NYS Controlled Substances: Licenses and Violations

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NYS Controlled Substances: Licenses and Violations

After an exhaustive search through governmental databases and other industry sources, we could not find any website or database where the public can find sanctions, revocation of controlled substance licenses for pharmacies and distributors or denials of applications in New York. However, we've pulled available resources to provide key findings: the New York State Department of Education through the Board of Regents “licenses individuals in more than 50 professions defined in Education Law, and is responsible for the final disposition of all disciplinary matters.” The Board of Regents provides a database where it documents all the disciplinary actions it has taken against licensees from 1994 to date. Continue below for our research strategy and a better understanding of why the requested information is not publicly available.

METHODOLOGY

To address this request, we started by reviewing the previous submission of the request to get a good understanding of the identified agency — New York State Department of Health, Bureau of Narcotic Enforcement Division (NYDOH-BNE). We also conducted research on this agency and were able to verify the information provided in the previous submission of this request. Hence, (as requested) we focused our search in finding some case studies around how the agency treated violators of its permits and licenses or how it specifies that violators of licenses and permits be treated. More so, finding these case studies will automatically demonstrate where the agency/division publicly posts license violation issues.
First, we searched through the identified website of the agency/division. There, we searched for any information regarding license violators. We also searched for the ‘FAQ’ section because the answers usually cover a broad category of questions pertaining to the operation of a particular system or process. We thought we could gather some insights into how the agency/division treats license violators; however, there was no pertinent information. The ‘FAQs’ we found were mainly about the regulations on the electronic prescription of controlled substances and other prescription-related issues. None of these were related to license violators or violations.

Furthermore, we could not find any press section because as a division of the NYDOH, the homepage of the Bureau of Narcotic Enforcement Division is a subdomain of the general official website of the NYDOH. Thus, we stepped down to search through the press sections of the official website of the NYDOH from 2011 to 2019. Yet, we could not find any case study or announcement around how the division/agency treated license violators. We only found some enforcement-related cases where the licenses of some laboratories and hospitals were suspended over issues not related to controlled substances. Also, we searched for the NYDOH’s annual report and found its 2016 annual report but it provided no relevant information. It only focused on New York State's general healthcare and quality of care.
Next, we searched other relevant and health-related governmental law enforcement bodies in New York State such as the database/press releases of the NYS Board of Health's Hearing and Notices and the NY Attorney General. But none of these yielded any positive result. On the NYS Board of Health’s Hearing and Notices, we found a piece of general information around permits and licenses but not on license violators. While it showed that registrants can contest summons issued to them at the OATH Hearings Division, further search on this division provided no pertinent information or any database of its rulings or hearings.

Delving deeper into other governmental disciplinary bodies, we found that the New York State Education Department's Office of the Professions (OP) “investigates and prosecutes professional misconduct in all professions except medicine.” Within this department, we found that the Board of Regents “licenses individuals in more than 50 professions defined in Education Law, and is responsible for the final disposition of all disciplinary matters.” The Board of Regents provides a database where it documents all the disciplinary actions it has taken against licensees from 1994 to date. We searched this database and found some case studies around the suspension of licenses of some registrants or licensees due to illegalities around controlled substances and other non-related offenses. However, we strongly believe that the Board of Regents, through the New York State Education Department issues and handles only professional licenses — one that authorizes/permits individuals and entities to practice their professions in the state.

This highly appears to differ with that issued by the NYDOH-BNE — one that specifically authorizes/permits an entity to handle controlled substances across various applications. If so, it is not an outright database to scour for any sanctions or revocation of controlled substance licenses for pharmacies and distributors despite the fact that it provides some case studies that cut across sanctions due to unprofessional offenses that ‘by chance,’ involved controlled substances. To further corroborate this, the National Association of State Controlled Substance Authorities also succinctly put that the New York State issues "State Controlled Substances Registration" to a variety of entities including manufacturers and distributors in New York. Thus, we proceeded to the next strategy.
Next, we searched for the requested information through third-party media sites and health-related media sites, especially those in New York State such as the Wall Street Journal, and The New York Times, etc. But we could not find any relevant information. We also tried to identify the leaders of the NYDOH-BNE and found the director and assistant director — Joshua Vinciguerra and Anita Murray — according to the New York State profile as provided by the National Association of State Controlled Substances Authorities. We tried to find out if these leaders have mentioned any license violation, sanctions or revocation in the media but we found no relevant information.
We have two hypotheses why this information is not publicly available.
  • There is a possibility that the NYDOH-BNE does not make their license database or discipline database public because controlled substances attract a lot of crime. If a drug addicted individual knew which business entities had access to controlled substances licensing, those businesses might be a target of theft, burglary or assault. This could be a reason why there are no public databases where one can access information on sanctions, revocation of controlled substance licenses for pharmacies and distributors, or denials of applications.
  • Since the "BNE Narcotic Investigators investigate suspected drug diversion or illegal sales involving theft, forgery, and fraudulent visits to practitioners' offices, and work closely with local, state, and federal law enforcement;" there is a possibility that it hands defaulters over to federal enforcement agencies which could range from the DEA to as high as the Office of the US Attorney General. There are no specific mentions about this though.

HELPFUL FINDINGS

The New York State Department of Education through the Board of Regents “licenses individuals in more than 50 professions defined in Education Law, and is responsible for the final disposition of all disciplinary matters.” The Board of Regents provides a database where it documents all the disciplinary actions it has taken against licensees from 1994 to date. Some sanctions related to controlled substances in 2009 include:

  • Fidelis Tony Ibeh was a pharmacist in Brooklyn, New York whose license was revoked for "failing to properly supervise a pharmacy; violating pharmacy rules and regulations governing the practice of pharmacy; failing to account for controlled substances purchased by the pharmacy, and dispensing controlled substances pursuant to forged prescriptions."
  • The license of Rite Quality Pharmacy, Inc. was also revoked for the same charges the above licensee was found guilty of.

According to the NYS Board of Health's Hearing and Notices, "the Health Department issues many types of licenses and permits under the NYC Health Code." If the New York State Department of Health issues a 'summons' to a registrant or licensee, it/he/she has the freedom and opportunity to contest the charges of violation(s) at the OATH Hearings Division.

According to the Diversion Control Division of the US DEA under the US Department of Justice, it revoked the DEA certificate of Hoi Y. Kam, M.D., of Fresh Meadows, New York in 2012. The DEA Certificate of Registration "authorizes a registrant to dispense controlled substances as a practitioner." He was also barred from renewing or modifying his registration. The registrant "materially falsified a renewal application, and committed acts which render his registration inconsistent with the public interest."

According to the database of the National Association of State Controlled Substance Authorities, the New York State's state-controlled substance authority, the Bureau of Narcotic Enforcement, issues State Controlled Substance Registration to the following:
  • Manufacturers and distributors in New York and out-of-state
  • Institutional dispensers (with a pharmacy)
  • Institutional dispensers-limited (without pharmacy)
  • Researchers
  • Instructional Activities
  • Analytical Laboratory
  • Importer (and broker)
  • Exporter (and broker)
  • Pharmacy-Limited to the operation of automated dispensing systems
  • Registration of licensed practitioners in the Official Prescription Program
  • Miscellaneous certifications including but not limited to certificate of need (needles) and animal euthanasia activities.
Sources
Sources

Quotes
  • "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. "
  • "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 narcotic@health.state.ny.us. 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."
Quotes
  • "The Bureau of Narcotic Enforcement (BNE) is responsible for protecting the public health by combating the illegal use and trafficking of prescription controlled substances. The Bureau provides millions of secure Official New York State Prescriptions annually to over 95,000 prescribing practitioners across the State. BNE monitors and regulates controlled substances through its issuance of licenses to manufacturers, distributors, hospitals, nursing homes, and researchers. BNE Narcotic Investigators investigate suspected drug diversion or illegal sales involving theft, forgery, and fraudulent visits to practitioners' offices, and work closely with local, state and federal law enforcement. The Bureau also prevents prescription drug abuse through educational materials and presentations for parents, educators, and healthcare professionals."