Effective Management of Acute and Chronic Pain with Opioid Analgesics, 2nd Edition _ ________________
(a) An approved controlled substance shall mean the following controlled substance which has been approved by the Food and Drug Administration (FDA) and the New York State Department of Health for the treatment of narcotic addiction: (1) buprenorphine (b) An authorized physician is a physician specifically registered with the Drug Enforcement Administration to prescribe, administer or dispense an approved controlled substance for the treatment of narcotic addiction, and approved for such purpose pursuant to the provisions of Article 32 of the Mental Hygiene Law. (1) The total number of such patients of an authorized physician at any one time shall not exceed 30. (2) An authorized physician prescribing an approved controlled substance for the treatment of narcotic addiction, in addition to preparing and signing an official New York State prescription in accordance with Section 3332 of the Public Health Law and Section 80.69 of this Part, shall also include his/her unique DEA identification number on the prescription. (c) A pharmacist may dispense an approved controlled substance for the treatment of narcotic addiction pursuant to a prescription issued by an authorized physician. Such dispensing shall be in accordance with Section 3333 of the Public Health Law and Section 80.74 of this Part. §80.85 Administration of controlled substances to addicts and habitual users. (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 order of a person authorized by law to practice medicine or osteopathy in this State and who possesses a Federal registration by the Drug Enforcement Administration, United States Department of Justice, authorizing him to use controlled substances in connection with his professional practice as follows: (1) for bona fide patients suffering from disease known to be incurable, such as cancer, advanced tuberculosis, and other diseases well recognized as coming within this class; (2) for addicts who are aged and infirm, or severely ill and it is determined that withdrawal of controlled substances would be dangerous to life, provided that: (i) such determination has been confirmed by adequate consultation; (ii) complete records of treatment, administration or dispensing of controlled substances including patient’s name, date and type and quantity of controlled substance administered or dispensed are kept; (iii) adequate safeguards have been taken against diversion of the controlled substances from the intended use; and (iv) the patient is carefully supervised; (3) to relieve acute withdrawal symptoms, except that: (i) only the amount of controlled substances essential for relief of such acute symptoms shall be administered; and (ii) administration shall be in an institutional or other setting reasonably certain to provide a drug-free environment; (4) for detoxification of an addict participating in an authorized treatment program approved pursuant to article 23 of the Mental Hygiene Law; and (5) for treatment of addicts participating in an authorized methadone or other controlled substances maintenance program approved pursuant to article 23 of the Mental Hygiene Law. (c) In properly verified cases of severe illness, infirmity, or physical disability, a licensed physician, registered nurse, licensed practical nurse, or registered pharmacist may deliver medication to the patient. REPORTS AND RECORDS §80.105 Practitioners. 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 substances purchased shall include date of delivery, type and quantity of drugs and the name and address of the supplier of the drug. A duplicate invoice or separate itemized list furnished by the vendor will be sufficient to satisfy this record requirement for schedule III, IV, and V controlled substances provided it includes all required information and is retained in a separate file. In addition, duplicate copies of Federal order forms for schedule I and II controlled substances shall be retained. (b) Records of disposition of controlled substances shall include date of dispensing or administering of such drug, name and address of patient, and type and quantity of drug.
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