled by a registered pharmacy; except that
					 controlled substances in emergency medication kits may be administered to
					 patients as provided in section
					 80.49(d) 
					 of this Part; however, controlled substances in emergency medication kits may
					 not be administered to patients in an adult care facility subject to the
					 provisions of 18 NYCRR Parts 487, 488 and 490.
(c) An institutional dispenser, limited,
					 licensed in class 3a, which is operated as an integral and physical part of a
					 facility licensed as a class 3 institutional dispenser may be provided with
					 bulk stocks of controlled substances obtained pursuant to such class 3
					 institutional dispenser license. Records of distribution and administration of
					 such bulk stocks of controlled substances shall be kept as provided in section
					 80.48(a) 
					 of this Part.