DEA Controlled Substances

This procedure is in place to ensure that PFW is in compliance with both State and Federal regulations concerning the use and handling of controlled substances. This procedure applies to Purdue University staff who utilize controlled substances while teaching or conducting research. Compliance will be accomplished by proper licensing with the State and the U.S. Department of Justice Drug Enforcement Administration (DEA), record keeping, inventory, and handling by University research staff.

Monitoring and Inspection

Environmental Health & Safety (EHS) is responsible for monitoring the record keeping, inventory, security, and disposal of controlled substances. Inspections will be conducted on an annual basis to assist you with controlled substances handling procedures and to assure University compliance with DEA regulations. If you have questions concerning controlled substances either contact EHS or the Regional DEA Office located in Merrillville, IN, at 219-681-7000.

How to Register

Individuals must first notify EHS of their intentions and then register with the State of Indiana for the use of controlled substances prior to registering with the DEA using the following links to instructions and forms:

Indiana State Board of Pharmacy Instructions and Forms:

• Instructions for Indiana Controlled Substances Registration (CSR)

DEA Registration Instructions and Forms:

• Instructions and Application for Registration (DEA)

Registration Tips:

1. Ensure the information that you are providing is legible. We suggest that you complete the DEA registration online and then print your submission copy. (This site is listed on our DEA Controlled Substances web page)
2. Obtain your Indiana Controlled Substance Registration (CSR) first. 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. You must attach a copy your State CSR card with the DEA registration form.

3. 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 Indiana controlled substance schedules are the reverse of the Federal schedules! The drug schedule license you apply for on the Federal application must correspond to the drug schedule you are licensed for in Indiana (e.g., if your Indiana license shows you are licensed for Schedule 2N you would request a Schedule 2 license on the Federal application).
4. When completing the DEA registration form, make sure the name and address are identical to those on the Indiana State license.
5. Schedule 1 Controlled Substances registrations require specific application instructions: Contact Robert Golden at 41496 for instructions.
6. Complete the "Fee Exemption" Section (section 10) on the DEA 225 form. Exemption from payment of application fee is limited to federal, state or local government operated hospitals, institutions and officials. The applicant's superior (i.e., your Department Head) or agency officer must certify exempt status. The signature, authority title, and telephone number of the certifying official (other than the applicant) must be provided.
7. FAX 62572 or send your DEA application form to Josh Brown EHS/CIVL. After EHS has reviewed the DEA 225 form, the registrant will send the application form to:
   
   Drug Enforcement Administration
   United States Department of Justice
   Central Station
   P.O. Box 28083
   Washington, D.C. 20038-8083
   
   Note: Every package sent to the DEA Washington location, especially bulky application packets, is subjected to a hazard analysis scan process. This Department of Justice security measure can add up to six weeks to your approval time frame. Send only the printed application; do not include other required information (see section 8 below) at this time.
8. Once your application request has been entered into the DEA database, an agent from the Merrillville 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 who 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 inventories.
9. Send all forms and documentation by registered mail. Keep a copy for your records.

DEA License Scope

Practitioner means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other institution or individual licensed, registered, or otherwise permitted to distribute, dispense, conduct research with respect to, or administer a controlled substance in the course of professional practice or research in Indiana.

A non-practitioner, in Indiana, would be anyone that performs research and does not have a practitioner's license. A researcher is classified as a non-practitioner and can only be registered as such. A non-practitioner cannot dispense or write prescriptions with a researcher registration but can purchase and/or administer controlled substances. A researcher works under a protocol, which directs the specific actions and the specific drugs that may be used in the research protocol.

Agents are authorized employees or lab staff who act on behalf of the registrant. The requirement of registration is waived for any agent or employee of a person who is registered to engage in any group of independent activities, if such agent or employee is acting in the usual course of his/her business or employment.

Power of attorney; any purchaser may authorize one or more individuals, whether or not located at the registered location of the purchaser, to obtain and execute order forms on his/her behalf by executing a power of attorney for each such individual. The authorization forms and further information can be found in Title 21Code of federal Regulations Section 1305.07 (21 CFR 1305.07).

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" for purposes of identification of the substances or class on certain Certificates of Registration issued by the Administration pursuant to 21 CFR 1301.35 and on certain order forms issued by the Administration pursuant to 21 CFR 1305.05. Refer to 21 CFR 1308 for the schedules of controlled substances.

Schedule I Controlled Substances

The Indiana State Board of Pharmacy shall recommend placement of a substances 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.

Schedule I Controlled Substances can be found in 21 CFR 1308.11. See Indiana Code 35-48-2-4 (IC 35-48-2-4) for the Indiana list of Schedule I Controlled Substances.

Schedule II Controlled Substances

The Indiana State Board of Pharmacy shall 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 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.

Schedule II Controlled Substances can be found in 21 CFR 1308.12. See IC 35-48-2-6 for the Indiana list of Schedule II Controlled Substances.

Schedule III Controlled Substances

The Indiana State Board of Pharmacy shall 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.

Anabolic steroids, codeine and hydrocodone with aspirin or Tylenol®, and some barbiturates are examples of Schedule III substances.

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.

Schedule III Controlled Substances can be found in 21 CFR 1308.13. See IC 35-48-2-8 for the Indiana list of Schedule III Controlled Substances.

Schedule IV Controlled Substances

The Indiana State Board of Pharmacy shall 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 Darvon®, Talwin®, Equanil®, 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.

Schedule IV Controlled Substances can be found in 21 CFR 1308.14. See IC 35-48-2-10 for the Indiana list of Schedule IV Controlled Substances.

Schedule V Controlled Substances

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

• The substance has low potential for abuse relative to the controlled substances listed in schedule IV under this chapter;
• The substance has currently accepted medical use in treatment in the United States; and
• 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.

Schedule V Controlled Substances can be found in 21 CFR 1308.15. See IC 35-48-2-12 for the Indiana list of Schedule V Controlled Substances.

Records of Registrants

Every registrant shall maintain records and inventories and shall file reports required by 21 CFR 1304.03. A registered individual practitioner is required to keep records of controlled substances in schedules II, III, IV, and V which are administered in the lawful course of professional practice if they regularly engage in dispensing or administering.

All records required shall 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 record keeping and inventory requirements of federal law. This includes all purchasing records, all administering and dispensing records, all Controlled Substance Ordering 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
• A copy of the packing slip

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
• The amount purchased (which should match the amount received)

The purchasing record (invoice, shipping document, or packing slip) must be annotated with the handwritten date of receipt. The date written on this document must match the date entered in the "Date Received" column on your Record of Controlled Substance Purchases (REMCS Form 2).

Administering and Dispensing Records

Administering records must contain:

• Your DEA number, name, and address
• The recipient's DEA number, name, and address
• A complete description of the product and the quantity distributed
• The date of distribution by the selling registrant
• The handwritten date received by the receiving registrant

Dispensing records must contain:

• The name and address of person (research subject) to whom administered/dispensed
• The date administered/dispensed
• The initials of person administering or dispensing on behalf of registrant
• The name of the controlled substance
• The strength and size of the controlled substance
• The amount administered/dispensed (number of units or volume)

Use the Record of Controlled Substance Administered/Dispensed (REMCS Form 3).

Inventory Records

Controlled substance inventory is one of the most important aspects of the DEA program. Inventory maintenance is the key to the loss detection, theft, and the diversion of controlled substances. The Controlled Substance Physical Inventory (REMCS Form 1) meets the DEA requirements for a Controlled Substance inventory record. Complete inventory requirements can be found at the following link:

http://www.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_11.htm

Security and Employee Authorization Documentation

Security depends greatly on the type, quantity, and form of controlled substances being used in the research project. Schedule I, II, III, IV, and V controlled substances must be stored in a locked steel cabinet or a locked substantially constructed cabinet. Controlled substances should not be located near a glass panel where they can be visible from the outside.

Researchers must provide effective controls to guard against theft of controlled substances. This includes limiting the number of keys and the number of employees who will have access to these keys. Developing a key accountability standard operating procedure is recommended. Only authorized personnel should be allowed in the laboratory where controlled substances are used or stored. Authorized users' names must be documented on the Controlled Substance Authorized Users List (REMCS Form 5) which is copied and forwarded to EHS, along with a completed and signed Controlled Substance Program Social Security Release (REMCS Form 6) for each individual listed on the Form 5. Keep ONLY a copy of the REMCS Form 5 with the controlled substance inventory.

Note: Always ask visitors or individuals entering these areas for identification and why they are there. When maintenance work is done in the controlled substance storage area the research staff must maintain adequate observation.

DEA Ordering Forms

To order a controlled substance you must first have a DEA license. The Controlled Substance Ordering Form (DEA Form 222) is a paper-based form 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 at:

https://www.deadiversion.usdoj.gov/online_forms_apps.html

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.

Use the Record of DEA Form 222 Use (REMCS Form 4) to maintain accountability of all DEA Form 222's.

Note: If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice, or changes his name or address as shown on his registration) or is suspended or revoked as to all controlled substances listed in Schedules I and II for which he/she is registered shall relinquish all unused controlled substances and order forms for such substance to the PFW Campus Police.

Disposal and Loss Records

To minimize waste, DEA registrants should only purchase quantities they intend to use. Damaged, expired, unwanted, unusable, or non-returnable Controlled Substances must be accounted for, retained, and disposed of in accordance with applicable State and Federal regulations.

A Registrant Record of Controlled Substances Destroyed (DEA Form 41) must be completed prior to disposing of any DEA controlled substance. Two (2) copies of the form must be sent to the local Indiana DEA branch and one (1) copy should be retained by the registrant for at least 2 years.

Disposal records must contain:

• Your DEA number, name, and address
• The reverse distributor's DEA number, name, and address
• The number of units (in finished forms and/or commercial containers) disposed of in any manner, including the manner of disposal

The disposal record must be dated to reflect when the products were sent for destruction and left your inventory.

There are three disposal options for expired or unwanted controlled substances recommended by EHS. EHS should be contacted to help determine the correct disposal method.

1. Contact the Supplier:
   Some suppliers will take back pharmaceuticals for credit. If possible, this is the best means of controlled substance disposal.
2. On-site Disposal:
   Small quantities (less than 1 pound) can be disposed onsite by the DEA registrant using the following six-step controlled substance disposal procedure:
   
   
   1. Contact Stephanie Phillips of EHS with a controlled substance disposal request.
   2. Complete the Registrant Record of Controlled Substances Destroyed (DEA Form 41) prior to disposal.
   3. Inform EHS when the DEA Form 41 has been completed and is ready for review.
   4. EHS will forward this form to the DEA with a projected two-week disposal date.
   5. At the end of the waiting period arrangements will be made for a Purdue Police Officer and EHS representative to be present as witnesses to the disposal, verify the DEA Form 41 and inventory records.
   6. EHS will forward two copies of the DEA Form 41 to the Agent in Charge of Indiana DEA, and provide one copy for the researcher's inventory records.
3. Reverse Distribution:
   For large quantities (greater than 1 pound), contact a Reverse Distributor. This option transfers ownership of the controlled substance to a DEA-approved Pharmaceutical Returns Processor for re-use, re-sale or destruction at a hazardous waste incinerator. This process may involve the completion of DEA Form 222 or DEA Form 41. Contact information for three reverse distributors is listed below.
   
   
   • MedTurn; 317-867-2552
   • National Notification Center: 800-636-9826
   • Guaranteed Returns, 800-729-3279

Spills

Breakage, spills, or other witnessed controlled substance losses do not need to be reported as lost. This type of loss must be documented by the registrant and witness 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.

Theft of or Missing Controlled Substances Reporting

The DEA license 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:

• Merrillville Resident Office
  1571 East 85th Avenue
  Suite 200
  Merrillville, IN 46410

Diversion Number: 219-681-7000
Diversion Fax: 219-681-7024

PFW Campus Police: 260-481-6827

Josh Brown, Purdue Biosafety Officer: 765-494-1496

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.

Reporting is also necessary if small quantities of controlled substances become unaccounted for on a re-occurring basis. 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 of
  • 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 shall be used as the date of receipt or distribution on any documents of transfer (e.g., invoices or packing slips).

Forms

These forms will be used to log the purchasing, administering, dispensing, and inventory of controlled substances possessed by DEA registrants.

• Controlled Substance Physical Inventory (REMCS Form 1)
• Record of Controlled Substance Purchases (REMCS Form 2)
• Record of Controlled Substances Administered/Dispensed (REMCS Form 3)
• Record of DEA Form 222 Use (REMCS Form 4)
• Controlled Substance Authorized Users List (REMCS Form 5)
• Controlled Substance Program Social Security Release (REMCS form 6)
• Registrant Record of Controlled Substances Destroyed (DEA Form 41)
• Report of Theft or Loss of Controlled Substances (DEA Form 106)
• DEA Order Forms Request (for DEA Form 222)