All licenses are issued for two years from the date of issue and must be renewed by the license holder. The Bureau of Controlled Substances of New York State issues two classes of research licenses: Class 4 or Class 7.

Class 4 Research License

Research that involves Controlled Substances in Schedules II-V, may only be conducted after a Class 4 research license is obtained. 

• NYSDOH Form 4430 - License to Engage in a Controlled Substance Activity
• NYSDOH Form 4430 Appendix A1 Class 4 Individual Researcher Protocol

Class 7 Research and Instructional License

Research involving Controlled Substances in Schedule I may only be conducted after obtaining a Class 7 research license and filing with the NYSDOH three copies of a research protocol describing the research project. At no time may any individual at Rensselaer possess any Schedule I substance without prior authorization of the Department Chair and EHS review and approval of the license application.

• NYSDOH Form 4430 - License to Engage in a Controlled Substance Activity
• NYSDOH Form 4430 Appendix A1 Class 7 Individual Researcher Protocol

Renewal of Registration

The NYSDOH license is only valid for a specified amount of time. Before expiration the licensee must renew their license using NYSDOH Form 4430 every two years.

• NYSDOH Form 4430 - License to Engage in a Controlled Substance Activity

A researcher cannot apply for a DEA registration until the NYS license is received. All Certificates of Registration are issued for one year from the date of issue and must be renewed by the license holder. A Certificate of Registration is required by the DEA to conduct research with controlled substances in drug Schedules I or Schedules II-V. If a researcher wished to conduct research in drug Schedules I and Schedules II-V, they must obtain two separate registrations.

At no time may any individual at Rensselaer possess any Schedule I substance without prior authorization of the Department Chair and EHS review and approval of the Registration application.

• DEA Form 225
• DEA Form 223 (DEA Certificate of Registration issued with approved registration) must be maintained at the registered location in a readily retrievable manner and kept available for official inspection.
• DEA Researcher's Manual

Renewal of Registration

The DEA license is only valid for a specified amount of time. Before expiration the licensee must renew their license using DEA Form 225a every year.

• DEA Form 225a

Principal Investigators are responsible for development and implementation of training for authorized users in the following: 

• The nature of Controlled Substance hazards including local and systemic toxicity. 
• The specific research procedures that could result in exposure.  
• Procedures for properly using, disposal, and securing Controlled Substances, proper use and maintenance of usage log, and incident procedures for lost and/or missing drugs and Inventory.  
• The purpose and application of emergency practices and procedures.  
• Conditions and situations that could result in personal exposure.
   

License holders should take responsibility for all ordering of Schedule I-V Controlled Substances. The following information needs to be provided to a vendor when ordering controlled substances.  

• Basic purchase information
• Proof of legitimate research use
• Storage location
• DEA and NYSDOH registration numbers

The stocks of Controlled Substances should be kept to the smallest quantity needed for efficient operation to conduct the indicated research.

For research performed at the RPI Bioresearch Core (BRC), the license holder must work with the Director of the BRC to ensure NYSDOH and DEA licenses are obtained and recertified and that orders are placed through a certified vendor.

Schedule I & II Controlled Substances

For Schedule I & II Controlled Substances, an official DEA Order Form (Form 222) will have to be prepared.

• DEA Form 222

Any registrant permitted to order schedule I and II controlled substances may do so electronically via the DEA Controlled Substance Ordering System (CSOS) and maintain the records of these orders electronically for two years. CSOS allows for secure electronic transmission of controlled substance orders without the supporting paper DEA Form 222. A record of DEA Form 222 should be kept for a minimum of 2 years.

1. An individual enrolls with DEA and once approved, is issued a personal CSOS Certificate.
2. The purchaser creates an electronic 222 order using approved ordering software. The order is digitally signed using the purchaser's personal CSOS Certificate and then transmitted to the suppliers. Paper 222 is not required for electronic ordering.
3. The supplier receives the purchase order and verifies that the purchaser's certificate is valid with DEA. Additionally, the supplier validates the electronic order information just like it would a paper order.
4. The supplier completes the order and ships it to the purchaser. Any communication regarding the order are sent electronically.
5. The order is reported by the supplier to DEA within two business days.

Schedule II, IV, & V Controlled Substances

The researcher must keep a receipt (invoice or packing slip) on which it records the date the controlled substances were received and confirm that the order is accurate.  The receipts must also contain the following information: 

• The name of the substance
• Each finished form and the number of units or volume of finished form in each commercial container
• The number of units of finished forms and/or commercial containers acquired from other people
• The number of commercial containers distributed to other people
• The number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant

In addition, these receipts must be maintained either separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant.

Controlled Substances shall at all times be properly safeguarded and securely kept at the address of the licensed department. Access to Controlled Substance stocks shall be limited to the minimum number of employees actually required to efficiently handle the custody, dispensing, or administration. The license holder is responsible for the proper safeguarding and handling of controlled substances.

An Authorized User Log must be utilized to record the identities of the staff members approved to access the locked drug storage areas.

NYSDOH sets specific requirements for storage which can be found on NYSDOH Form 4330. 

Thefts, suspect thefts or unauthorized uses of any Controlled Substance must be reported within 24 hours to the license holder, the Department of Public Safety (DPS), and EHS upon discovery. 

• DPS can be reached by calling the 24-hour non-emergency line, (518)-276-6656

Other losses, including spills or breakages, must be reported immediately to the license holder. The license holder has an obligation to report promptly the loss to the state or federal authorities. Federal regulations require that registrants notify the DEA Field Division Office in their area, in writing, of the theft or significant loss of any controlled substance within one business day of discovery of such loss or theft. A report must still be filed if lost or stolen material is recovered.

The following forms will be used for State and Federal reporting:

• NYSDOH Form 2094
• DEA Form 106

All records generated in connection with the Controlled Substances program should be maintained by the license holder for at least two years following termination of any license.  Following this two-year period documents should be disposed of in a secure manner such as shredding.

The controlled substance records researchers must maintain are: 

• Executed official order forms (DEA Form 222) or the electronic equivalent.
• Unexecuted official order forms (DEA Form 222). 
• Power of Attorney authorization to sign order forms, if applicable. 
• Receipts and/or invoices for schedules III, IV, and V controlled substances.  
• Records of controlled substances distributed (i.e., sales to other registrants, returns to vendors, distributions to reverse distributors). 
• Records of dispensing (dispensing log). 
• All inventory records of controlled substances, including the initial inventories and biennial inventories, dated as of beginning or close of business. 
• Reports of Theft or Significant Loss (DEA Form 106), if applicable.  
• Inventory of Drugs Surrendered for Disposal (DEA Form 41), if applicable.
   

Disposal must be performed in accordance with New York State Department of Health protocol. Controlled Substances may not be disposed of in the trash, Regulated Medical Waste containers or Satellite Accumulation Areas. Controlled Substance that are expired or no longer needed, must be removed by a NYS Approved Reverse Distributor.  

EHS will make the proper notifications and file and maintain the appropriate paperwork related to the disposal of Controlled Substances. Copies of this paperwork will be furnished to approved individuals upon request.  At the time of collection, the Principal Investigator must provide the Reverse Distributor with the following information: 

• Name and address and phone number of Department License Holder
• NYS License number
• DEA Registration number
• Trade or generic name of each drug
• Strength as a percentage of each drug
• Quantity of each drug
• Reason for the surrender
• Source of the drug(s)

Due to Federal and State regulations, EHS may not take possession or transport Controlled Substances and removal for disposal may only take place at the point of waste generation. The license holder bears all responsibility for the Controlled Substance until the ultimate destruction of the Controlled Substance has taken place.