Laboratory Safety Manual - Chapter 09: Controlled Substances

Title

Laboratory Safety Manual - Chapter 09: Controlled Substances

Purpose

This chapter gives definitions and protocols for chemicals that are classified as controlled substances by the U.S. Drug Enforcement Administration. Controlled substances have special rules for acquisition, storage, security, inventory/recordkeeping, disposal, and importing or exporting, detailed in this chapter. The appendices include a current list of controlled substances and forms for inventory support and personnel screening.

Table of Contents

1. Introduction
2. Controlled Substance Requirements
   1. Schedules
   2. Registration and Acquisition
   3. Security
   4. Disposal
   5. Importing and Exporting Controlled Substances
3. Appendices

I. Introduction

Because of their potential for abuse, controlled substances have specific regulatory requirements for their acquisition, storage, security, use, and disposal.

Controlled substances are any drugs or chemical substances whose possession and use are regulated under the United States Controlled Substances Act, or the North Carolina Controlled Substances Act. The U.S. Department of Justice, Drug Enforcement Administration (DEA) administers the federal law, and the North Carolina Department of Health and Human Services (DHHS), Drug Control Unit administers the state law. Controlled substances have stimulant, depressant, or hallucinogenic effects on the higher functions of the central nervous system, and tend to promote abuse or physiological/psychological dependence.

II. Controlled Substance Requirements

A. Schedules

Substances regulated under the U.S. Controlled Substances Act (CSA) are in one of five schedules. Schedule I substances have the most restrictions, and Schedule V substances the least. The CSA defines the schedules as follows:

• Schedule I: Drug or other substance with a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety protocols for use under medical supervision.
• Schedule II: High potential for abuse; a currently accepted use in treatment in the United States, or currently accepted medical use with severe restrictions; abuse may lead to severe psychological or physical dependence.
• Schedule III: Potential for abuse less than Schedule I or II substances; currently accepted medical use in treatment in the United States; abuse may lead to moderate or low physical dependence or high psychological dependence.
• Schedule IV: Low potential for abuse relative to Schedule III; currently accepted medical use in treatment in the United States; abuse may lead to limited physical or psychological dependence relative to Schedule III.
• Schedule V: Low potential for abuse relative to Schedule IV; currently accepted medical use in treatment in the United States; abuse may lead to limited physical or psychological dependence relative to Schedule IV.

The following link is the alphabetical list of the controlled substances and chemicals currently regulated by the DEA is provided: DEA Orange Book. Please note that the list describes basic or parent chemicals and do not describe the salts, isomers, salts of isomers, ester, ethers, and derivatives which may also be controlled substances.

B. Registration and Acquisition

Only registered personnel with the appropriate state and federal licenses can order controlled substances. Some departments at UNC have one or more persons who maintain controlled substance licenses and order these substances for authorized researchers within their department; other departments require each investigator seeking to use controlled substances to obtain their own licenses. Contact your department administrator to determine licensing and ordering requirements within the department.

For departments that allow license holders to authorize (and order substances for) additional personnel, see section C(2) below for further details. License holders who wish to transfer these substances to a designated authorized user can do so, but the license holder retains all liabilities for loss, theft, or misuse of the substance. Individual registration and licensing are required for use of Schedule I controlled substances without exception.

To order controlled substances, you must register at the state level with the North Carolina Department of Health and Human Services (NC-DHHS), Drug Control Unit and the federal level with the DEA. Information is available online for the NC-DHHS Drug Control Unit and for the North Carolina Controlled Substances Regulatory. The NC-DHHS, Drug Control Unit registration process can be completed by submitting the application to the email address: NCCSAREG@dhhs.nc.gov.

The state requires that registrants fill out the DHHS 225 form (for researchers and analytical laboratories) or DHHS 224 form (for clinicians and instructional activities). The forms can be found online at the NC Controlled Substances Regulatory website. In order to properly complete this form, you must know which schedule(s) your controlled substance(s) are in, and whether they are narcotic or non-narcotic (required for Schedule II and III substances only). You can find this information in the alphabetical list provided by the DEA Orange Book. The registration fee is currently $125 for researchers and $100 for analytical laboratories.

For Federal registration, researchers and analytical laboratory personnel must complete the DEA Form 225 for new applications, or the Form 225-A for renewal applications. For Practitioners/Physicians who plan to use the controlled substances in their professional practice, or teaching institutions using the substances for instructional activities, use DEA Form 224 for new applications, or Form 224-A for renewal applications. Because UNC is a state institution, UNC personnel are exempt from the Federal registration fee. Online versions of the Federal registration forms are on the DEA Office of Diversion Control website.

Once registration at the State and Federal level is complete, and you have passed a background check and received your licenses for controlled substances, you can proceed to ordering. Note that the NC-DHHS, Drug Control Unit and the DEA can (and often do) send out inspectors to verify that adequate security is in place before they issue the licenses. For ordering Schedule I and II substances, you must use the Official Order Form – DEA 222 by using the electronic order or you can obtain these forms free of charge from the DEA Greensboro Field Office:

DEA – Office of Diversion Control

1801 Stanley Road, Suite 201

Greensboro, NC 27407

(336) 632-4297 – phone

336-547-4209 – fax

You can also contact the Field Registration Technician at the DEA Atlanta Regional Office at (404)-893-7000 to obtain Official Order Form - DEA 222, or for any questions about registration.

C. Security

The registrant is responsible for managing the controlled substances in accordance with all regulatory requirements including security, inventory, and recordkeeping.

1. Facility Security

Regardless of schedule, all controlled substances must be kept under lock and key, in a substantially constructed cabinet or safe, and accessible only to authorized personnel. Storage cabinets must be heavy enough to be essentially immovable or built into the structure of the building. Doors must not be prone to forced opening by prying tools, or easily removable at the hinges. Wood or laminate casework is not likely to provide adequate security (Figure 9.1).

Keep the controlled substances locked in their storage locations except for the time required for authorized staff to remove, work with, and replace them.

Schedule I and II substances have the highest security requirements, and must be stored in an approved safe, steel cabinet, or vault. There are specific facility security requirements for researchers and analytical laboratory personnel who are not practitioners versus practitioner requirements.

Please contact EHS if you have questions about whether your facility security is adequate.

Figure 9.1. Left: Sturdy lockable steel cabinet for storage of controlled substances. Middle: Safe that is anchored to the wall and approved for Schedule I-II controlled substances. Right: Wood laminate casework island with drawers that could be pried open, and laminate wall cabinets with glass doors; no appropriate areas for secure storage of controlled substances.

2. Personnel Security

For substances in Schedules II-V, the registrant may authorize additional personnel to use the substances for approved activities. The registrant is required to screen these employees prior to authorization, using the following questions for non-practitioners who seek access to DEA controlled substances (ref. 21 CFR 1301.90):

• 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?
• Have you had an application for registration with the DEA denied, revoked, or surrendered for cause?

Use the questionnaire in Appendix 9-A to record these answers. Registrants must maintain the answers to these screening questions for authorized personnel in a secure place, away from the purview of unauthorized personnel.

Schedule I substances may not be issued to anyone other than the registrant or used by anyone other than the registrant. If additional personnel need to use Schedule I substances, they must individually register with NC-DHHS, Drug Control Unit and DEA.

3. Inventory and Recordkeeping

Registrants must maintain complete and accurate inventory records for all controlled substances. These records must be in or near the primary work area, separate from all other records and documents, and available for inspection during regular work hours.

Records must include at least the following information:

1. Receipt of Controlled Substance: A separate and current record indicating the date received, name and address of supplier, the type, strength, and concentration of substance, and the amount received. The person receiving the substance must sign each record.
2. Use of Controlled Substance: A separate and current record for the storage and use of each controlled substance, indicating the starting quantity, use date, building and room, specific research experiment or analysis, type and strength used, and the quantity used. Each use is a subtraction from the starting quantity, and the running amount must equal the total amount remaining. The person working with the substance must sign each record of use. Because these records require subtracting balances as the substances are used, they are often called “substance balance log sheets”. See Appendix 9-B for an example of a substance balance log sheet. If dilutions are being made and kept by the laboratory, dilutions must also be logged in a substance balance log to keep track of all use of the materials.
3. Inventory of Controlled Substance: In addition to the balance log records, initial and biennial inventory records are required for all controlled substances. These shall include the name of each substance, each finished form of the substance (solid, tincture, inhalant, etc.), the number of units or volume of each finished form, and the number of containers of each finished form. Damaged, defective, expired, or impure substances awaiting disposal must be included in the inventory until they are disposed. See Appendix 9-C for an example biennial inventory sheet.
4. Labeling of Controlled Substances: All containers of controlled substances must be individually identified by the following information:
   1. The name and schedule of the controlled substance.
   2. The lot number (or tracking number) of the product. This is unique and not a reusable number.
   3. The date reconstituted (powders) or combined with other substrates.
   4. The final concentration.
   5. The quantity of the controlled substance(s) per container.
   6. The expiration date (per manufacturer or most recent date of combined substance).
   7. The name of the Registrant for the controlled substance.

The original packaging for the controlled substance(s) should be utilized whenever possible. Containers (i.e., vials, ampoules) may be removed from the original packaging if the marking on the exterior of the vials or ampoules provide the above information or can be added to the container as appropriate.

5. Recording Waste Disposal: Any controlled substances that are declared unwanted products or expired still within their stock or manufacturer bottle must be destroyed and rendered irretrievable prior to disposal as a chemical waste. A controlled substance witnessed destruction must be completed by the registrant. The registrant must contact the University EHS Department Chemical Safety Office (chemsafety@ehs.unc.edu) to schedule a witnessed destruction. Each controlled substance destruction must be witnessed by EHS in addition to the NC Drug Control Inspector (DCI) regardless of quantity. The EHS and NC DCI witness must sign DEA Form 41 confirming the date of the destruction and subsequent disposal of the controlled substances involved. The registrant will keep the original copy of the completed DEA Form 41 and a copy of the completed DEA Form 41 should be sent to the NC DCI; a copy of the DEA Form 41 must also be transmitted to the EHS Chemical Safety Office.

If the registrant is not available to perform the destruction (for example, the registrant has left the institution, or is deceased), the laboratory manager must contact the University EHS Department Chemical Safety Office to arrange for an official to witness the destruction of the controlled substance(s) prior to disposal. The laboratory manager should also contact the DEA Diversion Control at (336) 632-4297 to inform them about the controlled substance and the registrant. Security for any found controlled substance(s) must follow all requirements of this document and any applicable state and federal regulations.

The registrant must maintain all the above-referenced records for a period of at least three years from the date of the last entry. In the event of an audit by DEA or NC-DHHS Drug Control Unit, the registrant must produce these records.

4. Loss, Theft, or Misuse

If controlled substances are lost, stolen, or used in an unauthorized manner, the registrant must immediately contact the UNC Police at 919-962-8100 (or 911), and the DEA Office of Diversion Control in Greensboro, phone number (336) 632-4297. The DEA staff will let you know whether you need to fill out a copy of DEA Form 106: Report of Theft or Loss of Controlled Substances. Complete Form 106 online and submit electronically via the internet to DEA Headquarters.

Diversions are likely to trigger audits. Please follow the facility and personnel security measures outlined above to reduce the chances of loss, theft, or misuse of controlled substances.

D. Waste Disposal

The registrant must account for all controlled substances prior to their destruction and disposal. The registrant must document the destruction and disposal of all controlled substances according to federal and state regulations. All controlled substances determined to be waste shall be destroyed and disposed of by the one of the following methods:

Waste/Contaminated Product (e.g. unused part of injection or ampule, or expired or unused dilutions):

In cases where small amounts of controlled substances are left over from an experiment or procedure, the registrant may properly dispose of the unused materials according to methods below:

6. Residue Powders: Mix powders with a liquid (e.g. Drug Buster®, bleach or other disinfectant) ensuring that the mixture is depleted of solids. Next, pour this new liquid onto absorbent material (e.g. soda-sorb, kitty litter) and contact the EHS Hazardous Materials Manager (919-962-5509) for incineration disposal.
7. Liquids: Pour onto absorbent material (e.g. soda-sorb, kitty litter) and contact the EHS Hazardous Materials Manager (919-962-5509) as described above for proper disposal methods.
8. Empty Bottles: Deface the label entirely and throw in sharps container for incineration or in container with absorbent material for incineration. Bottles with excess powder can be rinsed with a liquid (e.g. bleach or other disinfectant). All liquids must be placed onto absorbent material and disposed of as described above. This does not apply for Schedule 1 controlled substances.
9. Patches: Cut into small pieces and place in sharps container for incineration or use Drug Buster, ensuring that the mixture is depleted or solids. Next, pour this new liquid onto absorbent material (e.g. soda-sorb, kitty litter) to render irretrievable and contact the EHS Hazardous Materials Manager (919-962-5509) for incineration and disposal.
10. Syringe: Inject materials onto absorbent material (e.g. soda-sorb, kitty litter) and contact the EHS Hazardous Materials Manager (919-962-5509) as described above for proper disposal methods.

Note: Do not place any substances down the sink drain. Drug Buster®, kitty litter, and disposal containers can be provided by EHS upon request. All expired drugs can be stored for disposal as long as they are clearly labeled, “expired” AND segregated (e.g. Ziploc® bag) from all unexpired product. Record these trace amounts in your disposition record as waste.

Expired/Unwanted Product (e.g. >0.5 ml or mg by volume in leftover multiuse vials or bulk powder containers, unused tablets, capsules, ampules, or vials):

In cases where product is unwanted or expired, registrants must contact the University EHS Department Chemical Safety Office (chemsafety@ehs.unc.edu) to schedule a witnessed destruction. If large quantities of controlled substances are identified, (e.g. abandonment or retirement), registrants may also need to contact a DEA certified reverse distributor to arrange for reverse disposal. Because this list changes due to registration requirements, please contact NC-DHHS, Drug Control Unit at NCCSAREG@dhhs.nc.gov or DEA Diversion Control at (336) 632-4297 or the EHS Chemical Safety Office (chemsafety@ehs.unc.edu) for approved vendors.

Controlled Substances Found on Campus with No Registrant:

11. Secure any controlled substances by locking them in your controlled substances cabinet, lockable safe or desk drawer. Contact the Department Chair and the Chemical Hygiene Officer (919-962-9061) to make them aware of the found substance.
12. EHS will then contact the local DEA agent to arrange for a witness to the destruction of the found controlled substance(s). Please document this communication and contact the EHS Chemical Safety Office (chemsafety@ehs.unc.edu) for help and any additional instruction.

E. Importing and Exporting Controlled Substances

If you plan to import controlled substances into the United States, or export them out of the United States, you must complete additional forms. See the Import/Export pages of the DEA Office of Diversion Control website for additional information.

III. Appendices

• Appendix 9-A: Questionnaire for Personnel who will have Access to Substances Regulated by the U.S. Drug Enforcement Administration
• Appendix 9-B: Continuing Record for Acquisition and Disposition of Controlled Substances
• Appendix 9-C: Inventory of Controlled Substances

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Proceed to Chapter Ten