Controlled Substances

Introduction
Monitoring and Inspection
How to Register
Renewal of Registration
DEA Controlled Substances Schedules
Records and Forms
Manuals
Controlled Substance Links

Introduction

This procedure is in place to ensure that Purdue University 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 and 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 contact EHS Environmental Health.

How to Register

All applications and documentation must be reviewed and mailed to Professional Licensing Agency by EHS. Contact EHS Environmental Health for assistance wit the application process.

Registration Process:

Contact EHS Environmental Health for assistance through the entire process

Complete the application process for State registration.
Upon State approval, an Indiana Board of Pharmacy compliance officer will inspect the storage facility listed on your application.
After you receive your Indiana Controlled Substance Registration (CSR), EHS will initiate the DEA application process.

Documentation Needed for the Non-Practitioner Application Process:

Applicant will need to verify their identity by providing their provide social security number for the DEA application.
Applicant’s curriculum vitae.
Copy of Purdue's Institutional Animal Care and Use Committee (IACUC) or Institutional Biosafety Committee (IBC) protocol including signature approval page. If not applicable, a one page summary listing the procedures to be performed using the controlled substances; the types and quantities of drugs to be stored on site; specific protocols for monitoring drug usage, inventory control, destruction, security, storage, and access; and research objective.
Names of people who will be handling or have access to storage of the controlled substance inventory and/or records.

Documentation Needed for the Practitioner Application Process

If you are a veterinarian on the faculty of the School of Veterinary Medicine performing regular duties, or a veterinarian employed by the Animal Disease Diagnostic Laboratory, and you are applying for a Practitioner’s DEA registration, you will need to provide a copy of your DVM license.

Renewal of Registration

Both the State and Federal Agency responsible for controlled substance registration send notices via the U.S. Postal Service prior to expiration of registrations. If a letter is received, contact EHS for assistance with the renewal process. Do not let your registrations expire.

Controlled Substances 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. Use the following links to find Indiana And Federal DEA schedules.

NOTE: The Indiana controlled substance schedules are the reverse of the Federal DEA 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 DEA application.)

Records and Forms

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 statue 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 (EHSCS Form 2). This form meets the DEA requirements for a Controlled Substance Record of Purchases.

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 (EHSCS Form 3). This form meets the DEA requirements for recording the amounts of administered/dispensed controlled substances.

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 (EHSCS 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. When Possible, 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 (EHSCS Form 5) which is copied and forwarded to EHS. Keep a copy of the EHSCS 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 requests official DEA Form 222 on-line at:

https://www.deadiversion.usdoj.gov/webforms/orderFormsRequest.jsp.

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 (EHSCS Form 4) to maintain accountability of all DEA Form 222's. This form meets the DEA requirements for 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 substances. EHS must be contacted to determine the proper procedure to follow for surrendering the registration and relinquishing the order forms and controlled substances in inventory.

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 Registrants Inventory of Drugs Surrendered (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.

Supplier Disposal:
Some suppliers will take back pharmaceuticals for credit. Contact EHS Environmental Health to determine if this is a viable of controlled substance disposal.
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 Josh Brown or Dee Odum of EHS with a controlled substance disposal request.
2. Complete the Registrants Inventory of Drugs Surrendered (DEA Form 41) prior to disposal.
3. Inform EHS when the DEA Form 41 has been completed and is ready for review.
4. 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.
5. 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.
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. Contact EHS Environmental Health to determine if this is a viable of controlled substance disposal.

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 (Completion of DEA Form 41 required). 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:

Purdue University Police Department: (765) 494-8221

Indiana State Board of Pharmacy: (317) 234-2067

Nearest DEA office:

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

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

Josh Brown, Purdue Biological safety Officer: (765) 494-1496

Dee Odum, Environmental Technician: (765) 494-7968

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. Contact EHS Environmental Health to with any questions or concerns.

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.

Manuals

Controlled Substance Links

Campus Safety Contacts

If you see something, say something.

Purdue Police
Phone: (765) 494-8221

Purdue Fire
Phone: (765) 494-6919

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