REPORTS AND RECORDS

Section 80.100 - General requirements

REPORTS AND RECORDS

80.100 General requirements.

(a) Records of all transactions concerning controlled substances required to be kept by manufacturers, distributors, importers, exporters, institutional dispensers, persons conducting research, instructional, analytical or maintenance treatment programs, pharmacies and practitioners shall be kept for a period of five years from the date of transaction.

(b) Records, orders and prescriptions required by this Part or article 33 of the Public Health Law, shall be readily available and promptly produced for inspection and copying upon request by authorized representatives of the Bureau of Narcotic Enforcement, New York State Department of Health.

(c) Records, orders and prescriptions required by this Part or provisions of article 33 of the Public Health Law shall be maintained at the premises where the licensed activity is conducted. Records, orders and prescriptions required by this Part or provisions of article 33 of the Public Health Law that are maintained electronically shall be made available to the department upon request, in a hardcopy format that is readily understandable, at the premises where the licensed activity is conducted.

(d) Records, orders and prescriptions required to be maintained by this Part or article 33 of the Public Health Law and which may be required as evidence of a violation in connection with an investigation by this department shall be released to authorized representatives of the Bureau of Narcotic Enforcement, New York State Department of Health, upon request and upon the furnishing of a receipt therefor.

Effective Date: 
Wednesday, March 27, 2013
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Section 80.101 - Manufacturers, distributors, importers and exporters

80.101 Manufacturers, distributors, importers and exporters. Manufacturers, distributors, importers and exporters of controlled substances shall keep records required by article 33 of the Public Health Law, and as otherwise provided by this Part and in particular section 80.23.

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Section 80.102 - Research, instructional activities and chemical analysis

80.102 Research, instructional activities and chemical analysis. Persons conducting research, instructional activities or chemical analysis of controlled substances shall keep records required by article 33 of the Public Health Law, and as otherwise provided by this Part and in particular section 80.36.

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Section 80.103 - Institutional dispensers

80.103 Institutional dispensers. Persons acting as institutional dispensers of controlled substances shall keep records required by article 33 of the Public Health Law, and as otherwise provided by this Part and in particular section 80.48.

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Section 80.104 - Treatment programs

80.104 Treatment program. Persons conducting treatment programs pursuant to article 23 of the Mental Hygiene Law shall keep records required by section 3352 of the Public Health Law and submit a monthly methadone usage report on a form furnished by the department.

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Section 80.105 - Practitioners

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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Section 80.106 - Pharmacies

80.106 Pharmacies.

(a) Pharmacies shall keep records of all controlled substances received and delivered or disposed of by them.

(1) The records of controlled substances received by pharmacies shall include date of receipt, name and address of vendor, and kind and quantity of such drug received. 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 maintained in a separate file. Duplicate copies of Federal order forms for schedule II controlled substances shall be retained.

(2) The records of all controlled substances delivered or disposed of shall consist of the prescriptions filled for such drugs. The prescription shall indicate the name and address of the prescriber, Drug Enforcement Administration registration number, signature of the prescriber, name and address of the patient, date of issue, date of dispensing by pharmacist, serial number, type and quantity of drug and such other information as may be required by this Part or provisions of article 33 of the Public Health Law.

(b)(1) Schedule II controlled substances prescriptions shall be maintained together in a separate file.

(2) Schedule III, IV and V controlled substances prescriptions shall be maintained together in a separate file.

(c) If a prescription for a Schedule II, III, IV or V controlled substance is created, signed, transmitted and received electronically, all records related to that prescription shall be retained electronically. These records shall be readily retrievable from all other records, and shall be easily readable or easily rendered into a format that a person can read.

(d) If a pharmacy ceases to use an application service provider, the pharmacy shall ensure that the application service provider transfer any records subject to this Part to the pharmacy in a format that can be displayed, read, and printed, and in a manner readily accessible to, and readable by, representatives of the department.

(e) Pharmacies shall keep a separate record of all controlled substances distributed to an automated dispensing system and returned to the pharmacy from such system.

(f) Pharmacies shall keep a separate record for an automated dispensing system for all records required by this Part.

Effective Date: 
Wednesday, March 27, 2013
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Section 80.107 - Confidentiality

80.107 Confidentiality. No person who has knowledge by virtue of his office of the identity of a particular patient or research subject, a manufacturing process, a trade secret or a formula shall disclose such knowledge, or any report or record thereof, except:

(a) to another person who by virtue of his office as an employee of the department is entitled to obtain such information;

(b) pursuant to judicial subpoena or court order in a criminal investigation or proceedings;

(c) to an agency department of government, or official board authorized to regulate, license or otherwise supervise a person who is authorized by article 33 of the Public Health Law to deal in controlled substances, or in the course of any investigation or proceeding by or before such agency, department or board; or

(d) to the prescription monitoring program registry and to authorized users of such registry as set forth in Public Health Law section 3371(2);

(e) to a practitioner to inform him or her that a person under his or her treatment with a controlled substance also may be under treatment with a controlled substance by another practitioner for the purposes of Public Health Law section 3371(2), and to facilitate the department's review of individual challenges to the accuracy of controlled substance histories pursuant to Public Health Law section 3343-a(6);

(f) to a pharmacist to provide information regarding prescriptions for controlled substances presented to the pharmacist for the purposes of Public Health Law section 3371(2) and to facilitate the department's review of individual challenges to the accuracy of controlled substance histories pursuant to Public Health Law section 3343-a(6);

(g) to the deputy attorney general for Medicaid fraud control, or his or her designee, in furtherance of an investigation of fraud, waste or abuse of the Medicaid program, pursuant to an agreement with the department;

(h) to a local health department for the purpose of conducting public health research or education:

(1) pursuant to an agreement with the commissioner;

(2) when the release of such information is deemed appropriate by the commissioner;

(3) for use in accordance with measures required by the commissioner to ensure that the security and confidentiality of the data is protected; and

(4) provided that disclosure is restricted to individuals within the local health department who are engaged in the research or education;

(i) to a medical examiner or coroner who is an officer of or employed by a state or local government, pursuant to his or her official duties;

(j) to an individual for the purpose of providing such individual with his or her own controlled substance history or, in appropriate circumstances, in the case of a patient who lacks capacity to make health care decisions, a person who has legal authority to make such decisions for the patient and who would have legal access to the patient's health care records, if requested from the department pursuant to Public Health Law section 3343-a(6) or from a treating practitioner pursuant to Public Health Law section 3371(2)(a)(iv); and

(k) to appropriate law enforcement agencies, as reasonably appears to be necessary, for the purposes of providing relevant information about suspected criminal activity, including controlled substances prescribed or dispensed, where the department has reason to believe that a crime related to the diversion of controlled substances has been committed.

Effective Date: 
Tuesday, August 27, 2013
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Section 80.108 - Practitioner patient reporting

80.108 Practitioner patient reporting. It shall be the duty of every attending practitioner and every consulting practitioner to report promptly to the commissioner the name and address and such other data as may be required by the commissioner with respect to any person under treatment if he finds that such person is an addict or a habitual user of any narcotic drug. Such report shall be kept confidential and may be utilized only for statistical, epidemiological, or research purposes, except that those reports which originate in the course of a criminal proceeding other than section 210 of the Mental Hygiene Law shall be subject only to the confidentiality requirements of section 3371 of the Public Health Law.
 

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Section 80.109 - Confidential communications

80.109 Confidential communications. For the purpose of duties arising out of article 33 of the Public Health Law and provisions of this Part, no communication made to a practitioner shall be deemed confidential within the meaning of the Civil Practice Law and Rules relating to confidential communications between such practitioner and patient.

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Section 80.110 - Notification by licensee

80.110 Notification by licensee. Persons licensed or certified pursuant to article 33 of the Public Health Law and persons authorized to possess controlled substances in connection with his authorized activities shall promptly notify the department of:

(a) each incident or alleged incident of theft, loss or possible diversion of controlled substances manufactured, ordered, distributed or possessed by such person; a form of this purpose furnished by the department shall be filed with the Bureau of Narcotic Enforcement, New York State Department of Health.

(b) any charge or proceeding brought in any court or before any governmental agency, State or Federal, in which it is alleged that the licensee, its employees, subsidiaries, managing officers, or directors has failed to comply with the provisions of the Federal Controlled Substances Act or the laws of any State relating to controlled substances.

Effective Date: 
Wednesday, November 26, 2008
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Section 80.111 - Inventory; required substances

80.111 Inventory; required substances. Controlled substances listed in section 33O6 of the Public Health Law are designated as inventory required substances and a biennial inventory shall be prepared and maintained in accordance with the provisions of section 80.112 of this Part.

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Section 80.112 - Inventory; procedure for filing

80.112 Inventory; procedure for filing.

(a) All manufacturers, distributors, importers, and exporters licensed to deal in controlled substances; all institutional dispensers and persons conducting research, instructional activities, maintenance treatment programs and analytical laboratories certified for controlled substance privileges; and all physicians, dentists, podiatrists, veterinarians and other practitioners, and all pharmacies possessing, having under their control, selling, prescribing, administering, dispensing or compounding any controlled substances in New York State shall as of May 1, 1975 and every two years thereafter, prepare and maintain an inventory of all controlled substances specified by the State Commissioner of Health by regulation as substances requiring inventory. A separate entry shall be made with respect to each kind of substance or preparation, and each kind or size of package. Each entry shall show the name, quantity and content of controlled substance and the size of the individual package, the number of packages and the total content of all packages covered by the entry on hand as of the date of the inventory. Maintaining for inspection a biennial inventory of controlled substances prepared and maintained in compliance with federal statute and regulations shall be deemed compliance with this section.

(b) A copy of the inventory shall be retained on file with other controlled substances records, and shall be kept available for inspection for at least five years.
 

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