Laws and Regulations

Follow the instructions below to view the most current versions of the laws and regulations governing controlled substances and the official prescription forms in New York State.

Article 33 Public Health Law

  • Visit New York State Legislature
    • Select the link for "Laws of New York"
    • Select the link for "PBH Public Health"
    • Select the link Title 3 of Article 2-A then select the link for Section 281 – Official New York State Prescription Forms
    • Select the link for Article 33 - Controlled Substances

Part 80 Controlled Substance Regulations

  • Visit Part 80 Controlled Substance Regulations
    • Select the link for "Search Title 10"
    • In the "Search for" field, type "Part 80" and click the "Search" button
    • Select the link for "Part 80 - Rules And Regulations On Controlled Substances"

Part 910 Official New York State Prescription Forms Regulations

Changes to Controlled Substance Schedules Section 3306 of the Public Health Law

Effective November 25, 2012 the following changes will be made to the controlled substance schedules in Section 3306 of the New York State Public Health Law. Where applicable, some common brand name pharmaceutical preparations containing the controlled substances are listed in bold:

Schedule II Additions:

  • Tapentadol (Nucynta™)
  • Immediate precursor to fentanyl: 4-anilino-N-phenethyl-4-piperidine (ANPP)
  • Boldione (androsta-1,4-diene-3,17-dione)
  • Desoxymethyltestosterone (17[alpha]-methyl-5[alpha]-androst-2-en-17[beta]-ol) (a.k.a., madol)
  • 19-nor-4,9(10)-androstadienedione (estra-4,9(10)-diene-3,17-dione)

Schedule II Amendments:

  • Language defining an anabolic steroid was amended: 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 dehydroepiandrosterone).

Schedule III Amendments:

  • Language to clarify the description of dronabinol.

Schedule IV Additions:

  • Fospropofol (Lusedra™)
  • Carisoprodol (Soma®)

Schedule V Additions:

  • Ezogabine (Potiga™)
  • Lacosamide (Vimpat®)

Effective February 23, 2013 the following changes will be made to the controlled substance schedules in Section 3306 of the New York State Public Health Law. Where applicable, some common brand name pharmaceutical preparations containing the controlled substances are listed in bold:

Schedule II Additions:

  • Hydrocodone (dihydrocodeinone) (Vicodin®, Lortab®, Tussionex®) This action renders all products containing hydrocodone, including but not limited to hydrocodone in combination with acetaminophen or ibuprofen, Schedule II.

Schedule III Deletions:

  • Hydrocodone (dihydrocodeinone) (Vicodin®, Lortab®, Tussionex®) This action renders all products containing hydrocodone, including but not limited to hydrocodone in combination with acetaminophen or ibuprofen, Schedule II.

Schedule IV Additions:

  • Tramadol (Ultram®, Ultracet®, Ryzolt™)

Practitioners and pharmacists are responsible for ensuring prescriptions for all controlled substances including the medications listed above conform to all requirements of the law and regulations, both federal and state. Article 33 of the Public Health Law and Title 10 Part 80 Rules and Regulations on Controlled Substances in New York State may be accessed via the Bureau of Narcotic Enforcement webpage

Electronic Prescribing and Dispensing of Controlled Substances is now permissible in New York State Effective March 27, 2013 – Updated April 2013

Amendments to Title 10 NYCRR Part 80 Rules and Regulations on Controlled Substances have been adopted and became effective as final regulations on March 27, 2013. The amendments authorize a practitioner to issue an electronic prescription for controlled substances in Schedules II through V and allow a pharmacist to accept, annotate, dispense and electronically archive such prescriptions.

The amendments require the following;

  • Computer applications utilized must meet federal security requirements.The federal requirements are included in the Drug Enforcement Administration Interim Final Rule regarding Electronic Prescriptions for Controlled Substances. The rule may be accessed via the U.S Department of Justice DEA Office of Diversion Control website. Contact your software vendor to determine if your application meets the above mentioned requirements.
  • Computer applications meeting federal security requirements must be registered with the Department of Health, Bureau of Narcotic Enforcement.
  • Pharmacy computer applications must use American Society for Automation in Pharmacy (ASAP) Version 4.2 or greater in order to receive electronic prescriptions for controlled substances and to report those transactions to the Department of Health, Bureau of Narcotic Enforcement.
  • Pursuant to Public Health Law section 3302(37), an electronic prescription for controlled substances may only be issued in accordance with Department of Health regulations, as well as NYS Education Department regulations and federal requirements.NYS Education Department regulations may be accessed electronically.

New York State Regulations related to Electronic Prescribing of Controlled Substances may also be accessed electronically.

By March 27, 2015, all prescriptions (including prescriptions for non-controlled substances) issued in New York State must be electronically transmitted, with certain limited exceptions. Please continue to visit this webpage for information pertaining to electronic prescribing of controlled substances.

If you have met all federal security requirements and would like to register the application with the Bureau of Narcotic Enforcement, send an email to narcotic@health.ny.gov. Include "Electronic Prescribing" in the subject.

Electronic Prescriptions and Records for Hypodermic Needles and Hypodermic Syringes - Updated October, 2013

Amendments to Title 10 NYCRR Part 80 Rules and Regulations on Controlled Substances have been adopted and became effective as final regulations on October 9, 2013. The amendments specify the manner in which a practitioner may issue a prescription, including an electronic prescription, for hypodermic needles and syringes and would specify how a pharmacist should dispense and electronically archive such prescriptions. Pursuant to Public Health Law section 3381, a prescription for hypodermic needles and syringes may only be issued in accordance with Department of Health and NYS Education Department regulations.

To view the Department of Health Recently Adopted Regulations, amendments to Title 10 NYCRR Part 80 Rules and Regulations on Controlled Substances may be accessed electronically:

  • Go to www.health.ny.gov
  • On the right side of the Home Page click on Laws and Regulations
  • Under Rules and Regulations click on Recently Adopted Regulations (Prior Six Months)
  • Click on October 9, 2013 – Electronic Prescriptions and Records for Hypodermic Needles and Hypodermic Syringes

Prescription Drug Reform Act Internet System for Tracking Over-Prescribing (I-STOP) - Updated September, 2013

Amendments to Title 10 NYCRR Part 80 Rules and Regulations on Controlled Substances have been adopted and became effective as final regulations on August 27, 2013. The amendments specify the manner in which a practitioner must consult the Prescription Monitoring Program (PMP), and certain exceptions to that requirement. They clarify the practitioner's and pharmacist's ability to authorize a designee to consult the PMP on their behalf. The amendments change the frequency by which dispensing practitioners and pharmacies must submit dispensed controlled substance data to the Department of Health (Department), and include a requirement for reporting that no controlled substances were dispensed.

To view the Department of Health Recently Adopted Regulations, amendments to Title 10 NYCRR Part 80 Rules and Regulations on Controlled Substances may be accessed electronically:

  • Go to www.health.ny.gov
  • On the right side of the Home Page click on Laws and Regulations
  • Under Rules and Regulations click on Recently Adopted Regulations (Prior Six Months)
  • Click on August 27, 2013 – Prescription Monitoring Program

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