LSB 2024-01: Class 3/3a License
Date Issued: January 4, 2024
RECIPIENTS
● OASAS-Certified Addiction Treatment Programs
● Local Governmental Units (LGUs)
PURPOSE
This Local Services Bulletin clarifies which OASAS-licensed, certified or otherwise authorized addiction treatment providers must obtain a license, consistent with Article 33 of the Public Health Law (PHL) and Title 10 of the New York Code of Rules and Regulations (NYCRR) Part 80 (Rules and Regulations on Controlled Substances in New York State) in order to take possession of an individual’s prescription for a controlled substance (including "take home" medication for patients who are enrolled in an outside Opioid Treatment Program) for the purpose of safeguarding and administration of the medication.
Relevant licenses required by the above include the Class 3 Institutional Dispenser License or Class 3a Institutional Dispenser Limited License issued by the New York State Department of Health (NYSDOH).
BACKGROUND
Only certain OASAS programs (delineated in the chart below) must apply for the above licenses in order to take possession and administer controlled substances for patients of their programs. However, all OASAS licensed, certified or otherwise authorized providers have a responsibility to ensure that medications used by their patents are safely stored, that only the intended patient receives the medication, and that the administration or self-administration of medication is properly documented.
Individuals being admitted into addiction treatment programs may have a variety of prescription and non-prescription medication. For example, a patient who is engaged in opioid maintenance therapy. The storage, possession, dispensing and disposal of medication presents legal issues, as well as safety concerns for addiction treatment providers due to potential diversion and misuse of medication. However, no patient can be denied admission to an addiction treatment program solely on the basis that they are utilizing prescribed medication for addiction treatment. In fact, in many circumstances the use of such medication assists in the health and recovery of the individual.
To minimize the potential legal and safety issues, it is recommended that each addiction treatment provider develop specific policies and procedures which address, at a minimum, the following: medication storage, staff and patient training for management and accountability, provider responsibilities, patient responsibilities, and disposal in the event that medications are leftover when a patient separates from the program.
OASAS SERVICE TYPE & LICENSE ELIGIBILITY
OASAS Service Type | License Eligibility |
Section 816.6 – Medically Managed – Article 28 Hospitals | Class 3 |
Section 816.7 – Medically Supervised Inpatient – Article 28/32 | Class 3 for Article 28 Class 3A eligible for Article 32 |
Section 816.8 – Medically Supervised Outpatient – Article 28/32 | Not eligible for Class 3/3A |
Section 816.9 – Medically Monitored – Article 28/32 | Not eligible for Class 3/3A |
Section 817 – Substance Use Disorder Residential Rehabilitation Services for Youth (RRSY) – Article 32 Only | Class 3A eligible |
Section 818 – Substance Use Disorder Inpatient Rehabilitation Services – Article 28/32 or 32 Only | Class 3A eligible for Article 32 only |
Section 819 – Intensive Residential – Article 32 Only | Not eligible for Class 3/3A |
Section 819 – Community Residential – Article 32 Only | Not eligible for Class 3/3A |
Section 819 – Supportive Living – Article 32 Only | Not eligible for Class 3/3A |
Section 820 – Stabilization – Article 32 Only | Class 3A eligible |
Section 820 – Rehabilitation – Article 32 Only | Class 3A eligible |
Section 820 – Reintegration – Article 32 Only | Not eligible for Class 3/3A |
Section 822 – Outpatient Clinic – Article 28/32 or 32 Only | Not eligible for Class 3/3A |
Section 822 – Outpatient Rehabilitation – Article 28/32 or Article 32 Only | Not eligible for Class 3/3A |
Section 822 – Opioid Treatment Programs (OTP) – Article 28/32 or Article 32 Only | Not eligible for Class 3/3A |
CLASS 3 INSTITUTIONAL DISPENSER LICENSE
According to PHL § 3341 and 10 NYCRR Part 80.46, specific facilities including hospitals and mental hospitals that function as institutional dispensers of controlled substances, meaning they dispense them from an on-site registered pharmacy, are obligated to obtain a Class 3 Institutional Dispenser license from the Department of Health. Additionally, Class 3 license holders must also register with the Federal Drug Enforcement Administration (DEA). Class 3 facilities may purchase stocks of controlled substances from a licensed manufacturer or distributor for inpatient and outpatient use through an appropriately registered pharmacy. Controlled substances are distributed within the facility from the registered pharmacy. Administration of all controlled substances within a Class 3 facility is authorized only by a written order of an authorized practitioner. As such, the Class 3 license is not applicable to the dispensing of controlled substances, including for opioid treatment, unless the facility has an on-site registered pharmacy licensed in New York.
CLASS 3A INSTITUTIONAL DISPENSER LIMITED LICENSE
10 NYCRR Part 80.47 allows certain facilities that do not qualifying as institutional dispensers to apply for a Class 3A Institutional Dispenser Limited license. A facility with a 3A Institutional Dispenser Limited license does not have an onsite pharmacy and usually contracts with an outside pharmacy. Such license is required before a facility may take temporary custody of an individual’s prescribed controlled substances and assist them with administration of a controlled substance. Medications that are prescribed and dispensed to a patient are owned by that patient. Thus, once an individual is discharged, all medications prescribed to the person that are in temporary custody of the Class 3A licensee, must be turned over to them at the time of discharge.
CLASS 3A REQUIREMENTS
● Class 3A licensees may administer controlled substances to patients only pursuant to a prescription issued by an authorized physician or other authorized practitioner and filled by a registered pharmacy (except in the case of emergency medication kits). [10 NYCRR Part 80.47]
● Class 3A licensees are required to keep a daily running record of all prescribed controlled substances received. A separate record shall be maintained of the administration of prescribed controlled substances and these records must be maintained for at least 5 years. [10 NYCRR Parts 80.49 and 80.112]
● Working stocks of controlled substances must be kept in a stationary, locked, double cabinet. Both cabinets must have key-locked doors with separate keys, spring locks or combination locks are not acceptable. Cabinets must be made of steel or other approved metal. [10 NYCRR Part 80.50]
● The New York State Department of Health’s Bureau of Narcotic Enforcement (BNE) must approve the manner and detail of the disposal/destruction of controlled substances. In disposing of/destroying controlled substances, they must be rendered totally unrecoverable and beyond reclamation. Class 3A licensees must submit a Request for Approval of Disposal/Destruction of Controlled Substances (DOH-2340) and a Controlled Substance Inventory Form (DOH-166) to the BNE before disposing of/destroying controlled substances. The request must include the names of two individuals who will conduct the disposal/destruction. At least one of these individuals must be a NYS licensed practitioner, nurse, pharmacist or other person authorized by the BNE. [10 NYCRR Part 80.51]
● Class 3A licensees are under a continuing duty to promptly notify the BNE of any theft, loss or possible diversion of controlled substances using a Loss of Controlled Substances Report (DOH-2094). [PHL § 3374 and 10 NYCRR Part 80.20]
● Opioid Treatment Program (OTP) controlled substances must be kept totally separate from a class 3 or a 3A licensee’s activities. OTPs would not full under BNE licensure, only DEA registration.
● All new applicants are subject to an on-site facility inspection by the BNE. The application must include a copy of the current OASAS Operating Certificate.
To obtain a Class 3A license, a License Application to Engage in a Controlled Substance Activity (DOH-4330) must be submitted to the BNE. See DOH guidelines and application for details on the fees and registration periods.
To obtain a Class 3A license, a License Application to Engage in a Controlled Substance Activity (DOH-4330) must be submitted to the BNE. See DOH guidelines and application for details on the fees and registration periods.
ENTITIES NOT ELIGIBLE FOR A CLASS 3A LICENSE
As indicated above, there are multiple OASAS certified programs, including Part 819, Part 820 reintegration, and Part 822 programs that are not eligible to obtain a Class 3A license.
OASAS certified Part 819 and 820 reintegration programs must be mindful that patient medications are the property of the patient. These programs must have policies for the safe storage of patient medication, which include, but are not limited to:
• Storage in a centralized, secure location in patient-specific containers. Medication must be stored consistently with state and federal requirements, which may include double-locked storage facilities within the program (i.e., in a locker or lockbox located within a locked room).
• Clearly defined provider and patient responsibilities;
• Staff and patient training for management and accountability;
• Establishing and implementing a policy for tracking the self-administration of medications by patients.
Providers should review LSB 2022-01 Policies for Self-Administration of Medication in OASAS Programs at Policies for Self-Administration of Medication in OASAS Programs | Office of Addiction Services and Supports (ny.gov).
In addition, Part 819 and 820 reintegration programs must have policies and procedures for the safe pharmaceutical disposal of any medication that is discontinued or abandoned when a patient separates from treatment. This disposal must be consistent with state and federal law. Providers should evaluate the use of available options for environmentally sound disposal methods that comply with such laws.
Part 822 outpatient clinic providers can prescribe patient specific medications or have a stock of medication to be administered to a patient pursuant to a valid order issued by the DEA registered practitioner within the 822 program. The safe ordering, storage, and administration of controlled substance and disposal is all conducted under the license of the ordering practitioner.
CONTACT
For clinical questions or clarification of the issues detailed in this bulletin, please contact [email protected]. Legal questions regarding this bulletin should be directed to the OASAS Counsel’s Office ([email protected]). OASAS cannot provide legal advice to agencies. Please contact your agency counsel for questions requiring legal advice.