HLT-46-08-00003-E Controlled Substances Data Submissions
11/12/08 N.Y. St. Reg. HLT-46-08-00003-E
NEW YORK STATE REGISTER
VOLUME XXX, ISSUE 46
November 12, 2008
RULE MAKING ACTIVITIES
DEPARTMENT OF HEALTH
EMERGENCY RULE MAKING
I.D No. HLT-46-08-00003-E
Filing No. 1061
Filing Date. Oct. 27, 2008
Effective Date. Oct. 27, 2008
Controlled Substances Data Submissions
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Amendment of sections 80.2, 80.23, 80.67, 80.68, 80.69, 80.71, 80.73, 80.74, 80.132 and 80.134 of Title 10 NYCRR.
Statutory authority:
Public Health Law, section 3308(2)
Finding of necessity for emergency rule:
Preservation of public health and public safety.
Specific reasons underlying the finding of necessity:
We are proposing that these regulations be adopted on an emergency basis as authorized by Section 21 of the Public Health Law because immediate adoption is necessary to protect the public health from the threat posed by prescription drug abuse. Statistics from the National Institute on Drug Abuse indicate that the abuse of prescription pain relievers, stimulants, sedatives, and depressants is second only to the abuse of marijuana. The federal Drug Abuse Warning Network reports that emergency room visits due to abuse of prescription drugs are more than the visits due to abuse of cocaine and heroin combined. Experts in addiction medicine estimate that for every person addicted to heroin, there are two persons addicted to prescription narcotics. The trafficking in prescription controlled substances increases the threat to the public health by exponential proportions.
Immediate adoption of these regulations is necessary to protect the public health from an alarming increase in the non-medical use of prescription controlled substances, by both adults and children. The emergency regulations will provide immediate enhancements to the monitoring capability of the Official Prescription Program to detect and prevent drug diversion by allowing the Department to immediately begin more efficient monitoring of the acquisition of controlled substances by healthcare professionals authorized to possess them for legitimate medical use. Such monitoring will detect non-legitimate use and protect the public health from professionals who are impaired by their own drug abuse or traffic in drugs for profit. The regulations will also immediately allow practitioners increased flexibility to treat chronic pain from conditions other than diseases and afford hospice patients with more time to partial fill their controlled substance prescriptions to better meet their medication needs at this crucial stage in their lives.
Immediate adoption of these regulations is also necessary to facilitate more humane euthanasia of animals in animal control facilities through the utilization of additional drugs. Immediate adoption is also necessary to bring Part 80 regulations regarding euthanasia of animals in conformity with statute. Section 3305(1)(d) of the Public Health Law was previously enacted to authorize the safe and efficient use of ketamine hydrochloride and sodium pentobarbital for euthanasia in animal shelters, however, regulations implementing the statute were not promulgated at the time.
Subject:
Controlled Substances Data Submissions.
Purpose:
Govern and control-possession prescribing manufacturing dispensing administering and distribution of controlled substances within NYS.
Text of emergency rule:
Section 80.2, subdivision (a), paragraph (6), of Title 10 NYCRR is hereby amended to read as follows:
Section 80.2 Exemptions.
(a) Pursuant to section 3305 of the Public Health Law, the provisions of this Part restricting the possession of controlled substances shall not apply to:
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(6) 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 sodium pentobarbital to registered and certified personnel, to euthanize animals and ketamine hydrochloride to anesthetize animals prior to euthanasia.
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Section 80.23, a new subdivision (f), of Title 10 NYCRR is hereby added to read as follows:
Section 80.23 - Records and reports
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(f) Reports. Manufacturers and distributors shall report to the Department, in a manner approved by the Department, information from the sale of controlled substances. Such information shall be filed electronically with the Bureau of Narcotic Enforcement, utilizing a transmission format acceptable to the Department. The information filed with the Department shall include, but not be limited to:
(i) the manufacturer's or distributor's name, address, phone number, DEA registration number and controlled substance license number issued by the Department;
(ii) the name, address and DEA registration number of the entity to whom the controlled substance was sold;
(iii) the date of the sale of the controlled substance;
(iv) the name and National Drug Code (NDC) of the controlled substance sold; and
(v) the number of containers and the strength and metric quantity of controlled substance in each container of controlled substance sold.
Section 80.67, subdivision (d), subparagraph (1), of Title 10 NYCRR is hereby amended to read as follows:
Section 80.67 - Schedule II and certain other substances
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(d)(1) A practitioner may issue a prescription for 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 the prescription has been issued for the treatment of:
(i) panic disorders, designated as code A;
(ii) attention deficit disorder, designated as code B;
(iii) chronic debilitating neurological conditions characterized as a movement disorder or exhibiting seizure, convulsive or spasm activity, designated as code C;
(iv) relief of pain in patients suffering from conditions or diseases known to be chronic [and] or incurable, designated as code D;
(v) narcolepsy, designated as code E; or
(vi) hormone deficiency states in males, gynecologic conditions that are responsive to treatment with anabolic steroids or chorionic gonadotropin, metastatic breast cancer in women, anemia and angioedema, designated as code F.
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Section 80.68, subdivision (d) of Title 10 NYCRR is hereby amended to read as follows:
Section 80.68 - Emergency oral prescriptions for schedule II substances and certain other controlled substances
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(d)(1) The pharmacist filling the prescription shall endorse upon the prescription the date of delivery, and his/her signature.
(2) The endorsed prescription shall be retained by the proprietor of the pharmacy for a period of five years. The prescription information shall be filed electronically with the Bureau of Narcotic Enforcement, utilizing a transmission format acceptable to the Department, not later than the 15th day of the next month following the month in which the substance was delivered. The information filed with the department shall include but not be limited to:
(i) pharmacy prescription number;
(ii) pharmacy's National Identification Number;
(iii) patient name;
(iv) patient address, including street, city, state, zip code;
(v) patient date of birth;
(vi) patient's sex;
(vii) date prescription filled;
(viii) metric quantity;
(ix) national drug code number of the drug;
(x) number of days supply;
(xi) prescriber's Drug Enforcement Administration (DEA) number;
(xii) date prescription written; [and]
(xiii) serial number of official prescription form or an identifier designated by the department[.]; and
(xiv) payment method.
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Section 80.69, subdivision (d), subparagraph (1), of Title 10 NYCRR is hereby amended to read as follows:
80.69 Schedule III, IV and V substances.
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(d)(1) A practitioner may issue a prescription for up to a three month supply of a controlled substance if used in accordance with the directions for use, provided that the prescription has been issued for the treatment of:
(i) panic disorders, designated as code A;
(ii) attention deficit disorder, designated as code B;
(iii) chronic debilitating neurological conditions characterized as a movement disorder or exhibiting seizure, convulsive or spasm activity, designated as code C;
(iv) relief of pain in patients suffering from conditions or diseases known to be chronic [and] or incurable, designated as code D;
(v) narcolepsy, designated as code E; or
(vi) hormone deficiency states in males, gynecologic conditions that are responsive to treatment with anabolic steroids or chorionic gonadotropin, metastatic breast cancer in women, anemia and angioedema, designated as code F.
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Section 80.71, subdivision (e), of Title 10 NYCRR is hereby amended to read as follows:
(e) The practitioner shall submit dispensing information, for all controlled substances dispensed, electronically to the department utilizing a transmission format acceptable to the department by not later than the 15th day of the next month following the month in which the substance was delivered. The information filed with the department shall include but not be limited to:
(1) dispenser [practitioner] identifier;
(2) patient name;
(3) patient address, including street, city, state, ZIP code;
(4) patient date of birth;
(5) patient's sex;
(6) date controlled substance dispensed;
(7) metric quantity;
(8) national drug code number of the drug;
(9) number of days supply; [and]
(10) prescriber's Drug Enforcement Administration (DEA) number[.]; and
(11) payment method.
Section 80.73, subdivision (f) and subdivision (l), paragraph (5), of Title 10 NYCRR are hereby amended to read as follows:
Section 80.73 - Pharmacists; dispensing schedule II substances and certain other controlled substances
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(f) The endorsed official New York State prescription shall be retained by the proprietor of the pharmacy for a period of five years. The prescription information shall be filed electronically with the Bureau of Narcotic Enforcement, utilizing a transmission format acceptable to the department, not later than the 15th day of the next month following the month in which the substance was delivered. The information filed with the department shall include but not be limited to:
(1) pharmacy prescription number;
(2) pharmacy's national identification number;
(3) patient name;
(4) patient address, including street, city, state, ZIP code;
(5) patient date of birth;
(6) patient's sex;
(7) date prescription filled;
(8) metric quantity;
(9) national drug code number of the drug;
(10) number of days supply;
(11) prescriber's Drug Enforcement Administration number;
(12) date prescription written; [and]
(13) serial number of official prescription form, or an identifier designated by the department;
(14) payment method;
(15) number of refills authorized; and
(16) refill number.
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(l) A pharmacist may partially fill an official New York State prescription for a schedule II controlled substance or those schedule III or schedule IV controlled substances listed in section 80.67(a) of this Part provided that:
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(5) The official New York State prescription shall be valid for a period not to exceed 30 days from the date the prescription was issued by the practitioner unless terminated sooner upon notification from the practitioner of the discontinuance of medication. All partial fillings filled under subdivision (1) of this section must occur within 30 days from the date the prescription was issued[.], except that partial fillings of prescriptions issued for more than a 30 day supply for patients residing in a residential healthcare facility or for patients enrolled in a hospice program that is licensed or approved by the Department must occur within 60 days from the date the prescription was issued.
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Section 80.74, subdivision (e), of Title 10 NYCRR is hereby amended to read as follows:
Section 80.74 - Pharmacists; dispensing schedule III, IV and V controlled substances
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(e) The pharmacist filling the official prescription shall endorse on such prescription his/her signature, the date of filling, and the number of the prescription under which it is recorded in the pharmacy prescription file. Such endorsed prescription shall be retained by the proprietor of the pharmacy for a period of five years. Prescription information from the [original] filling of such prescription shall be filed with the department in accordance with section 80.73(f) of this Part.
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Section 80.132, subdivision (a), paragraph 14, of Title 10 NYCRR is hereby amended to read as follows:
Section 80.132 Hypodermic syringes and needles; designation of persons or classes of persons.
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(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;
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Section 80.134, subdivision (a), paragraphs (3) and (4) of Title 10 NYCRR are hereby amended to read as follows:
Section 80.134. Authorization for the purchase, possession and dispensing of ketamine hydrochloride only to anesthetize animals for euthanasia, and of sodium pentobarbital to euthanize animals.
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(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.
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This notice is intended
to serve only as a notice of emergency adoption. This agency intends to adopt this emergency rule as a permanent rule and will publish a notice of proposed rule making in the State Register at some future date. The emergency rule will expire January 24, 2009.
Text of rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of House Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.state.ny.us
Regulatory Impact Statement
Statutory Authority:
Section 3308(2) of the Public Health Law authorizes and empowers the Commissioner to make any regulations necessary to supplement the provisions of Article 33 of the Public Health Law in order to effectuate its purposes and intent. Section 21 of the Public Health Law authorizes the Commissioner to promulgate emergency regulations in furtherance of Section 21, which expanded the Official Prescription Program, the Department's Prescription Drug Monitoring Program (PDMP).
Section 3305(1)(d) authorizes the Department to adopt regulations that provide for the safe and efficient use of ketamine hydrochloride to anesthetize animals only as part of the euthanasia procedure, and sodium pentobarbital to euthanize animals, by incorporated societies for the prevention of cruelty to animals and animal control facilities.
Legislative Objectives:
Article 33 of the Public Health Law, officially known as the New York State Controlled Substances Act, was enacted in 1972 to govern and control the possession, prescribing, manufacturing, dispensing, administering and distribution of controlled substances within New York. The legislative purposes of Article 33 are to combat the illegal use of and trade in controlled substances and to allow the legitimate use of controlled substances in health care, including palliative care, veterinary care, research and other uses authorized by the law.
Needs and Benefits:
The Department of Health's most valuable means of combating drug abuse is its Official Prescription Program, which effectively monitors the prescribing and dispensing of controlled substances highly prone to diversion and trafficking. Current Part 80 regulations require pharmacies to submit specific information from the original fillings of all prescriptions dispensed for controlled substances. These regulations also require practitioners to submit information when they dispense controlled substances. Analysis of the prescription and dispensing data curtails diversion of controlled substances by detecting individuals who seek drugs because of addiction or for trafficking.
Because the existing regulations do not require pharmacies to submit information from the refilling of controlled substance prescriptions, the data may indicate that an individual has only obtained a controlled substance once, when it may have been obtained numerous times as refills. Because the current regulations also do not require pharmacies or practitioners to submit prescription or dispensing information indicating method of payment, drug-seeking individuals can obtain controlled substances or prescriptions from multiple practitioners. They do so by filling the prescriptions at different pharmacies, paying cash to evade detection by pharmacies and third party payers. Drug-seekers obtaining controlled substances directly from dispensing practitioners also avoid detection when the payment for dispensing the drugs is included in the practitioner's overall fee for the office visit.
The Department proposes amendments to Part 80 regulations to require pharmacies to submit prescription information indicating whether a controlled substance was dispensed as a new prescription or a refill. The proposed amendments will also require pharmacies and practitioners who dispense controlled substances to patients to submit information on the method of payment for the dispensed substance. These amendments will prevent diversion by allowing the Department to continue to monitor the dispensing of controlled substance prescriptions, as well as controlled substances dispensed to patients by practitioners, but with a more complete history of a drug-seeking individual's prescription and controlled substance activity.
The Department also combats drug diversion through the analysis of records and reports of licensed manufacturers and distributors to detect inappropriate procurement of controlled substances by practitioners, pharmacies and institutional dispensers. While four companies voluntarily submit reports to the Bureau of Narcotic Enforcement regarding their sales of controlled substances, more than 500 do not because it is not required by existing regulations.
Amendments to Part 80 will require all such companies to submit to the Department information from distribution of controlled substances. Such information will be reported electronically through a secure account established with the Department's Health Provider Network. These amendments will protect the public health by enhancing the Department's monitoring capability—through the use of remote analyses comparing distribution and dispensing records—to detect and prevent controlled substance diversion by healthcare professionals who are authorized by law to purchase and possess these drugs solely for legitimate use within their scope of practice.
In the past, the Bureau has discovered diversion by monitoring and analysis of company distribution records indicating individual practitioners ordering large quantities of controlled substances. These identified practitioners have obtained controlled substances under the guise of dispensing them to their patients. However, they instead abused these substances to sustain their own addiction or trafficked in them for profit. Requiring that these records of distribution be reported electronically to the Department on a monthly basis will ensure a more efficient method of monitoring by the Bureau and result in timely identification of those practitioners who divert controlled substances to non-legitimate use. Controlled substance distribution records can be compared with controlled substance administration and dispensing records to detect unlawful activity.
While one purpose of the regulations is to prevent the diversion of controlled substances, an equally important purpose is to ensure access to controlled substances for treatment of legitimate medical conditions. The Department proposes to amend the regulations to allow practitioners who treat patients for chronic pain from conditions other than diseases the ability to issue prescriptions for greater than a thirty-day supply when such prescriptions are designated with the Code D. This flexibility in issuing prescriptions for larger quantities will aid those patients by not requiring them to obtain a new prescription from their practitioner each month, which they then must bring to their pharmacy. This amendment will ease some of the burden for these patients, who may be experiencing decreased mobility in addition to their chronic pain. By also amending the regulations to allow hospice patients up to 60 days to partial fill their controlled substance prescriptions, it will allow the patients to better adjust their changing medication needs.
Current Part 80 regulations authorize an incorporated society for the prevention of cruelty to animals and a municipal animal control facility to utilize sodium pentobarbital to euthanize animals. Such facilities and their agents also must first register with the Department and the federal Drug Enforcement Administration in order to purchase, possess, and dispense sodium pentobarbital for euthanasia.
Animal control facilities provide a valuable public service by treating stray, injured, aged, sick, and feral animals. However, current Part 80 regulations authorize such animal shelters to euthanize animals only with a schedule III formulation of sodium pentobarbital, which is not approved by the U.S. Food and Drug Administration for use with cats and smaller animals. While licensed veterinarians are authorized to euthanize with Schedule II sodium pentobarbital, they are not regularly available to perform the euthanasia in animal shelters.
Humane Societies and animal control facilities have apprised the Department that the available schedule III sodium pentobarbital formulation is recommended only for the euthanizing of dogs and larger animals. The formulation's high viscosity renders it difficult to utilize for cats and other small pets. Required use of this drug often results in seizures, fear and pain to the animals at the time of euthanasia and creates a hardship for the shelters. The facilities state that such difficulty results in less humane treatment of the animals when necessary to euthanize.
The Department is proposing amendments to Part 80 that authorize animal control facilities to utilize ketamine hydrochloride for anesthesia only as part of the euthanasia procedure and both a schedule II and a schedule III formulation of sodium pentobarbital for euthanasia. The amendments will allow pets and animals of all sizes to be more humanely treated when these drugs are indicated for use.
COSTS:
Costs to Regulated Parties:
Pharmacies currently collect and maintain the dispensing information that the Department proposes to be additionally included with the information that is now submitted; therefore, there are only minor anticipated additional costs to pharmacies. Because practitioners are currently required to electronically submit dispensing information to the Department, there are only minor anticipated increased costs to practitioners to submit a minimal addition to that information. Practitioners and pharmacies who dispense small amounts of controlled substances submit dispensing information through the Department's Health Provider Network (HPN) by manually uploading the data into fields already provided on the HPN site. A minimal addition to those data fields should only incur a minor increase in data submission costs. The American Society for Automation in Pharmacy (ASAP) is the nationwide software system that pharmacies and practitioners that dispense large amounts of controlled substances utilize to submit required dispensing information to the Department. The ASAP software already contains the capability to transmit the additional data fields required by the proposed regulations. Activating those additional ASAP data fields will require only minor programming costs by pharmacies and dispensing practitioners.
Manufacturers and distributors are required to maintain records of distribution. The requirement to report this information electronically to the Department may create a slight expenditure, but because manufacturers and distributors currently maintain these records in an electronic format, such expense is anticipated to be minimal to make the format compatible with the Department's system of receiving the information.
There will be no increased costs associated with the proposed amendment to allow practitioners to issue controlled substance prescriptions in quantities greater than a 30-day supply to treat patients suffering from chronic pain caused by an incurable condition or disease. No increased costs are anticipated by allowing hospice patients more time to partial fill their controlled substance prescriptions.
There may be a minimal cost to the incorporated society for the prevention of cruelty to animals, municipal animal control facility or animal shelter utilizing the additional drugs proposed for euthanasia. This cost is associated with the purchase of ketamine hydrochloride and schedule II pentobarbital for more humane euthanasia of all sizes of animals.
Costs to State and Local Government:
There will be no costs to state or local government.
Costs to the Department of Health:
There will be no additional costs to the Department.
Local Government Mandates:
The proposed rule does not impose any new programs, services, duties or responsibilities upon any county, city, town, village, school district, fire district or other specific district.
Paperwork:
No additional paperwork is required for pharmacies, practitioners, manufacturers and distributors. Pharmacies and practitioners currently maintain the records that the Department will require to be transmitted electronically. Manufacturers and distributors are required to maintain records of distribution of controlled substances. The electronic transmission of such records will not create any additional paperwork, and may actually reduce some paperwork.
There will not be any additional paperwork associated with the proposed amendment to allow practitioners to issue controlled substance prescriptions in quantities greater than a 30-day supply to treat patients suffering from chronic pain caused by an incurable condition or disease. In fact, there may be less paperwork, as practitioners would be able to issue a controlled substance prescription every three months as opposed to monthly.
There may be a minimal increase in paperwork for pharmacies to document partially filled prescriptions for hospice patients.
Including ketamine hydrochloride for anesthesia only as part of the euthanasia procedure and schedule II formulation of sodium pentobarbital for euthanasia may involve a minimal increase in record-keeping paperwork for animal control facilities.
Duplication:
The requirements of this proposed regulation do not duplicate any other state or federal requirement.
Alternatives:
There are no alternatives that would support the approach to be taken under the regulations. The information the Department is seeking through these new regulations is not available from any other source.
Federal Standards:
The regulatory amendment does not exceed any minimum standards of the federal government.
Compliance Schedule:
These regulations will become effective upon filing with the Department of State.
Regulatory Flexibility Analysis
Effect of Rule on Small Business and Local Government:
This proposed rule would affect retail pharmacies that partially dispense controlled substance prescriptions for hospice patients. The rule will also affect practitioners who dispense controlled substances and prescribe them for the treatment of chronic pain. The rule will also affect licensed manufacturers and distributors of controlled substances.
According to the New York State Board of Pharmacy, there are approximately 4,500 registered pharmacies in New York State. According to the Bureau of Narcotic Enforcement, there are approximately 600 manufacturers and distributors licensed by the Department to distribute controlled substances in New York State.
Compliance Requirements:
The proposed regulations follow the intent of Article 33 of Public Health Law and will further enhance the Department's ability to curtail diversion of controlled substances.
Currently, pharmacies are required to submit the dispensing data for the original dispensing of all controlled substance prescriptions. The only new compliance requirement is the submission of the method of payment for the controlled substance prescription and whether the drug was the original dispensing or the refill dispensing of a controlled substance prescription. The only new compliance requirement for dispensing practitioners is to submit a minimal amount of additional information.
Manufacturers and distributors are required to maintain records of distribution of controlled substances. The proposed regulations will require reports based upon these records to be electronically transmitted to the Department.
Proposed regulations place compliance requirements on animal control facilities only if they choose to utilize ketamine hydrochloride for anesthesia only as part of the euthanasia procedure and/or schedule II sodium pentobarbital for euthanasia of animals.
Professional Services:
No additional professional services are necessary.
Compliance Costs:
Pharmacies and dispensing practitioners may require minor adjustments in computer software programming due to additional dispensing and prescription data submission requirements; however, this should require only minimal additional costs. The system utilized by pharmacies and practitioners already contains the additional data fields for submission of information. A slight expenditure may be necessary for activation of those fields by an Information Technology technician. Manufacturers and distributors may incur a slight expenditure due to the requirement for electronic transmission of data, but such expenditure should not create a financial hardship. There will be no compliance costs for authorizing practitioners to prescribe more than a 30-day supply of a controlled substance to treat a patient for chronic pain cause by an incurable condition or disease. Compliance costs to animal control facilities will be as a result of utilizing the proposed drugs for more humane euthanasia of animals, however, while the proposed regulations authorize the use of the additional drugs, the regulations do not require their use.
Economic and Technological Feasibility:
The proposed rule is both economically and technologically feasible. The process utilizes existing electronic systems for reporting of dispensing by pharmacies and practitioners. The regulations will create new requirements for manufacturers and distributors but the Department expects most of these entities to currently maintain the required records of distribution in an electronic format. There are minimal technological and economic constraints anticipated for animal control facilities because the proposed rule authorizes the use of ketamine hydrochloride and schedule II pentobarbital for the euthanasia process but does not require that facilities utilize the additional drugs.
Minimize Adverse Impact:
The regulations require only a minimal increase in reporting requirements. These requirements are for the electronic transmission of records that current regulations require pharmacies, practitioners, manufacturers and distributors to maintain.
Small Business and Local Government Participation:
During the drafting of these regulations, the Department met with or solicited comment from the Pharmaceutical Society of the State of New York, the Medical Society of the State of New York, the National Association of Pharmaceutical Manufacturers, the Humane Society of the United States, the Community Hospice and the Mohawk & Hudson River Humane Society. Local governments are not affected, except for those municipalities operating animal shelters.
Rural Area Flexibility Analysis
Types and Estimated Numbers of Rural Areas:
The proposed rule will apply to pharmacies, practitioners, manufacturers and distributors located in all rural areas of the state. Outside of major cities and metropolitan population centers, the majority of counties in New York contain rural areas. These can range in extent from small towns and villages and their surrounding areas, to locations that are sparsely populated.
Compliance Requirements:
The only compliance requirements are for the electronic transmission of information to the Department that pharmacies, practitioners, manufacturers and distributors are required by current regulations to maintain.
Professional Services:
None necessary.
Compliance Costs:
The systems utilized by pharmacies and practitioners to submit dispensing data already contain the additional data fields. The compliance costs to activate those fields are anticipated to be minimal. The cost for an Information Technology technician to make electronic record systems of manufacturers and distributors compatible with the Department's system of receipt of controlled substance sales information is also anticipated to require minimal expenditures.
Minimizing Adverse Impact:
The regulations require only a minimal increase in reporting and record-keeping requirements.
Rural Area Participation:
During the drafting of this regulation, the Agency met with and solicited comments from pharmacy, practitioner, hospice and manufacturer associations who represent these professions in rural areas. No particular issues relating to the effect of this program on rural areas were expressed.
Job Impact Statement
This proposal will not have a negative impact on jobs and employment opportunities. In benefiting the public health by ensuring that drug diversion is curtailed through enhanced analysis of information from controlled substance prescriptions and the dispensing and distribution of controlled substances, the proposed amendments are not expected to either increase or decrease jobs overall. No overall increase or decrease in jobs is anticipated for animal control facilities utilizing the proposed additional drugs for more humane euthanasia of animals.
