TOXIC VAPORS, HYPODERMIC SYRINGES AND NEEDLES

Section 80.130 - Toxic solvents

TOXIC VAPORS, HYPODERMIC SYRINGES AND NEEDLES

80.130 Toxic solvents.

(a) All glue, cement or other adhesives containing one or more of the following chemical compounds are designated as glue substances containing a solvent having the property of releasing toxic vapors or fumes: acetone, cellulose acetate, benzene, butyl alcohol, ethyl alcohol, ethylene dichloride, ethylene trichloride, isopropyl alcohol, methyl alcohol, methyl ethyl ketone, pentachlorophenol, petroleum ether, and toluene, or such other similar material as the commissioner shall by regulation prescribe.

(b) No person shall sell or offer to sell, to any person, any tube or container of glue containing a solvent having the property of releasing toxic vapors or fumes:

(1) if he has knowledge that the product sold or offered for sale will be used in violation of article 33 of the Public Health Law;

(2) unless there has been added to such glue a sufficient quantity of an additive approved by the commissioner which shall act as a deterrent to inhalation and not be harmful or toxic to the human body. This provision shall not apply to glue manufactured and sold for industrial use.

(i) Industrial use shall mean glue packaged in a container of more than four ounces by volume.

(ii) Approval as an additive, which shall act as a deterrent to inhalation of allyl isothiocynate (oil of mustard) when added at a level of not less than 0.25 nor more than 0.35 per centum by weight of total product is withdrawn for any glue manufactured 180 days after the effective date of this Part; a request for approval of any other such additive shall be made to the Bureau of Narcotic Enforcement of the department.

Effective Date: 
Wednesday, November 26, 2008
Doc Status: 
Complete

Section 80.131 - Prescription, sale and possession of hypodermic syringes and hypodermic needles

80.131 Prescription, sale and possession of hypodermic syringes and hypodermic needles.

(a) For purposes of this section, "prescription" shall have the same meaning as provided in section 3302 of the public health law, as supplemented by the meaning provided in section 3381 of the public health law. It shall be unlawful for any person to sell or furnish, to any other person or persons, or to possess, a hypodermic syringe, hypodermic needle, or a hypodermic syringe or hypodermic needle pre-filled with a non-controlled substance, except:

(1) pursuant to a prescription; or

(2) such sale, furnishing or possession has been authorized by the commissioner; or

(3) pursuant to Section 80.137 of this Part.

(b) Subject to the provisions of this section, a practitioner may orally prescribe or authorize a refill, and an employee of the prescribing practitioner, or a health care professional in a Residential Health Care Facility (RHCF) who is licensed by the state education department pursuant to the education law, may orally communicate a prescription or refill for, one or more hypodermic syringes or hypodermic needles. Subject to the provisions this section, a pharmacist may dispense, to an ultimate user, such hypodermic syringes or hypodermic needles; provided, however, the pharmacist shall:

(1) contemporaneously reduce such oral prescription to a written or electronic memorandum indicating the name, address and telephone number of the prescriber, the name, address, and age of the ultimate user, date on which the hypodermic syringe or hypodermic needle was ordered, quantity prescribed, directions for use, the name and strength of the drug, if applicable, number of refills authorized, the signature or readily identifiable initials of the pharmacist accepting the oral memorandum and documenting the fact that it is a telephone order;

(2) indicate on the memoranda the date filled and the number of the prescription under which it is recorded in the pharmacy prescription file, and sign or electronically sign the memorandum; and

(3) make a good faith effort to verify the identity of the practitioner and the practitioner's employee or RHCF professional, if applicable, and the ultimate user, if not known to the pharmacist.

(c) A prescription for one or more hypodermic syringes or hypodermic needles shall include:

(1) the name, address and age of the ultimate user;

(2) the name, address, telephone number and signature or electronic signature of the practitioner;

(3) the date on which it was issued; and

(4) the name, and strength of the drug, if applicable, the directions for use, the quantity of the hypodermic syringes or hypodermic needles prescribed, and the number of authorized refills.

(d) Any pharmacist selling or furnishing a hypodermic syringe or hypodermic needle pursuant to a prescription shall record upon the prescription, his or her signature or, as applicable, electronic signature, and the date of the sale or furnishing of the hypodermic syringe or hypodermic needle. Prescriptions and oral prescription memorandums shall be retained on file for a period of five years and be readily accessible for inspection by any public officer or employee engaged in the enforcement of this section. A prescription may be refilled not more than the number of times specifically authorized by the prescriber upon the prescription; provided, however, no such authorization shall be effective for a period longer than two years from the date the prescription is signed.

(e) A pharmacist receiving an oral authorization for the refill of a prescription for one or more hypodermic syringes or hypodermic needles shall enter on the original prescription or electronic record maintained on an electronic data processing system, the date, time, and name of the authorizing practitioner and the name of the practitioner’s employee or RHCF professional, if applicable, and shall sign or electronically sign such record.

(f) Pharmacists at registered pharmacies may, at the express request and approval of a patient or a person authorized to act on behalf of the patient, and subject to the requirements of 8 NYCRR Section 63.6(8), transfer information relating to a prescription for one or more hypodermic syringes or hypodermic needles, including a prescription for one or more hypodermic syringes or hypodermic needles pre-filled with a non-controlled substance, or accept a transfer of such information from another registered pharmacy or a pharmacy authorized to do business in another jurisdiction for the exclusive purpose of providing one authorized refill per transfer.

(g) Any prescription for one or more hypodermic syringes or hypodermic needles prefilled with a controlled substance shall be issued and dispensed according to the requirements as set forth in 80.67, 80.68, 80.69, 80.70, 80.73 and 80.74 of this Part.

Effective Date: 
Wednesday, October 9, 2013
Doc Status: 
Complete

Section 80.132 - Hypodermic syringes and needles; designation of persons or classes of persons

80.132 Hypodermic syringes and needles; designation of persons or classes of persons.

(a) The following persons or classes of persons may obtain hypodermic syringes and hypodermic needles without prescription for use within the scope of their professions or activities:

(1) physicians;

(2) dentists;

(3) veterinarians;

(4) undertakers;

(5) nurses;

(6) podiatrists;

(7) registered pharmacists;

(8) hospitals;

(9) sanitariums;

(10) clinical laboratories;

(11) medical institutions;

(12) manufacturers or dealers in medical, pharmaceutical, surgical or dental supplies or their agents;

(13) resident physicians or interns of hospitals, sanitariums or other medical institutions;

(14) 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 (i) sodium pentobarbital to registered and certified personnel to euthanize animals and (ii) ketamine hydrochloride to registered and certified personnel to anesthetize animals prior to euthanasia;

(15) persons engaged in an agricultural activity, provided that the manufacturer, distributor or supplier of the hypodermic syringe or hypodermic needle or of any product pre-packaged in a hypodermic syringe has an established needle and syringe return program in compliance with any applicable law;

(i) for purposes of this section, agricultural activity shall mean the production of food for human consumption and fiber through crops, livestock and livestock products.

(16) an advanced life support agency; and

(17) persons certified by the New York State Department of Environmental Conservation as wildlife rehabilitators. Wildlife rehabilitators are responsible for the proper safeguarding and handling of hypodermic syringes and needles and must comply with section 80.133(h)-(j) of this Part. All needles and syringes shall be stored in compliance with section 80.133(g) of this Part;

(18) licensed respiratory therapists and licensed respiratory therapy technicians;

(19) certified home health agencies, licensed home care services agencies and long term home health care programs approved under Article 36 of the Public Health Law; and

(20) certified hospices licensed under Article 40 of the Public Health Law.
 

Effective Date: 
Wednesday, February 25, 2009
Doc Status: 
Complete

Section 80.133 - Hypodermic syringes and needles; certificate of need

80.133 Hypodermic syringes and needles; certificate of need.

(a) The following are authorized to possess hypodermic syringes and hypodermic needles, provided they file with the commissioner a certificate of need and obtain a written authorization from the commissioner to possess and use such hypodermic syringes and needles:

(1) educational institutions, which also must comply with section 811 of the Education Law and file a separate certificate of need with the Commissioner of Education; and

(2) persons engaged in commercial, industrial or agricultural activities.

(b) The certificate of need shall set forth the names of individuals authorized by the educational institution or commercial or industrial firms to have custody of the hypodermic syringes and needles to be used in connection with their activities and the names of individuals designated as responsible for supervision of the use of such hypodermic syringes and needles.

(c) Any administrative officer of the institution or firm filing a certificate of need may be designated as responsible for the custody of hypodermic syringes and needles used on their premises. It shall be the duty of the designated custodial administrative officer to provide for safeguards and maintenance of records of receipt and disposition of all hypodermic syringes and needles acquired or possessed by the institution or firm.

(d) The head of any department, laboratory or division of an educational institution or commercial, agricultural or industrial firm filing a certificate of need may be designated as the person responsible for supervising the use of hypodermic syringes and needles used within the institution or firm. It shall be the responsibility of such designated person to supervise the use of hypodermic syringes and needles by students or other members of such institutions or firms and to keep and maintain records of all hypodermic syringes and needles used under his supervision.

(e) Any change in designated custodial or supervisory personnel shall be reported within 30 days to the department.

(f) Location of use. The location of authorized use of hypodermic syringes and needles includes any classroom, laboratory, lecture hall, department or division, designated by the institution or the firm in its certificate of need on file with the department. Any change in designated location of use shall be reported within 30 days to the department.

(g) Storage. (1) Hypodermic syringes and needles shall be stored in a locked secure place. In no instance shall spring or combination dial locks be employed.

(2) Reserve or main stock shall be kept in double cabinets under locked protection of suitable locks and keys. Both cabinets, inner and outer, shall be stationary.

(3) Hypodermic syringes and needles not in reserve, not in main stocks, and not in use, shall be kept under suitable locked protection.

(h) Records. (1) A record of all purchases of hypodermic syringes and needles shall be maintained.

(2) Main storage records shall include a running inventory of all hypodermic syringes and needles indicating type, size and number of each item purchased, distribution made, balance on hand, and date of receipt or disposition.

(3) An annual physical inventory shall be taken each June 30th and entered in the running inventory record.

(4) A record of all hypodermic syringes and needles destroyed shall be kept, indicating the type, size, and number of each item destroyed, the date of destruction, and the person by whom destroyed. The records shall be kept for a period of two years from the date of the transaction. Every such record shall list hypodermic syringes and needles lost or stolen, indicating kind and number and the date of discovery of such loss or theft. A report of such loss or theft, and other pertinent related facts, shall be made immediately upon discovery to the department.

(i) Disposal of hypodermic syringes and needles.

(1) All hypodermic syringes and needles which are no longer usable or required shall be disposed of in a manner consistent with universal precautions so as to be rendered inoperable.

(2) Procedures for disposal may include but are not limited to placement of such syringes, needles and disposable units in a leak-proof, puncture resistant container prior to disposal.

(j) Inspection. All records and stocks of hypodermic syringes and needles maintained by educational institutions or commercial or industrial firms shall be readily available and promptly produced for inspection by authorized representatives of the State Commissioner of Health.
 

Effective Date: 
Wednesday, October 9, 2013
Doc Status: 
Complete

Section 80.134 - Authorization for the purchase, possession and dispensing of sodium pentobarbital to euthanize animals

80.134 Authorization for the purchase, possession and dispensing of ketamine hydrochloride only to anesthetize animals for euthanasia and sodium pentobarbital to euthanize animals.

(a) Except where different meanings are specified expressly, the terms in this section shall have the following meanings:

(1) An incorporated society for the prevention of cruelty to animals (society) shall include any incorporated humane society or society for the prevention of cruelty to animals having facilities for the care and eventual disposition of animals, within the State.

(2) Municipal animal control facility (facility) shall include any pound or shelter maintained by or under contract or agreement with any county, city, town or village within the State.

(3) Solution shall mean:

(i) a premixed solution of sodium pentobarbital, manufactured only and specifically for the euthanasia of animals, which contains such other ingredients as to place such solution within schedule III of the Controlled Substances Act (article 33, Public Health Law);

(ii) schedule II sodium pentobarbital; and

(iii) ketamine hydrochloride only for the purpose of anesthetizing animals for euthanasia.

(4) An agent is a person or persons other than a licensed veterinarian appointed by the incorporated society or municipal animal control facility, and duly registered with the department, authorized to purchase, possess and dispense:

(i) ketamine hydrochloride only to anesthetize animals for euthanasia, and

(ii) sodium pentobarbital to euthanize animals.

(5) A registered individual is a person certified and registered pursuant to subdivision (f) of this section.

(b) No society, facility or its agent shall purchase, possess, dispense or cause to be administered, a controlled substance within this State without first registering with the department.

(c) A society or facility and its agents shall also register with the Federal Drug Enforcement Administration (DEA) in the controlled substance schedule provided for under this Part.

(d) Any society or facility may register an agent to purchase, possess and dispense a controlled substance, by application to the department.

(1) The department shall issue such registration unless the commissioner 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 DEA registration, failure to provide adequate safeguards against diversion of the solution, or other good and sufficient reason such as conviction for a violent felony or a felony related to theft, an administrative determination that article 33 of the Public Health Law or provisions of this Part were violated, conviction for a misdemeanor relating to controlled substances, or any conviction under the Agriculture and Markets Law relating to the treatment of animals.

(2) Such registration shall be valid for a period of three years from the date of issuance and may be suspended or revoked upon a finding by the commissioner that the society, facility, agent or certified personnel have violated the provisions of this section, or any other requirement of this Part or article 33 or any other State law or regulation relating to the proper care of animals by societies or facilities.

(3) Any society or facility registering an agent shall immediately notify the department of any change in the employment or contractual relationship with the designated agent.

(4) Such registration shall be valid only at the registered location.

(e)(1) Registered agents of societies or facilities may dispense solution for the euthanasia of animals only to registered individuals certified by the department to administer such a solution; or to a licensed and properly registered veterinarian and only for on-premises use.

(2) Solution may be dispensed for use off the premises only where the animal to be euthanized is injured or transport of such animal to the society or facility is not practical.

(f) Registration and certification of individuals to administer solution for euthanasia of animals.

(1) No person other than a licensed veterinarian shall receive a controlled substance from a duly authorized agent of a society or facility to euthanize animals unless the person is certified and registered with the department.

(2) To obtain a certification and registration from the department in order to administer a solution to euthanize animals, the applicant must:

(i) be 21 years of age or older;

(ii) hold a bachelor or associate degree in animal health sciences or related field; and

(iii) obtain a written certification from two licensed veterinarians or one licensed veterinarian and one licensed animal health technician in which the veterinarians or technicians state that they have observed the proficient use, by the applicant, of injections for the euthanasia of animals.

(3) Any person who meets the minimum qualifications stated in subparagraphs 2 (i) and (iii) of this subdivision, but who lacks the required bachelor or associate degrees, may obtain certification and registration from the department if such person has two years' experience in animal care including euthanasia of animals.

(4) The department shall issue such registration and certification unless the commissioner finds that the application should be denied by reason of false statements in the application, the applicant's conviction of a felony relating to controlled substances or for other good and sufficient reason.

(5) Such registration and certification shall be valid for a period of three years from the date of issuance and may be suspended or revoked upon a finding by the commissioner that the registered individual has violated the provisions of this Part, article 33 or any other State law or regulation relating to the proper care of animals, or is not competent to administer solution in the euthanasia of animals by injection.

(g) Renewal of registrations. Registrations issued under this section shall be renewed by the department upon receipt of a completed renewal application which includes proof of attendance at a department-sponsored or -approved course in the safe and effective use of a solution in the euthanasia of animals.

(h) Safeguarding of solution. Agents shall safeguard the solution in compliance with the standards for safeguarding controlled substances set out in section 80.6(a) and (b) of this Part.

(i) Minimum security standards for a society, facility and its agents.

(1) The solution must be stocked in a securely locked cabinet of substantial construction. The cabinet shall be stationary and made of steel or other approved metal and of sufficient size to store the stock of solution.

(2) The cabinet shall be limited to the storage of the solution, needles and syringes and solution records.

(j) Recordkeeping requirements.

(1) Agents shall keep records of all solution purchased, dispensed and administered.

(2) All purchase records, including a copy of the invoice, shall be kept in a separate file and filed by date received.

(3) A separate record of solution activities and transactions in the form of a running inventory shall be maintained and include the following:

(i) the name of the drug (by brand name);

(ii) the name of the manufacturer, lot number, NDC number;

(iii) the strength of the drug in milligrams (mg) per milliliter (ml);

(iv) the total amount of drug received in milliliters;

(v) the name, address and DEA registration number of the supplier of the drug;

(vi) the date the solution was received;

(vii) the signature of the person receiving the solution;

(viii) the date of any transaction or activity, the amount of the solution dispensed at each dispensing;

(ix) the signature of the agent who dispensed the solution;

(x) the signature of the registered individual administering the solution; and

(xi) the remaining amount of drug on hand.

(4) Any unused solution must be returned to the agent. The agent must record the date, the amount returned, the signatures of the agent and the registered individual returning the drug, and the amount on hand after such transaction.

(5) A separate record shall be maintained of all losses with a brief statement describing the incident and signed by the agent and a witness.

(6)(i) Agents shall cause the registered individual and any contracting practitioner to receive a work card or medical record sheet when dispensing the solution and such record shall be returned to the agent upon completion of each workday.

(ii) The work card or medical report sheet shall contain information to properly identify each animal to whom the solution is administered. For each female with litter, utilize only one record or card.

(iii) The registered individual euthanizing such animal shall document on such record the date of the administration of the drug, the amount of the drug used and the registered individual's signature.

(7) All records pertaining to the solution shall be kept on the premises of the society or facility for a period of five years and shall be available readily and produced promptly for inspection by authorized representatives of the commissioner.

(k) Quarterly reports. Within 10 days of the end of each quarter of each year, the society or facility shall submit a report to the department signed by an officer or official and the agent and include the following:

(1) the name, address and phone number of the society or facility;

(2) the agent's name, bureau registration number, DEA registration number;

(3) the total amount of solution received from suppliers;

(4) the total amount of solution dispensed to personnel;

(5) the total amount of solution returned from personnel;

(6) the total amount of solution lost for any reason;

(7) the total amount of solution on hand at the end of the quarter;

(8) an actual physical inventory count of solution on hand; and

(9) the total number of animals euthanized by species. (l) All agents and registered individuals are under continuing duty to report immediately to the department any loss, theft or diversion of solution from the society or facility.

(m) Certification or registration by the department under this section does not authorize the use of medicated darts in a handgun.

(n) Registered individuals may administer solution for euthanasia of animals only when in the employ of a registered society or facility and only when solution is obtained from the registered agent of such society or facility.

(o) An agent of a society or facility may also obtain registration and certification to administer the solution as defined in paragraph (f)(2) of this section. However, the same individual may not act as both the agent dispensing and the registered individual administering in the same facility at the same time.

(p) Agents of an incorporated society or a facility are responsible for the proper safeguarding and handling of hypodermic syringes and needles and must comply with section 80.133(h)-(j) of this Part. All needles and syringes shall be stored in compliance with subdivision (i) of this section.

(q) The agent of a society or facility is not relieved of his responsibilities to detect or correct any diversion or mishandling of any solution by a delegation of responsibility.
 

Effective Date: 
Wednesday, February 25, 2009
Doc Status: 
Complete

Section 80.136 - Controlled substances for emergency medical services: purchasing, possessing, delivering, administering and safeguarding of controlled substances

80.136 Controlled Substances for Emergency Medical Services: Purchasing, possessing, delivering, administering, and safeguarding of controlled substances.

(a) Definitions:

(1) Ambulance Service means an individual, partnership, association, corporation, municipality or any other legal entity or subdivision, thereof, engaged in providing emergency medical care and the transportation of sick, or injured persons by motor vehicle, aircraft or other form of transportation to or from facilities providing hospital services.

(2) Medical Director means a New York State licensed physician who is responsible for authorizing treatment protocols and quality assurance activities for participating advanced life support agencies within an advanced life support system. The medical director of any advanced life support system with 10 or more advanced life support agencies and/or 100 or more advanced emergency medical technicians (AEMTS) shall designate associate physicians to provide quality assurance according to a plan submitted to and approved by the Emergency Medical Services Program.

(3) Agent means a person or persons certified as an emergency medical technician-critical care or emergency medical technician-paramedic who is appointed by an advanced life support agency, approved in writing by the medical director, and registered with the Department's Bureau of Narcotic Enforcement, to purchase, possess, and deliver controlled substances for use by an advanced life support agency.

(4) Advanced Life Support First Response Service means an organization which provides advanced life support care but does not transport patients.

(5) Advanced Life Support Agency (ALS Agency) means a certified ambulance service or certified advanced life support first response service which is authorized by the medical director of an advanced life support system to provide advanced life support care.

(6) Contracting Hospital means a hospital licensed as an Institutional Dispenser Class 3 which has a written agreement with one or more ALS Agencies to provide stocks of controlled substances to such services.

(7) Advanced Life Support System means an acute medical care system organized to provide advanced life support care on site or en route to a hospital in accordance with section 3031 of the Public Health Law.

(b)(1) A hospital licensed as an Institutional Dispenser Class 3 may:

(i) enter into a written agreement with an ALS Agency to provide, sell or deliver stocks of controlled substances, to such agency for use in an advanced life support system; or

(ii) enter into a written agreement with an ALS Agency to act as agent for such agency and supply a substock of controlled substances for use in the ALS Agency's response vehicles; and

(iii) provide only those controlled substances approved by the Department and the medical director.

(2) Only those ambulance services or advanced life support services meeting the conditions of and approved under this Part may possess, deliver or administer controlled substances.

(c) An ALS Agency and/or its agent shall:

(1) purchase, possess, deliver or cause to be administered only those controlled substances approved and listed by the Department and approved by the medical director of the advanced life support system;

(2) possess a certificate issued pursuant to article 30 of the Public Health Law;

(3) possess a class 3(c) institutional dispenser limited license from the Department, except that an ALS agency, owned and operated by a hospital, is exempt from obtaining a class 3(c) institutional dispenser limited license and shall:

(i) utilize the hospital's class 3 institutional dispenser license for the delivery of controlled substances for use in any authorized response vehicle;

(ii) maintain the ALS agency's controlled substances as part of the hospital's controlled substances substock;

(iii) have the hospital act as the agent for its ambulance service;

(iv) comply with all other sections of this Part;

(4) permit only a licensed physician or a person certified pursuant to Article 30 of the Public Health Law as an advanced emergency medical technician - critical care or advanced emergency medical technician - paramedic, and authorized by the medical director of the advanced life support system to receive or administer a controlled substance.

(d)(1) Any ALS Agency may be denied approval to purchase, possess, or deliver controlled substances upon a finding by the Department that the approval should be denied or revoked by reason of false statements in the application, failure to provide adequate safeguards against diversion of the controlled substances, or other good and sufficient reason such as an administrative determination that article 30 or 33 of the Public Health Law or a provision of Part 800 of this Title or of this Part was violated.

(e) Agents.

(1) An ALS Agency shall register an agent to purchase, possess, and deliver controlled substances, by making application to the Department.

(2) The Department shall issue such registration unless the Department finds that the application should denied by reason of false statements in the application, failure to provide adequate safeguards against diversion of the controlled substances, other good and sufficient reason such as an administrative determination that article 30 or 33 of the Public Health Law was violated, or conviction of one or more criminal offenses, as defined in section 800.3(ak), unless the applicant is found eligible after a balancing of the factors set out in Article 23-A of the Correction Law. In accordance with that Article, no application for registration shall be denied by reason of the applicant having been previously convicted of one or more criminal offenses unless (i) there is a direct relationship between one or more of the previous criminal offenses and duties required of the registration or (ii) registering the applicant would involve an unreasonable risk to property or the safety or welfare of a specific individual or the general public. In determining these questions, the department will look at all factors listed under New York State Correction Law section 753.

(3) Such registration shall be valid for a period of two years and may be suspended or revoked upon a finding by the Department that the ALS Agency, agent, or its members have violated article 30 or 33 of the Public Health Law or any provision within Part 800 of this Title or any provision within this Part.

(4) Each ALS agency or its agent shall immediately notify the Department and the medical director of any change in the membership, employment, or contractual relationship with the designated agent or the dispensing hospital.

(5) Such registration shall be valid only for the ALS Agency and at the specified location(s) appointing the agent.

(6) An agent of an ALS Agency may deliver controlled substances, only for administration by their ALS Agency, to a licensed physician and individuals certified and authorized to administer controlled substances.

(f) Agents shall ensure that:

(1) Controlled substances shall be safeguarded properly and kept securely at the registered address on file with the Department;

(2) All stocks and/or substocks will be made available for inspection by authorized representatives of the Department;

(3) Access to controlled substances stocks shall be limited to the minimum number of individuals actually required to manage the administration, delivering and handling of such controlled substances efficiently;

(4) A plan is submitted to the Department for review, modification and/or approval that details the location(s) of all stocks or substocks, the safeguarding of, access to, and security standards for all controlled substances;

(5) A quality assurance plan for the administration of controlled substances is submitted to the Department; and

(6) Only a reasonable quantity of controlled substances as approved by the medical director is stored as substocks.

(g) Minimum security standards for ALS Agencies, their agents and all certified and authorized individuals:

(1) Any stock or substock of controlled substances shall be maintained in a secure manner and in compliance with this Part.

(2) Any stock or substock of controlled substances shall be stored in a locked cabinet of substantial construction at the location registered with the Department. The cabinet shall be stationary, be made of steel or other metal and be of sufficient size to store all controlled substances. This cabinet shall be limited to the storage of controlled substances, needles and syringes and associated records.

(3) Access to any stock or substock of controlled substances will be limited to the agent and require at least two locks with different keys.

(4) Any substock of controlled substances in an authorized response vehicle shall be stored as follows:

(i) When access to the patient compartment of an ambulance is kept locked at all times, controlled substances shall be secured in a locked cabinet using a key lock different than the patient compartment.

(ii) When the access to the patient compartment of an ambulance is not kept locked at all times or any other response vehicle is used, controlled substances must be secured in a locked box within a locked stationary cabinet under a two lock system using different keys.

(iii) The key(s) to access the cabinet where controlled substances are stored must be maintained under the direct control of a certified and authorized individual.

(iv) Controlled substances may be maintained in the direct possession and control of a certified and authorized individual at all times while such individual is on duty for the ALS Agency, however, at no time shall controlled substances be carried in any personal automobile.

(v) A written change of shift inventory for any substock shall be conducted when custody of controlled substances passes between certified and authorized individuals during a shift change.

(vi) Alternative forms of securing or maintaining controlled substances in authorized response vehicles are subject to the approval of the Department upon written application by the chief executive/operating officer of the ALS Agency. The application must describe the alternative methods, state reasons why the alternate method is necessary and fully describe procedures for safeguarding and controlling controlled substances and limiting access to certified and authorized individuals. (vii) Only individuals certified and authorized under this Part shall have access to controlled substances. If an agency operates at various times with different levels of personnel, all of whom are not certified and authorized, provisions shall be made to prohibit access to all controlled substances by persons who are not certified or authorized.

(h)(1) Controlled substances may only be administered pursuant to a physician's order or a protocol authorized by the medical director and approved by the Department pursuant to Article 30 of the Public Health Law and section 800.15 of this Title. A copy of the approved protocol shall be on file with the Department. Any change in such protocol shall be approved by the Department prior to being implemented.

(2) A certified and authorized individual making any administration of a controlled substance pursuant to a physician order or protocol order shall notify a medical control location to make a record of the administration as described in section 80.136(h)(3). Such notification shall be made during or immediately following the run.

(3) At any medical control location, the physician ordering or confirming the administration of a controlled substance shall make and maintain a record of such administration to include but not be limited to:

(i) physician name and signature;

(ii) date, time, and run identification;

(iii) patient name;

(iv) ALS Agency name;

(v) AEMT number and name;

(vi) patient's chief complaint and presenting problem;

(vii) name of controlled substance;

(viii) dosage and route of administration;

(ix) quantity administered; and

(x) receiving hospital name and record number.

(4) Each certified and authorized individual receiving an order or using a protocol to administer a controlled substance shall make a record of the administration to include but not be limited to:

(i) ordering physician identification;

(ii) date, time, and run identification;

(iii) patient name;

(iv) ALS Agency name;

(v) AEMT number and name;

(vi) patient's chief complaint and presenting problem;

(vii) name of controlled substance;

(viii) dosage and route of administration;

(ix) quantity administered, and

(x) receiving hospital name and record number.

The required record shall be the Department's Pre-hospital Care Report and any necessary supplement. A copy of the pre-hospital record shall become part of the patient's hospital record. Patient confidentiality shall be maintained at all times.

(5) A certified and authorized individual shall maintain an administration inventory record for all controlled substances. This record shall be returned to the agent before any controlled substances can be replenished.

(i) Recordkeeping Requirements.

(1) Agents shall keep records of all controlled substances obtained, purchased, delivered and administered.

(2) All purchase records, including date, quantity obtained and source shall be maintained in a separate file by date received.

(3) An inventory record shall be maintained and shall include the following:

(i) the name of the controlled substance;

(ii) the name of the manufacturer and lot number;

(iii) the strength of the controlled substance;

(iv) the total amount of controlled substance stock received;

(v) the name, address, and DEA registration number of the authorized person or hospital supplying the controlled substance stock;

(vi) the date the controlled substance stock was received;

(vii) the signature of the person receiving the controlled substance stock;

(viii) the date and the amount of the controlled substance delivered to a substock;

(ix) the signature of the agent who delivered the controlled substance substock;

(x) the signature of the certified and authorized individual receiving the controlled substance substock;

(xi) the vehicle identification number or location of substock; and

(xii) the remaining amount of controlled substance on hand.

(4) A separate record shall be maintained of all non-administered losses from any stock or substock with a brief statement describing the incident and signed by the certified and authorized individual and the agent.

(5) Partial doses remaining after the parental administration of a portion of an ampule or unit dose of a controlled substance may be destroyed and properly disposed of provided that:

(i) a notation is made on the administration record; and

(ii) the destruction is witnessed by a second certified emergency medical technician member of the ALS Agency, the agent, or other licensed health care provider.

(6) An administration record shall be kept for each substock. This record will indicate the substock location and/or the vehicle identification number, the name of each controlled substance, dose and quantities furnished to the substock and:

(i) date and hour of administration;

(ii) name of patient;

(iii) run and medical control information;

(iv) dose administered;

(v) balance on hand after each administration; and

(vi) the name and signature of the administering individual.

(j) All records pertaining to controlled substances shall be kept at the location registered with the Department by the ALS Agency for a period of five years and shall be readily available and produced promptly for inspection by authorized representatives of the Department.

(1) Within 30 days of June 30 and December 31 of each year, the ALS Agency shall submit a report for that six month period to the Department signed by the agent which report shall include the following:

(i) the name, address, and telephone number of the ALS Agency;

(ii) the Bureau of Narcotic Enforcement license number;

(iii) the agent's name;

(iv) the total amount of controlled substances received from the dispensing hospital;

(v) the total amount of controlled substances dispensed to personnel;

(vi) the total amount of controlled substances returned from personnel;

(vii) the total amount of controlled substances lost for any reason;

(viii) the total amount of controlled substances on hand at the end of the period; and

(ix) an actual physical inventory count of all controlled substances on hand.

(k) Responsibilities.

(1) All agents and members of an ALS Agency are under a continuing duty to report immediately to the Department and the medical director any loss, theft, or diversion of controlled substances.

(2) Agents and certified and authorized members of the ALS Agency are responsible for the proper safeguarding and handling of controlled substances, needles and syringes.

(3) The medical director of the advanced life support system authorizing the use and administration of controlled substances shall be accountable for the proper use and administration of the controlled substances and for maintaining a quality assurance plan and protocols approved by the Department.

(4) The chief executive/operating officer of the ALS Agency is responsible for the proper safeguarding, handling and accountability of controlled substances and for assuring that all reports and reporting procedures are carried out in accordance with this Part. The chief executive/operating officer shall not be relieved from any responsibility under this Part as a result of any delegation of responsibility.

Effective Date: 
Wednesday, July 20, 2016
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, section 3002

Section 80.138 - Opioid Overdose Prevention Programs

Section 80.138. Opioid Overdose Prevention Programs.

(a) Definitions.

(1) Opioid means an opiate as defined in section 3302 of the public health law.

(2) Opioid antagonist means a drug approved by the Food and Drug Administration, that, when administered, negates or neutralizes in whole or in part the pharmacological effects of an opioid in the body. The opioid antagonist is limited to naloxone or other medications approved by the department for this purpose.

(3) Opioid overdose prevention program means a program the purpose of which is to train individuals to prevent a fatal opioid overdose in accordance with these regulations.

(4) Opioid overdose prevention training curriculum refers to any set of instructions, consistent with guidance from the department, which provides a person encountering a suspected opioid overdose with the steps to take for preventing a fatality, including contacting emergency medical services, administering an opioid antagonist and, where appropriate, providing resuscitation.

(5) Registered provider for the purposes of this section shall mean any of the following that have the services of both a program director and a clinical director and that have registered with the department pursuant to subdivision (b) of this section:

(i) a health care facility licensed under the public health law;

(ii) a physician, physician assistant, or nurse practitioner who is authorized to prescribe the use of an opioid antagonist;

(iii) a drug treatment program licensed under the mental hygiene law;

(iv) a not-for-profit community-based organization incorporated under the not-for-profit corporation law;

(v) a local health department, public safety agency, or other local or state government agency;

(vi) an institution of higher education, recognized and approved by the regents of the university of the state of New York, which provides a course of study leading to the granting of a post-secondary degree or diploma;

(vii) a business, trade, technical or other occupational school approved as such by the regents of the university of the state of New York or accredited by a nationally recognized accrediting agency or association accepted as such by the regents of the state of New York; and

(viii) a pharmacy registered in accordance with the Article 137 of the Education Law.

(6) Program director means an individual who is identified to manage and have overall responsibility for the opioid overdose prevention program.

(7) Clinical director means a physician, physician assistant or nurse practitioner who is designated in an opioid overdose prevention program's registration for prescribing an opioid antagonist to individual or an identifiable pool of trained overdose responders and who provides oversight of the clinical aspects of the opioid overdose prevention program. This oversight includes serving as a clinical advisor and liaison concerning medical issues related to the opioid overdose prevention program, providing consultation on training and reviewing reports of all administrations of an opioid antagonist.

(8) Affiliated prescriber means a physician, physician assistant or nurse practitioner, who, in addition to the clinical director, is designated in an opioid overdose prevention program's registration for prescribing an opioid antagonist to individual or an identifiable pool of trained overdose responders.

(9) Trained overdose responder means any individual not otherwise permitted by law to administer an opioid antagonist, who is either:

(i) an opioid antagonist recipient as defined in PHL Section 3309 who has successfully completed an opioid overdose prevention training curriculum offered by an authorized opioid overdose prevention program and has been authorized by a registered provider to possess the opioid antagonist;

(ii) a public safety officer who has completed a curriculum approved by the division of criminal justice services for purposes of intervening in opioid overdoses prior to the arrival of emergency medical services; or

(iii) a firefighter who has completed a comparable curriculum approved by the department.

(b) Registration.

(1) Registered providers may operate an opioid overdose prevention program if they obtain a certificate of approval from the department authorizing them to operate an opioid overdose prevention program and otherwise comply with the provisions of this section.

(2) Providers eligible to register to operate an opioid overdose prevention program that are in good standing may apply to the department to operate an opioid overdose prevention program on forms prescribed by the department which must include, at a minimum, the following information:

(i) the provider name, address and operating certificate or license number where appropriate;

(ii) the name, address, telephone number, fax number, e-mail address and signature of the program director;

(iii) the name, address, telephone number, fax number, e-mail address, license type, license number and signature of the clinical director;

(iv) the name, license type and license number of the affiliated prescribers, if any;

(v) the name and address of the sites at which the opioid overdose prevention program will be conducted; and

(vi) a description of the targeted population to be served and recruitment strategies to be employed by the opioid overdose prevention program.

(c) Program Operation.

(1) Each opioid overdose prevention program shall have a program director who is responsible for managing the opioid overdose prevention program and shall, either directly or through a designee, at a minimum:

(i) identify a clinical director to oversee the clinical aspects of the opioid overdose prevention program;

(ii) establish the content of the program's opioid overdose prevention training curriculum consistent with guidance from the department;

(iii) identify and train other program staff;

(iv) select and identify persons as trained overdose responders;

(v) issue certificates of completion to trained overdose responders who have successfully completed the program's opioid overdose prevention training curriculum; however, certificates of completion of curriculum under subparagraphs (ii) and (iii) of paragraph (9) of subdivision (a) of this section are not required for public safety or firefighting personnel;

(vi) establish and maintain the opioid overdose prevention program's mandated recordkeeping system;

(vii) ensure that all trained overdose responders successfully complete the program's opioid overdose prevention training curriculum;

(viii) provide liaison with local emergency medical services and emergency dispatch agencies, where appropriate;

(ix) assist the clinical director with review of reports of all overdose responses, particularly those involving administration of an opioid antagonist;

(x) report all administrations of an opioid antagonist on forms prescribed by the department; however, public safety and firefighting personnel are required to report administrations of an opioid antagonist directly, or through their department or agency, to the department; and

(xi) report the number of trained overdose responders and the number of doses of an opioid antagonist provided on a quarterly basis on forms prescribed by the department.

(2) Each opioid overdose prevention program shall have a clinical director who is responsible for clinical oversight and liaison concerning medical issues related to the opioid overdose prevention program and, at a minimum, shall:

(i) provide clinical consultation, expertise, and oversight;

(ii) serve as a clinical advisor and liaison concerning medical issues related to the opioid overdose prevention program;

(iii) provide consultation to ensure that all trained overdose responders are properly trained;

(iv) adapt and approve opioid overdose prevention training curriculum content and protocols;

(v) review reports of all administrations of an opioid antagonist; and

(vi) designate individuals, either by name or by description, who are authorized to dispense or furnish an opioid antagonist to trained overdose responders and/or individuals who are responsible for ensuring orderly, controlled, shared access to an identifiable pool of trained overdose responders pursuant to a non-patient specific prescription.

(3) The trained overdose responders shall:

(i) complete an initial training consistent with the program's opioid overdose prevention training curriculum;

(ii) complete a refresher training consistent with the opioid overdose prevention training curriculum at least every two (2) years or otherwise demonstrate competence in opioid overdose recognition and response to the satisfaction of the opioid overdose prevention program director or to someone designated by the program director;

(iii) ensure that emergency medical service has been contacted when encountering a victim of a suspected drug overdose and advise responding emergency medical services personnel if an opioid antagonist has been used;

(iv) comply with protocols for response to victims of suspected drug overdose consistent with the program's opioid overdose prevention training curriculum, or, in the case of responders who are public safety or firefighting personnel, comply with policies developed by their local public safety agency or fire department; and

(v) report all responses to victims of suspected drug overdose to the opioid overdose prevention program director or to someone designated by the program director.

(4) The opioid antagonist shall be provided or furnished to the trained overdose responder in accordance with all applicable laws, rules and regulations.

(5) The opioid overdose prevention program will maintain and provide response supplies consistent with its policies and procedures; however, these supplies must include:

(i) a mask or other barrier where rescue breathing is part of the curriculum;

(ii) an agent to prepare skin before injection where an injectable form of an opioid antagonist is used; and

(iii) instructional material required by the department, including information on how to recognize symptoms of an opioid overdose; the steps to be taken in responding to an overdose; and how to access the office of alcoholism and substance abuse services through both a toll free number and its website.

(6) The opioid overdose prevention program's record keeping system must include, at a minimum, the following elements:

(i) the names of trained overdose responders, the dates they were trained, and the dates they were furnished naloxone; however, where an opioid antagonist is furnished or dispensed by an opioid overdose prevention program pursuant to a non-patient specific prescription, the program must also maintain records on who has issued the non-patient specific prescription and which designated program staff have dispensed or furnished the opioid antagonist and/or are responsible for ensuring orderly, controlled, shared access to an identifiable pool of trained overdose responders;

(ii) program policies and procedures;

(iii) copy of the contract/agreement with the clinical director, if appropriate;

(iv) opioid antagonist administration usage reports and forms;

(v) documentation of review of administration of an opioid antagonist; and

(vi) an inventory of overdose response supplies.

(7) The opioid overdose prevention program will establish a procedure by which any administration of opioid antagonist to another individual by a trained overdose responder affiliated with an opioid overdose prevention program, shall be reported on forms prescribed by the department.

(8) Approval obtained pursuant to this section shall consist of a certificate of approval provided by the department that shall remain in effect for two years or until receipt by the authorized provider of a written notice of termination of the program from the department, whichever shall first occur. The department may renew a certificate of approval for a subsequent two-year period if the registered provider is in good standing with all applicable state and federal licensing agencies and such provider is found to have complied with the requirements of this section.

(9) Pursuant to Public Health Law section 3309(2), the purchase, acquisition, possession or use of an opioid antagonist by an opioid overdose prevention program or a trained overdose responder in accordance with this section shall not constitute the unlawful practice of a profession or other violation under title eight of the education law or article 33 of the public health law.

(10) Trained overdose responders may have shared access to, and use of, an opioid antagonist so long as the following conditions are met:

(i) they are trained in accordance with these regulations;

(ii) they have a common organizational or workforce bond; and

(iii) there are policies and procedures in place within that organization or workforce that ensure orderly, controlled access to an opioid antagonist by an identifiable pool of trained overdose responders.

(11) Clinical directors and affiliated prescribers of registered providers are authorized to direct the furnishing or dispensing of an opioid antagonist to trained overdose responders pursuant to a patient-specific prescription or a non-patient specific prescription.

(12) All dispensing or furnishing of an opioid antagonist pursuant to a non-patient-specific prescription shall be to individuals who have been trained in opioid overdose recognition and response and be accompanied by documentation indicating:

(i) that the opioid antagonist has been furnished pursuant to a non-patient specific prescription;

(ii) the name of the prescriber;

(iii) the opioid antagonist being prescribed;

(iv) the date of the dispensing or furnishing; and

(v) the name of the person (or identification of the pool under subparagraph (iii) of paragraph (10) of this subdivision) receiving the opioid antagonist.

(d) Nothing in this section shall prevent a health care practitioner from issuing a patient-specific prescription for an opioid antagonist as otherwise permitted by law.

Effective Date: 
Wednesday, May 6, 2015
Doc Status: 
Complete