reglab/statecodes huggingface dataset:
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 80.48 - Records and reports of institutional dispensers

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Hospitals and other facilities licensed
					 and authorized by the department to purchase, possess and use controlled
					 substances shall keep the following records:
(1) An order, signed by a person authorized
					 to prescribe under the provisions of this Part, specifying the controlled
					 substances medication for an indicated person or animal.
(2) A separate record, at the main point of
					 supply for controlled substances showing the type and strength of each drug in
					 the form of a running inventory indicating the dates and amounts of such drugs
					 compounded by them or received from other persons and their distribution or
					 use.
(3) A record of authorized
					 requisitions for such drugs for distribution to substations or wards. Such
					 records shall show receipt at substation or ward by the signature of a person
					 authorized to control such substation or ward; and:
(i) with each substock of schedule II
					 controlled substances, an administration sheet shall be furnished;
(ii) the administration sheet shall list the
					 type of controlled substances, dose and number of doses furnished to the
					 substock; and
(a) date and hour of
					 administration;
(b) name of
					 patient;
(c) name of prescribing
					 physician or practitioner;
(d)
					 quantity of administration;
(e)
					 balance on hand after each administration; and
(f) signature of administering
					 nurse.
(4) A
					 record in the patient's chart indicating administration of the controlled
					 substance including the name of the administering attendant and the date and
					 hour of administration.
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 80.49 - Records and reports of institutional dispensers limited

Current through Register Vol. 46, No. 28, July 10, 2024
(a) All nursing homes, convalescent homes,
					 health-related facilities, homes for the aged and other facilities licensed and
					 authorized by the department as institutional dispensers limited and authorized
					 to possess and distribute controlled substances prescribed for individual
					 patients in their care shall keep a record of all such drugs received in
					 custody and dispensed to patients.
(b) A separate daily running record shall be
					 kept of all prescribed controlled substances received, indicating the date,
					 name and quantity of prescribed controlled substances, name of the prescriber,
					 name of the patient, name of the pharmacy and the pharmacy prescription number
					 of the prescription containing the controlled substance, for patients under
					 their care.
(c) A separate record
					 shall be maintained of the administration of prescribed controlled substances
					 indicating the date and hour of administration, name and quantity of controlled
					 substances, name of the prescriber, patient's name, signature of person
					 administering and the balance of the controlled substances on hand after such
					 administration.
(d) In an emergency
					 situation, a controlled substance from a sealed emergency medication kit may be
					 administered to a patient by an order of an authorized practitioner. An oral
					 order for such controlled substance shall be immediately reduced to writing and
					 a notation made of the condition which required the administration of the drug.
					 Such oral order shall be signed by the practitioner within 48 hours.
(1) For purposes of this subdivision,
					 emergency means that the immediate administration of the drug is necessary and
					 that no alternative treatment is available.
(2) A separate record shall be maintained of
					 the administration of controlled substances from an emergency medication kit.
					 Such record shall indicate the date and hour of administration, name and
					 quantity of controlled substances, name of the practitioner ordering the
					 administration of the controlled substance, patient's name, signature of the
					 person administering and the balance of the controlled substances in the
					 emergency medication kit after such administration.
(3) The institutional dispenser limited shall
					 notify the pharmacy furnishing controlled substances for the emergency
					 medication kit within 24 hours of each time the emergency kit is unsealed,
					 opened, or shows evidence of tampering.
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 80.50 - Minimum security standards for institutional dispensers, institutional dispensers limited, treatment programs, license holders engaging in research, instructional activities and chemical analysis

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Reserve or main stocks of controlled
					 substances shall be securely kept as follows:
(1) Schedule I and II controlled substances
					 shall be kept in one of the following secure storage areas:
(i) A GSA class 5 rated steel cabinet or
					 equivalent safe approved by the Bureau of Narcotic Enforcement of the
					 Department of Health. Any cabinet or safe weighing less than 750 pounds shall
					 be bolted or cemented to the floor or wall in such a way that it cannot be
					 removed. The door of the cabinet or safe shall contain a multiple position
					 combination lock, a relocking device or the equivalent, and steel plate having
					 a thickness of at least one-half inch.
(ii) A vault, constructed of substantial
					 masonry and having a multiple position combination lock, a relocking device or
					 the equivalent, and a door having a thickness of steel plate of at least
					 one-half inch. For new construction, floor, walls and ceiling shall not be less
					 than eight inches of reinforced concrete, but less may be accepted where there
					 are compensating extra safeguards.
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 80.51 - Surrender and disposal of controlled substances

Current through Register Vol. 46, No. 28, July 10, 2024
(a) As described in this section, the
					 destruction of controlled substances shall mean that the substances have been
					 rendered totally unrecoverable and beyond reclamation.
(b) Single-unit doses or partial doses
					 remaining after the administration or attempted administration of a portion of
					 a liquid or solid unit dose of a controlled substance may be destroyed on the
					 premises of an institutional dispenser by a pharmacist or nurse provided that:
(1) a notation is made on the administration
					 record sheet; and
(2) the
					 destruction is witnessed by a second pharmacist or nurse or other responsible
					 person designated by the administrator.
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 80.52 - Returns to supplier

Current through Register Vol. 46, No. 28, July 10, 2024
Any person holding a Federal registration number who is
						in possession of a controlled substance listed in any schedule may, without
						being licensed as a distributor, return that substance to either the
						distributor from whom he obtained it or to the manufacturer of the substance
						provided that:
(a) In the case of a
					 schedule II controlled substance, an order form is used as provided under
					 Federal regulations.
(b) In the
					 case of a schedule III, IV or V controlled substance, a written record is
					 maintained which indicated the:
(1) date of
					 transaction;
(2) name, form and
					 quantity of the substance;
(3)
					 name, address and registry number of the person making the return;
					 and
(4) name, address and registry
					 number of the supplier or manufacturer.
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 › Prescribing and Dispensing Controlled Substances › Section 80.60 - Ordering

Current through Register Vol. 46, No. 28, July 10, 2024
No practitioner shall obtain schedule II controlled
						substances except by means of his or her official Federal written order forms.
						Schedules II, III, IV and V controlled substances shall be obtained from
						manufacturers or distributors licensed under article 33 of the Public Health
						Law and 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 › Prescribing and Dispensing Controlled Substances › Section 80.61 - Personal use

Current through Register Vol. 46, No. 28, July 10, 2024
A person authorized by law to obtain controlled
						substances for professional use shall not use such drugs for the treatment of
						his own addiction, or habitual use.
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 › Prescribing and Dispensing Controlled Substances › Section 80.62 - Use of controlled substances in treatment

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Physicians and other authorized
					 practitioners in the course of their professional practice, may dispense,
					 administer or prescribe controlled substances for legitimate medical purposes
					 or treatment, other than treatment for addiction to controlled substances, when
					 the practitioner regulates the dosage and prescribes or administers a quantity
					 of such drugs no greater than that ordinarily recognized by members of his
					 profession as sufficient for proper treatment in a given case.
(b) Such practitioners shall maintain a
					 written patient record of administration, dispensing and prescription of all
					 controlled substances. The patient record shall contain sufficient information
					 to justify the diagnosis and warrant the treatment. The record shall contain at
					 least the following information: patient identification data; chief complaint;
					 present illness; physical examination as indicated; diagnosis; other data which
					 support the diagnosis or treatment; and the regimen including the amount,
					 strength, and directions for use of the controlled substance. This subdivision
					 shall not be construed to require a record distinct from the medical record of
					 the patient.
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 › Prescribing and Dispensing Controlled Substances › Section 80.63 - Prescribing

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A prescription
					 as defined by the Public Health Law means:
(1) an official New York State
					 prescription;
(2) an electronic
					 prescription;
(3) an oral
					 prescription; or
(4) an
					 out-of-state prescription, which means a prescription issued in lieu of an
					 official prescription by a practitioner in another state who is licensed by
					 that state to prescribe controlled substances.
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 › Prescribing and Dispensing Controlled Substances › Section 80.64 - Who may issue

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A
					 prescription for a controlled substance may be issued only by a practitioner
					 who is:
(1) authorized to prescribe
					 controlled substances pursuant to his licensed professional practice;
					 and
(2) either registered under the
					 Federal Controlled Substances Act and in possession of a registration number
					 from the Drug Enforcement Administration, United States Department of Justice,
					 or its successor agency, or exempted from such registration as an exempt
					 official.
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 › Prescribing and Dispensing Controlled Substances › Section 80.65 - Purpose of issue

Current through Register Vol. 46, No. 28, July 10, 2024
A prescription, in order to be effective in legalizing
						the possession of controlled substances, shall be issued for legitimate medical
						purposes only. The responsibility for the proper prescribing and dispensing of
						controlled substances shall be on the physician, dentist, podiatrist,
						veterinarian or other authorized practitioner, but a corresponding liability
						shall rest with the pharmacist who fills the prescription. An order purporting
						to be a prescription, issued to an addict or habitual user of controlled
						substances, not in the course of professional treatment but for the purpose of
						providing the user with narcotics or other controlled substances sufficient to
						keep him comfortable by maintaining his customary use, is not a prescription
						within the meaning of subdivision 30 of section 3302  of the Public Health Law and the
						person knowingly filling such an order, as well as the person issuing it, shall
						be subject to the penalties provided for violation of the provisions of law
						relating to controlled substances.
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 › Prescribing and Dispensing Controlled Substances › Section 80.66 - Schedule i substances

Current through Register Vol. 46, No. 28, July 10, 2024
No prescriptions shall be made or filled for controlled
						substances in schedule I.
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 › Prescribing and Dispensing Controlled Substances › Section 80.68 - Emergency oral prescriptions for schedule ii substances and certain other controlled substances

Current through Register Vol. 46, No. 28, July 10, 2024
(a) In an
					 emergency, a practitioner may orally prescribe and a pharmacist may dispense,
					 to an ultimate user, controlled substances in schedule II and those controlled
					 substances listed in section
					 80.67 
					 of this Part; provided, however, the pharmacist shall:
(1) contemporaneously reduce such
					 prescription to writing or, to the extent authorized by Federal requirements to
					 an electronic record;
(2) dispense
					 the substance in conformity with the labeling requirements applicable to the
					 type of prescription which would be required but for the emergency;
					 and
(3) make a good-faith effort to
					 verify the identity of both the practitioner and the ultimate 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 › Prescribing and Dispensing Controlled Substances › Section 80.70 - Oral prescriptions for schedule iii, iv and v substances

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Except as
					 provided in sections
					 80.67
					 and
					 80.68 
					 of this Part, a practitioner may orally prescribe and a pharmacist may
					 dispense, to an ultimate user, controlled substances in schedule III, IV or V;
					 provided, however, the pharmacist shall:
(1)
					 contemporaneously reduce such prescriptions to written memoranda, or to the
					 extent authorized by Federal requirements, to an electronic record, indicating
					 the name and address of the prescriber and the practitioner's Drug Enforcement
					 Administration registration number, name and address of ultimate user, date on
					 which the controlled substance was ordered, name and quantity of controlled
					 substances prescribed, directions for use and the fact that it is a telephone
					 order. The memoranda for such oral prescriptions shall be filed in the schedule
					 III, IV and V prescription file, or in the case of an electronic record, shall
					 be filed electronically. The pharmacist filling such oral orders shall indicate
					 on the memoranda the date filled, the signature of the pharmacist filling the
					 prescription and the pharmacy prescription number under which it is recorded in
					 the pharmacy prescription file;
(2)
					 dispense the substance in conformity with the labeling requirements applicable
					 to a written prescription; and
(3)
					 make a good faith effort to verify the identity of both the practitioner and
					 the ultimate 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 › Prescribing and Dispensing Controlled Substances › Section 80.71 - Practitioner; dispensing controlled substances

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Practitioners, in good faith and in the
					 course of their professional practice only, and as limited in this Part may
					 dispense controlled substances.
(b)
					 Except as provided in subdivision (c) of this section, the quantity of
					 substances dispensed may not exceed a 30-day supply if the substances were used
					 in accordance with the directions for use. No additional dispensing of a
					 controlled substance may be made by a practitioner to an ultimate user within
					 30 days of the date of the previous dispensing unless and until the ultimate
					 user has exhausted all but a seven days' supply of that controlled substance
					 previously dispensed.
(c)
(1) A practitioner may dispense up to a
					 three-month supply of a controlled substance, including chorionic gonadotropin,
					 or up to a six-month supply of an anabolic steroid if used in accordance with
					 the directions for use, provided that such supply has been dispensed for the
					 treatment of a condition specified in sections
					 80.67(d)
					 and
					 80.69(d) 
					 of 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 › Prescribing and Dispensing Controlled Substances › Section 80.72 - Issuance of official new york state prescription forms

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A practitioner shall register with the
					 department to be issued official New York State prescription forms. The
					 registration application shall include, but not be limited to, the requesting
					 practitioner's name, specialty, primary address and other practice site
					 address(s), number of prescriptions requested, the Federal registration number
					 or exemption certificate, the State professional practice license number, and
					 shall be signed by the requesting practitioner.
(b) A practitioner's registration shall be
					 without fee and subject to approval by the department. Such registration shall
					 be valid for a period of two years.
(c) A practitioner registered to be issued
					 official prescription forms shall order such forms in the manner required by
					 the department.
(1) The number of
					 prescriptions requested by practitioners shall be subject to approval by the
					 department and shall be issued free of charges in the manner and quantity
					 approved by the department.
(2) The
					 address of the practitioner to which the forms shall be sent shall be the
					 address of a registered practitioner's Federal Drug Enforcement Administration
					 (DEA) registration.
(3) The
					 commissioner may specify that such forms or series of forms shall be valid for
					 a limited period of time and may be cancelled by the commissioner by giving
					 notice to the practitioner.
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 › Prescribing and Dispensing Controlled Substances › Section 80.73 - Pharmacists; dispensing schedule ii substances and certain other controlled substances

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A
					 licensed, registered pharmacist, or a pharmacy intern acting in conformity with
					 the provisions of section 6806 
					 of the Education Law and regulations thereunder in a registered pharmacy, may,
					 in good faith and in the course of his/her professional practice, sell and
					 dispense to an ultimate user schedule II controlled substances or those
					 schedule III or schedule IV controlled substances listed in section
					 80.67(a) 
					 of this Part, provided they are dispensed pursuant to an official New York
					 State prescription, an out-of-state prescription or an electronic prescription
					 delivered within 30 days of the date such prescription was signed by the
					 authorized practitioner or an oral prescription where permitted.
(b) No such substance shall be dispensed or
					 sold unless it is enclosed within a suitable and durable container to which is
					 affixed, in such a manner which would inhibit its removal, an orange label upon
					 which is indelibly typed, printed or otherwise legibly written:
(1) the name and address of the ultimate user
					 for whom the substance is intended, or, if intended for use upon an animal, the
					 species of such animal and the name and address of the owner or person having
					 custody of such animal;
(2) the
					 name, address and telephone number of the pharmacy from which such substance is
					 dispensed;
(3) specific directions
					 for use as stated on the prescription;
(4) the name of the prescribing
					 practitioner;
(5) the legend,
					 prominently marked or printed in either boldface or upper case lettering:
					 "CONTROLLED SUBSTANCE, DANGEROUS UNLESS USED AS DIRECTED";
(6) the number of the prescription under
					 which it is recorded in the pharmacy prescription file;
(7) the date of filling; and
(8) the name of the controlled substance or
					 such code number assigned by the department for the particular substance
					 pursuant to section
					 80.24 
					 of 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 › Prescribing and Dispensing Controlled Substances › Section 80.76 - Dispensing; prohibition

Current through Register Vol. 46, No. 28, July 10, 2024
Controlled substances shall not be prescribed for,
						administered or dispensed to addicts or habitual users of controlled substances
						except as provided by the Public Health Law or 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 › Prescribing and Dispensing Controlled Substances › Section 80.77 - Practitioners; control and reporting of official new york state prescription forms and electronic prescribing credentials

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Adequate safeguards and security measures
					 shall be undertaken by practitioners holding official New York State
					 prescription forms to assure against the loss, destruction, theft or
					 unauthorized use of the forms. Practitioners shall maintain a record of the
					 disposition of all forms, including but not limited to use as a prescription,
					 cancellation, return, loss, destruction, unauthorized use and nonreceipt. The
					 forms may be used only by the practitioner to whom they are issued and are not
					 transferable.
(b) Practitioners
					 shall immediately notify the department, upon forms supplied by the department,
					 of the loss, destruction, theft or unauthorized use of any official New York
					 State prescription forms issued to them, as well as the failure to receive
					 official New York State prescription forms within a reasonable time after
					 ordering them from the department.
(c) Practitioners shall retain sole
					 possession and safeguard credentials used to sign electronic prescriptions for
					 controlled substances and shall not share such credentials with any other
					 person. The practitioner shall not allow any other person to use such
					 credentials to sign prescriptions for controlled substances.
(d) Practitioners shall immediately notify
					 the Bureau of Narcotic Enforcement that his or her credentials used to sign
					 electronic prescriptions for controlled substances have been lost, stolen or
					 compromised.
(e) Practitioners
					 shall immediately notify the Bureau of Narcotic Enforcement upon discovery that
					 one or more prescriptions issued under that practitioner's DEA registration
					 were prescriptions the practitioner had not signed or were not consistent with
					 the prescription the practitioner signed.
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 › Prescribing and Dispensing Controlled Substances › Section 80.78 - Pharmacists; dispensing out-of-state prescriptions; schedule ii, iii, iv and v controlled substances

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A
					 licensed, registered pharmacist, or a pharmacy intern acting in conformity with
					 the provisions of section 6808  of the Education Law, and regulations
					 thereunder, in a registered pharmacy may, in good faith and in the course of
					 his/her professional practice, dispense to an ultimate user, controlled
					 substances in schedule II, III, IV and V upon delivery to such pharmacist of an
					 out-of-state prescription within 30 days of the date such prescription was
					 signed by an authorized practitioner.
(b) Such prescription shall have been written
					 with ink, indelible pencil, typewriter, or by other electronic means approved
					 by the department, and shall be signed by the practitioner. Electronic
					 prescriptions may be created, signed and transmitted electronically, provided
					 the practitioner complies with all other requirements for issuing controlled
					 substance prescriptions in this Part and with Federal requirements for
					 electronic prescribing of controlled substances. A prescription generated on an
					 electronic system that is printed out or transmitted via facsimile is not
					 considered an electronic prescription and shall be manually signed. The
					 prescription shall contain the following:
(1)
					 name, sex, address and age of the ultimate user for whom the substance is
					 intended, or, if the ultimate user is an animal, the species of such animal and
					 the name and address of the owner or person in custody of such
					 animal;
(2) the printed name,
					 address, Drug Enforcement Administration registration number, telephone number
					 and the handwritten signature or, in the case of an electronic prescription,
					 the electronic signature of the prescribing practitioner;
(3) specific directions for use, including,
					 but not limited to, the dosage and frequency of dosage;
(4) the date upon which such prescription was
					 prepared and actually signed by the prescribing practitioner. The prescription
					 shall have been dated as of, and signed on, the date it is issued;
					 and
(5) the quantity of dosage
					 units prescribed;
(6) an electronic
					 prescription shall contain the requirements as provided in paragraphs (1)-(5)
					 of this subdivision except such prescription shall contain an electronic
					 signature and shall be transmitted and received by electronic means. Such
					 electronic signature shall meet the signature requirements set forth in
					 paragraph (2) of this subdivision.
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 › Dispensing to Addicts and Habitual Users, and Treatment Programs › Section 80.84 - Practitioners and pharmacies; prescribing, administering and dispensing for the treatment of narcotic addiction

Current through Register Vol. 46, No. 28, July 10, 2024
Pursuant to the provisions of the federal Drug Addiction
						Treatment Act of 2000 (DATA 2000) (106 P.L. 310, Div. B, Title XXXV, Section
						3502(a)), an authorized practitioner may prescribe, administer or dispense an
						approved controlled substance, and a license d registered pharmacist may
						dispense an approved controlled substance, to a patient participating in an
						authorized controlled substance maintenance program approved pursuant to
						Article 32 of the Mental Hygiene Law for the treatment of narcotic
						addiction.
(a) An approved controlled
					 substance shall mean the following controlled substance which has been approved
					 by the Food and Drug Administration (FDA), or its successor agency, and the New
					 York State Department of Health for the treatment of narcotic addiction:
(1) buprenorphine
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 › Dispensing to Addicts and Habitual Users, and Treatment Programs › Section 80.85 - Administration of controlled substances to addicts and habitual users

Current through Register Vol. 46, No. 28, July 10, 2024
(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.
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 › Dispensing to Addicts and Habitual Users, and Treatment Programs › Section 80.86 - Records and reports of treatment programs

Current through Register Vol. 46, No. 28, July 10, 2024
(a) All persons approved pursuant to article
					 32 of the Mental Hygiene Law to operate a chemical dependence program, other
					 than authorized physicians and pharmacists as defined in section
					 80.84 
					 of this Part who are registered with the department to prescribe, administer or
					 dispense approved controlled substances for the treatment of narcotic
					 addiction, and who possess a Federal registration by the Drug Enforcement
					 Administration, United States Department of Justice to purchase, possess and
					 use controlled substances shall keep the following records:
(1) records of controlled substances received
					 by approved persons including date of receipt, name and address of distributor,
					 type and quantity of such drugs received and the signature of the individual
					 receiving the controlled substance. A duplicate invoice or separate itemized
					 list furnished by the distributor will be sufficient to satisfy this record
					 requirement provided it includes all required information and is maintained in
					 a separate file. In addition, duplicate copies of Federal order forms for
					 schedule II controlled substances must be retained; and
(2) records of controlled substances
					 administered or dispensed including date of administration or dispensing, name
					 of patient, signature of person administering or dispensing, type and quantity
					 of drug and such other information as may be required by 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 › Dispensing to Addicts and Habitual Users, and Treatment Programs › Section 80.87 - Repealed

Current through Register Vol. 46, No. 28, July 10, 2024
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 › Dispensing to Addicts and Habitual Users, and Treatment Programs › Section 80.88 - Repealed

Current through Register Vol. 46, No. 28, July 10, 2024
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 › Dispensing to Addicts and Habitual Users, and Treatment Programs › Section 80.89 - Repealed

Current through Register Vol. 46, No. 28, July 10, 2024
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 › Dispensing to Addicts and Habitual Users, and Treatment Programs › Section 80.90 - Repealed

Current through Register Vol. 46, No. 28, July 10, 2024
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 › Dispensing to Addicts and Habitual Users, and Treatment Programs › Section 80.93 - Repealed

Current through Register Vol. 46, No. 28, July 10, 2024
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 › Dispensing to Addicts and Habitual Users, and Treatment Programs › Section 80.94 - Repealed

Current through Register Vol. 46, No. 28, July 10, 2024
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 › Reports and Records › Section 80.100 - General requirements

Current through Register Vol. 46, No. 28, July 10, 2024
(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.
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 › Reports and Records › Section 80.101 - Manufacturers, distributors, importers and exporters

Current through Register Vol. 46, No. 28, July 10, 2024
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.
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 › Reports and Records › Section 80.102 - Research, instructional activities and chemical analysis

Current through Register Vol. 46, No. 28, July 10, 2024
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.
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 › Reports and Records › Section 80.103 - Institutional dispensers

Current through Register Vol. 46, No. 28, July 10, 2024
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.
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 › Reports and Records › Section 80.104 - Treatment program

Current through Register Vol. 46, No. 28, July 10, 2024
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.
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 › Reports and Records › Section 80.105 - Practitioners

Current through Register Vol. 46, No. 28, July 10, 2024
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.
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 › Reports and Records › Section 80.106 - Pharmacies

Current through Register Vol. 46, No. 28, July 10, 2024
(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.
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 › Reports and Records › Section 80.107 - Confidentiality

Current through Register Vol. 46, No. 28, July 10, 2024
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;
(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;