Bill S7637-2011

Relates to prescription drug reform; repealer

Enacts the Internet system for tracking over-prescribing (I-STOP) act and creates a prescription monitoring program registry (part A); relates to prescription drug forms, electronic prescribing and language assistance (part B); relates to schedules of controlled substances (part C); relates to continuing education for practitioners and pharmacists in prescription pain medication awareness and the duties of the pain management awareness workgroup (part D); relates to the safe disposal of controlled substances (part E).

Details

Actions

  • Aug 27, 2012: SIGNED CHAP.447
  • Aug 27, 2012: DELIVERED TO GOVERNOR
  • Jun 11, 2012: returned to senate
  • Jun 11, 2012: passed assembly
  • Jun 11, 2012: ordered to third reading rules cal.142
  • Jun 11, 2012: substituted for a10623
  • Jun 11, 2012: referred to ways and means
  • Jun 11, 2012: DELIVERED TO ASSEMBLY
  • Jun 11, 2012: PASSED SENATE
  • Jun 11, 2012: ORDERED TO THIRD READING CAL.1142
  • Jun 11, 2012: REPORTED AND COMMITTED TO RULES
  • Jun 8, 2012: REFERRED TO HEALTH

Meetings

Calendars

Votes

VOTE: COMMITTEE VOTE: - Rules - Jun 11, 2012
Ayes (22): Skelos, Alesi, Farley, Fuschillo, Hannon, Johnson, Larkin, LaValle, Libous, Marcellino, Maziarz, Nozzolio, Saland, Seward, Sampson, Breslin, Dilan, Hassell-Thompson, Parker, Perkins, Smith, Stewart-Cousins
Ayes W/R (2): Duane, Montgomery
Excused (1): Krueger

Memo

BILL NUMBER:S7637

TITLE OF BILL: AN ACT to amend the public health law, in relation to enacting the internet system for tracking over-prescribing (I-STOP) act and creating a prescription monitoring program registry (Part A); to amend the public health law and the education law, in relation to prescription drug forms, electronic prescribing and language assistance; and to repeal section 21 of the public health law, relating thereto (Part B); to amend the public health law and the penal law, in relation to schedules of controlled substances; and to repeal certain provisions of the public health law relating thereto (Part C); to amend the public health law, in relation to continuing education for practitioners and pharmacists in prescription pain medication awareness and the duties of the prescription pain management awareness workgroup (Part D); and to amend the public health law, in relation to the safe disposal of controlled substances (Part E)

PURPOSE: This bill would promote the safe and effective use of prescription drugs and curb the diversion and abuse of such drugs by: (1) modernizing the state's Prescription Monitoring Program and enacting the Internet System for Tracking Over-Prescribing Act; (2) requiring all prescriptions to be transmitted by electronic means; (3) updating the State's controlled substance schedules; (4) expanding the duties of the workgroup established under the Prescription Pain Medication Awareness Program with respect to continuing education for practitioners and pharmacists; and (5) requiring the Department of Health (DOH) to establish a safe disposal program to facilitate consumer disposal of unused medications.

SUMMARY OF PROVISIONS: Section 1 of the bill sets forth the legislative intent and findings explaining the measures taken by the bill to address diversion and abuse of controlled substances.

Section 2 of the bill provides that each part is a separate component of the bill with its own effective date.

Section 3 of the bill, which appears after Part E, sets forth a severability provision.

Section 4 sets forth an overall effective date for the bill.

A. The "Internet System for Tracking Over-Prescribing" (I-STOP) Act (Part A)

Section 1 of Part A of the bill provides that the bill would enact the "Internet System for Tracking Over-Prescribing" (I-STOP) Act.

Section 2 of Part A of the bill would add new Public Health Law (PHL) 3343-a. New PHL § 3343-a(1) would require the Commissioner of Health to

update the State's existing Prescription Monitoring Program by establishing and maintaining a system for collecting, monitoring and reporting data concerning the prescribing and dispensing of controlled substances. Known as the Prescription Monitoring Program Registry (PMP Registry or Registry), the Registry would be secure, easily accessible by practitioners and pharmacists, and compatible with the electronic transmission of prescriptions for controlled substances required under Part B of the bill.

New PHL § 3343-a(2) would require health care practitioners or their authorized designees to consult the Registry before prescribing or dispensing any controlled substance listed on Schedule II, III or IV of PHL § 3306, with certain exceptions.

New PHL § 3343-a(3) would permit pharmacists or their authorized designees to consult the Registry before dispensing a controlled substance.

New PHL § 3343-a(4) would provide practitioners, pharmacists or their designees who act reasonably and in good faith immunity from civil liability arising from any false, incomplete or inaccurate information submitted to or reported by the Registry or for any resulting failure of the system to accurately or timely report such information.

New PHL § 3343-a(5) would require the Commissioner of Health to provide guidance to practitioners and, in consultation with the Commissioner of Education, to pharmacists and pharmacies, regarding the purposes and uses of the Registry established by this section.

New PHL § 3343-a(6) would permit individuals to request copies of their controlled substance history maintained in the Registry and to seek correction of erroneous information.

New PHL § 3343-a(7) would require DOH to periodically analyze data contained in the Registry and provide information about potential violations of law or breaches of professional standards to the appropriate entities.

New PHL § 3343-a(8) would require DOH to seek funding, as appropriate, from the federal government or other entities to support operation of the Registry, and to prohibit DOH from specifically imposing fees for such operation on practitioners, pharmacists, designees or patients.

New PHL § 3343-a(9) would require the Commissioner of Health to promulgate rules and regulations necessary to effectuate the provisions of new PHL § 3343-a.

Section 3 of Part A of the bill would amend PHL § 3333(4) to require that pharmacies file prescription information with DOH by electronic means on a real time basis pursuant to DOH regulations, and to authorize DOH to waive the real time requirement if and to the extent that the Commissioner of Health finds it warranted, in his or her discretion, due

to a pharmacy's demonstration of economic hardship or other exceptional circumstance.

Section 4 of Part A of the bill would amend PHL § 3371(1)(d), which currently permits DOH to disclose controlled substances information to a central registry, to refer instead to the Registry.

Section 4 also would amend PHL § 3371(1)(e), which currently permits DOH to disclose information about dispensed controlled substances to a practitioner under limited circumstances, so that DOH also could provide notifications of relevant controlled substance activity and allow practitioners to consult the Registry as required by new PHL § 3343-a.

Section 4 also would add new PHL § 3371(1)(f) to permit DOH to disclose relevant information about controlled substance activity to pharmacists, including as permitted by new PHL § 3343-a.

Section 4 also would add new PHL § 3371(1)(g) to permit DOH to disclose information to the Attorney General's Medicaid Fraud Control Unit, in furtherance of an investigation of fraud, waste or abuse of the Medicaid program and pursuant to an agreement with DOH.

Section 4 also would add new PHL § 3371(1)(h) to permit DOH to disclose information to local health departments for purposes of public research and education pursuant to an agreement with DOH.

Section 4 also would add new PHL § 3371(1)(i) to permit DOH to disclose information to medical examiners and coroners.

Section 4 also would add new PHL § 3371(1)(j) to permit DOH to provide individuals with their controlled substance histories maintained in the Registry, as permitted by new PHL § 3343-a(6).

Section 5 of Part A of the bill would renumber PHL § 3371(2) and add a new provision to provide that the Registry may be accessed by practitioners and pharmacists as set forth in new PHL § 3343-a, under terms and conditions established by DOH as necessary to maintain the security and confidentiality of the information contained in the Registry.

Section 5 also would add a new PHL § 3371(3) to provide that if it appears that a crime related to the diversion of controlled substances has been committed, DOH may notify the appropriate law enforcement agency and provide such information about the suspected criminal activity as reasonably appears to be necessary.

Section 6 of Part A of the bill would add new PHL § 3302(41) to define the Registry.

Section 7 of Part A of the bill provides that Part A would take effect one year after enactment, except that the Commissioner of Health and the Commissioner of Education would be authorized to promulgate rules and

regulations and take other action necessary to implement Part A on its effective date.

Part B. Electronic Prescribing

Section 1 of Part B of the bill would revise PHL Article 2-A to create a new Title I, which would incorporate existing PHL §§ 270 through 276 and section 277.

Section 1-a of Part B of the bill would renumber PHL §§ 276-a and 276-b as §§ 278 and 279 respectively, and designate such sections and § 280 as a new Title II.

Section 2 of Part B of the bill would amend PHL Article 2-A to add a new Title III, consisting of new PHL § 281.

New PHL § 281 would incorporate the provisions of existing PHL § 21 into subdivisions (1) and (2) and include a subdivision (3) requiring the Commissioner of Health to promulgate regulations on or before December 31, 2012, establishing standards for electronic prescriptions for controlled substances that are feasible and lawful under federal law. New PHL § 281(3) would further provide that all prescriptions made in this State on or after two years from that determination must be made by electronic transmission from practitioners to pharmacists, with certain specified exceptions.

Section 3 of Part B of the bill would amend Education Law § 6810 to similarly require electronic prescribing for non-controlled substances.

Section 4 of Part B of the bill would repeal PHL § 21.

Section 5 of Part B of the bill provides that Part B would take effect immediately.

Part C. Controlled Substance Schedules

Section 1 of Part C of the bill would amend Schedule II(b)(1) of PHL 3306 to specify that hydrocodone, already listed, may also be known as dihydrocodeinone, and to update the classification of oripavine.

Section 2 of Part C of the bill would add new Schedule II(b)(1) to PHL 3306 to add to Schedule II those formulations of hydrocodone that currently appear on Schedule III.

Section 3 of Part C of the bill would add new PHL § 3307(5) to require the Commissioner of Health to establish minimum standards for the storage, reporting, ordering and record keeping of the hydrocodone formulations added to new Schedule II(b)(1) as if they were set forth in Schedule III.

Section 4 of Part C of the bill would repeal Schedule II(b)(6), which lists oripavine.

Section 5 of Part C of the bill would add a new Schedule II(c)(28) to list tapentadol, which is an opiate, as a Schedule II substance.

Section 6 of Part C of the bill would amend the opening paragraph of Schedule II(d) to clarify that the inclusion of salts and isomers applies whenever such salts or isomers are possible within the specific chemical designation of a substance.

Section 7 of Part C of the bill would add a new Schedule II(g)(3) to provide the chemical designation of a precursor to fentanyl.

Section 8 of Part C of the bill would amend Schedule II(h), pertaining to anabolic steroids, to eliminate language describing the purposes of such substances. The section would also add boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione to Schedule II and correct typographical errors in the chemical designation of some of the other listed substances.

Section 9 of Part C of the bill would amend the opening paragraph of Schedule II1(c), to clarify that the inclusion of salts and isomers applies whenever such salts or isomers are possible within the specific chemical designation of a substance.

Section 10 of Part C of the bill would amend Schedule III(e) to remove references to hydrocodone (dihydrocodeinone).

Section 11 of Part C of the bill would amend Schedule III(f) to clarify the description of dronabinol.

Section 12 of Part C of the bill would amend Schedule IV(c) to add fospropofol and carisoprodol to Schedule IV.

Section 13 of Part C of the bill would amend Schedule IV(e)(11)to correct a typographical error.

Section 14 of Part C of the bill would add tramadol to Schedule IV.

Section 15 of Part C of the bill would amend Schedule V(b) to correct a typographical error.

Section 16 of Part C of the bill would amend Schedule V(d) to add two additional substances, ezogabine and lacosamide, which are depressants, to Schedule V.

Section 17 of Part C of the bill would make a technical change to PHL 3331(7), correcting a reference to a drug that had been moved from one place on the controlled substances schedules to another.

Section 18 of Part C of the bill would amend Penal Law § 220.00(8) to classify hydrocodone, as added to Schedule II(b-1), as a "narcotic preparation."

Section 21 of Part C of the bill provides that Part C would take effect 90 days after enactment, except that sections 2, 3, 10, 14 and 18 would take effect 180 days after enactment and sections 15 and 17 would take effect immediately.

Part D. Prescription Pain Medication Awareness Program

Sections 1 and 2 of Part D of the bill would amend PHL § 3309-a, which requires DOH to establish a workgroup to make recommendations in the implementation of the Prescription Pain Medication Awareness Program enacted in the 2012-13 budget, to expand its functions. Under the bill, the workgroup will be responsible for making recommendations on: (1) continuing education for practitioners and pharmacists on pain management issues; (2) protection and promotion of access of patients with a legitimate need for controlled substances; (3) the implementation of the Prescription Monitoring. Program provisions; and (4) the inclusion of certain Schedule V substances in the consultation requirements of the Prescription Monitoring Program.

Section 2 also would require the Commissioner of Health to include additional stakeholders in the workgroup, including but not limited to consumer advocacy organizations, health care practitioners and providers, pharmacists and pharmacies, and law enforcement agencies.

Section 3 of Part D of the bill provides that Part D would take effect immediately.

Part E. Safe Disposal

Section 1 of Part E of the bill would require DOH to establish a program for the safe disposal of unused controlled substances by consumers.

Section 2 of Part E of the bill provides that Part E would take effect immediately.

LEGISLATIVE HISTORY: This is a new bill, although certain of its components have been included in various legislative proposals.

STATEMENT IN SUPPORT: Illicit use of prescription medicine has become the nation's "fastestgrowing drug problem," according to R. Gil Kerlikowske, Director of the White House Office of National Drug Control Policy. According to the federal Centers for Disease Control and Prevention (CDC), nearly 15,000 people die every year of overdoses due to prescription painkillers. In 2010, 1 in 20 people in the United States over the age of 11 reported using prescription painkillers for nonmedical reasons in the past year. During the period 1999 through 2008, overdose death rates, sales, and substance abuse treatment admissions related to prescription painkillers all increased substantially. Sales of opioid painkillers quadrupled between 1999 and 2010. Enough opioid painkillers were prescribed in 2010 to medicate every American adult with 5 mg of hydrocodone every four

hours for a month. Moreover, an estimated 70 percent of people who abuse prescription painkillers obtained them from friends or relatives who originally received the medication from a prescription. The problem is of particular concern with respect to young adults and teens.

Criminal diversion and abuse of prescription drugs results in addiction, adverse drug events, accidental death due to overdose, violent or selfinjurious behavior, family conflicts, and increased costs to businesses and the health care system. As a result, many individuals who suffer from prescription drug abuse - as well as their families - have paid heavy costs from this epidemic. This bill, together with other initiatives that will be implemented by DOH, sets forth a new strategy to address the growth of prescription drug abuse in New York. This approach seeks to minimize opportunities for addiction, abuse and criminal diversion while protecting the ability of patients to access needed medications on a timely basis.

Part A. Creating a Modernized and Improved Prescription Monitoring Program (I-STOP)

This legislation will require updating and modernization of DOH's Prescription Monitoring Program (PMP) Registry - making it one of the best systems in the nation to monitor prescription drug abuse and to help the medical community provide better care. The PMP Registry will be secure and easily accessible by practitioners and pharmacists, allowing them to view their patients' controlled substance histories.

The new system will substantially decrease opportunities for "doctor shoppers" to illegally obtain prescriptions from multiple practitioners. The legislation will include information about dispensed controlled substances reported by pharmacies on a "real time" basis-as determined through a regulatory process, to effectively stop doctor shopping and combat the circulation of illegally-obtained prescription drugs. The "real time" approach in this legislation was modeled on the system recently implemented in Oklahoma. Currently in New York, pharmacists are required to report each controlled substance they dispense by no later than the 15th day of the next month following the month in which the substance was dispensed, which essentially means between 15 and 45 days after dispensing.

In addition, practitioners will be required to consult the PMP before prescribing or dispensing controlled substances listed on Schedule II, III or IV of PHL § 3306 for the purpose of reviewing a patient's controlled substance prescription history to help the practitioner assess whether such prescription is necessary. Although this legislation requires health care practitioners to consult the PMP Registry before prescribing or dispensing the controlled substances that are most prone to abuse and diversion, it strikes the right balance by exempting practitioners from consulting in specific situations in order to protect patient access to needed medications.

To help minimize administrative burdens on practitioners, the bill will permit a practitioner to designate another person employed by or under contract with the practitioner's practice to access the information on behalf of the practitioner.

Moreover, pharmacists, for the first time, will now be able to consult the PMP Registry before dispensing a controlled substance. Currently, pharmacists do not have access to the PMP, meaning that they cannot check to see if a person who presents a prescription has a history that suggests abuse or diversion of controlled substances. Many times a patient who is attempting to obtain drugs for illegitimate purposes presents a prescription where the prescribing practitioner is not from the local area; the patient is unfamiliar to the pharmacist or is from out of town; or the patient is picking up a prescription for someone else. Access to a patient's recent controlled substance history that is otherwise not available would provide additional information to pharmacists that may have concerns of the legitimacy of a prescription or potential diversion.

Part B. Requiring Electronic Prescribing

New York will become a national leader by being one of the first states to move from paper prescriptions to a system mandating the electronic prescribing (e-prescribing) for all controlled substances. E-prescribing is critical to help eliminate diversion that results from the alteration, forgery, or theft of prescription paper.

Under this bill, e-prescribing would be mandatory for essentially all prescriptions within approximately three years, with limited exceptions. E-prescribing is a secure method of transmitting prescriptions from practitioners to pharmacists. Since an e-prescription cannot be physically altered, forged, or stolen by individuals attempting to divert controlled substances for addiction and illegal sale, it curtails prescription fraud.

In addition, electronic prescribing enhances patient care by minimizing medication errors due to misinterpretations of handwriting on written prescriptions. It is estimated that 20 percent of the approximately 7,000 annual deaths caused by medication errors are attributable to misinterpretations of written prescriptions. Moreover, medication errors are estimated to cost the nation's health care system over $70 billion each year. In New York, adverse drug events due to errors in written and oral prescriptions carry an annual cost to the health care system of approximately $130 million.

E-prescribing should also improve the efficiency of practitioners and pharmacies; it has been estimated that approximately 30 percent of prescriptions require pharmacists to call physicians due to poor handwriting on prescription forms. Additionally, e-prescribing is also more convenient for consumers, who would otherwise need to either wait at the pharmacy for a prescription to be filled or make separate trips to drop off the prescription form and then pick up the medication.

Part C. Updating Controlled Substance Schedules

There are five controlled substance schedules. Schedule I controlled substances may not be prescribed, dispensed, possessed, distributed or administered except for research purposes with the approval of DOH. Substances listed on Schedules II, III, IV and V may be prescribed only by authorized practitioners. Schedule II controlled substances have a high potential for abuse and addiction and are more difficult to divert since a prescriber must issue a new prescription for each dispensing. By regulation, Schedule II substances can be prescribed or dispensed in supplies that do not exceed 30 days. However, to protect access to those patients who need it the most, practitioners can prescribe a supply of up to 90 days if he or she indicates, on the face of the prescription, that the patient has one of several enumerated conditions, including chronic pain.

Entries on the State schedules are not identical to those on the five federal schedules of controlled substances (21 U.S.C. § 801). Drugseeking individuals often exploit the fact that certain drugs classified as controlled substances under federal law are not controlled substances under New York law and are more easily diverted. It is therefore important, whenever appropriate, to add substances scheduled under federal law to the State schedules. At the same time, the State should not wait for federal action when it appears that a substance is dangerous and should be scheduled. This bill would add several additional substances, including some which have yet to be federally scheduled but warrant inclusion in the State drug schedule, and move others from one schedule to another, as specified below.

First, the bill would remove hydrocodone from Schedule III, where it is listed for small quantities, meaning that hydrocodone would appear only on Schedule II. Hydrocodone is among the most abused and diverted prescription medications. Nationally, according to the 2010 Monitoring the Future report by the University of Michigan, eight percent of all high school seniors used hydrocodone for non-medical purpose. In 2009 alone, there were over 86,000 emergency room visits resulting from the non-medical use of hydrocodone.

Second, the bill would add tramadol, a painkiller that has been shown to be prone to abuse. Accordingly, the bill would add tramadol as a Schedule IV substance.

Third, the bill would add carisoprodol to the schedules. Carisoprodol is a skeletal muscle relaxant that acts directly on the central nervous system and whose action in the body is similar to meprobamate, a Schedule IV controlled substance. Excessive use of meprobamate can result in psychological and physical dependence. Carisoprodol, when abused, is typically combined with other controlled substances or alcohol. Abusers who combine carisoprodol with hydrocodone claim that this combination produces effects similar to those of heroin. On January 11, 2012, the DEA placed carisoprodol in Schedule IV of the federal Controlled Substance Act. In New York, the 2009 New York State Police Toxicology

Drug Statistics indicated that almost 200 of the 2,269 cases of driving while ability-impaired (DWAI) related to drug use in that year were due to carisoprodol use - an incidence that was higher than other controlled substances such as stimulants, methadone and zolpidem. This bill would add the substance to Schedule IV.

Fourth, the bill would add fospropofol to the State's controlled substance Schedule IV. Fospropofol is currently used in sedation of adult patients undergoing monitored anesthesia care sedation for diagnostic or therapeutic procedures. On November 11, 2009, fospropofol was added by the DEA to Schedule IV of the federal Controlled Substance Act. The DEA cited abuse among medical professionals as well as the potential use of fospropofol as a "date-rape" drug in support of the decision to schedule fospropofol.

Fifth, the bill would appropriately schedule oripavine, in conformance with current DEA scheduling, under the category of opium and opiates and any salt, compound, derivative or preparation of opium or opiates. The DEA placed oripavine in Schedule II of the federal Controlled Substance Schedule in 2007. Oripavine is a derivative of thebaine, a natural constituent of opium.

Part D. Enhancing the Prescription Pain Medication Awareness Program

According to the CDC, a significant proportion - 17.3 percent - of abused medications are prescribed to the person that abuses them. This indicates a need for increased efforts to educate prescribers about the dangers of overprescribing controlled substances, particularly opioids.

This bill therefore would enhance the Prescription Pain Medication Awareness Program established by PHL § 3309-a, which requires DOH to establish a workgroup to educate the public and health care practitioners about the risks associated with prescribing and taking controlled substance pain medications. The workgroup will be expanded to include additional stakeholders on the workgroup, including but not limited to consumer advocacy organizations, health care practitioners and providers, pharmacists and pharmacies, and law enforcement agencies. Moreover, under the bill, the workgroup would be charged with making recommendations related to continuing education for practitioners and pharmacists and to provide guidance in the implementation of the Prescription Monitoring Program.

Part E. Establishing a Safe Disposal Program

An estimated 70 percent of people who abuse prescription painkillers obtained them from friends or relatives, Therefore, it is critical to provide consumers with a means of safely disposing of prescriptions. Part D of this bill would require DOH to institute a program for the safe disposal of unused controlled substances by consumers. DOH would work with local police departments to establish secure disposal sites for controlled substances on the premises of police stations. At these

sites, individuals would be able to voluntarily surrender unwanted and unused controlled substances.

Under present law, individuals can only safely dispose of controlled substances during an approved "take back" event. Various methods of self-disposal are either burdensome or harmful to the environment. Moreover, current federal regulations prohibit patients from returning unused controlled substances to pharmacists and doctors. This program would help alleviate this problem by providing a continual safe disposal option to New Yorkers.

BUDGET IMPLICATIONS: The bill is not expected to have a fiscal impact, as initial investments can be covered within existing budgeted resources. In future years, funds needed to support a contract to enhance and ultimately replace the existing Registry will be substantially if not totally offset by a decrease in costs associated with the State's obligation to provide official forge-proof paper prescription forms to prescribers,

EFFECTIVE DATE: The bill would take effect upon enactment, except that Part A would take effect one year after enactment, although necessary regulations could be promulgated before such time. In addition, Part C would take effect 90 days after enactment, except that sections 2, 3, 10, 14 and 18 would take effect 180 days after enactment and sections 15 and 17 would take effect immediately.


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STATE OF NEW YORK ________________________________________________________________________ 7637 IN SENATE June 8, 2012 ___________
Introduced by Sens. LANZA, HANNON, GOLDEN, SALAND -- (at request of the Governor) -- (at request of the Attorney General) -- read twice and ordered printed, and when printed to be committed to the Committee on Health AN ACT to amend the public health law, in relation to enacting the internet system for tracking over-prescribing (I-STOP) act and creat- ing a prescription monitoring program registry (Part A); to amend the public health law and the education law, in relation to prescription drug forms, electronic prescribing and language assistance; and to repeal section 21 of the public health law, relating thereto (Part B); to amend the public health law and the penal law, in relation to sche- dules of controlled substances; and to repeal certain provisions of the public health law relating thereto (Part C); to amend the public health law, in relation to continuing education for practitioners and pharmacists in prescription pain medication awareness and the duties of the prescription pain management awareness workgroup (Part D); and to amend the public health law, in relation to the safe disposal of controlled substances (Part E) THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM- BLY, DO ENACT AS FOLLOWS: Section 1. Legislative findings and intent. The legislature finds that prescription drugs, particularly controlled substances, are increasingly subject to criminal diversion and abuse, which can result in addiction, adverse drug events, accidental death due to overdose, violent or self-injurious behavior, family conflicts, and increased costs to businesses and the health care system. The legislature further finds that such diversion and abuse will be mitigated by: establishing a prescription monitoring program registry containing data about controlled substances dispensed to individuals, reported on a real time basis; requiring health care practitioners and permitting pharmacists to access such registry before prescribing or dispensing additional such substances; and requiring that prescriptions be transmitted electronically from practitioners to pharmacists. There- fore, the legislature finds it appropriate and necessary to establish a
prescription monitoring program registry that is designed to utilize real time data, integrate electronic prescribing, combat overprescribing and doctor-shopping, and curtail abuse and illegal diversion without compromising access to controlled substances for legitimate health care purposes. The legislature further finds that these objectives will be promoted by updating the state's schedules of controlled substances, establishing a program for the safe disposal of controlled substances by consumers, and enhancing opportunities to promote education about controlled substances for the public and practitioners. S 2. This act enacts into law major components of legislation which are necessary to implement fundamental changes to the way controlled substances are prescribed, dispensed and monitored in this state. Each component is wholly contained within a Part identified as Parts A through E. The effective date of each particular provision contained within such Part is set forth in the last section of such Part. Any provision in any section contained within a Part, including the effec- tive date of the Part, which makes reference to a section "of this act", when used in connection with that particular component, shall be deemed to mean and refer to the corresponding section of the Part in which it is found. Section four of this act sets forth the general effective date of this act. PART A Section 1. This act shall be known and may be cited as the "Internet System for Tracking Over-Prescribing (I-STOP) Act". S 2. The public health law is amended by adding a new section 3343-a to read as follows: S 3343-A. PRESCRIPTION MONITORING PROGRAM REGISTRY. 1. ESTABLISHMENT OF SYSTEM. (A) THE COMMISSIONER SHALL, IN ACCORDANCE WITH THE PROVISIONS OF THIS SECTION, ESTABLISH AND MAINTAIN AN ELECTRONIC SYSTEM FOR COLLECTING, MONITORING AND REPORTING INFORMATION CONCERNING THE PRESCRIBING AND DISPENSING OF CONTROLLED SUBSTANCES, TO BE KNOWN AS THE PRESCRIPTION MONITORING PROGRAM REGISTRY. THE REGISTRY SHALL INCLUDE INFORMATION REPORTED BY PHARMACIES ON A REAL TIME BASIS, AS SET FORTH IN SUBDIVISION FOUR OF SECTION THIRTY-THREE HUNDRED THIRTY-THREE OF THIS ARTICLE. (B) THE REGISTRY SHALL INCLUDE, FOR EACH PERSON TO WHOM A PRESCRIPTION FOR CONTROLLED SUBSTANCES HAS BEEN DISPENSED, ALL PATIENT-SPECIFIC INFORMATION COVERING SUCH PERIOD OF TIME AS IS DEEMED APPROPRIATE AND FEASIBLE BY THE COMMISSIONER, BUT NO LESS THAN SIX MONTHS AND NO MORE THAN FIVE YEARS. SUCH PATIENT-SPECIFIC INFORMATION SHALL BE OBTAINED FROM THE PRESCRIPTION INFORMATION REPORTED BY PHARMACIES PURSUANT TO SUBDIVISION FOUR OF SECTION THIRTY-THREE HUNDRED THIRTY-THREE OF THIS ARTICLE AND BY PRACTITIONERS WHO DISPENSE PURSUANT TO SUBDIVISION SIX OF SECTION THIRTY-THREE HUNDRED THIRTY-ONE OF THIS ARTICLE, AND SHALL BE PROCESSED AND INCLUDED IN THE REGISTRY BY THE DEPARTMENT WITHOUT UNDUE DELAY. FOR PURPOSES OF THIS ARTICLE, "PATIENT-SPECIFIC INFORMATION" MEANS INFORMATION PERTAINING TO INDIVIDUAL PATIENTS INCLUDED IN THE REGISTRY, WHICH SHALL INCLUDE THE FOLLOWING INFORMATION AND SUCH OTHER INFORMATION AS IS REQUIRED BY THE DEPARTMENT IN REGULATION: (I) THE PATIENT'S NAME; (II) THE PATIENT'S RESIDENTIAL ADDRESS; (III) THE PATIENT'S DATE OF BIRTH; (IV) THE PATIENT'S GENDER; (V) THE DATE ON WHICH THE PRESCRIPTION WAS ISSUED;
(VI) THE DATE ON WHICH THE CONTROLLED SUBSTANCE WAS DISPENSED; (VII) THE METRIC QUANTITY OF THE CONTROLLED SUBSTANCE DISPENSED; (VIII) THE NUMBER OF DAYS SUPPLY OF THE CONTROLLED SUBSTANCE DISPENSED; (IX) THE NAME OF THE PRESCRIBER; (X) THE PRESCRIBER'S IDENTIFICATION NUMBER, AS ASSIGNED BY THE DRUG ENFORCEMENT ADMINISTRATION; (XI) THE NAME OR IDENTIFIER OF THE DRUG THAT WAS DISPENSED; AND (XII) THE PAYMENT METHOD. (C) THE REGISTRY SHALL BE SECURE, EASILY ACCESSIBLE BY PRACTITIONERS AND PHARMACISTS, AND COMPATIBLE WITH THE ELECTRONIC TRANSMISSION OF PRESCRIPTIONS FOR CONTROLLED SUBSTANCES, AS REQUIRED BY SECTION TWO HUNDRED EIGHTY-ONE OF THIS CHAPTER, AND SECTION SIXTY-EIGHT HUNDRED TEN OF THE EDUCATION LAW, AND ANY REGULATIONS PROMULGATED PURSUANT THERETO. TO THE EXTENT PRACTICABLE, IMPLEMENTATION OF THE ELECTRONIC TRANSMISSION OF PRESCRIPTIONS FOR CONTROLLED SUBSTANCES SHALL SERVE TO STREAMLINE CONSULTATION OF THE REGISTRY BY PRACTITIONERS AND REPORTING OF PRESCRIPTION INFORMATION BY PHARMACISTS. THE REGISTRY SHALL BE INTEROP- ERABLE WITH OTHER SIMILAR REGISTRIES OPERATED BY FEDERAL OR STATE GOVERNMENTS, TO THE EXTENT DEEMED APPROPRIATE BY THE COMMISSIONER, AND SUBJECT TO THE PROVISIONS OF SECTION THIRTY-THREE HUNDRED SEVENTY-ONE-A OF THIS ARTICLE. (D) THE DEPARTMENT SHALL ESTABLISH AND IMPLEMENT SUCH PROTOCOLS AS ARE REASONABLY NECESSARY TO ENSURE THAT INFORMATION CONTAINED IN THE REGIS- TRY IS MAINTAINED IN A SECURE AND CONFIDENTIAL MANNER AND IS ACCESSIBLE ONLY BY PRACTITIONERS, PHARMACISTS OR THEIR DESIGNEES FOR THE PURPOSES ESTABLISHED IN SUBDIVISIONS TWO AND THREE OF THIS SECTION, OR AS OTHER- WISE SET FORTH IN SECTIONS THIRTY-THREE HUNDRED SEVENTY-ONE AND THIRTY- THREE HUNDRED SEVENTY-ONE-A OF THIS ARTICLE. SUCH PROTOCOLS SHALL INCLUDE A MECHANISM FOR THE DEPARTMENT TO MONITOR AND RECORD ACCESS TO THE REGISTRY, WHICH SHALL IDENTIFY THE AUTHORIZED INDIVIDUAL ACCESSING AND EACH CONTROLLED SUBSTANCE HISTORY ACCESSED. 2. DUTY TO CONSULT PRESCRIPTION MONITORING PROGRAM REGISTRY; PRACTI- TIONERS. (A) EVERY PRACTITIONER SHALL CONSULT THE PRESCRIPTION MONITOR- ING PROGRAM REGISTRY PRIOR TO PRESCRIBING OR DISPENSING ANY CONTROLLED SUBSTANCE LISTED ON SCHEDULE II, III OR IV OF SECTION THIRTY-THREE HUNDRED SIX OF THIS ARTICLE, FOR THE PURPOSE OF REVIEWING A PATIENT'S CONTROLLED SUBSTANCE HISTORY AS SET FORTH IN SUCH REGISTRY; PROVIDED, HOWEVER, THAT NOTHING IN THIS SECTION SHALL PRECLUDE AN AUTHORIZED PRAC- TITIONER, OTHER THAN A VETERINARIAN, FROM CONSULTING THE REGISTRY AT HIS OR HER OPTION PRIOR TO PRESCRIBING OR DISPENSING ANY CONTROLLED SUBSTANCE. THE DUTY TO CONSULT THE REGISTRY SHALL NOT APPLY TO: (I) VETERINARIANS; (II) A PRACTITIONER DISPENSING PURSUANT TO SUBDIVISION THREE OF SECTION THIRTY-THREE HUNDRED FIFTY-ONE OF THIS ARTICLE; (III) A PRACTITIONER ADMINISTERING A CONTROLLED SUBSTANCE; (IV) A PRACTITIONER PRESCRIBING OR ORDERING A CONTROLLED SUBSTANCE FOR USE ON THE PREMISES OF AN INSTITUTIONAL DISPENSER PURSUANT TO SECTION THIRTY-THREE HUNDRED FORTY-TWO OF THIS TITLE; (V) A PRACTITIONER PRESCRIBING A CONTROLLED SUBSTANCE IN THE EMERGENCY DEPARTMENT OF A GENERAL HOSPITAL, PROVIDED THAT THE QUANTITY OF CONTROLLED SUBSTANCE PRESCRIBED DOES NOT EXCEED A FIVE DAY SUPPLY IF THE CONTROLLED SUBSTANCE WERE USED IN ACCORDANCE WITH THE DIRECTIONS FOR USE;
(VI) A PRACTITIONER PRESCRIBING A CONTROLLED SUBSTANCE TO A PATIENT UNDER THE CARE OF A HOSPICE, AS DEFINED BY SECTION FOUR THOUSAND TWO OF THIS CHAPTER; (VII) A PRACTITIONER WHEN: (A) IT IS NOT REASONABLY POSSIBLE FOR THE PRACTITIONER TO ACCESS THE REGISTRY IN A TIMELY MANNER; (B) NO OTHER PRACTITIONER OR DESIGNEE AUTHORIZED TO ACCESS THE REGIS- TRY, PURSUANT TO PARAGRAPH (B) OF THIS SUBDIVISION, IS REASONABLY AVAIL- ABLE; AND (C) THE QUANTITY OF CONTROLLED SUBSTANCE PRESCRIBED DOES NOT EXCEED A FIVE DAY SUPPLY IF THE CONTROLLED SUBSTANCE WERE USED IN ACCORDANCE WITH THE DIRECTIONS FOR USE; (VIII) A PRACTITIONER ACTING IN COMPLIANCE WITH REGULATIONS THAT MAY BE PROMULGATED BY THE COMMISSIONER AS TO CIRCUMSTANCES UNDER WHICH CONSULTATION OF THE REGISTRY WOULD RESULT IN A PATIENT'S INABILITY TO OBTAIN A PRESCRIPTION IN A TIMELY MANNER, THEREBY ADVERSELY IMPACTING THE MEDICAL CONDITION OF SUCH PATIENT; (IX) A SITUATION WHERE THE REGISTRY IS NOT OPERATIONAL AS DETERMINED BY THE DEPARTMENT OR WHERE IT CANNOT BE ACCESSED BY THE PRACTITIONER DUE TO A TEMPORARY TECHNOLOGICAL OR ELECTRICAL FAILURE, AS SET FORTH IN REGULATION; OR (X) A PRACTITIONER WHO HAS BEEN GRANTED A WAIVER DUE TO TECHNOLOGICAL LIMITATIONS THAT ARE NOT REASONABLY WITHIN THE CONTROL OF THE PRACTI- TIONER, OR OTHER EXCEPTIONAL CIRCUMSTANCE DEMONSTRATED BY THE PRACTI- TIONER, PURSUANT TO A PROCESS ESTABLISHED IN REGULATION, AND IN THE DISCRETION OF THE COMMISSIONER. (B) FOR PURPOSES OF THIS SECTION, A PRACTITIONER MAY AUTHORIZE A DESIGNEE TO CONSULT THE PRESCRIPTION MONITORING PROGRAM REGISTRY ON HIS OR HER BEHALF, PROVIDED THAT: (I) THE DESIGNEE SO AUTHORIZED IS EMPLOYED BY THE SAME PROFESSIONAL PRACTICE OR IS UNDER CONTRACT WITH SUCH PRAC- TICE; (II) THE PRACTITIONER TAKES REASONABLE STEPS TO ENSURE THAT SUCH DESIGNEE IS SUFFICIENTLY COMPETENT IN THE USE OF THE REGISTRY; (III) THE PRACTITIONER REMAINS RESPONSIBLE FOR ENSURING THAT ACCESS TO THE REGIS- TRY BY THE DESIGNEE IS LIMITED TO AUTHORIZED PURPOSES AND OCCURS IN A MANNER THAT PROTECTS THE CONFIDENTIALITY OF THE INFORMATION OBTAINED FROM THE REGISTRY, AND REMAINS RESPONSIBLE FOR ANY BREACH OF CONFIDEN- TIALITY; AND (IV) THE ULTIMATE DECISION AS TO WHETHER OR NOT TO PRESCRIBE OR DISPENSE A CONTROLLED SUBSTANCE REMAINS WITH THE PRACTI- TIONER AND IS REASONABLY INFORMED BY THE RELEVANT CONTROLLED SUBSTANCE HISTORY INFORMATION OBTAINED FROM THE REGISTRY. THE COMMISSIONER SHALL ESTABLISH IN REGULATION REASONABLE PARAMETERS WITH REGARD TO A PRACTI- TIONER'S ABILITY TO AUTHORIZE DESIGNEES PURSUANT TO THIS SECTION, WHICH SHALL INCLUDE PROCESSES NECESSARY TO ALLOW THE DEPARTMENT TO: (A) GRANT ACCESS TO THE REGISTRY IN A REASONABLY PROMPT MANNER TO AS MANY DESIG- NEES AS ARE AUTHORIZED BY PRACTITIONERS, UP TO THE NUMBER DEEMED APPRO- PRIATE BY THE COMMISSIONER FOR PARTICULAR PROFESSIONAL PRACTICES OR TYPES OF PRACTICES, TAKING INTO ACCOUNT THE NEED TO MAINTAIN SECURITY OF THE REGISTRY AND THE PATIENT-SPECIFIC INFORMATION MAINTAINED THEREIN, AND THE OBJECTIVE OF MINIMIZING BURDENS TO PRACTITIONERS TO THE EXTENT PRACTICABLE; (B) REQUIRE THAT PRACTITIONERS NOTIFY THE DEPARTMENT UPON TERMINATING THE AUTHORIZATION OF ANY DESIGNEE; AND (C) ESTABLISH A MECH- ANISM TO PREVENT SUCH TERMINATED DESIGNEES FROM ACCESSING THE REGISTRY IN A REASONABLY PROMPT MANNER FOLLOWING SUCH NOTIFICATION. 3. AUTHORITY TO CONSULT PRESCRIPTION MONITORING PROGRAM REGISTRY; PHARMACISTS. (A) A PHARMACIST MAY CONSULT THE PRESCRIPTION MONITORING PROGRAM REGISTRY IN ORDER TO REVIEW THE CONTROLLED SUBSTANCE HISTORY OF
AN INDIVIDUAL FOR WHOM ONE OR MORE PRESCRIPTIONS FOR CONTROLLED SUBSTANCES IS PRESENTED TO SUCH PHARMACIST. (B) FOR PURPOSES OF THIS SECTION, A PHARMACIST MAY DESIGNATE ANOTHER PHARMACIST, A PHARMACY INTERN, AS DEFINED BY SECTION SIXTY-EIGHT HUNDRED SIX OF THE EDUCATION LAW, OR OTHER INDIVIDUAL AS MAY BE PERMITTED BY THE COMMISSIONER IN REGULATION, TO CONSULT THE PRESCRIPTION MONITORING PROGRAM REGISTRY ON THE PHARMACIST'S BEHALF, PROVIDED THAT SUCH DESIGNEE IS EMPLOYED BY THE SAME PHARMACY OR IS UNDER CONTRACT WITH SUCH PHARMA- CY. THE COMMISSIONER SHALL ESTABLISH IN REGULATION REASONABLE PARAME- TERS WITH REGARD TO A PHARMACIST'S ABILITY TO AUTHORIZE DESIGNEES PURSU- ANT TO THIS SECTION, WHICH SHALL INCLUDE PROCESSES NECESSARY TO ALLOW THE DEPARTMENT TO: (A) GRANT ACCESS TO THE REGISTRY IN A REASONABLY PROMPT MANNER TO AS MANY DESIGNEES AS ARE AUTHORIZED BY PHARMACISTS, UP TO THE NUMBER DEEMED APPROPRIATE BY THE COMMISSIONER FOR PARTICULAR PHARMACIES, TAKING INTO ACCOUNT THE NEED TO MAINTAIN SECURITY OF THE REGISTRY AND THE PATIENT-SPECIFIC INFORMATION MAINTAINED THEREIN, AND THE OBJECTIVE OF MINIMIZING BURDENS TO PHARMACISTS TO THE EXTENT PRACTI- CABLE; (B) REQUIRE THAT PHARMACISTS NOTIFY THE DEPARTMENT UPON TERMINAT- ING THE AUTHORIZATION OF ANY DESIGNEE; AND (C) ESTABLISH A MECHANISM TO PREVENT SUCH TERMINATED DESIGNEES FROM ACCESSING THE REGISTRY IN A REASONABLY PROMPT MANNER FOLLOWING SUCH NOTIFICATION. 4. IMMUNITY. NO PRACTITIONER OR PHARMACIST, AND NO PERSON ACTING ON BEHALF OF SUCH PRACTITIONER OR PHARMACIST AS PERMITTED UNDER THIS SECTION, ACTING WITH REASONABLE CARE AND IN GOOD FAITH SHALL BE SUBJECT TO CIVIL LIABILITY ARISING FROM ANY FALSE, INCOMPLETE OR INACCURATE INFORMATION SUBMITTED TO OR REPORTED BY THE REGISTRY OR FOR ANY RESULT- ING FAILURE OF THE SYSTEM TO ACCURATELY OR TIMELY REPORT SUCH INFORMA- TION; PROVIDED, HOWEVER, THAT NOTHING IN THIS SUBDIVISION SHALL BE DEEMED TO ALTER THE OBLIGATION TO SUBMIT OR REPORT PRESCRIPTION INFORMA- TION TO THE DEPARTMENT AS OTHERWISE SET FORTH IN THIS ARTICLE OR IN REGULATIONS PROMULGATED PURSUANT THERETO. 5. GUIDANCE TO PRACTITIONERS AND PHARMACISTS. THE COMMISSIONER SHALL, IN CONSULTATION WITH THE COMMISSIONER OF EDUCATION, PROVIDE GUIDANCE TO PRACTITIONERS, PHARMACISTS, AND PHARMACIES REGARDING THE PURPOSES AND USES OF THE REGISTRY ESTABLISHED BY THIS SECTION AND THE MEANS BY WHICH PRACTITIONERS AND PHARMACISTS CAN ACCESS THE REGISTRY. SUCH GUIDANCE SHALL REFERENCE EDUCATIONAL INFORMATION AVAILABLE PURSUANT TO THE PRESCRIPTION PAIN MEDICATION AWARENESS PROGRAM ESTABLISHED PURSUANT TO SECTION THIRTY-THREE HUNDRED NINE-A OF THIS ARTICLE. 6. INDIVIDUAL ACCESS TO CONTROLLED SUBSTANCE HISTORIES. THE COMMIS- SIONER SHALL ESTABLISH PROCEDURES BY WHICH AN INDIVIDUAL MAY: (A) REQUEST AND OBTAIN HIS OR HER OWN CONTROLLED SUBSTANCES HISTORY CONSIST- ING OF PATIENT-SPECIFIC INFORMATION OR, IN APPROPRIATE CIRCUMSTANCES, THAT OF A PATIENT WHO LACKS CAPACITY TO MAKE HEALTH CARE DECISIONS AND FOR WHOM THE INDIVIDUAL HAS LEGAL AUTHORITY TO MAKE SUCH DECISIONS AND WOULD HAVE LEGAL ACCESS TO THE PATIENT'S HEALTH CARE RECORDS; OR (B) SEEK REVIEW OF ANY PART OF HIS OR HER CONTROLLED SUBSTANCES HISTORY OR, IN APPROPRIATE CIRCUMSTANCES, THAT OF A PATIENT WHO LACKS CAPACITY TO MAKE HEALTH CARE DECISIONS AND FOR WHOM THE INDIVIDUAL HAS LEGAL AUTHOR- ITY TO MAKE SUCH DECISIONS AND WOULD HAVE LEGAL ACCESS TO THE PATIENT'S HEALTH CARE RECORDS, THAT SUCH INDIVIDUAL DISPUTES. SUCH PROCEDURES SHALL REQUIRE THE DEPARTMENT TO PROMPTLY REVISE ANY INFORMATION ACCESSI- BLE THROUGH THE REGISTRY THAT THE DEPARTMENT DETERMINES TO BE INACCU- RATE. SUCH PROCEDURES SHALL BE DESCRIBED ON THE DEPARTMENT'S WEBSITE AND INCLUDED WITH THE CONTROLLED SUBSTANCES HISTORY PROVIDED TO AN INDIVID- UAL PURSUANT TO A REQUEST MADE UNDER THIS SUBDIVISION OR UNDER SUBPARA-
GRAPH (IV) OF PARAGRAPH (A) OF SUBDIVISION TWO OF SECTION THIRTY-THREE HUNDRED SEVENTY-ONE OF THIS ARTICLE. 7. DEPARTMENT ANALYSIS OF DATA. THE DEPARTMENT SHALL PERIODICALLY ANALYZE DATA CONTAINED IN THE PRESCRIPTION MONITORING PROGRAM REGISTRY TO IDENTIFY INFORMATION THAT INDICATES THAT A VIOLATION OF LAW OR BREACH OF PROFESSIONAL STANDARDS MAY HAVE OCCURRED AND, AS WARRANTED, PROVIDE ANY RELEVANT INFORMATION TO APPROPRIATE ENTITIES AS PERMITTED UNDER SECTION THIRTY-THREE HUNDRED SEVENTY-ONE OF THIS ARTICLE. THE DEPART- MENT SHALL KEEP A RECORD OF THE INFORMATION PROVIDED, INCLUDING, BUT NOT LIMITED TO, THE SPECIFIC INFORMATION PROVIDED AND THE AGENCY TO WHICH SUCH INFORMATION WAS PROVIDED, INCLUDING THE NAME AND TITLE OF THE PERSON TO WHOM SUCH INFORMATION WAS PROVIDED AND AN ATTESTATION FROM SUCH PERSON THAT HE OR SHE HAS AUTHORITY TO RECEIVE SUCH INFORMATION. 8. FUNDING THE PRESCRIPTION MONITORING PROGRAM REGISTRY. (A) THE COMMISSIONER SHALL MAKE REASONABLE EFFORTS TO APPLY FOR MONIES AVAILABLE FROM THE FEDERAL GOVERNMENT AND OTHER INSTITUTIONS, TO THE EXTENT DEEMED APPROPRIATE BY THE COMMISSIONER, AND USE ANY MONIES SO OBTAINED TO SUPPLEMENT ANY OTHER MONIES MADE AVAILABLE FOR THE PURPOSES OF THIS TITLE. (B) OPERATION OF THE REGISTRY ESTABLISHED BY THIS SECTION SHALL NOT BE FUNDED, IN WHOLE OR IN PART, BY FEES IMPOSED SPECIFICALLY FOR SUCH PURPOSES UPON PRACTITIONERS, PHARMACISTS, DESIGNEES OR PATIENTS SUBJECT TO THIS SECTION. 9. RULES AND REGULATIONS. THE COMMISSIONER SHALL PROMULGATE SUCH RULES AND REGULATIONS AS ARE NECESSARY TO EFFECTUATE THE PROVISIONS OF THIS SECTION, IN CONSULTATION WITH THE WORK GROUP ESTABLISHED PURSUANT TO SUBDIVISION THREE OF SECTION THIRTY-THREE HUNDRED NINE-A OF THIS ARTI- CLE. S 3. Subdivision 4 of section 3333 of the public health law, as amended by chapter 178 of the laws of 2010, is amended to read as follows: 4. The endorsed original prescription shall be retained by the propri- etor of the pharmacy for a period of five years. The proprietor of the pharmacy shall file OR CAUSE TO BE FILED such prescription information with the department by electronic means [in such manner and detail] ON A REAL TIME BASIS as the commissioner in consultation with the commission- er of education shall, by regulation, require; PROVIDED, HOWEVER, THAT THE COMMISSIONER MAY, PURSUANT TO A PROCESS ESTABLISHED IN REGULATION, GRANT A WAIVER ALLOWING A PHARMACY TO MAKE SUCH FILINGS WITHIN A LONGER PERIOD OF TIME IF AND TO THE EXTENT THAT THE COMMISSIONER FINDS IT WARRANTED, IN HIS OR HER DISCRETION, DUE TO ECONOMIC HARDSHIP, TECHNO- LOGICAL LIMITATIONS THAT ARE NOT REASONABLY WITHIN THE CONTROL OF THE PHARMACY, OR OTHER EXCEPTIONAL CIRCUMSTANCE DEMONSTRATED BY THE PHARMACY; AND PROVIDED, FURTHER, HOWEVER, THAT SUCH REGULATIONS SHALL SPECIFY THE MANNER IN WHICH SUCH REQUIREMENTS SHALL APPLY TO THE DELIV- ERY OF CONTROLLED SUBSTANCES TO INDIVIDUALS IN THIS STATE BY MEANS OF MAIL OR LICENSED EXPRESS DELIVERY SERVICES. S 4. Paragraphs (d) and (e) of subdivision 1 of section 3371 of the public health law, as amended by chapter 178 of the laws of 2010, are amended and five new paragraphs (f), (g), (h), (i) and (j) are added to read as follows: (d) to [a central] THE PRESCRIPTION MONITORING PROGRAM registry [established pursuant to this article; and] AND TO AUTHORIZED USERS OF SUCH REGISTRY AS SET FORTH IN SUBDIVISION TWO OF THIS SECTION; (e) to a practitioner to inform him or her that a patient may be under treatment with a controlled substance by another practitioner[.] FOR THE
PURPOSES OF SUBDIVISION TWO OF THIS SECTION, AND TO FACILITATE THE DEPARTMENT'S REVIEW OF INDIVIDUAL CHALLENGES TO THE ACCURACY OF CONTROLLED SUBSTANCES HISTORIES PURSUANT TO SUBDIVISION SIX OF SECTION THIRTY-THREE HUNDRED FORTY-THREE-A OF THIS ARTICLE; (F) TO A PHARMACIST TO PROVIDE INFORMATION REGARDING PRESCRIPTIONS FOR CONTROLLED SUBSTANCES PRESENTED TO THE PHARMACIST FOR THE PURPOSES OF SUBDIVISION TWO OF THIS SECTION AND TO FACILITATE THE DEPARTMENT'S REVIEW OF INDIVIDUAL CHALLENGES TO THE ACCURACY OF CONTROLLED SUBSTANCES HISTORIES PURSUANT TO SUBDIVISION SIX OF SECTION THIRTY-THREE HUNDRED FORTY-THREE-A OF THIS ARTICLE; (G) TO THE DEPUTY ATTORNEY GENERAL FOR MEDICAID FRAUD CONTROL, OR HIS OR HER DESIGNEE, IN FURTHERANCE OF AN INVESTIGATION OF FRAUD, WASTE OR ABUSE OF THE MEDICAID PROGRAM, PURSUANT TO AN AGREEMENT WITH THE DEPART- MENT; (H) TO A LOCAL HEALTH DEPARTMENT FOR THE PURPOSE OF CONDUCTING PUBLIC HEALTH RESEARCH OR EDUCATION: (I) PURSUANT TO AN AGREEMENT WITH THE COMMISSIONER; (II) WHEN THE RELEASE OF SUCH INFORMATION IS DEEMED APPRO- PRIATE BY THE COMMISSIONER; (III) FOR USE IN ACCORDANCE WITH MEASURES REQUIRED BY THE COMMISSIONER TO ENSURE THAT THE SECURITY AND CONFIDEN- TIALITY OF THE DATA IS PROTECTED; AND (IV) PROVIDED THAT DISCLOSURE IS RESTRICTED TO INDIVIDUALS WITHIN THE LOCAL HEALTH DEPARTMENT WHO ARE ENGAGED IN THE RESEARCH OR EDUCATION; (I) TO A MEDICAL EXAMINER OR CORONER WHO IS AN OFFICER OF OR EMPLOYED BY A STATE OR LOCAL GOVERNMENT, PURSUANT TO HIS OR HER OFFICIAL DUTIES; AND (J) TO AN INDIVIDUAL FOR THE PURPOSE OF PROVIDING SUCH INDIVIDUAL WITH HIS OR HER OWN CONTROLLED SUBSTANCE HISTORY OR, IN APPROPRIATE CIRCUM- STANCES, IN THE CASE OF A PATIENT WHO LACKS CAPACITY TO MAKE HEALTH CARE DECISIONS, A PERSON WHO HAS LEGAL AUTHORITY TO MAKE SUCH DECISIONS FOR THE PATIENT AND WHO WOULD HAVE LEGAL ACCESS TO THE PATIENT'S HEALTH CARE RECORDS, IF REQUESTED FROM THE DEPARTMENT PURSUANT TO SUBDIVISION SIX OF SECTION THIRTY-THREE HUNDRED FORTY-THREE-A OF THIS ARTICLE OR FROM A TREATING PRACTITIONER PURSUANT TO SUBPARAGRAPH (IV) OF PARAGRAPH (A) OF SUBDIVISION TWO OF THIS SECTION. S 5. Subdivision 2 of section 3371 of the public health law is renum- bered subdivision 4 and two new subdivisions 2 and 3 are added to read as follows: 2. THE PRESCRIPTION MONITORING PROGRAM REGISTRY MAY BE ACCESSED, UNDER SUCH TERMS AND CONDITIONS AS ARE ESTABLISHED BY THE DEPARTMENT FOR PURPOSES OF MAINTAINING THE SECURITY AND CONFIDENTIALITY OF THE INFORMA- TION CONTAINED IN THE REGISTRY, BY: (A) A PRACTITIONER, OR A DESIGNEE AUTHORIZED BY SUCH PRACTITIONER PURSUANT TO PARAGRAPH (B) OF SUBDIVISION TWO OF SECTION THIRTY-THREE HUNDRED FORTY-THREE-A OF THIS ARTICLE, FOR THE PURPOSES OF: (I) INFORM- ING THE PRACTITIONER THAT A PATIENT MAY BE UNDER TREATMENT WITH A CONTROLLED SUBSTANCE BY ANOTHER PRACTITIONER; (II) PROVIDING THE PRACTI- TIONER WITH NOTIFICATIONS OF CONTROLLED SUBSTANCE ACTIVITY AS DEEMED RELEVANT BY THE DEPARTMENT, INCLUDING BUT NOT LIMITED TO A NOTIFICATION MADE AVAILABLE ON A MONTHLY OR OTHER PERIODIC BASIS THROUGH THE REGISTRY OF CONTROLLED SUBSTANCES ACTIVITY PERTAINING TO HIS OR HER PATIENT; (III) ALLOWING THE PRACTITIONER, THROUGH CONSULTATION OF THE PRESCRIPTION MONITORING PROGRAM REGISTRY, TO REVIEW HIS OR HER PATIENT'S CONTROLLED SUBSTANCES HISTORY AS REQUIRED BY SECTION THIRTY-THREE HUNDRED FORTY-THREE-A OF THIS ARTICLE; AND (IV) PROVIDING TO HIS OR HER PATIENT, OR PERSON AUTHORIZED PURSUANT TO PARAGRAPH (J) OF SUBDIVISION ONE OF THIS SECTION, UPON REQUEST, A COPY OF SUCH PATIENT'S CONTROLLED
SUBSTANCE HISTORY AS IS AVAILABLE TO THE PRACTITIONER THROUGH THE PRESCRIPTION MONITORING PROGRAM REGISTRY; OR (B) A PHARMACIST, PHARMACY INTERN OR OTHER DESIGNEE AUTHORIZED BY THE PHARMACIST PURSUANT TO PARAGRAPH (B) OF SUBDIVISION THREE OF SECTION THIRTY-THREE HUNDRED FORTY-THREE-A OF THIS ARTICLE, FOR THE PURPOSES OF: (I) CONSULTING THE PRESCRIPTION MONITORING PROGRAM REGISTRY TO REVIEW THE CONTROLLED SUBSTANCES HISTORY OF AN INDIVIDUAL FOR WHOM ONE OR MORE PRESCRIPTIONS FOR CONTROLLED SUBSTANCES IS PRESENTED TO THE PHARMACIST, PURSUANT TO SECTION THIRTY-THREE HUNDRED FORTY-THREE-A OF THIS ARTICLE; AND (II) RECEIVING FROM THE DEPARTMENT SUCH NOTIFICATIONS OF CONTROLLED SUBSTANCE ACTIVITY AS ARE MADE AVAILABLE BY THE DEPARTMENT. 3. WHERE IT HAS REASON TO BELIEVE THAT A CRIME RELATED TO THE DIVER- SION OF CONTROLLED SUBSTANCES HAS BEEN COMMITTED, THE DEPARTMENT MAY NOTIFY APPROPRIATE LAW ENFORCEMENT AGENCIES AND PROVIDE RELEVANT INFOR- MATION ABOUT THE SUSPECTED CRIMINAL ACTIVITY, INCLUDING CONTROLLED SUBSTANCES PRESCRIBED OR DISPENSED, AS REASONABLY APPEARS TO BE NECES- SARY. THE DEPARTMENT SHALL KEEP A RECORD OF THE INFORMATION PROVIDED, INCLUDING, BUT NOT LIMITED TO: THE SPECIFIC INFORMATION PROVIDED AND THE AGENCY TO WHICH SUCH INFORMATION WAS PROVIDED, INCLUDING THE NAME AND TITLE OF THE PERSON TO WHOM SUCH INFORMATION WAS PROVIDED AND AN ATTES- TATION FROM SUCH PERSON THAT HE OR SHE HAS AUTHORITY TO RECEIVE SUCH INFORMATION. S 6. Section 3302 of the public health law is amended by adding a new subdivision 41 to read as follows: 41. "REGISTRY" OR "PRESCRIPTION MONITORING PROGRAM REGISTRY" MEANS THE PRESCRIPTION MONITORING PROGRAM REGISTRY ESTABLISHED PURSUANT TO SECTION THIRTY-THREE HUNDRED FORTY-THREE-A OF THIS ARTICLE. S 7. This act shall take effect one year after it shall have become a law; provided, however, that: (a) the commissioners of health and education are authorized to add, amend or repeal any rule or regulation necessary and take other action necessary for the implementation of such provisions on such effective date; (b) prior to such effective date, to the extent practicable, the department of health shall authorize practitioners, pharmacists and designees to access the prescription monitoring registry as set forth in this act and shall permit such access prior to such effective date, to the extent practicable; and (c) nothing in subdivision (b) of this section shall require a practi- tioner to consult the registry prior to the effective date of this act. PART B Section 1. Sections 270 through 276 and section 277 of article 2-A of the public health law are designated title I and a new title heading is added to read as follows: PREFERRED DRUG AND CLINICAL DRUG REVIEW PROGRAMS S 1-a. Sections 276-a and 276-b of article 2-A of the public health law are renumbered sections 278 and 279, respectively, and such sections and section 280 of such article are designated title II and a new title heading is added to read as follows: PRESCRIPTION DRUGS; VARIOUS PROVISIONS S 2. Article 2-A of the public health law is amended by adding a new title III to read as follows: TITLE III PRESCRIPTION FORMS, ELECTRONIC PRESCRIBING AND LANGUAGE ASSISTANCE
SECTION 281. OFFICIAL NEW YORK STATE PRESCRIPTION FORMS. S 281. OFFICIAL NEW YORK STATE PRESCRIPTION FORMS. 1. IN ADDITION TO THE REQUIREMENTS OF SECTION SIXTY-EIGHT HUNDRED TEN OF THE EDUCATION LAW OR ARTICLE THIRTY-THREE OF THIS CHAPTER, ALL PRESCRIPTIONS WRITTEN IN THIS STATE BY A PERSON AUTHORIZED BY THIS STATE TO ISSUE SUCH PRESCRIPTIONS SHALL BE ON SERIALIZED OFFICIAL NEW YORK STATE PRESCRIPTION FORMS PROVIDED BY THE DEPARTMENT. SUCH FORMS SHALL BE FURNISHED TO PRACTITIONERS AUTHORIZED TO WRITE PRESCRIPTIONS AND TO INSTITUTIONAL DISPENSERS, AND SHALL BE NON-REPRODUCIBLE AND NON-TRANS- FERABLE. THE COMMISSIONER, IN CONSULTATION WITH THE COMMISSIONER OF EDUCATION, MAY PROMULGATE EMERGENCY REGULATIONS FOR THE ELECTRONIC TRAN- SMISSION OF PRESCRIPTIONS FROM PRESCRIBERS TO PHARMACISTS OR FOR ORDER- ING AND FILLING REQUIREMENTS OF PRESCRIPTION DRUGS FOR PRESCRIPTIONS WRITTEN FOR RECIPIENTS ELIGIBLE FOR MEDICAL ASSISTANCE PURSUANT TO TITLE ELEVEN OF ARTICLE FIVE OF THE SOCIAL SERVICES LAW, FOR PARTICIPANTS IN THE PROGRAM FOR ELDERLY PHARMACEUTICAL INSURANCE COVERAGE PURSUANT TO TITLE THREE OF ARTICLE TWO OF THE ELDER LAW AND FOR PRESCRIPTIONS WRIT- TEN PURSUANT TO ARTICLE THIRTY-THREE OF THIS CHAPTER. NOTHING IN THIS SECTION SHALL PROHIBIT THE COMMISSIONER IN CONSULTATION WITH THE COMMIS- SIONER OF EDUCATION FROM PROMULGATING ANY ADDITIONAL EMERGENCY REGU- LATIONS IN FURTHERANCE OF THIS SUBDIVISION. 2. THE COMMISSIONER, IN CONSULTATION WITH THE COMMISSIONER OF EDUCA- TION, SHALL PROMULGATE REGULATIONS REQUIRING THAT PRESCRIPTION FORMS AND ELECTRONIC PRESCRIPTIONS INCLUDE: (A) A SECTION WHEREIN PRESCRIBERS MAY INDICATE WHETHER AN INDIVIDUAL IS LIMITED ENGLISH PROFICIENT, AS DEFINED IN SECTION SIXTY-EIGHT HUNDRED TWENTY-NINE OF THE EDUCATION LAW; AND (B) IF THE PATIENT IS LIMITED ENGLISH PROFICIENT, A LINE WHERE THE PRESCRI- BER MAY SPECIFY THE PREFERRED LANGUAGE INDICATED BY THE PATIENT. FAIL- URE TO INCLUDE SUCH INDICATION ON THE PART OF THE PRESCRIBER SHALL NOT INVALIDATE THE PRESCRIPTION. 3. ON OR BEFORE DECEMBER THIRTY-FIRST, TWO THOUSAND TWELVE, THE COMMISSIONER SHALL PROMULGATE REGULATIONS, IN CONSULTATION WITH THE COMMISSIONER OF EDUCATION, ESTABLISHING STANDARDS FOR ELECTRONIC PRESCRIPTIONS. NOTWITHSTANDING ANY OTHER PROVISION OF THIS SECTION OR ANY OTHER LAW TO THE CONTRARY, EFFECTIVE TWO YEARS SUBSEQUENT TO THE DATE ON WHICH SUCH REGULATIONS ARE PROMULGATED, NO PERSON SHALL ISSUE ANY PRESCRIPTION IN THIS STATE UNLESS SUCH PRESCRIPTION IS MADE BY ELEC- TRONIC PRESCRIPTION FROM THE PERSON ISSUING THE PRESCRIPTION TO A PHAR- MACY IN ACCORDANCE WITH SUCH REGULATORY STANDARDS, EXCEPT FOR PRESCRIPTIONS: (A) ISSUED BY VETERINARIANS; (B) ISSUED IN CIRCUMSTANCES WHERE ELECTRONIC PRESCRIBING IS NOT AVAILABLE DUE TO TEMPORARY TECHNO- LOGICAL OR ELECTRICAL FAILURE, AS SET FORTH IN REGULATION; (C) ISSUED BY PRACTITIONERS WHO HAVE RECEIVED A WAIVER OR A RENEWAL THEREOF FOR A SPECIFIED PERIOD DETERMINED BY THE COMMISSIONER, NOT TO EXCEED ONE YEAR, FROM THE REQUIREMENT TO USE ELECTRONIC PRESCRIBING, PURSUANT TO A PROC- ESS ESTABLISHED IN REGULATION BY THE COMMISSIONER, IN CONSULTATION WITH THE COMMISSIONER OF EDUCATION, DUE TO ECONOMIC HARDSHIP, TECHNOLOGICAL LIMITATIONS THAT ARE NOT REASONABLY WITHIN THE CONTROL OF THE PRACTI- TIONER, OR OTHER EXCEPTIONAL CIRCUMSTANCE DEMONSTRATED BY THE PRACTI- TIONER; (D) ISSUED BY A PRACTITIONER UNDER CIRCUMSTANCES WHERE, NOTWITH- STANDING THE PRACTITIONER'S PRESENT ABILITY TO MAKE AN ELECTRONIC PRESCRIPTION AS REQUIRED BY THIS SUBDIVISION, SUCH PRACTITIONER REASON- ABLY DETERMINES THAT IT WOULD BE IMPRACTICAL FOR THE PATIENT TO OBTAIN SUBSTANCES PRESCRIBED BY ELECTRONIC PRESCRIPTION IN A TIMELY MANNER, AND SUCH DELAY WOULD ADVERSELY IMPACT THE PATIENT'S MEDICAL CONDITION, PROVIDED THAT IF SUCH PRESCRIPTION IS FOR A CONTROLLED SUBSTANCE, THE
QUANTITY OF CONTROLLED SUBSTANCES DOES NOT EXCEED A FIVE DAY SUPPLY IF THE CONTROLLED SUBSTANCE WERE USED IN ACCORDANCE WITH THE DIRECTIONS FOR USE; OR (E) ISSUED BY A PRACTITIONER TO BE DISPENSED BY A PHARMACY LOCATED OUTSIDE THE STATE, AS SET FORTH IN REGULATION. 4. IN THE CASE OF A PRESCRIPTION FOR A CONTROLLED SUBSTANCE ISSUED BY A PRACTITIONER UNDER PARAGRAPH (B) OF SUBDIVISION THREE OF THIS SECTION, THE PRACTITIONER SHALL FILE INFORMATION ABOUT THE ISSUANCE OF SUCH PRESCRIPTION WITH THE DEPARTMENT AS SOON AS PRACTICABLE, AS SET FORTH IN REGULATION. 5. IN THE CASE OF A PRESCRIPTION FOR A CONTROLLED SUBSTANCE ISSUED BY A PRACTITIONER UNDER PARAGRAPH (D) OR (E) OF SUBDIVISION THREE OF THIS SECTION, THE PRACTITIONER SHALL, UPON ISSUING SUCH PRESCRIPTION, FILE INFORMATION ABOUT THE ISSUANCE OF SUCH PRESCRIPTION WITH THE DEPARTMENT BY ELECTRONIC MEANS, AS SET FORTH IN REGULATION. 6. THE WAIVER PROCESS ESTABLISHED IN REGULATION PURSUANT TO PARAGRAPH (C) OF SUBDIVISION THREE OF THIS SECTION SHALL PROVIDE THAT A PRACTI- TIONER PRESCRIBING UNDER A WAIVER MUST NOTIFY THE DEPARTMENT IN WRITING PROMPTLY UPON GAINING THE CAPABILITY TO USE ELECTRONIC PRESCRIBING, AND THAT A WAIVER SHALL TERMINATE WITHIN A SPECIFIED PERIOD OF TIME AFTER THE PRACTITIONER GAINS SUCH CAPABILITY. S 3. Section 6810 of the education law is amended by adding four new subdivisions 10, 11, 12 and 13 to read as follows: 10. NOTWITHSTANDING ANY OTHER PROVISION OF THIS SECTION OR ANY OTHER LAW TO THE CONTRARY, EFFECTIVE TWO YEARS SUBSEQUENT TO THE DATE ON WHICH REGULATIONS ESTABLISHING STANDARDS FOR ELECTRONIC PRESCRIPTIONS ARE PROMULGATED BY THE COMMISSIONER OF HEALTH, IN CONSULTATION WITH THE COMMISSIONER PURSUANT TO SUBDIVISION THREE OF SECTION TWO HUNDRED EIGHT- Y-ONE OF THE PUBLIC HEALTH LAW, NO PRACTITIONER SHALL ISSUE ANY PRESCRIPTION IN THIS STATE, UNLESS SUCH PRESCRIPTION IS MADE BY ELEC- TRONIC PRESCRIPTION FROM THE PRACTITIONER TO A PHARMACY, EXCEPT FOR PRESCRIPTIONS: (A) ISSUED BY VETERINARIANS; (B) ISSUED OR DISPENSED IN CIRCUMSTANCES WHERE ELECTRONIC PRESCRIBING IS NOT AVAILABLE DUE TO TEMPORARY TECHNOLOGICAL OR ELECTRICAL FAILURE, AS SET FORTH IN REGU- LATION; (C) ISSUED BY PRACTITIONERS WHO HAVE RECEIVED A WAIVER OR A RENEWAL THEREOF FOR A SPECIFIED PERIOD DETERMINED BY THE COMMISSIONER OF HEALTH, NOT TO EXCEED ONE YEAR, FROM THE REQUIREMENT TO USE ELECTRONIC PRESCRIBING, PURSUANT TO A PROCESS ESTABLISHED IN REGULATION BY THE COMMISSIONER OF HEALTH, IN CONSULTATION WITH THE COMMISSIONER DUE TO ECONOMIC HARDSHIP, TECHNOLOGICAL LIMITATIONS THAT ARE NOT REASONABLY WITHIN THE CONTROL OF THE PRACTITIONER, OR OTHER EXCEPTIONAL CIRCUM- STANCE DEMONSTRATED BY THE PRACTITIONER; (D) ISSUED BY A PRACTITIONER UNDER CIRCUMSTANCES WHERE, NOTWITHSTANDING THE PRACTITIONER'S PRESENT ABILITY TO MAKE AN ELECTRONIC PRESCRIPTION AS REQUIRED BY THIS SUBDIVI- SION, SUCH PRACTITIONER REASONABLY DETERMINES THAT IT WOULD BE IMPRACTI- CAL FOR THE PATIENT TO OBTAIN SUBSTANCES PRESCRIBED BY ELECTRONIC PRESCRIPTION IN A TIMELY MANNER, AND SUCH DELAY WOULD ADVERSELY IMPACT THE PATIENT'S MEDICAL CONDITION, PROVIDED THAT IF SUCH PRESCRIPTION IS FOR A CONTROLLED SUBSTANCE, THE QUANTITY THAT DOES NOT EXCEED A FIVE DAY SUPPLY IF THE CONTROLLED SUBSTANCE WAS USED IN ACCORDANCE WITH THE DIRECTIONS FOR USE; OR (E) ISSUED BY A PRACTITIONER TO BE DISPENSED BY A PHARMACY LOCATED OUTSIDE THE STATE, AS SET FORTH IN REGULATION. 11. IN THE CASE OF A PRESCRIPTION ISSUED BY A PRACTITIONER UNDER PARA- GRAPH (B) OF SUBDIVISION TEN OF THIS SECTION, THE PRACTITIONER SHALL BE REQUIRED TO FILE INFORMATION ABOUT THE ISSUANCE OF SUCH PRESCRIPTION WITH THE DEPARTMENT OF HEALTH AS SOON AS PRACTICABLE, AS SET FORTH IN REGULATION.
12. IN THE CASE OF A PRESCRIPTION ISSUED BY A PRACTITIONER UNDER PARA- GRAPH (D) OR (E) OF SUBDIVISION TEN OF THIS SECTION, THE PRACTITIONER SHALL, UPON ISSUING SUCH PRESCRIPTION, FILE INFORMATION ABOUT THE ISSU- ANCE OF SUCH PRESCRIPTION WITH THE DEPARTMENT OF HEALTH BY ELECTRONIC MEANS, AS SET FORTH IN REGULATION. 13. THE WAIVER PROCESS ESTABLISHED IN REGULATION PURSUANT TO PARAGRAPH (C) OF SUBDIVISION TEN OF THIS SECTION SHALL PROVIDE THAT A PRACTITIONER PRESCRIBING UNDER A WAIVER MUST NOTIFY THE DEPARTMENT IN WRITING PROMPT- LY UPON GAINING THE CAPABILITY TO USE ELECTRONIC PRESCRIBING, AND THAT A WAIVER SHALL TERMINATE WITHIN A SPECIFIED PERIOD OF TIME AFTER THE PRAC- TITIONER GAINS SUCH CAPABILITY. S 4. Section 21 of the public health law is REPEALED. S 5. This act shall take effect immediately; provided, however, that the provisions of subdivision 2 of section 281 of the public health law, as added by section two of this act, shall take effect March 30, 2013, except that as of such date, the commissioner of health, the commission- er of education and the state board of pharmacy are immediately author- ized and directed to take actions necessary to implement such provisions as of such date; provided, further, that any rules or regulations that have been adopted or proposed prior to the effective date of this act which are applicable to section 21 of the public health law shall now apply to section 281 of the public health law as added by section two of this act; and provided, further, that any rules or regulations that have been adopted or proposed prior to the effective date of this act which are applicable to sections 276-a and 276-b of the public health law shall now apply to section 278 and 279 of the public health law, respec- tively, renumbered by section one-a of this act. PART C Section 1. Paragraph 1 of subdivision (b) of schedule II of section 3306 of the public health law, as amended by chapter 457 of the laws of 2006, is amended to read as follows: (1) Opium and opiate, and any salt, compound, derivative, or prepara- tion of opium or opiate, excluding apomorphine, dextrorphan, nalbuphine, nalmefene, naloxone, and naltrexone, and their respective salts, but including the following: 1. Raw opium. 2. Opium extracts. 3. Opium fluid. 4. Powdered opium. 5. Granulated opium. 6. Tincture of opium. 7. Codeine. 8. Ethylmorphine. 9. Etorphine hydrochloride. 10. Hydrocodone (ALSO KNOWN AS DIHYDROCODEINONE). 11. Hydromorphone. 12. Metopon. 13. Morphine. 14. Oxycodone. 15. Oxymorphone. 16. Thebaine. 17. Dihydroetorphine. 18. ORIPAVINE.
S 2. Schedule II of section 3306 of the public health law is amended by adding a new subdivision (b-1) to read as follows: (B-1) UNLESS SPECIFICALLY EXCEPTED OR UNLESS LISTED IN ANOTHER SCHED- ULE, ANY MATERIAL, COMPOUND, MIXTURE, OR PREPARATION CONTAINING ANY OF THE FOLLOWING, OR THEIR SALTS CALCULATED AS THE FREE ANHYDROUS BASE OR ALKALOID, IN LIMITED QUANTITIES AS SET FORTH BELOW: (1) NOT MORE THAN THREE HUNDRED MILLIGRAMS OF DIHYDROCODEINONE (HYDRO- CODONE) PER ONE HUNDRED MILLILITERS OR NOT MORE THAN FIFTEEN MILLIGRAMS PER DOSAGE UNIT, WITH A FOURFOLD OR GREATER QUANTITY OF AN ISOQUINOLINE ALKALOID OF OPIUM. (2) NOT MORE THAN THREE HUNDRED MILLIGRAMS OF DIHYDROCODEINONE (HYDRO- CODONE) PER ONE HUNDRED MILLILITERS OR NOT MORE THAN FIFTEEN MILLIGRAMS PER DOSAGE UNIT, WITH ONE OR MORE ACTIVE NONNARCOTIC INGREDIENTS IN RECOGNIZED THERAPEUTIC AMOUNTS. S 3. Section 3307 of the public health law is amended by adding a new subdivision 5 to read as follows: 5. THE COMMISSIONER SHALL ESTABLISH MINIMUM STANDARDS FOR THE STORAGE, REPORTING, ORDERING AND RECORD KEEPING OF CONTROLLED SUBSTANCES SPECI- FIED IN SUBDIVISION (B-1) OF SCHEDULE II OF SECTION THIRTY-THREE HUNDRED SIX OF THIS ARTICLE BY MANUFACTURERS AND DISTRIBUTORS AS IF SUCH SUBSTANCES WERE SET FORTH IN SCHEDULE III OF SECTION THIRTY-THREE HUNDRED SIX OF THIS ARTICLE. S 4. Paragraph 6 of subdivision (b) of schedule II of section 3306 of the public health law is REPEALED. S 5. Subdivision (c) of schedule II of section 3306 of the public health law is amended by adding a new paragraph 28 to read as follows: (28) TAPENTADOL. S 6. Subdivision (d) of schedule II of section 3306 of the public health law, as added by chapter 664 of the laws of 1985, paragraph 5 as added by chapter 178 of the laws of 2010, is amended to read as follows: (d) Stimulants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, INCLUDING ITS SALTS, ISOMERS, AND SALTS OF ISOMERS: (1) Amphetamine[, its salts, optical isomers, and salts of its optical isomers]. (2) Methamphetamine[, its salts, isomers, and salts of its isomers]. (3) Phenmetrazine [and its salts]. (4) Methylphenidate. (5) Lisdexamfetamine. S 7. Subdivision (g) of schedule II of section 3306 of the public health law is amended by adding a new paragraph 3 to read as follows: (3) IMMEDIATE PRECURSOR TO FENTANYL: (I) 4-ANILINO-N-PHENETHYL-4-PIPERIDINE (ANPP). S 8. Subdivision (h) of schedule II of section 3306 of the public health law, as amended by chapter 178 of the laws of 2010, is amended to read as follows: (h) Anabolic steroids. Unless specifically excepted or unless listed in another schedule, "anabolic steroid" shall mean any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids and dehydroepiandros- terone) [that promotes muscle growth, or any material, compound, mixture, or preparation which contains any amount of the following substances] AND INCLUDES: (1) 3{beta}, 17-dihydroxy-5a-androstane.
(2) 3{alpha}, 17{beta}-dihydroxy-5a-androstane. (3) 5{alpha}-androstan-3,17-dione. (4) 1-androstenediol (3{beta},17{beta}-dihydroxy-5{alpha}-androst-1- ene). (5) 1-androstenediol (3{alpha},17{beta}-dihydroxy-5{alpha}-androst-1- ene). (6) 4-androstenediol (3{beta}, 17{beta}-dihydroxy-androst-4-ene). (7) 5-androstenediol (3{beta}, 17{beta}-dihydroxy-androst-5-ene). (8) 1-androstenedione ({5{alpha}}-androst-1-en-3,17-dione). (9) 4-androstenedione (androst-4-en-3,17-dione). (10) 5-androstenedione (androst-5-en-3,17-dione). (11) Bolasterone (7{alpha},17{alpha}-dimethyl-17{beta}-hydroxyandrost- 4-en-3-one). (12) Boldenone (17{beta}-hydroxyandrost-1, 4,-diene-3-one). (13) BOLDIONE (ANDROSTA-1,4-DIENE-3,17-DIONE). (14) Calusterone (7{beta}, 17{alpha}-dimethyl-17{beta}-hydroxyandrost- 4-en-3-one). [(14)] (15) Clostebol (4-chloro-17{beta}-hydroxyandrost-4-en-3-one). [(15)] (16) Dehydrochloromethyltestosterone [(4-chloro-17{beta}- hydroxy-17{alpha}-methyl-androst-1] (4-CHLORO-17{BETA}-HYDROXY-17 {ALPHA}-METHYL-ANDROST-1, 4-dien-3-one). [(16)] (17) {Delta} 1-dihydrotestosterone (a.k.a. '1-testosterone') (17 {beta}-hydroxy-5{alpha}-androst-1-en-3-one). [(17)] (18) 4-dihydrotestosterone (17{beta}-hydroxy-androstan-3-one). [(18)] (19) Drostanolone (17{beta}-hydroxy-2{alpha}-methyl-5{alpha} -androstan-3-one). [(19)] (20) Ethylestrenol (17{alpha}-ethyl-17{beta}-hydroxyestr- 4-ene). [(20)] (21) Fluoxymesterone (9-fluoro-17{alpha}-methyl-11{beta}, 17 {beta}-[dihydroxandrost]DIHYDROXYANDROST-4-en-3-one). [(21)] (22) Formebolone (2-formyl-17{alpha}-methyl-11{alpha}, 17{beta}-dihydroxyandrost-1, 4-dien-3-one). [(22)] (23) Furazabol (17{alpha}-methyl-17{beta}-hydroxyandrostano {2, 3-c}-furazan). [(23) 13{beta}-ethyl-17{alpha}-hydroxygon-4-en-3-one] (24) 13{BETA}-ETHYL-17{BETA}-HYROXYGON-4-EN-3-ONE. [(24)] (25) 4-hydroxytestosterone [(4,17 {beta}-dihydroxyandrost-4- en-3-one)] (4, 17{BETA}-DIHYDROXY-ANDROST-4-EN-3-ONE). [(25)] (26) 4-hydroxy-19-nortestosterone (4,17{beta}-dihydroxy-estr-4-en-3-one). [(26)] (27) DESOXYMETHYLTESTOSTERONE (17{ALPHA}-METHYL-5{ALPHA}-ANDROST-2-EN-17{BETA}-OL) (A.K.A., MADOL). (28) Mestanolone (17{alpha}-methyl-17{beta}-hydroxy- 5-androstan-3-one). [(27)] (29) Mesterolone (1{alpha}[-]methyl-17{beta}-hydroxy- {5{alpha}}-androstan-3-one). [(28)] (30) Methandienone (17{alpha}-methyl-17{beta}-hydroxyandrost-1, 4-dien-3-one). [(29)] (31) Methandriol (17{alpha}-methyl-3{beta}, 17{beta}-dihydroxyandrost-5-ene). [(30)] (32) Methenolone (1-methyl-17{beta}-hydroxy-5{alpha}-androst- 1-en-3-one). [(31)] (33) 17{alpha}-methyl-3{beta},17{beta}-dihydroxy-5a-androstane. [(32)] (34) 17{alpha}-methyl-3{alpha}, 17{beta}-dihydroxy- 5a-androstane. [(33)] (35) 17{alpha}-methyl-3{beta}, 17{beta}-dihydroxyandrost-4-ene.
[(34)] (36) 17{alpha}-methyl-4-hydroxynandrolone (17{alpha}-methyl-4- hydroxy-17{beta}-hydroxyestr-4-en-3-one). [(35)] (37) Methyldienolone (17{alpha}-methyl-17{beta}-hydroxyestra- 4,9(10)-dien-3-one). [(36)] (38) Methyltrienolone (17{alpha}-methyl-17{beta}-hydroxyestra-4, 9-11-trien-3-one). [(37)] (39) Methyltestosterone (17{alpha}-methyl-17{beta}-hydroxyandrost- 4-en-3-one). [(38)] (40) Mibolerone (7{alpha},17{alpha}-dimethyl-17{beta}-hydroxyestr- 4-en-3-one). [(39)] (41) 17{alpha}-methyl-{Delta} 1-dihydrotestosterone (17b{beta}-hydroxy-17{alpha}-methyl-5{alpha}-androst-1-en-3-one) (a.k.a. '17-{alpha}-methyl-1-testosterone'). [(40)] (42) Nandrolone(17{beta}-hydroxyestr-4-en-3-one). [(41)] (43) 19-nor-4-androstenediol (3{beta},17{beta}-dihydroxyestr -4-ene). [(42)] (44) 19-nor-4-androstenediol (3{alpha},17{beta}-dihydroxyestr- 4-ene). [(43)] (45) 19-nor-5-androstenediol (3{beta},17{beta}-dihydroxyestr -5-ene). [(44)] (46) 19-nor-5-androstenediol (3{alpha},17{beta}-dihydroxyestr- 5-ene). [(45)] (47) 19-NOR-4,9(10)-ANDROSTADIENEDIONE (ESTRA-4,9(10)-DIENE-3,17-DIONE). (48) 19-nor-4-androstenedione (estr-4-en-3,17-dione). [(46)] (49) 19-nor-5-androstenedione (estr-5-en-3,17-dione). [(47)] (50) Norbolethone (13{beta}, 17{alpha}-diethyl-17{beta} -hydroxygon-4-en-3-one). [(48)] (51) Norclostebol (4-chloro-17{beta}-hydroxyestr-4-en-3-one). [(49)] (52) Norethandrolone (17{alpha}-ethyl-17{beta}-hydroxyestr- 4-en-3-one). [(50)] (53) Normethandrolone (17{alpha}-methyl-17{beta} -hydroxyestr-4-en-3-one). [(51)] (54) Oxandrolone (17{alpha}-methyl-17{beta}-hydroxy-2-oxa- {5{alpha}}-androstan-3-one). [(52)] (55) Oxymesterone (17{alpha}-methyl-4, 17{beta}-dihydroxy[-] androst-4-en-3-one). [(53)] (56) Oxymetholone (17 {alpha}-methyl-2-hydroxymethylene-17 {beta}-hydroxy-{5{alpha}}- androstan-3-one). [(54)] (57) Stanozolol (17{alpha}-methyl-17{beta}-hydroxy-{5{alpha}}- androst-2-eno{3, 2-c}-pyrazole). [(55)] (58) Stenbolone (17{beta}-hydroxy-2-methyl-{5{alpha}}-androst- 1-en-3-one). [(56)] (59) Testolactone (13-hydroxy-3-oxo-13, 17-secoandrosta-1, 4-dien-17-oic acid lactone). [(57)] (60) Testosterone (17{beta}-hydroxyandrost-4-en-3-one). [(58)] (61) Tetrahydrogestrinone (13{beta}, 17{alpha}-diethyl -17{beta}-hydroxygon-4, 9, 11-trien-3-one). [(59)] (62) Trenbolone (17{beta}-hydroxyestr-4, 9, 11-trien-3-one). [(60)] (63) Any salt, ester or ether of a drug or substance described or listed in this subdivision. S 9. The opening paragraph of subdivision (c) of schedule III of section 3306 of the public health law, as added by chapter 664 of the laws of 1985, is amended to read as follows: Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity
of the following substances having a depressant effect on the central nervous system, INCLUDING ITS SALTS, ISOMERS, AND SALTS OF ISOMERS: S 10. Subdivision (e) of schedule III of section 3306 of the public health law, as added by chapter 664 of the laws of 1985, paragraphs 3 and 4 as amended by chapter 589 of the laws of 1996 and paragraph 9 as added by chapter 457 of the laws of 2006, is amended to read as follows: (e) Narcotic drugs. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calcu- lated as the free anhydrous base or alkaloid, in limited quantities as set forth below: (1) Not more than 1.8 grams of codeine per one hundred milliliters or not more than ninety milligrams per dosage unit, with an equal or great- er quantity of an isoquinoline alkaloid of opium. (2) Not more than 1.8 grams of codeine per one hundred milliliters or not more than ninety milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. (3) [Not more than three hundred milligrams of dihydrocodeinone (hydrocodone) per one hundred milliliters or not more than fifteen milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium. (4) Not more than three hundred milligrams of dihydrocodeinone (hydro- codone) per one hundred milliliters or not more than fifteen milligrams per dosage unit, with one or more active nonnarcotic ingredients in recognized therapeutic amounts. (5)] Not more than 1.8 grams of dihydrocodeine per one hundred milli- liters or not more than ninety milligrams per dosage unit, with one or more active nonnarcotic ingredients in recognized therapeutic amounts. [(6)] (4) Not more than three hundred milligrams of ethylmorphine per one hundred milliliters or not more than fifteen milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. [(7)] (5) Not more than five hundred milligrams of opium per one hundred milliliters or per one hundred grams or not more than twenty- five milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. [(8)] (6) Not more than fifty milligrams of morphine per one hundred milliliters or per one hundred grams, with one or more active, nonnar- cotic ingredients in recognized therapeutic amounts. [(9)] (7) Buprenorphine in any quantities. S 11. Subdivision (f) of schedule III of section 3306 of the public health law, as amended by chapter 178 of the laws of 2010, is amended to read as follows: (f) [(i)] Dronabinol (SYNTHETIC) in sesame oil and encapsulated in a soft gelatin capsule in a [drug product approved for marketing by the] U.S. Food and Drug Administration [(FDA)] APPROVED PRODUCT. [(ii) Any drug product in tablet or capsule form containing natural dronabinol derived from the cannabis (plant) or synthetic dronabinol (produced from synthetic materials) for which an abbreviated new drug application (ANDA) has been approved by the FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act which references as its listed drug the drug product referred to in paragraph (i) of this subdivision.] Some other names for dronabinol include: (6aR-trans)-6a, 7, 8, 10a-tet- rahydro-6, 6, 9-trimethyl-3-pentyl-6H-dibenzo{b,d} pyran-1-o1, or (-)-delta-9-(trans) - tetrahydrocannabinol.
S 12. Subdivision (c) of schedule IV of section 3306 of the public health law is amended by adding two new paragraphs 52 and 53 to read as follows: (52) FOSPROPOFOL. (53) CARISOPRODOL. S 13. Paragraph 11 of subdivision (e) of schedule IV of section 3306 of the public health law, as added by chapter 457 of the laws of 2006, is amended to read as follows: (11) [Modafanil] MODAFINIL. S 14. Subdivision (f) of schedule IV of section 3306 of the public health law is amended by adding a new paragraph 3 to read as follows: (3) TRAMADOL IN ANY QUANTITIES. S 15. Subdivision (b) of schedule V of section 3306 of the public health law, as added by chapter 664 of the laws of 1985, is amended to read as follows: (b) Narcotic drugs containing nonnarcotic active medicinal ingredi- ents. Any compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhyd- rous base or alkaloid, in limited quantities as set forth below, which shall include one or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or prepara- tion valuable medicinal [qualitites] QUALITIES other than those possessed by narcotic drugs alone: (1) Not more than two hundred milligrams of codeine per one hundred milliliters or per one hundred grams. (2) Not more than one hundred milligrams of dihydrocodeine per one hundred milliliters or per one hundred grams. (3) Not more than one hundred milligrams of ethylmorphine per one hundred milliliters or per one hundred grams. (4) Not more than 2.5 milligrams of diphenoxylate and not less than twenty-five micrograms of atropine sulfate per dosage unit. (5) Not more than one hundred milligrams of opium per one hundred milliliters or per one hundred grams. (6) Not more than 0.5 milligram of difenoxin and not less than twen- ty-five micrograms of atropine sulfate per dosage unit. S 16. Subdivision (d) of schedule V of section 3306 of the public health law, as added by chapter 178 of the laws of 2010, is amended to read as follows: (d) Depressants. Unless specifically exempted or excluded or unless listed in another schedule, any material, compound, mixture, or prepara- tion which contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts, ISOMERS, AND SALTS OF ISOMERS: (1) EZOGABINE {N-{2-AMINO-4-(4-FLUOROBENZYLAMINO)-PHENYL}-CARBAMIC ACID ETHYL ESTER}. (2) LACOSAMIDE {(R)-2-ACETOAMIDO-N-BENZYL-3-METHOXY-PROPIONAMIDE}. (3) Pregabalin [(]{(S)-3-(aminomethyl)-5-methylhexanoic acid[)]}. S 17. Subdivision 7 of section 3331 of the public health law, as amended by chapter 640 of the laws of 1990, is amended to read as follows: 7. A practitioner may not administer, prescribe or dispense any substance referred to in subdivision (h) [or subdivision (j)] of Sched- ule II, AND SUBDIVISION (G) OF SCHEDULE III, of section three thousand three hundred six of this article for other than therapeutic purposes. A practitioner may not administer, prescribe or dispense any such substance to any individual without first obtaining the informed consent
of such individual, or where the individual lacks capacity to give such consent, a person legally authorized to consent on his or her behalf. S 18. Subdivision 8 of section 220.00 of the penal law, as amended by chapter 664 of the laws of 1985, is amended to read as follows: 8. "Narcotic preparation" means any controlled substance listed in schedule II(B-1), III(d) or III(e). S 19. This act shall take effect on the ninetieth day after it shall have become a law; provided that sections two, three, ten, fourteen and eighteen shall take effect on the one hundred eightieth day after it shall have become a law; and provided that sections fifteen and seven- teen of this act shall take effect immediately. PART D Section 1. Subparagraphs (i), (ii) and (iii) of paragraph (b) of subdivision 2 of section 3309-a of the public health law, as added by section 52 of part D of chapter 56 of the laws of 2012, are amended and a new subparagraph (iv) is added to read as follows: (i) Report to the commissioner regarding the development of recommen- dations and model courses for continuing medical education, refresher courses and other training materials for licensed health care profes- sionals on appropriate use of prescription pain medication. Such recom- mendations, model courses and other training materials shall be submit- ted to the commissioner, who shall make such information available for the use in medical education, residency programs, fellowship programs, and for use in continuing medication education programs no later than January first, two thousand thirteen. SUCH RECOMMENDATIONS ALSO SHALL INCLUDE RECOMMENDATIONS ON: (A) EDUCATIONAL AND CONTINUING MEDICAL EDUCATION REQUIREMENTS FOR PRACTITIONERS APPROPRIATE TO ADDRESS PRESCRIPTION PAIN MEDICATION AWARENESS AMONG HEALTH CARE PROFESSIONALS; (B) CONTINUING EDUCATION REQUIREMENTS FOR PHARMACISTS RELATED TO PRESCRIPTION PAIN MEDICATION AWARENESS; AND (C) CONTINUING EDUCATION IN PALLIATIVE CARE AS IT RELATES TO PAIN MANAGEMENT, FOR WHICH PURPOSE THE WORK GROUP SHALL CONSULT THE NEW YORK STATE PALLIATIVE CARE EDUCATION AND TRAINING COUNCIL; (ii) No later than January first, two thousand thirteen, provide outreach and assistance to health care professional organizations to encourage and facilitate continuing medical education training programs for their members regarding appropriate prescribing practices FOR THE BEST PATIENT CARE and the risks associated with [prescription] OVERPRES- CRIBING AND UNDERPRESCRIBING pain medication; [and] (iii) Provide information to the commissioner for use in the develop- ment and continued update of the public awareness campaign, including information, resources, and active web links that should be included on the website[.]; AND (IV) CONSIDER OTHER ISSUES DEEMED RELEVANT BY THE COMMISSIONER, INCLUDING HOW TO PROTECT AND PROMOTE THE ACCESS OF PATIENTS WITH A LEGITIMATE NEED FOR CONTROLLED SUBSTANCES, PARTICULARLY MEDICATIONS NEEDED FOR PAIN MANAGEMENT BY ONCOLOGY PATIENTS, AND WHETHER AND HOW TO ENCOURAGE OR REQUIRE THE USE OR SUBSTITUTION OF OPIOID DRUGS THAT EMPLOY TAMPER-RESISTANCE TECHNOLOGY AS A MECHANISM FOR REDUCING ABUSE AND DIVERSION OF OPIOID DRUGS. S 2. Subdivision 3 of section 3309-a of the public health law, as added by section 52 of part D of chapter 56 of the laws of 2012, is amended to read as follows:
3. ON OR BEFORE SEPTEMBER FIRST, TWO THOUSAND TWELVE, THE COMMISSION- ER, IN CONSULTATION WITH THE COMMISSIONER OF THE OFFICE OF ALCOHOLISM AND SUBSTANCE ABUSE SERVICES, THE COMMISSIONER OF EDUCATION, AND THE EXECUTIVE SECRETARY OF THE STATE BOARD OF PHARMACY, SHALL ADD TO THE WORKGROUP SUCH ADDITIONAL MEMBERS AS APPROPRIATE SO THAT THE WORKGROUP MAY PROVIDE GUIDANCE IN FURTHERANCE OF THE IMPLEMENTATION OF THE I-STOP ACT. FOR SUCH PURPOSES, THE WORKGROUP SHALL INCLUDE BUT NOT BE LIMITED TO CONSUMER ADVISORY ORGANIZATIONS, HEALTH CARE PRACTITIONERS AND PROVIDERS, ONCOLOGISTS, ADDICTION TREATMENT PROVIDERS, PRACTITIONERS WITH EXPERIENCE IN PAIN MANAGEMENT, PHARMACISTS AND PHARMACIES, AND REPRESENTATIVES OF LAW ENFORCEMENT AGENCIES. 4. The commissioner shall report to the governor, the temporary presi- dent of the senate and the speaker of the assembly no later than March first, two thousand thirteen, and annually thereafter, on the work group's findings. The report shall include information on opioid over- dose deaths, emergency room utilization for the treatment of opioid overdose, the utilization of pre-hospital addiction services and recom- mendations to reduce opioid addiction and the consequences thereof. THE REPORT SHALL ALSO INCLUDE A RECOMMENDATION AS TO WHETHER SUBDIVISION TWO OF SECTION THIRTY-THREE HUNDRED FORTY-THREE-A OF THIS ARTICLE SHOULD BE AMENDED TO REQUIRE PRACTITIONERS PRESCRIBING OR DISPENSING CERTAIN IDEN- TIFIED SCHEDULE V CONTROLLED SUBSTANCES TO COMPLY WITH THE CONSULTATION REQUIREMENTS OF SUCH SUBDIVISION. S 3. This act shall take effect immediately. PART E Section 1. The public health law is amended by adding a new section 3343-b to read as follows: S 3343-B. SAFE DISPOSAL OF UNUSED CONTROLLED SUBSTANCES. THE DEPART- MENT SHALL ESTABLISH A PROGRAM FOR THE SAFE DISPOSAL OF UNUSED CONTROLLED SUBSTANCES BY CONSUMERS IN ACCORDANCE WITH FEDERAL LAW. THE PROGRAM SHALL PERMIT INDIVIDUAL MEMBERS OF THE PUBLIC TO VOLUNTARILY SURRENDER CONTROLLED SUBSTANCES LISTED ON SCHEDULE II, III, IV OR V OF SECTION THIRTY-THREE HUNDRED SIX OF THIS ARTICLE IN A SECURE MANNER, WITHOUT IDENTIFYING THEMSELVES, AND SHALL BE PUBLICIZED CONSISTENT WITH THE PRESCRIPTION PAIN MEDICATION AWARENESS PROGRAM ESTABLISHED PURSUANT TO SECTION THIRTY-THREE HUNDRED NINE-A OF THIS ARTICLE. THE SURRENDER OF A CONTROLLED SUBSTANCE PURSUANT TO THE PROGRAM ESTABLISHED PURSUANT TO THIS SECTION SHALL NOT CONSTITUTE THE POSSESSION, TRANSFER OR SALE OF SUCH CONTROLLED SUBSTANCE FOR PURPOSES OF THIS ARTICLE OR THE PENAL LAW. IN DEVELOPING SUCH PROGRAM, THE DEPARTMENT SHALL CONSIDER THE FOLLOWING: APPROPRIATE SITES FOR DISPOSAL THROUGHOUT THE STATE; THE ROLE OF LAW ENFORCEMENT AND FEDERAL AUTHORITIES, AS APPROPRIATE; AND THE MANNER IN WHICH POTENTIAL COSTS TO LOCALITIES OR TO THE STATE WILL BE ADDRESSED. DISPOSAL SITES SHALL BE OPERATED BY LAW ENFORCEMENT AGENCIES ON A VOLUN- TARY BASIS IN COLLABORATION WITH THE DEPARTMENT. NOTHING IN THIS SECTION SHALL REQUIRE ANY POLITICAL SUBDIVISION OF THE STATE TO PARTIC- IPATE IN THE PROGRAM ESTABLISHED IN THIS SECTION. S 2. This act shall take effect immediately. S 3. Severability clause. If any clause, sentence, paragraph, subdivi- sion, section or part of this act shall be adjudged by any court of competent jurisdiction to be invalid, such judgment shall not affect, impair or invalidate the remainder thereof, but shall be confined in its operation to the clause, sentence, paragraph, subdivision, section or part thereof directly involved in the controversy in which such judgment
shall have been rendered. It is hereby declared to be the intent of the legislature that this act would have been enacted even if such invalid provisions had not been included herein. S 4. This act shall take effect immediately; provided, however, that the applicable effective date of Parts A through E of this act shall be as specifically set forth in the last section of such Parts.

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