Application Instructions for Non-Practitioner CSR

Application for Controlled Substances Registration for Non-Practitioners

è All applications for CSRs must be signed by the responsible party or practitioner who assumes legal responsibility for the controlled substances except for surgery center applications, which must be signed by the medical director.

è Application fee must be made payable to "Professional Licensing Agency" (certain facilities are exempt from registration and renewal fees, please see below for additional information.)

è Applicants for change of ownership or relocation are required to submit all required documents as listed out below.  In addition, these applicants are required to submit a statement indicating their current CSR number as well as their current location; the application will be completed indicating the new location or new ownership information.

è Application, fee, and documentation can be mailed to the following address:

Professional Licensing Agency
402 W Washington Street, Room W072
Indianapolis, IN  46204

Upon receipt of a completed new CSR or relocation application, fee (if applicable) and all requested documentation as indicated below, the Board office will contact the individual listed on the application to schedule an inspection.  Those applications received for a change of ownership will be reviewed by the Board at their next regularly scheduled meeting. If the application is approved, a new CSR number will be issues to the new owner.

Controlled substance registrations are site specific; you cannot have controlled substances at the new site until you have a CSR approved for the new location.
 

Please review 856 IAC 2-3-30 (b) for a complete listing of security required by the Committee.

Hospitals/Clinics, Wholesale Distributors, and Analytical Labs must submit:

• Completed CSR application and $100 fee;
• A list of procedures to be performed;
• Types and quantities of controlled substances to be stored on site organized by schedule number;
• Specific protocols for monitoring drug usage, inventory control, destruction, security, storage, and access.

Surgery Center applicants must submit:

• Completed CSR application and $100 fee;
• A list of procedures to be performed;
• Types and quantities of controlled substances to be stored on site organized by schedule number; 
• Specific protocols for drug monitoring drug usage, inventory control, destruction, security, storage, and access;
• Names, credentials, past training, and copies of current DEA registrations of all medical staff;
• A copy of the agreement for pharmacy services, if applicable;
• Application is required to be signed by the Medical Director.

Researchers and Teaching Institutions must submit:

• Completed CSR application and $100 fee;
• A list of procedures to be performed;
• Types and quantities of drugs to be stored on site (formulary) organized by Schedule number;
• Specific protocols for monitoring drug usage, inventory control, destruction, security, storage, and access;
• A one page summary of research objectives, research protocol, and curriculum vitae.

Manufacturers must submit:

• Completed CSR application and $100 fee;
• A list of procedures to be performed;
• Types and quantities of drugs to be stored on site (formulary) organized by Schedule number;
• Specific protocols for monitoring drug usage, inventory control, destruction, security, storage, and access;
• must describe their products and manufacturing procedures.

Non-practitioner owner CSR applicants must submit:

• Completed CSR application and $100 fee;
• A list of procedures to be performed;
• Types and quantities of controlled substances to be stored on site organized by schedule number;
• Specific protocols for monitoring drug usage, inventory control, destruction, security, storage, and access;
• Names, credentials, past training, and copies of all practitioners employed or contracted to dispense controlled substances
• A copy of the contract or employment agreement between he non-practitioner owner and the dispenser
• Documentation describing the ownership of the facility
• Policies and procedures that ensure controlled substances are dispensed in a manner that complies with las, rules, and regulations

Humane Societies or Animal Control Facilities must provide the following information:

(If you are only requesting sodium pentobarbital, ketamine and ketamine products, and/or a combination product containing tiletimine and zolazepam, please see the section entitled "Limited Permits" below)

• Completed CSR application and $100 fee;
• A list of procedures to be performed;
• Types and quantities of controlled substances to be stored on site organized by schedule number;
• Specific protocols for monitoring drug usage, inventory control, destruction, security, storage, and access;
• Must provide written documentation of the training of the personnel administering the controlled substances (copies of training certificates will be sufficient);
• The name and license number of the veterinarian associated with the facility (a written statement from the DVM acknowledging the association and a copy of licenses will be sufficient).

K9 Training:

• Types and quantities of controlled substances to be stored on site organized by schedule number

• Specific protocols for monitoring drug usage, inventory control, destruction, security, storage, and access

Limited Permits:

Any humane society, animal control agency, or governmental entity operating an animal shelter or other animal impounding facility may apply to receive a limited permit only for the purpose of buying, possessing, and using:

1. sodium pentobarbital to euthanize injured, sick, homeless, or unwanted domestic pets and animals;
2. ketamine and ketamine products to anesthetize or immobilize fractious domestic pets and animals; and
3. a combination product containing tiletimine and zolazepam as an agent for the remote chemical capture of domestic pets or animals that otherwise cannot be restrained or captured.

The applicant shall submit the completed CSR application, $50 application fee, and provide the following information:

• Completed CSR application and $50 fee;
• Type of facility;
• Documentation describing the ownership of the facility;
• Specific protocols for monitoring drug usage, inventory control, destruction, security, storage, and access;
• Written policies relating to storage, security, and procedures for access, handling, and administration of drugs;
• Proof that the employees of the applicant who will handle a controlled substance are sufficiently trained to use and administer the controlled substance (copies of training certificates will be sufficient);
• Proof that a licensed Indiana veterinarian holding a valid Indiana controlled substances registration and federal DEA registration has been retained to provide technical advice to the facility (a written statement from the DVM acknowledging the association and a copy of licenses will be sufficient).

Additional Information Pertaining to CSRs:

Registration and renewal fees are waived for the following applicants:

1. any official or agency of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Veterans' Administration or Public Health Service who or which is authorized to procure or purchase controlled substances for official use; and
2. any official, employee, or other civil officer of the United States, or any State, or any political subdivision or agency thereof, who or which is authorized to purchase controlled substances, to obtain such substances from official stocks, to dispense or administer such substances, to conduct research, instructional activities, or chemical analysis with such substances in the course of his or its official duties or employment.

In order to claim exemption from payment, the applicant or registrant must put the request in writing and state why they believe they are exempt.  Exemption from payment does not relieve the applicant or registrant of any other requirements or duties prescribed by law.

Drug Enforcement Administration:

DEA registrations may be updated via their website at http://www.deadiversion.usdoj.gov/drugreg/index.html#regapps.

If you have questions regarding your controlled substance registration application, you may e-mail pla4@pla.IN.gov for additional information.