Controlled Substances

Maintain current, complete, and accurate records to reflect controlled substances:

• Received (purchased).
• Sold (administered and 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 must be used as the date of receipt or distribution on any documents of transfer (e.g. invoices or packing slips).

As required by 21 CFR 1304.3, ALL registrants must maintain records, inventories, and file reports. A registered individual practitioner is required to keep records of controlled substances in schedules I, II, III, IV, and IV which are administered in the lawful course of professional practice if they regularly engage in dispensing or administering.

All records required MUST be maintained for a minimum of two years from the date of such inventory or records, for inspection and copy by authorized employees of the Drug Enforcement Administration (DEA). Retention of records for 5 years is advisable. 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 from other records in a reasonable amount of time.

All registrants are required to maintain purchasing records of all controlled substances.

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 Drug Enforcement Administration (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 actual amount received).

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

All registrants are required to keep up-to-date records of when a controlled substance was administered or dispensed through the course of the research protocol.

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 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 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 ORI Record of Controlled Substance Administered/Dispensed Form (Word) to record this information.

The controlled substance inventory is one of the most important aspects of the Drug Enforcement Administration (DEA) procedure and program. Inventory maintenance is critical to the detection of loss, theft, and the diversion of controlled substances. Researchers should use the ORI Controlled Substance Physical Inventory Form (Word) to satisfy DEA requirements on proper Controlled Substance inventory record keeping.

To minimize waste, the Drug Enforcement Administration (DEA) registrant(s) should only purchase quantities they fully intended 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, and ORI Standard Operating Procedures.

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 a minimum of 2 years (recommended 5 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/method of disposal.

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

There are three (3) disposal options for expired or unwanted controlled substances recommended by the Office of Research Integrity. Prior to disposal, ORI should be contacted to assist the researcher determine the correct disposal method.

On-site Disposal

Small quantities (less than 1 pound) can be disposed on-site by the DEA registrant using the following six-step controlled substance disposal standard operating procedure:

• Step 1: Contact Chris Mangelli of the Office of Research Integrity with a controlled substance disposal request.
• Step 2: Complete the Registrants Inventory of Drugs Surrendered (DEA Form 41) and ORI Controlled Substance Destruction Record (Word) prior to disposal.
• Step 3: Inform ORI when the DEA Form 41 and ORI Controlled Substance Destruction Record has been completed and is ready for review.
• Step 4: After review, you may then forward the DEA Form 41 to the Drug Enforcement Administration.
• Step 5: At the end of the waiting period, arrangements will be made for a Law Enforcement Officer and ORI representative to be present as witnesses to the disposal of the controlled substance, and verify the DEA Form 41 and inventory records on-site.
• Step 6: ORI will forward two (2) copies of the DEA Form 41 to the Agent in Charge of Indiana DEA, and provide one (1) copy for the researcher's inventory records.

Supplier Disposal

Some suppliers will take back pharmaceutical for credit.

Contact Chris Mangelli to determine if this is a viable method of controlled substance disposal.

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 completion of a DEA Form 222 or DEA Form 41.

Contact Chris Mangelli to determine if this is a viable method of controlled substance disposal.

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 and/or misuse of a controlled substance is a criminal act that must be reported to the following appropriate agencies IMMEDIATELY:

• Ball State University Police Department: (765) 285-1832.
• Indiana State Board of Pharmacy: (317) 234-2067.
• Indianapolis DEA Office: (317) 226-7977.
• Office of Research Integrity: (765) 285-5034.

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 a controlled substance become unaccounted for on a re-occurring basis. Keep copies of the DEA Form 106 in your inventory records. Contact the Office of Research Integrity with any questions or concerns.

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 (e.g. tablets), must be placed in the disposal/destruction waste stream (completion of the Drug Enforcement Administration's Registrants Inventory of Drugs Surrendered AND ORI Controlled Substance Destruction Record (Word) form is REQUIRED). If the spilled controlled substance is not recoverable (e.g. liquids), the registrant must document the circumstances in their inventory records and witnesses must also sign.

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 or window where they could be visible from the outside of the room.

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. A list of all persons with key access is REQUIRED, and MUST be satisfied using the ORI Controlled Substance Cabinet Access-Key List Form (Word). Developing a key accountability standard operating procedure is highly recommended.

When possible, only authorized personnel should be allowed in the laboratory where controlled substances are used or stored. Authorized user names MUST be documented on the ORI Controlled Substance Authorized Users form (Word), which must be copied and forwarded to the Office of Research Integrity whenever a person or persons are added or removed from the list. Researchers MUST keep a copy of the ORI Controlled Substance Authorized Users form (Word) with the controlled substance inventory.

Ordering Schedule I or II Substances

To order a schedule I or II controlled substance, you must first have a Drug Enforcement Administration (DEA) license. The DEA Controlled Substance Ordering Form (Form 222) is a paper-based form use to order controlled substances. It is requisitioned directly from the DEA, and is required to be filled out in triplicate. The DEA Controlled Substance Ordering Form also allows the exchange of controlled substances from the registrant to another party registered with the DEA.

Schedule I or II registrants are required to maintain accountability of all DEA Form 222's. Use the ORI Record of Form 222 (Word) to satisfy this requirement.

Ordering Schedule III, IV, and V Substances

Schedule III, IV and V controlled substance orders do not require a DEA Form 222. These controlled substances may 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.

Controlled substances are designated as schedule I - V (C-1, C-II, C-III, C-IV, and C-V) according to their medical use, potential for abuse, and safety or dependence. BE AWARE, Indiana controlled substance schedules are the reverse of the Federal DEA controlled substance schedules. The drug schedule license you apply for on federal application must correspond to the drug schedule you are licensed for in Indiana.