NYS Controlled Substances: Licenses and Violations
In the state of New York, the department that oversees licensing for the handling of controlled substances is the New York State Department of Health, Bureau of Narcotic Enforcement Division. The department oversees all types of licenses for distributors, importers and exporters, researchers, and pharmacy retailers. The confidential records (license records) are the responsibilities of the licensees and are monitored by authorized representatives of the Bureau of Narcotic Control, New York State Department of Health.
To be qualified as a "controlled substance prescriber" in New York state, one should have DEA registration number and the appropriate practitioner license issued by the US Department of Justice- Drug Enforcement Administration. According to the New York's Department of Health website, "there is not a separate state controlled substance license needed for practitioners in New York State." Below, we've summarized more details.
CONTROLLED SUBSTANCE PRESCRIPTION IN NEW YORK STATE
The New York state law authorizes nurse practitioners to prescribe controlled substances to treat patients. All prescribers, after completing the New York State Education Department approved pharmacology coursework and being certified by the New York State Education Department to prescribe, must obtain other required government approvals.
The prescriber must have the National Provider Identifier (NPI) issued by the US Center for Medicaid and Medicare Services (CMS), a Federal Drug Enforcement Administration Registration (DEA) Number issued by the US Department of Justice-Drug Enforcement Administration, New York State Official Prescription Forms (ONYSRx), a Health Commerce System Account (HCSA) from the New York State Department of Health, registration with the New York State Department of Health’s Bureau of Narcotic Enforcement, registration of “Certified” Electronic Prescribing Computer Applications (for e-prescribing purposes), and a Medicaid Provider Number (MPN).
According the state's Department of Health, after obtaining or acquiring all the above requirements, one can officially prescribe controlled substances in the state. In New York, there is not a separate state controlled substance license needed for practitioners.
CONTROLLED SUBSTANCE LICENSE APPLICATIONS FOR DISTRIBUTORS, MANUFACTURERS, AND PHARMACIES IN NEW YORK STATE
The department in charge of the handling of the license application to engage in a controlled substance activity in New York is the New York State Department of Health, Bureau of Narcotic Enforcement Division (NYDOH-BNE). The department provides or allows various types of these licenses which we've copied below.
Licenses are issued in the following classifications:
Class 1: Manufacturer
Class 1a: Manufacturer (Out-of-State)
Class 2: Distributor
Class 2a: Distributor (Out-of-State)
Class 3: Institutional Dispenser
Class 3a: Institutional Dispenser Limited
Class 4: Researcher (Schedules II-V)
Class 5: Instructional Activities (Schedules II-V)
Class 7: Research/Instructional (Schedule I)
Class 8: Analytical Laboratory
Class 9: Importer
Class 9a: Importer Broker
Class 10: Exporter
Class 10a: Exporter Broker
Class 11: Pharmacy — Automated Dispensing System (ADS)
The detailed instructions on how to obtain a license application to engage in a controlled substance activity in New York state can be found here.
ACCESS OF RECORDS
Upon application, the New York State Department of Health’s (NYSDOH) Bureau of Narcotic Enforcement (BNE) will register for inclusion the applicant's records in the New York State Prescription Monitoring Program (PMP) Registry. It is required that controlled substance applicants—pharmacy providers, dispensing practitioners, and manufacturers and distributors—registered within New York State to electronically transmit information regarding dispensed controlled substances to the New York State Department of Health (NYSDOH). The records will be closely monitored by the Bureau of Narcotic Enforcement/Control.
All documents shall be entered and submitted in the NYSDOH Health Commerce System (HCS) portal. To access, the applicant must log in using the unique HCS account. To obtain an account number, one should request it via the provided email of the Bureau of Narcotic Enforcement at firstname.lastname@example.org. Details of the email content and the step-by-step guide can be found here. Only users with the portal account number can browse and access all relevant information including the status of the application.
For any violations, offenses, and/or non-compliance found of the controlled substance law in New York, the Commissioner of Health of the State of New York, or any representative authorized by him, is the authorized official to revoke or terminate any related licenses issued.