In April 2023, the New York State Department of Health’s (NYSDOH) Bureau of Narcotic Enforcement (BNE) revised its controlled substance licensing application procedures. The revisions include changes to the supporting documents that must be submitted with the application, the required reporting as a license holder, and the type of application for certain amendments to the licensee’s controlled substance program.
The supporting documents that must be submitted with a controlled substance license application vary depending on the license classification. Researchers hold Class 4 and/or Class 7 licenses, depending on the types of controlled substances that are stored and used. As of April 2023, new Class 4 and 7 license applications must include photos of the controlled substance storage lockbox or safe, and comprehensive photos of the room the storage is located in. The photos must show the storage in the room, which means the storage must be installed when the application is submitted to the BNE. This affects the submission timeline of a new license application for companies that are moving into new facilities. This also affects the timeline for commencing work with controlled substances, because a NYSDOH license number is required for a Drug Enforcement Administration (DEA) registration.
Current license holders are not exempt from the new supporting documents requirements. Renewal applications must include any supporting documents, including photos, that were not previously submitted with their initial application or previous renewals.
Class 4 and 7 license holders must submit biannual reports every January and June. The reports must include an inventory of each controlled substance and the quantity administered or dispensed.
The BNE has also revised license amendment procedures. Previously, relocation or change in ownership warranted a new license. Now, there is an option to “change” the license for a relocation or change in ownership. The change could warrant a new license number, and will likely result in an inspection.
For additional information about NYSDOH controlled substance licensing and how it affects your facility, please email us at [email protected].
This blog was written by Rae Moore, Safety Partners’ Senior Quality, Research, and Training Specialist
