__________________ Effective Management of Acute and Chronic Pain with Opioid Analgesics, 2nd Edition
The following excerpt is reprinted from the New York Codes, Rules, and Regulations Relating to the Regulation of Controlled Substances. Available online at https://regs.health.ny.gov/volume-1a-title-10/content/ part-80-rules-and-regulations-controlled-substances.
NEW YORK CODES, RULES, AND REGULATIONS RELATING TO THE REGULATION OF CONTROLLED SUBSTANCES
Part 80: Rules and Regulations on Controlled Substances GENERAL PROVISIONS §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. §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.
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