Licensing and Certification
Due to the ongoing COVID-19 state of emergency, we ask that you email all license and registration applications to firstname.lastname@example.org for processing. If a licensing fee is required, please mail the application only (no ancillary documents) and your check to the address on the application.
Public Health Law requires any person acting as a manufacturer, distributor, importer, exporter, institutional dispenser or institutional dispenser limited of controlled substances, or conducting research, instructional activities or chemical analysis with controlled substances in New York State to obtain a license from the Department of Health. The Bureau of Narcotic enforcement also registers other entities for controlled substance activities; such as the Expanded Syringe Access Program (ESAP), Certificate of Need (CON) to Possess Hypodermic Syringes and Needles, and Euthanasia Activities of Animals.
Notification of Disciplinary Action
Persons licensed or certified by the Bureau of Narcotic Enforcement (BNE), must notify BNE of, “any charge or proceeding brought in any court or before any governmental agency, State or Federal, in which it is alleged that the licensee, its employees, subsidiaries, managing officers, or directors has failed to comply with the provisions of the Federal Controlled Substances Act or the law of any State relating to controlled substances.” 10 NYCRR Part 80.110(b)
Controlled Substance License
Please Note: The requirement to prescribe a controlled substance in New York State is the appropriate practitioner license and a DEA registration. There is not a separate state controlled substance license needed for practitioners in New York State.
- Licensing Requirements
- License Application to Engage in a Controlled Substance Activity (DOH-4330) (PDF)
- Instructions to Apply for a License to Engage in a Controlled Substance Activity (PDF)
- Appendix A1: Class 4 & 7 Individual Researcher Protocol (PDF)
- Appendix A2: Class 5 & 7 Instructional Activities Protocol (PDF)
- Appendix B: Class 4 & 7 Institutional Researcher Statement (PDF)
- Appendix C: Class 8 Analytical Laboratory Protocol (PDF)
- Appendix D: Class 11 Pharmacy – ADS 'New', 'Renewal' and 'Amendment' (Proposed Installation) (PDF)
- Manufacturer Distributor Additional Information
- EMS Controlled Substance License Requirements
- Guideline for Registered Community Pharmacy (Retail Pharmacy) Operation of Automated Dispensing Systems in Residential Health Care Facilities (PDF, 47KB)
- Reverse Distributor List (Surrender to Independent Companies)
- Request for Approval of Disposal/Destruction of Controlled Substances (Important Note: Class 3A facilities only. DEA Registrants must see Reverse Distributor List or DEA Website)
- Instructions for Disposal/Destruction of Controlled Substances (PDF, 48KB, 2pg.)
- Request for Approval of Disposal/Destruction of Controlled Substances (DOH-2340) (PDF, 34KB, 1pg.)
- Controlled Substance Inventory Form (DOH-166) (PDF, 38KB, 1pg.)
Animal Euthanasia Activities
- Instructions for Registration and Certification for Euthanasia of Animals (PDF, 60KB)
- Application for Registration of an Incorporated Society or Municipal Animal Control Facility to Euthanize Animals (DOH-4333) (PDF, 21KB, 1pg.)
- Application for Certification as Euthanasia Technician for Animals (DOH-4332) (PDF, 22KB, 1pg.)
- Quarterly Controlled Substances Inventory Form for Humane Societies (DOH-4331) (PDF, 51KB, 1pg.)
- Renewal Application for Certification as a Euthanasia Technician for Animals (DOH-5274) (PDF, 510KB)
- Application for Registration as a Controlled Substance Agent for a Facility Certified for Euthanasia of Animals (DOH-5273) (PDF, 554KB)
Certificate of Need (CON) to Possess Hypodermic Syringes and Needles
Section 80.133 of the Part 80 Rules and Regulations on Controlled Substances in New York State outlines the Department of Health's Certificate of Need process, which is intended to authorize educational institutions and persons engaged in commercial, industrial or agricultural activities to possess hypodermic needles and syringes.
In 2007, the Public Health Law was amended to exempt farmers engaged in livestock production or persons supplying farmers engaged in livestock production from the requirements for sale or furnishing of needles and syringes. Individuals who meet this criteria are not required to hold a Certificate of Need from the Department of Health in order to purchase hypodermic syringes and needles in New York State.