Possession of Ether, Prescription and Controlled Drugs
OP-G-5.2
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Table of Contents

Introduction

University researchers may, in the course of lawful research, teaching or testing, find it necessary to use ether, prescription or legend drugs or federally controlled substances. Various Federal and State statutes and regulations address this need. Florida State University has the responsibility to ensure that all departments, units and employees comply with all applicable laws and requirements with regard to these substances. This policy was developed to be in accordance with Chapters 499 and 893 of the Florida Statutes, Rule 64F-12 of the Florida Administrative Code and the Code of Federal Regulation, Title 21, Parts 1300-1308. The following information is provided to University researchers as guidance for obtaining necessary exemptions, licenses and permits as well as instruction on purchasing, storage, record keeping and destruction or disposal of such substances. Failure to comply with this policy may be grounds for suspension or termination of research by the University IRB or ACUC, referral for academic misconduct proceedings and/or reporting to external licensing authorities.

Throughout the remainder of this policy, any references to EH&S shall mean the Florida State University Department of Environmental Health & Safety, Research Support and Environmental Compliance Section.

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Objective

The objective of the FSU Controlled Substances Policy is to ensure compliance with State and Federal regulations governing the use of Drug Enforcement Administration (DEA) controlled substances.

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Authority

Authority for this policy was delegated to EH&S by the University President on October 28, 2002.

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Ether

General Information

Throughout the remainder of this policy, any references to ether shall mean diethyl ether.

Persons who either purchase or possess ether in the quantity of 2.5 gallons or more to use for lawful research, teaching, or testing must obtain a letter of exemption from the Florida Department of Health, Board of Pharmacy Services (see Appendix 1-Ether). Persons meeting this definition must submit correspondence to the Florida Department of Health explaining the conditions of the lawful research, teaching, or testing, along with a statement signed by the person who will be responsible for the ether, that the ether will be secured, that access will be restricted to authorized persons, and that the ether is not for resale. This correspondence should also identify the name in which purchases will be made, the quantity which will be purchased, the anticipated frequency of the purchases, and the name and Florida license number of the supplier of the ether.

EH&S will assist researchers in obtaining an exemption from licensing by submitting a letter requesting an exemption to the DOH on the PI's behalf. EH&S will provide the PI with the DOH letter granting exemption from licensing upon receipt. Purchases will not be approved until a copy of this letter is on file. EH&S will assist researchers in obtaining biannual renewals.

Additional information may be required by the Florida Department of Health before an exemption letter is issued. This additional information may include photographs and verification of fingerprints.

As an alternative, researchers may apply for a Purchaser's License that has an annual fee of $150.

Records

All persons who are exempt from licensure and reside in the State of Florida shall keep records of ether purchases, use, or disposition. A copy of the letter of exemption must be kept with the required record documentation. All records shall be made immediately available to authorized agents of the Florida Department of Law Enforcement upon request. Such records may be reviewed by EH&S during laboratory inspections or by the Florida Department of Health upon request.

A copy of the letter of exemption must be kept with an original invoice for purchases of ether in excess of 2.5 gallons for use in lawful research, teaching, or testing. Documentation shall include the name, address, and license/permit number of the seller/transferor and purchaser/recipient as well as the date of transfer and the signature of the purchaser.

All records shall be retained for five (5) years. Electronic records of purchases and transactions are allowed. Records are subject to audit by the University, Department of Health, or the Florida Department of Law Enforcement (FDLE).

Security

Every person in the State who possesses ether shall secure it in a manner that functionally and practically deters unauthorized access to the ether.

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Prescription or Legend Drugs

General Information and Application for Exemption

Principal investigators who are not licensed in the State of Florida to practice medicine or pharmacology may not acquire prescription or legend drugs without first applying to the Florida Department of Health, Bureau of Pharmacy Services, for an exemption number. EH&S will obtain an exemption from licensing for researchers, and will assist researchers in obtaining renewals.

To obtain a State exemption number, EH&S will prepare a letter requesting the exemption, print it on the PI's Departmental letterhead, obtain the PI's signature, and mail the letter to the Florida Department of Health, Board of Pharmacy Services.

The following information will be provided in the letter to the DOH:

  • The conditions of the lawful research, teaching, or testing
  • A signed statement that the drugs will be secured and that access will be restricted to authorized individuals only
  • A statement that the prescription or legend drugs are not for resale
  • The exact physical address/location where the drugs will be used/kept if different from the address on the letterhead
  • The specific prescription or legend drug(s) required for the activity
  • The quantity that will ordinarily be purchased
  • The frequency of the purchases
  • The name and state license/permit number of the supplier(s)

To enable EH&S to write a letter on the researcher's behalf, requesting an exemption from State licensing, the PI should provide the appropriate information by filling out the EH&S form, "Controlled Substances Request for Registration Information."

The Department of Health, Board of Pharmacy Services, may waive any or all of these specific elements due to the nature of the research, teaching, or testing. EH&S will assist the PI in obtaining a renewal of exemptions by requesting renewal on a biannual basis.

A letter and exemption number will be assigned to the person that authorizes the purchase or other acquisition and possession of Prescription or Legend Drugs. This exemption or registration number must be included on invoices as required by Florida Statute 499.0121 (6) (a).

Upon receipt of the exemption, EH&S will provide the DOH exemption document to the PI. Purchases will not be approved until a copy of this letter is on file.

Records

The record of movement of Prescription or Legend Drugs must be maintained and available to the Department of Health, Bureau of Pharmacy Services. Records must provide a complete audit trail from receipt or acquisition to disposition of the drug. At a minimum, records shall consist of invoices from suppliers or the source of acquisition. Ideally, records should include the date of receipt, the supplier, the quantity and dose of the drug received, the expiration date and the date when the drug was exhausted or discarded as expired. Accurate inventories of Prescription or Legend Drugs must be kept beginning at the time the prescription or legend drug is received by the exemption or license holder. Records must be retained for a period of two (2) years following disposition of the drug (64F-12.012 / 10D-45.053, subsection 10). To assist the researcher in keeping detailed receipt and use records, EH&S has prepared a Controlled Substance Use Record (Form EHS 9-5).

Audit of prescription or legend drug records and inventories will be performed at least annually by EH&S. Discrepancies found during these audits must be corrected in a timely manner. Suspected potential for criminal activity will be reported to the FSU Police Department for investigation. Records must be retained beyond two (2) years if an investigation has been initiated and not yet completed by the two-year limit.

Security and Storage

Areas where prescription or legend drugs are stored must be secured against unauthorized entry or unauthorized access when authorized personnel are not present. prescription or legend drugs, when not in use for lawful research, teaching, or testing, shall be stored in an area that is clearly marked and designated separate and apart from any other place where chemicals are stored to avoid confusion or contamination. All prescription or legend drugs must be maintained within the recommended temperature tolerances by the manufacturer.

An isolation area must be maintained for all prescription or legend drugs that are out of date, deteriorated, mislabeled, or otherwise unfit for use. This area must be clearly marked and separate from other storage areas so that products within it are not confused with usable products.

A residence cannot be used to store any prescription or legend drug that has not been dispensed, unless a natural person residing at that residence is licensed or otherwise authorized to possess prescription or legend drugs.

Disposal

For information on disposal of unwanted or outdated prescription or legend drugs contact EH&S at 644-8916.

Contact the Laboratory Safety Coordinator at 644-8916 if you have any questions regarding registration or purchase of prescription or legend drugs. You may also call the Florida Department of Health, Board of Pharmacy Services.

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Substances Controlled by the U.S. Drug Enforcement Administration (DEA)

General Information

The Florida State University requires that all individuals working with DEA controlled substances have current registration with the DEA and comply with all State and Federal regulations regarding the acquisition, storage, use, record keeping, and disposal of those substances.

Controlled substances are those materials that may have a narcotic, stimulant, depressant, or hallucinogenic effect on the central nervous system as well as other regulated chemicals. These substances have a tendency to be subject to abuse, physiological or psychological dependence and, as such, have been identified as items needing extensive licensing, registration, storage, security, use and disposal requirements. State and Federal agencies (e.g. the DEA) have comprehensive regulatory and enforcement schemes that are designed to prevent the diversion of legitimately produced controlled substances and regulated chemicals to illicit or illegal activities. Registered researchers, by their adherence to the law, constitute a powerful resource for protection of public health and safety.

Both State and Federal law classify controlled substances into five categories according to their medical use and potential for abuse. Schedule I and II substances are categorized as having the highest potential for abuse, are the most regulated. Schedule I substances are classified as having no medical value and include designated opiates, LSD and marijuana. Schedule II drugs include the barbiturates, morphine, and designated opiates. Schedule III drugs include many medically relevant chemicals (cough suppressants, anesthetic agents, narcotic pain killers) and Schedule IV covers the balance of lower abuse potential stimulants and depressants. Schedule V is categorized as having the least potential for abuse. Due to their high risk for abuse, orders for Schedule I or II substances must be in writing and accompanied by DEA Form 222 (DEA official order form).

A list of all controlled substances is available at the DEA Diversion Program website. http://www.deadiversion.usdoj.gov/schedules/index.html

Responsibilities

Each principal investigator working with DEA controlled substances will be responsible for registering for a DEA controlled substance license after first obtaining an exemption number for prescription or legend drugs from the Florida Department of Health, Bureau of Pharmacy Services. EH&S will assist the researcher in registering for a DEA controlled substance license by filling out the DEA registration forms for the PI, obtaining the PI's signature, and submitting the forms to the DEA office. EH&S will use the information provided on the EH&S form "Controlled Substances Request for Registration Information." This form, with instructions, may be obtained from the Laboratory Safety Coordinator (644-8916) or by downloading from the Laboratory Safety website using the forms link.

Application for Use of Controlled Substances in Research, Teaching, or Testing

After obtaining an exemption number for prescription or legend drugs from the Florida Department of Health, Bureau of Pharmacy Services, each principal investigator working with DEA controlled substances must provide EH&S with the necessary information to register the PI for a DEA controlled substance license. It may take 3-12 months to receive the registration certificate from the DEA, so researchers need to plan accordingly. There is no fee for researchers working at state institutions.

For Schedule I substances, the applicant must additionally submit 3 copies of a research protocol along with the EH&S form "Controlled Substances Request for Registration Information. The protocol should include:

  • Investigator - Name, address, institution, and a qualifications statement including a curriculum vitae with bibliography.
  • Project - Title, statement of purpose, controlled substance name and amount needed, location of research, security statement, and a technical description of the substance use.
  • Authority - Institutional approval and grant number if applicable.

Researchers intending to use Schedule I drugs should contact the Laboratory Safety Coordinator at 644-8916 for guidance.

EH&S will assist researchers in obtaining annual renewal of DEA registrations.

The DEA will send the license registration directly to the PI. Once received, a copy of the registration must be sent to EH&S.

Authorized Use

The permit holder is legally responsible for managing the controlled substances in accordance with the regulations, including inventory, record keeping, and security provisions.

Agents of the permit holder may engage in approved activities under the direction of the permit holder. The permit holder is required to screen those employees prior to authorization. As part of the screening process, EH&S provides a questionnaire (see Appendix 3-Controlled Substances) that includes the following questions:

Within the past five years, have you been convicted of a felony; or, within the past two years, any misdemeanor; or, are you presently charged with committing a criminal offense?

In the past three years, have you knowingly used narcotics, amphetamines, or barbiturates other than those prescribed to you by a physician?

All individuals authorized to use controlled substances must have a completed questionnaire on file with the permit holder. Completed questionnaires must either be kept with the records of controlled substances acquisition and use or able to be readily retrieved upon request during inspections. Any individuals that answer yes to either of the questions shall not be permitted to use any controlled substances. A copy of the Questionnaire should be provided to EH&S.

Procurement

All procurement of controlled substances must be coordinated with EH&S. All materials must be delivered to EH&S at 1200 Carothers Hall utilizing an EH&S DEA license. Materials will then be transferred in accordance with applicable regulations upon receipt. The following information identifies the process used for transfer after receipt. Contact EH&S for additional information concerning this process.

Procurement process for Schedule I and II Controlled Substances:

All orders for Schedule I and II controlled substances must include a DEA Form 222 to be given to EH&S, requesting the controlled substance FROM EH&S. These forms will be requested for the PI at the time of initial registration; also additional forms can be ordered from the DEA as necessary. Complete Form 222 without mistakes (void any forms with corrections and keep on file) and be sure all information is accurate. Following completion of the DEA form, complete the process for ordering the material through the OMNI System in accordance with applicable department procedures. An account code #for controlled substances must be entered on the OMNI requisition. This account code will alert Purchasing to request EH&S approval for the order. Also enter the EH&S DEA and the EH&S DOH license numbers on the purchase order, and the EH&S “ship to” code as indicated in the Controlled Substance order worksheet provided by the Laboratory Safety Office. The Controlled substance will be shipped to the EH&S Research Support Office in Milton Carothers Hall room 1225. Upon receipt, EH&S will open the outer packaging to verify the contents and ensure that no damage to the contents has occurred. EH&S will notify the PI or authorized representatives that the controlled substance has been delivered. EH&S will deliver the controlled substance to the PI or an authorized representative. At that time, the PI or authorized representative will verify the contents of the order, sign an EH&S transfer form, and enter the receipt onto the PI’s “Controlled Substance Use Log.” EH&S must be notified of receipt of any controlled substances directly to the laboratory.

Procurement Process for Schedule III-V Controlled Substances.

The DEA Form 222 is not required. For these materials, PI’s may order through the OMNI system, but must use the controlled substance account code, which alerts Purchasing that the order will need EH&S approval. Fiscal representatives or PI’s must also indicate the EH&S shipping code and note the EH&S DEA and EH&S DOH license numbers on the requisition. Shipping, receipt and transfer are handled as above.

NOTE: Controlled substances are not transferable between researchers/laboratories.

Storage and Security

Environmental storage conditions should meet manufacturer's recommendations.

Permit holders of schedule II-V drugs shall provide effective controls to guard against the theft or diversion of controlled substances. Substances are required to be stored in securely locked, substantially constructed cabinets (i.e. not easily broken into or moved) or safes. In addition, the cabinet or safe must be kept in a room that is locked or otherwise secured after hours. The intent of the law is that controlled substances must be adequately safeguarded. Therefore, depending upon other security measures, a wooden cabinet or not permanently mounted metal cabinet may or may not be considered adequate.

A substantially constructed cabinet is one that is made of wood or metal and is resistant to easy entry by tools such as screwdrivers, crowbars, tire tools or pry bars. Hinges should not be mounted on the outside. Locking devices should be permanently installed and of a deadbolt type or having protected screws/bolts. The cabinet should be permanently constructed or attached to the building structure. This should prevent the cabinet from being physically removed from the premises.

Permit holders for Schedule I drugs will be required to contain the regulated materials in a GSA Class V safe which will be alarmed to a 24-hour monitoring service or police department.

Access to storage area must be controlled and properly designated. Updated lists of authorized personnel must maintained in the laboratory and a copy be provided to EH&S after any changes.

Record Keeping

Real time inventories (Controlled Substance Use Logs) are required for each substance and must be kept for 3 years after disposition (via use or disposal) of the substance. All permit holders are required to report any loss from theft or suspected theft to the FSU Police immediately. EH&S will assist the PI in filling out DEA form 106 for report of the theft or loss to the local DEA office. Inventories and other records including: certificate of registration, purchase orders (or Form 222), loss records, and screening questionnaires are required to be kept in a designated location by the permit holder for at least 2 years. Records for schedule I and II substances are required to be maintained separately from all other records (i.e. a dedicated file). All records must be kept readily retrievable and are subject to audit.

Records must include the name of the drug, the date and amount received, the number of units or volume in each commercial container, the date and amount used, the use or purpose and the name or initials of the individual making the written entry. A Controlled Substance Use form (Form EHS 9-5) is available for record keeping or receipt and use of controlled substances. Minor loss occurring in routine use and handling should be recorded when noticed to maintain an accurate inventory. Any loss due to breakage, contamination or related circumstances should be reported to EH&S for determination of appropriate actions and noted on the inventory. A Controlled Substance Spill form (Form EHS 9-6) has been provided to record the loss of a controlled substance through spilling. The entry must include the date, the estimated amount lost, the reason for loss (e.g. spillage) and the name or initials of the individual responsible.

Inventory

EH&S will assist each registrant in conducting an inventory and reconciliation of all controlled substances annually. Inventory records must be kept for three (3) years from the date of inventory.

Disposal

Please contact EH&S at 644-8916 for information concerning disposal of DEA Controlled Substances. Researchers must fill out appropriate EH&S transfer paperwork at the time of pickup. A copy of this form must be kept with other records for a period of three (3) years following disposal. Researchers are responsible for disposal of controlled substances within 30 days of the expiration date. Materials will be picked up by EH&S with completed EH&S transfer/disposal form and disposed of in accordance with DEA protocols.

Controlled substances that are mixed with radioactive waste, chemical hazardous waste, or medical waste are not eligible to be disposed of using the regular controlled substance methods. They should be accounted for on the inventory records and disposed of as radioactive, chemical or medical waste, respectively.

DEA Contacts and Phone Numbers

Tallahassee Resident Office
3384 Capital Circle NE
Tallahassee, FL 32308
Diversion Number: (850) 942-8417
Diversion Fax: (850) 942-8420
Jurisdiction: Northern Florida

Washington, D.C.
1-800-882-953
1-202-307-7255

Miami Registration Office
(800) 667-9752
(305) 590-4880/4882
(305) 590-4578 (fax)

DEA Diversion home Web Page: http://www.deadiversion.usdoj.gov/index.html

Forms

See Appendix 3-Controlled Substances for all necessary forms.

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Appendix 1-Ether

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Appendix 2-Prescription or Legend Drugs

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Appendix 3-Controlled Substances

Format
 Form Number Form Name
web doc pdf
  EHS 9-1 Controlled Substance Request for Registration Information
  EHS 9-2 Security Screening Form
  EHS 9-3 Employee Questionnaire for Controlled Substance Access
  EHS 9-4 Controlled Substance Order/Receipt Record
  EHS 9-5 Controlled Substance Use Log
  EHS 9-6 Controlled Substance Spill Record

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References

  1. Florida Statute 449
  2. Florida Statute 893
  3. FAC 64F-12
  4. 21 CFR 1300-1308

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