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 the University by providing the information on the Drug Enforcement Administration (DEA) Registration Survey.

Registration

Individuals must first notify IUEHS for your respective campus of their intentions and then register with the State of Indiana for the use of controlled substances by completing the form found at DEA License Survey Form. 

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. Complete the Drug Enforcement Administration (DEA) Registration Survey.

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.

Schedules

Controlled substances are designated as Schedule I - V (C-I, C-II, C-III, C-IV and C-V) according to their medical use, potential for abuse, and safety or dependence liability. Each controlled substance, or basic class thereof, has been assigned an "Administration Controlled Substances Code Number."

Specific controlled substances, regulated chemicals, and scheduling actions are listed alphabetically and by code number at the Office of Diversion Control.

The Certificate of Registration (DEA form 223) will contain the name, address, and registration number of the registrant, the activity authorized by the registration, the schedules and/or administration controlled substances code number of the controlled substances which the registrant is authorized to handle, the amount of fee paid (or exemption), and the expiration date of the registration.

The code number may not appear on any DEA forms. Typically, the approved drug schedules will be on the certificate of registration and DEA 222 order form with the exception of GHB, carfentanil, etorphine hydrochloride, and diprenorphine which require additional record keeping and handling requirements.

• The Certificate of Registration will be issued by the Administration pursuant to: 21 CFR 1301.35

• DEA 222 forms may be filled in accordance with special procedures pursuant to: 21 CFR 1305.05

• And maintained separately pursuant to: 21 CFR 1305.17

Schedule I controlled substances

The Indiana State Board of Pharmacy must recommend placement of a substance in Schedule I if it finds that:

1. The substance has high potential for abuse; and

2. The substance has no accepted medical use in treatment in the United States or lacks accepted safety for use in treatment under medical supervision.

Examples of Schedule I substances include heroin, lysergic acid diethylamide (LSD), marijuana, and methaqualone.

The board may recommend placement of a substance in Schedule I under this chapter if it finds that the substance is classified as a controlled substance in Schedule I under federal law.

• DEA Schedule I Controlled Substances can be found in: 21 CFR 1308.11

• Indiana Schedule I Controlled Substances can be found in: IC 35-48-2-4 (Version b)

Schedule II controlled substances

The Indiana State Board of Pharmacy must recommend placement of a substance in Schedule II if it finds that:

1. The substance has high potential for abuse;
2. The substance has currently accepted medical use in treatment in the United States, or currently accepted medical use with severe restrictions; and
3. The abuse of the substance may lead to severe psychological or physical dependence.

Examples of Schedule II substances include pentobarbital, morphine, phencyclidine (PCP), cocaine, methadone, and methamphetamine.

The board may recommend placement of a substance in Schedule II under this chapter if it finds that the substance is classified as a controlled substance in Schedule II under federal law.

DEA Schedule II Controlled Substances can be found in: 21 CFR 1308.12 Indiana Schedule II Controlled Substances can be found in: IC 35-48-2-6

Schedule III controlled substances

The Indiana State Board of Pharmacy must recommend placement of a substance in Schedule III if it finds that:

1. The substance has a potential for abuse less than the substances listed in Schedule I and II under this chapter;

2. The substance has currently accepted medical use in treatment in the United States; and

3. Abuse of the substance may lead to moderate or low physical dependence or high psychological dependence.

Ketamine, anabolic steroids, codeine and hydrocodone with aspirin or Tylenol®, and some barbiturates such as phenobarbitol are examples of Schedule III substances.

• The list of anabolic steroids can be found at: 21 CFR 1300.01 (a)(4)

The board may recommend placement of a substance in Schedule III under this chapter if it finds that the substance is classified as a controlled substance in Schedule III under federal law.

• DEA Schedule III Controlled Substances can be found in: 21 CFR 1308.13

• Indiana Schedule III Controlled Substances can be found in: IC 35-48-2-8

Schedule IV controlled substances

The Indiana State Board of Pharmacy must recommend placement of a substance in Schedule IV if it finds that:

1. The substance has a low potential for abuse relative to substances in Schedule III under this chapter;

2. The substance has currently accepted medical use in treatment in the United States; and

3. Abuse of the substance may lead to limited physical dependence or psychological dependence relative to the substances in Schedule III under this chapter.

Examples of drugs included in Schedule IV are all the benzodiazepines, such as alproazolam and diazepam, etc. (otherwise known as Valium®, and Xanax®).

The board may recommend placement of a substance in Schedule IV under this chapter if it finds that the substance is classified as a controlled substance in Schedule IV under federal law.

• DEA Schedule IV Controlled Substances can be found in: 21 CFR 1308.14

• Indiana Schedule IV Controlled Substances can be found in: IC 35-48-2-10

Schedule V controlled substances

The Indiana State Board of Pharmacy must recommend placement of a substance in Schedule V if it finds that:

1. The substance has low potential for abuse relative to the controlled substances listed in Schedule IV under this chapter;

2. The substance has currently accepted medical use in treatment in the United States; and

3. The substance has limited physical dependence or psychological dependence liability relative to the controlled substances listed in Schedule IV under this chapter.

Cough medicines with codeine are examples of Schedule V drugs.

The board may recommend placement of a substance in Schedule V under this chapter if it finds that the substance is classified as a controlled substance in Schedule V under federal law.

• DEA Schedule V Controlled Substances can be found in: 21 CFR 1308.15

• Indiana Schedule V Controlled Substances can be found in:  IC 35-48-2-12

Spills

Breakage, spills, or other witnessed controlled substance losses should 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.