Understanding & Maintaining
NY Controlled Substance Compliance

Part 1 | Introduction, Background & Terms

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Understanding & Maintaining Controlled Substance Compliance

When clinicians and LVT’s utilize and prescribe controlled substances within a facility, they must be aware of and adhere to the Federal and State regulations and policies that govern their use. This workshop is designed as an introduction to these regulations and policies, as well as to the paperwork and record keeping required for the use of controlled substances.

The objectives of this training are to provide:

  • An understanding of the Federal and State regulations for using controlled substances.
  • An understanding of the policy for using controlled substances.
  • A detailed description of record-keeping requirements for using controlled substances.
  • A resource for personnel about the forms, instruction documents and other information available to help simplify compliance with the regulations and policy.

Background

A controlled substance is a drug or chemical whose manufacture, possession and use are regulated by the Federal and State government. This may include illegal drugs and prescription medications.

Controlled drugs are rated in the order of their abuse risk and placed in Schedules by the Federal Drug Enforcement Administration (DEA). The drugs with the highest abuse potential are placed in Schedule I, and those with the lowest abuse potential are in Schedule V. These schedules are commonly designated as C-I, C-II, C-III, C-IV, and C-V.

The mission of the Drug Enforcement Administration (DEA) is to enforce the controlled substances laws and regulations of the United States. The DEA is responsible for suppressing illegal drug use and distribution by enforcing the Controlled Substances Act. The DEA requires a registration for the possession and use of controlled substances. For more information on the DEA, go to http://www.usdoj.gov/dea/index.htm.

The New York Board of Pharmacy (NYBP) is the agency authorized by NY statute to regulate controlled substances in the State of NY. The NYBP exists to protect the public from adulterated, misbranded and illicit drugs, and from unethical or unprofessional conduct on the part of pharmacists or other licensees. The NYBP requires researchers using controlled substances to obtain an NYBP registration certificate. For more information on the NYBP go to http://www.op.nysed.gov/prof/pharm/.

Terms used in the policy

The DEA policy for, Using Controlled Substances, contains several unique terms that form the structure of the policy:

For each of these terms, think about how it applies in your facility.

Unit: A department or other administrative structure, like a division or institute.

Location: A room or designated area where controlled substances are stored in a safe.

Unit Registrant: A person who is appointed by the administrator to hold the DEA and NYSBP registrations for the Unit, exercises signature authority and approves or appoints the Location Registrants for the Unit. Also referred to as the DEA registrant.

Location Registrant: A person, usually the principal investigator (PI) or lab supervisor, who obtains an NYSBP registration for the (lab) Location, supervises the Authorized Users and assures compliance with the controlled substances policy and regulations at the Location.

Authorized Users: All personnel who perform one or more activities (receiving, using, disposing, etc.) with research controlled substances under supervision of a Location Registrant. Authorized Users are not required to have a specific registration. Authorized Users must receive training for lab-specific use of controlled substances.

Standard Operating Procedure

Controlled substances must be properly handled at all stages of purchase, use, storage, transfer and disposal. The DEA has a Standard Operating Procedure (SOP), that can serve as a reference. We recommend that you bookmark the SOP for future reference. The SOP defines the person who is responsible for each of the activities related to using controlled substances.

Part 2 | Registering, Purchasing, Receiving, Labeling, Storing & Securing

Registering for Controlled Substances

The DEA requires a registration for different types of activities when using controlled substances, e.g., research, teaching, clinical practice and other activities.

Unit Registrants and Location Registrants must understand the Unit and Location structure, registration process, roles and responsibilities.

Authorized Users do not need a specific registration.

Everyone performing any activity with controlled substances must sign the Authorized Users Signature Log. The Authorized Users Signature Log is one of the documents required by DEA policy that must be kept up-to-date and filed in your controlled substances records.

Authorized Users Signature Log

Authorized Users Signature Log

The Authorized User Signature Log, like all controlled substance records, must be kept for a minimum of seven years. When a DVM departs the facility, note the date the person left on the form. If there is high turnover in your facility, you may need to start a new log, but remember to keep the original document with your controlled substance records.

Purchasing Controlled Substances

The DEA policy has specific procedures to be followed when purchasing controlled substances:

  • The Unit Registrant must be aware of all purchases of controlled substances. Ensure this by providing an initialed and dated copy of the purchase receipt to the Unit Registrant.
  • File the purchase receipt with the Location controlled substances records.
  • Purchasing controlled substances from centralized sources is highly recommended.
  • To pick up controlled substances, pharmacies require a copy of the DEA registration, the Authorized Users Signature Log and photo identification.

The purchase of C-I and C-II substances require completion of a DEA Form 222.

DEA Form 222 Order Forms

Sample Blank DEA Form-222

PDF version of blank Form 222

After the DEA has approved your use of C-I or C-II controlled substances, they will send you the DEA Forms 222. After initial approval, you may request additional Forms 222 online from the DEA website.

Follow the guidance provided in "Using DEA Form 222 to Order Controlled Substances," http://www.health.state.ny.us/professionals/narcotic/laws_and_regulations.htm.

Receiving Controlled Substances

When receiving controlled substances, or if controlled substances are shipped to your facility, ensure that, the controlled substances are processed as soon as possible, by:

  • Recording receipt of substances in the disposition record.
  • Locking controlled substances in the safe immediately.

In addition, ensure that the purchase records meet the DEA regulations by:

  • Initialing and dating purchase receipt.
  • Providing a copy for Unit Registrant’s records.
  • Filing the purchase records with the controlled substances records.

Labeling Controlled Substances

All containers of controlled substances must be properly labeled. If a facility re-packages, compounds or dilutes controlled substances, appropriately label the re-packaged, compounded or diluted substance and store it in the safe.

The label on diluted or combined controlled substances that will be stored in the safe must include the following information:

  • Name of controlled substance.
  • Schedule of drug.
  • Lot number.
  • Final strength or concentration of controlled substance.
  • Volume or amount of substance per container.
  • Date of dilution and initials/expiration date no more than 30 days after dilution.

Storing and Securing Controlled Substances

Controlled substances must be stored securely, according to the DEA regulations. The following points highlight the requirements:

  • Store controlled substances in a locked safe bolted to an immovable object.
  • Store controlled substances separately from other drugs and materials.
  • Limit access to the safe.
  • For expired drugs, mark the container "Expired" and segregate in the safe.
  • Store the slurry bottle with contaminated waste controlled substances in the safe.
  • Store controlled substances requiring cold storage in a refrigerator or freezer with a locked door.

For guidance on purchasing a controlled substances safe for use in your laboratory, read http://www.health.state.ny.us/professionals/narcotic/laws_and_regulations.htm

Part 3 | Using, Transferring, Disposing

Using Controlled Substances

The DEA policy mandates the following about the use and record-keeping of controlled substances:

  • Only Unit Registrants, Location Registrants and Authorized Users may use controlled substances.
  • The person using the controlled substances must be the one to initial and date the disposition record for the particular action performed.

Record-keeping for Use of Controlled Substances

Every activity with controlled substances must be recorded on the disposition record, which is the primary record of all activities with controlled substances. The recording requirements vary by the type of drug being used:

  • For C-III, C-IV and C-V drugs, the total volume used on a daily basis may be recorded on the disposition record. For instance, if ten animals were given 0.3 ml of a substance on a specific day, the total in the disposition record could read 3.0 ml. However, the individual use must be recorded in a surgical, anesthetic or other medical record that is accessible.
  • The regulations for use of C-II controlled substances (e.g. pentobarbital) are more stringent. Each individual dose must be recorded in the disposition record.
    • In the instance of an animal surgery, the individual recorded dose can be the total per animal per anesthetic episode. If an animal was given 1.0 ml of a substance and boosted with 0.5 ml three times during the surgery, the total individual dose would be recorded as 2.5 ml.
  • The DEA requires the use of a Controlled Substance Disposition Record that contains all the required elements. A template is available on the DEA website for reference at: http://www.health.state.ny.us/professionals/narcotic/laws_and_regulations.htm. A modified form may be used, as long as it possesses all required elements.

Note that the disposition records are dedicated exclusively to tracking all controlled substances activities. The actual use of the controlled substances must be demonstrated by recording it in surgical, anesthetic, post operative or other experimental record. This would be analogous to a hospital pharmacy dispensing a drug and a clinician writing the use of the drug in the medical record.

Example: Using the Disposition Record for C-II Controlled Substances

This example uses sodium pentobarbital, a C-II controlled substance, to demonstrate the more stringent record-keeping requirements. For a C-II controlled substance, remember that the total use for each animal must be recorded individually. For C-II drugs, do not combine the total use per day in multiple animals, as you can for C-III through C-V drugs.

The disposition record is used to track all activities:

  • Receiving.
  • Using.
  • Diluting or combining.
  • Disposing of.
  • Transferring.

This section will introduce the form, and demonstrate how each activity is recorded.

Controlled Substances Disposition Record

Controlled Substance Disposition Record

The recommended disposition record contains the required elements from the DEA regulations, which are included at the top and bottom of the form:

  • Name of controlled substance
  • Concentration or strength
  • Form or type
  • Amount per container
  • Unit (DEA) and Location Registrant’s names
  • Location
  • Sequential page numbers

Line 1: Receiving controlled substances

Controlled Substance Disposition Record - Filled Out Sample

Information to be recorded in the spaces provided on disposition record:

  • Date: Date of activity.
  • Quantity Received: Number of containers received.
  • Received From: Name and address of source.
  • Ref #: reference number, if your facility assigns a number to each bottle.
  • Initials: Initials of Authorized User who received the drug.

*Date and initial each activity.

*Cross out unused columns and lines.

Lines 2-4: Using controlled substances

Controlled Substance Disposition Record - Filled Out Sample 2

In this example, Lines 2-4 represent the use of sodium pentobarbital in three animals, each recorded individually. The first two animals, 214 and 215, received 0.8 ml of drug. 216 received 1.0 ml of sodium pentobarbital.

The lines referring to the receipt of controlled substances are crossed out.

Each activity is dated and initialed by the person using the controlled substance.

In the "Use Information" column, write enough specific information so that you can go to the surgical sheet where that use of the controlled substance is recorded. Writing only "canine" or "feline" Is not enough information when using controlled substances.

Line 5: Diluting or combining controlled substances

When controlled substances are diluted or combined, it must be recorded on the disposition record. When a drug combination is used, track the combination use separately from the stock bottle use.

Controlled Substance Disposition Record - Filled Out Sample 3

In Line 5 of the disposition record, 0.5 ml of sodium pentobarbital is used from the stock bottle and diluted 5-fold to make 2.5 ml total volume to use in mice.

When diluting (as in this example using sodium pentobarbital) or combining drugs (when using ketamine-xylazine or other drug combinations), it is necessary to record the amount used from the stock bottle(s) AND to record the amount of diluted or combined drugs used.

A sterile container and pharmaceutical grade diluents must be used when diluting or combining controlled substances for use in animals. The diluted or combined controlled substance expires after 30 days.

In Line 5, the 0.5 ml is the stock bottle amount used. The 2.5 ml of diluted sodium pentobarbital (new concentration of 10 mg/ml) is the diluted amount of controlled substances that must also be tracked.

In the example, this 2.5 ml diluted sodium pentobarbital will also be recorded on the Controlled Substances Single Drug Disposition Record.

Controlled Substances Single Drug Disposition Record

Veterinary Controlled Drug Disposition Record

Using the Single Drug Disposition Record is convenient when multiple animals are logged and/or when other information, e.g., animal weight, is needed. It is important to remember that with a C-II controlled substance like sodium pentobarbital you are required to record the drug use for each animal separately along with all patients.

Complete the required information at the top of the Controlled Substances Single Drug Disposition Record.

In the body of the record, the columns on the left side pertain to use of the controlled substance and the columns on the right side could be used to record information relevant to your research.

In this example with diluted sodium pentobarbital, each of 10 mice received 0.2 ml, which leaves 0.5 ml diluted sodium pentobarbital remaining.

As noted on this disposition form, the 0.5 ml was put in the slurry bottle for disposal. The volume placed in the slurry bottle must also be recorded on the disposal form. More information on the use of the disposal form and slurry bottle is presented below.

When large numbers of animals are used and the information is the same (e.g. euthanizing a large number of animals with the same dosage of drug), this record could be prefilled on the Single Drug Disposition Record which is an Excel spreadsheet. If this is done, the record must be printed and signed or initialed by the person performing the activity.

In addition, to save time or minimize duplication of recording, researchers may choose to use the Controlled Substances Single Drug Disposition Record as a surgical or procedure record by adding other research elements to the record. If this is done, file the original record with your research records and a copy in your controlled substances records.

If your laboratory uses only the Single Drug Disposition Record as a controlled substance record, it is very important to clearly record all the controlled substances activities (receiving, using, diluting or combining, disposing and transferring) on the form.

Returning to the Controlled Substances Disposition Record

Line 6 and 7: Using and disposing of controlled substances.

Controlled Substance Disposition Record - Filled Out Sample 4

Line 6 records the use of 0.8 ml of sodium pentobarbital 3/12/09 in Rat #217 for perfusion.

Line 7 records the disposal of 0.2 ml that was contaminated in the syringe. The 0.2 ml is placed in the slurry bottle and recorded on the disposal form.

By recording the amount you put in the slurry bottle on both the disposition record and disposal record, you can easily track the controlled substance. More information on disposal is provided below.

Controlled Substance Disposition Record - Filled Out Sample 5

Line 8: Transferring controlled substances

Although it is not advised, it is possible to transfer controlled substances to another DEA registration. Only transfer unopened bottles of controlled substances so that both parties are certain of the amount being transferred. Both the receiving and the supplying laboratories must record the transfer in their disposition records.

In this example, Line 8 records the transfer of one 50 ml bottle of sodium pentobarbital to another laboratory. The receiving laboratory must record the 50 ml bottle in their disposition records, who they received it from and the DEA number. Because sodium pentobarbital is a C-II substance, a Form 222 order form must be used to make the transfer.

More instructions are provided in "Using DEA Form 222 to Order Controlled Substances," http://www.health.state.ny.us/professionals/narcotic/laws_and_regulations.htm

Disposing of Controlled Substances

The DEA registration does allow facilities to register for pick up and disposal of expired, contaminated or excess controlled substances. Substances to be disposed of must be kept in the safe until picked or disposal is authorized.

Dispose of expired and excess controlled substances in the original bottle. Mark the container "Expired" and segregate, if possible, from other controlled substances in your safe.

Collect and dispose of small amounts of contaminated or waste controlled substances (i.e. in a syringe) in the "slurry bottle."

A slurry bottle is a bottle that contains a contaminant. Slurry bottles can be obtained by various authorized vendors or by contacting the DEA. Multiple types of waste controlled substances can be put in the slurry bottle. The slurry bottle must be kept in the safe.

Slurry Bottle
Slurry Bottle

The DEA website contains specific directions for the proper disposal of controlled substances. Use this link to review the instructions:

http://www.health.state.ny.us/professionals/narcotic/laws_and_regulations.htm

Transfer controlled substances to DEA using the disposal form

  • Complete the disposal form and submit as indicated.
  • Pick-up of controlled substances is arranged by the DEA.
  • File a copy of the disposal form in the controlled substances records.

Record-keeping for Controlled Substances Disposal

Each disposal into the slurry bottle must be recorded on the disposal form, which is used to record amounts of expired or waste controlled substances for disposal. It is also recommended that the amount placed in the slurry bottle is recorded on the disposition record.

The two-page Controlled Substances Disposal Form is required by DEA policy and is available on the DEA website.

http://www.health.state.ny.us/professionals/narcotic/laws_and_regulations.htm

Controlled Substances Disposal Form

Controlled Substances Disposal Form

Destruction of Controlled Substances

IMPORTANT NOTICE: Only those persons registered with and authorized by DEA to handle controlled substances may utilize/submit this form.

The instructions provided on the DEA Form 41 are incorrect. Please disregard instruction number 5. That instruction directs the registrant to ship the drugs to the Special Agent in Charge of the DEA office that serves the registrant's area. Registrants should send the forms to DEA as detailed in instruction number 3, and await instructions on how to proceed.

Currently the DEA Form 41 (Registrants Inventory of Drugs Surrendered) is available in PDF format in two ways – 1. As an interactive form which can be completed online and printed on your printer, or 2. As a blank form to be printed on your printer. This second version is not recommended; fewer errors occur if the form is entered online and then printed.

You will need Adobe Acrobat Reader 4.05 or better to view these forms

This PDF form will print out both the front and back of the official forms.

INSTRUCTIONS
DEA Form 41 Registrants Inventory of Drugs Surrendered

  1. List the name of the drug in column 1, the number of containers in column 2, the size of each container in column 3, and in column 4 the controlled substance content of each unit described in column 3; e.g., morphine sulfate tabs., 3 pkgs., 100 tabs., 1/4 gr. (16 mg.) or morphine sulfate tabs., 1 pkg., 83 tabs., 1/2 gr. (32mg.), etc.
  2. All packages included on a single line should be identical in name, content and controlled substance strength.
  3. Prepare this form in quadruplicate. Mail two (2) copies of this form to the Special Agent in Charge, under separate cover. Enclose one additional copy in the shipment with the drugs. Retain one copy for your records. One copy will be returned to you as a receipt. No further receipt will be furnished to you unless specifically requested. Any further inquiries concerning these drugs should be addressed to the DEA District Office which serves your area.
  4. There is no provision for payment for drugs surrendered. This is merely a service rendered to registrants enabling them to clear their stocks and records of unwanted items.
  5. Drugs should be shipped tape-sealed via prepaid express or certified mail (return receipt requested) to Special Agent in Charge, Drug Enforcement Administration, of the DEA District Office which serves your area.

The instructions provided on the DEA Form 41 are incorrect. Please disregard instruction number 5. That instruction directs the registrant to ship the drugs to the Special Agent in Charge of the DEA office that serves the registrant's area. Registrants should send the forms to DEA as detailed in instruction number 3, and await instructions on how to proceed.

Privacy Act Information for DEA Form 41


Authority:

Section 307 of the Controlled Substances Act of 1970 (PL-513).

 

 

Purpose:

To document the surrender of controlled substances which have been forwarded by registrants to DEA for disposal.

 

 

Routine Uses:

This form is required by Federal Regulations for the surrender of unwanted Controlled Substances.  Disclosures of information from this system are made to the following categories of users for the purposes stated:

  1. Other Federal law enforcement and regulatory agencies for law enforcement and regulatory purposes.
  2. State and local law enforcement and regulatory agencies for law enforcement and regulatory purposes.

 

Effect:

Failure to document the surrender of unwanted Controlled Substances may result in prosecution for violation of the Controlled Substances Act.

Under the Paperwork Reduction Act, a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Public reporting burden for this collection of information is estimated to average 30 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for this burden, to the Drug Enforcement Administration, FOI and Records Management Section, Washington, D.C. 20537; and to the Office of Management and Budget, Paperwork Reduction Project no. 1117-0007, Washington

Part 3 has covered the use of the disposition record to track all activities using controlled substances:

  • Receiving.
  • Using.
  • Diluting or combining.
  • Disposing of.
  • Transferring.

Part 4 | Taking Inventory, Loss or Theft, Record Maintenance, Oversight

Taking Inventory of Controlled Substances

The DEA policy requires that each Location using controlled substances must complete a annual inventory. An inventory is the comparison of the quantity of controlled substances in your safe with the quantity written in your disposition records. These amounts should be the same.

The recommended Controlled Substances Inventory Record contains the required elements from the DEA regulations.

Controlled Substance Inventory Record

Controlled Substance Inventory Record

Looking at the example inventory form, the "Impromed Amount" is what is recorded in your disposition record and the "Actual Inventory" is what you count in your safe at the time of the inventory.

If you find a discrepancy between the amount of controlled substances in your safe and the amount recorded in your records, this discrepancy must be reported. These reporting requirements are covered below.

The Expected Amount is found in your disposition record for each controlled substance.
The Actual Inventory is the amount you count in the safe. Be sure to use "mls" or "mg" for each entry. Unused lines are crossed out. Each entry is initialed and the inventory must be dated.

The following are important requirements for taking an inventory:

  • An inventory must be conducted at least once per year, according to the DEA policy.
  • The Location Registrant is usually the one to perform the inventory.
  • The Location Registrant must provide a copy of the inventory to the Unit Registrant and file the original inventory with the Location records.

Reporting Theft and Loss of Controlled Substances

The DEA regulations require reporting the loss of controlled substances. The DEA Form 106 “Report of Theft or Loss of Controlled Substances must be used to file this report online.

Before you file a DEA Form 106 to report theft or loss of controlled substances, read the document "Guidance from DEA on When to Use Form 106." The links to Form 106 and the guidance documents are:

http://www.health.state.ny.us/professionals/narcotic/laws_and_regulations.htm.

Procedures to follow concerning a loss of controlled substances:

If there is an obvious or suspected break-in to your safe or other diversion of controlled substances, immediately contact the Police.

If a discrepancy is identified during an inventory or other reconciliation:

  • The Location Registrant must investigate the discrepancy.
  • Immediately report the discrepancy to the Unit Registrant.
  • The Unit and Location Registrants must decide if it is necessary to use Form 106 to report the loss to the DEA.
  • If there is consistent loss of controlled substance that can be explained, write a Memo to File for your controlled substance records the explains this consistent loss. An example would be loss in the hub of the needle that is consistent over a number of experiments.

If a discrepancy cannot be reconciled or if there has been a diversion, it must be reported to the DEA using DEA Form 106.
The Unit Registrant and Location Registrant must file a copy of the completed Form 106 with the controlled substance records.

Reporting Accidental Loss

In case of accidental loss of controlled substances due to spilling or breaking a container, use DEA Form 41.

DEA Form 41

Follow the instructions provided in "Reporting Accidental Loss on DEA Form 41" to report the loss, http://www.health.state.ny.us/professionals/narcotic/laws_and_regulations.htm.

Maintaining and Retaining Records of Controlled Substances

DEA regulations have requirements for maintaining and retaining records about the use of controlled substances for research.

Maintain and retain the following records on use of controlled substances for research:

  • DEA registrations.
  • Authorized Users Signature Log.
  • Copy of purchase records: purchase receipts for all schedules and Forms 222 for C-II.
  • Disposition records.
  • Inventory records.
  • Copy of disposal records.

Important points about maintaining records:

  • The person performing the tasks (receiving, using, diluting, disposing) is responsible for documenting information on the disposition record.
  • It is highly recommended that records be maintained in a 3-ring binder so that nothing is lost or misplaced.

Important point about retaining records:

  • Keep disposition records and other associated records at the Location for a minimum of 5 years according to the DEA.

Oversight: Inspection and Compliance Reviews

Compliance reviews and inspections can happen at any time, and can be done by the DEA.

DEA Inspections can occur with or without notice. These inspections focus on storage, security and all controlled substances records.

Part 4 of the controlled substances tutorial covered the following topics:

  • Taking inventory.
  • Reporting theft and loss.
  • Maintaining and retaining records.
  • Oversight.

The knowledge assesment test will award you 2 hours of NY State CE credit. A certificate will be emailed to you upon successful completion.

[Take the test]

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