Scope

The Controlled Substances Program applies to any Indiana University personnel who utilize controlled substances while conducting research.

Monitoring and inspections

The security and recordkeeping requirements of the controlled substances will be visually inspected annually. The inspections are informational only and intended to assist the registrant with compliance of the regulations.  Management of controlled substances, Inventory and dispensing records are the responsibility of the registrant.

Note: Failure to maintain accurate and complete inventory and dispensing records is a violation of federal law by the registrant (see Appendix C).

To ensure that annual monitoring and inspections are performed, new or existing researchers who utilize controlled substances must notify IUEHS for the respective campus of the information identified in section 2.2.4 of this document.  

Registration

Individuals must first notify IUEHS for your respective campus of their intentions for using a controlled substance by providing IUEHS with the PI name, e-mail address, phone number, school/department, room number of research, and the room number of intended storage.  After notifiying IUEHS for the respective campus, individuals may then register with the State of Indiana for the use of controlled substances. 

The purpose of this information is to ensure that all users and locations of controlled substances in research are known and that the proper procedures are in place to provide compliance with the regulatory requirements and safe authorized use of these materials.

Note: This does not include the use of prescription drugs in research unless that prescription drug is a controlled substance (See Schedules I-V, Section 3.4, and Controlled Substance Schedule).

In most instances research scientists are considered “non-practitioners” and must complete the applications for Non-Practitioners. The following instructions and forms can be used to register.

Indiana State Board of Pharmacy registration

To begin the registration process, instructions for Indiana Controlled Substances Registration (CSR) are found at the Indiana Professional Licensing Agency. 

Note: Do not move your inventory without notifying the State Board of Pharmacy and DEA. To move or relocate your inventory to a different location (or room), change the ownership, or change your name, you must notify the State Board of Pharmacy (first) using the same application form above. Then you must notify the federal DEA once you have received an approved state license. 

DEA registration

Instructions for the Drug Enforcement Agency (DEA) Office of Diversion Control registration can be found at the Office of Diversion Control (Follow the link and select New Applications or Renewal Applications as necessary.)

New applications may be submitted electronically or on paper forms. Renewals may only be completed electronically.

• • Research scientists use DEA Form 225 for Non-Practitioners.

  • Physicians and veterinarians use DEA Form 224 for Practitioners.

Electronic forms and downloadable paper forms are found at the following link. Forms are occasionally updated. Check for the most recent version at the Office of Diversion Control.

Note: To report inventory location changes, name or address changes, or drug code and schedule changes follow the Registration Changes link at the website above after receiving an approved statelicense for the change.

Registration guidelines:

• Obtain your Indiana Controlled Substance Registration (CSR) first. The CSR will be needed to complete the DEA application and if filing electronically, the DEA will not let you advance without filling in the CSR. Make sure you remind the Indiana State Board of Pharmacy inspector to include your name on the CSR. This inspector will make a site visit to your lab prior to issuing the state CSR.

 Note: The state does not inform the DEA Office when you are registered. There is no need to attach a copy of your state CSR with the DEA registration form. This must be available and provided to the Diversion Investigator assigned to the pre-registration investigation.

• Complete the DEA Form 225 application after you have received the state CSR. When completing the DEA registration form, make sure the name and address are identical to those on the state CSR.

• Researchers using Schedule 1 substances need to list the drug code numbers for the DEA application. Make sure you have the proper controlled substance Schedule listed for the drug(s) you will be using. Also make sure you have listed the proper drug codes. They must coincide with the schedules requested.

CAUTION: The narcotic/non-narcotic designations in Indiana are the reverse of the federal Schedules! The designation “N” refers to a narcotic in Indiana, whereas the designation “N” refers to a non-narcotic according to the DEA.  The drug Schedule registration you apply for on the federal application must correspond to the drug schedule you are registered for in Indiana (e.g. if your Indiana registration shows you are registered for Schedule 2N you would request a Schedule 2 registration on the federal application as shown below).

Indiana 2N = DEA 2

Indiana 2   = DEA 2N

Indiana 3N = DEA 3

Indiana 3   = DEA 3N

• Schedule 1 Controlled Substances registrations require specific application instructions: Contact IUEHS for your respective campus (Section 3.8) for assistance.

• Complete the "Fee Exemption" section (Section 6) on the paper DEA 225 form (Section 1 of the electronic application). Exemption from payment of application fee is limited to federal, state or local government operated hospitals, institutions and officials.

Enter the word “Exempt” into the appropriate space on the form to indicate the fee exempt status. IUEHS for your respective campus (Section 3.8) can also certify the tax/fee exempt status. If so, the signature, authority title, and telephone number of the certifying official (other than the applicant) must be provided. Please call the IUEHS contact for your respective campus for information.

• If not completing an on-line form, the registrant must send the DEA application form to:

Note: If an application must be reviewed by DEA headquarters (such as an application for use of a Schedule 1 controlled substance) the review might add up to 6 weeks to the approval time frame. Every package sent to the DEA, especially bulky application packets, is subjected to a hazard analysis scan process. Send only the printed application; do not include other required information (see item 9. below) at this time.

• Once your application request has been entered into the DEA database, an agent from the Indianapolis Regional DEA Office will contact you to request that you mail or fax to them the additional required documentation that will include:

  • Controlled Substance Authorized User Signature List listing all staff that will have access to controlled substances.

  • Copy of your research protocol and/or a completed DEA research protocol information sheet.

  • Curriculum vitae.

  • Narrative covering how you will secure the controlled substances and how you will conduct and maintain dispensing records and inventories.

• Send all forms and documentation by registered mail. Keep a copy for your records.
• Upon receipt of the DEA registration, the investigator must report the registration to IUEHS.

Registration renewal

Federal DEA renewal applications are mailed to the registered location 60 days prior to the expiration. On-line renewal information and applications are found at the Office of Diversion Control. Click on “Renewal Applications” and you will be directed to the proper DEA Registration Renewal Form Login. You will need the following information as it appears on your original registration:

• DEA registration number

• Last name or business name and first name

• Social security number and/or tax identification number

• Registration expiration date

• State and zip code

Note: Information from your original application will be filled in for you including the tax/fee exempt status of the University. Enter your name as the certifying applicant/official upon completion of the application.

Recordkeeping

All records must be maintained for at least two years from the date of such inventory or records for inspection and copying by authorized employees of the DEA. Retaining records for five years is advisable due to the statute of limitations. These records must be in conformance with the recordkeeping and inventory requirements of federal law. This includes all purchasing records, all administering and dispensing records, all Schedules I and II Order Forms (DEA Form 222), and all physical inventories.

Schedules I and II must be maintained separately from all other records of the registrant, and Schedule III, IV, and V 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. The phrase "readily retrievable" means they can be separated out from other records in a reasonable time.

Note: Records must be made available within five (5) working days after a request by the Indiana Board of Pharmacy for such records or information on controlled substances transactions.

Purchasing records

Purchasing records can be:

• A copy of the invoice;
• A copy of the shipping document; or
• A copy of the packing slip.

Note: These are acceptable records for Schedules III, IV, and V controlled substances but DEA Form 222 is the only approved receipt record for Schedule I and II controlled substances.

Purchasing records must contain:

• The name, address, and DEA number of the company from which the controlled substance was purchased;
• The name of the controlled substance purchased;
• The size and strength of the controlled substance purchased; and
• The amount purchased (which must match the amount received).

The purchasing record (invoice, shipping document, or packing slip) must be annotated with the handwritten date of receipt.

Dispensing records

Dispensing records must contain:

The name and address of person (research subject) or identification numbers of animal subjects (or groups of animals) to whom it was dispensed;
The date dispensed;
The initials of person dispensing on behalf of registrant;
The name of the controlled substance;
The strength and size of the controlled substance; and
The amount dispensed (number of units or volume).
An example dispensing record form is found in Appendix B.

Title 21 of the Code of Federal Regulations, Section 1304.22 (c) Records for dispensers and researchers, states that:

“Each person registered or authorized to dispense or conduct research with controlled substances shall maintain records with the same information required of manufacturers pursuant to paragraph (a)(2)(i), (ii), (iv), (vii), and (ix) of this section. In addition, records shall be maintained of the number of units or volume of such finished form dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the dispenser.”

Researchers using animal subjects, and not humans, must use the animal species and identification (ID) instead of the requirement for recording the name and address of the person receiving the controlled substance.

Inventory records

Controlled substance inventory is one of the most important aspects of the DEA program. The dispensing records and the inventory records can be the same and is acceptable to the State Pharmacy Board. An initial inventory is required a) when first registered with the DEA or b) when the registrant first engages in research activity. A biennial inventory (at least every two years) is required thereafter and can be performed whenever necessary as long as it is within the two year increment.

This can be a “perpetual” inventory with the starting amount and a running log of what is dispensed and when (see above under "Dispensing records"). Inventory and dispensing record maintenance is the key to the loss detection, theft, and the diversion of controlled substances. Complete inventory requirements can be found at the DEA website.

Theft of or Missing Controlled Substances Reporting

The DEA registration holder must have complete accountability of all controlled substances stored or used in their area. This makes keeping good records essential so that any shortages or missing controlled substances will not go unnoticed. Theft or misuse of a controlled substance is a criminal act that must be reported to the following agencies:

• Indiana State Board of Pharmacy: (317) 234-2067
• Nearest DEA office within one (1) day of discovery:

• Indiana University Police Department
• Indiana University Environmental Health and Safety for your respective campus.

In addition to the immediate phone reporting, a Report of Theft or Loss of Controlled Substances (DEA Form 106) must be completed and submitted to the Indiana DEA office to report any theft or a significant loss.

Reporting is also necessary if small quantities of controlled substances become unaccounted for on a re-occurring basis and must be investigated which may lead to reporting on a DEA Form 106. Keep copies of DEA Form 106 in your inventory records.

Other Pertinent Record Information

Maintain current, complete and accurate records to reflect substances:

• Received (Purchased);
• Sold (Administered & Dispensed);
• Delivered to another registrant;
• Otherwise disposed; and
• Theft or loss.

Separate records are required for each location.

Separate records are required for each independent activity for which he/she is registered.
When recording dates of receipt, importation, distribution, exportation, or other transfers, the date on which the controlled substances are actually received, imported, distributed, exported, or otherwise transferred must be used as the date of receipt or distribution on any documents of transfer (e.g. invoices or packing slips).

DEA Ordering Forms

To order a controlled substance you must first have a DEA registration.  The Schedule I and II Controlled Substance Order Form (DEA Form 222) is a paper-based form that comes in triplicate and is used to order controlled substances.  It is requisitioned directly from the DEA and is required to be filled out in triplicate.  The DEA Form 222 also allows the exchange of controlled substances from the registrant to another party registered with the DEA (typically used when a controlled substance is sent to a reverse distributor for credit or disposal).

Schedule I or II registrants can request official DEA Form 222 on-line 

You will receive the maximum number of order form books allowed for your business activity.

Schedule III, IV, and V drug orders do not require a DEA Form 222.  These drugs can be ordered directly from the manufacturer.  However, you may be asked to provide a copy of your DEA Registration before your order will be prepared and shipped.

Note: If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice) or is suspended or revoked as to all controlled substances (Schedules I through V) for which he/she is registered, they must return all unused substances and their order forms to the Indiana Board of Pharmacy or their authorized agent (such as Indiana University Police Department) or place all substances under seal. The IUEHS contact for your respective campus can facilitate this.

Spills

Breakage, spills, or other witnessed controlled substance losses do not need to be reported as lost to the DEA, however, this type of loss must be documented by the registrant and witnessed on the inventory record. Controlled substances that can be recovered after a spill, but cannot be used because of contamination (tablets), must be placed in the disposal/destruction waste stream. If the spilled controlled substance is not recoverable (liquids); the registrant must document the circumstances in their inventory records and the witnesses must sign.