Washington State University
BUSINESS POLICIES AND PROCEDURES MANUAL

RESEARCH
45.75
New 12-13
Office of the Campus Veterinarian
335-6246

Controlled Substances

PDF link

POLICY

This policy addresses obtaining, using, storing, recordkeeping, dispensing, and disposing of controlled substances at WSU. This policy provides information and procedures to enable individuals and departments to comply with state and federal law and to meet applicable safety standards.

This policy does not supersede state or federal law. In the case of any inconsistency, state and federal law govern.

NOTE: This policy does not apply to licensed pharmacies or pharmacists at WSU. Any entity or individual licensed as a pharmacy or pharmacist must follow all laws, rules, and regulations that pertain to that license.

Improper storage, recordkeeping, dispensing, or disposal of controlled substances may result in civil and criminal liability, which may include incarceration, or license suspension or revocation.

This policy includes the following subsections:

DEA CRITERIA

Controlled substances are drugs or other chemicals that have the potential to be addictive or habit forming. The U.S. Drug Enforcement Administration (DEA) has separated controlled substances into five schedules based on potential to be habit forming and usefulness in medicine. To view the comprehensive DEA schedule, go to:

http://www.deadiversion.usdoj.gov/schedules/index.html

Below are the criteria established by the DEA for narcotic and nonnarcotic controlled substances.

Schedule I

Schedule I substances are defined as drugs or other substances that have:

Examples

Examples of Schedule I substances include: heroin; marijuana.

Schedule II

Schedule II substances are defined as drugs or other substances that:

Examples

Examples of Schedule II substances include: methamphetamine; pentobarbital.

Schedule III

Schedule III substances are defined as drugs or other substances that:

Examples

Examples of Schedule III substances include: beuthanasia solution; ketamine; testosterone.

Schedule IV

Schedule IV substances are defined as drugs or other substances that:

Examples

Examples of Schedule IV substances include: Valium; butorphanol.

Schedule V

Schedule V substances are defined as drugs or other substances that:

Examples

Examples of Schedule V substances include: pregabalin; not more than 100mg of opium per 100ml, or per 100g.

RESPONSIBILITIES

Every person who engages in research with controlled substances must be registered with the DEA and the Washington State Board of Pharmacy or be an authorized user under an existing registrant.

Registrants are responsible for:

NOTE: State laws may be more restrictive than federal laws. The stricter law applies.

REGISTRATION

Controlled substance use in Washington requires participating individuals and/or departments to register with both the federal Drug Enforcement Administration (DEA) and the Washington State Department of Health Board of Pharmacy.

NOTE: DEA registration requires prior registration with the Washington State Department of Health Board of Pharmacy.

Washington State Department of Health Board of Pharmacy Registration

Prior to registering with the DEA, applicants in the state of Washington must obtain controlled substance researcher registration from the Washington State Department of Health (DOH) Board of Pharmacy. There is an annual registration fee. The state fee may not be waived. The current fee schedule is available from the DOH Controlled Substance Research Fee Schedule website:

http://tinyurl.com/m4p6f6q

Different registrations are required for different activities involving controlled substances. Further, one registration type may not cover two different activities, such as research with controlled substances and dispensing of controlled substances. The required forms and detailed instructions are available on the DOH Controlled Substance Researcher website:

http://tinyurl.com/nyfsn59

Upon completion and approval of the state registration, the Board of Pharmacy issues a state license and number to the applicant. The applicant must include the state license number on the DEA registration application.

DEA Registration

As with state registration, different activities may require different DEA registration types.

Forms

The required forms and detailed instructions are available on the DEA website:

http://www.deadiversion.usdoj.gov/drugreg/reg_apps/index.html

Research or Laboratory Chemical Analysis

To conduct research on, or with, controlled substances in Schedules II-V or to conduct analysis with controlled substances listed in any schedule, applicants complete:

Dispensing Controlled Substances and/or Instructional Activity

To obtain authorization to dispense controlled substances on any schedule for clinical and hospital use (including clinical research) or to conduct instructional activity only with Schedule II-V controlled substances, applicants complete:

Required Information

On all DEA registration forms, University applicants must:

An employee of a federal or state agency, e.g., WSU, who is required to obtain DEA registration in order to carry out his or her duties is exempt from DEA registration fees.

SCREENING EMPLOYEES

Authorized users (i.e., designated employees) of the registrant (e.g., principal investigator (PI)) may engage in approved activities under the direction of the registrant. Approved activities may include:

Such access is defined as use, control, or possession of a key to the storage unit or the means to unlock the storage unit.

The registrant must screen potential authorized users prior to assigning work with controlled substances. (See "Authorized User Questionnaire" below.)

Criminal Records

DEA recommends that registrants conduct inquiries concerning employees' criminal records.

Authorized User Questionnaire

Before allowing an authorized user access to controlled substances, the registrant must require the applicant to complete a questionnaire as part of the screening process. The questionnaire is mandated and providing access to persons who would answer "yes" to any of the questions is a violation of federal law. (21 CFR 1301.90)

The registrant must have each employee who is authorized by the registrant to handle DEA controlled substances under the registrant's supervision complete a questionnaire. The registrant must have each new hire complete a questionnaire before he or she is allowed to handle DEA controlled substances.

The registrant must keep completed questionnaires on file at the registered location, as per the state and DEA registration forms.

Obtaining Form

Complete and/or print the PDF master form on 45.75.13 to obtain copies of the University's Authorized User Questionnaire.

ORDERING SUBSTANCES

Schedule I or II

Any person registered to conduct research or otherwise work with Schedule I or II controlled substances must use DEA Form 222 (Official Order Form) to place an order for such chemicals. NOTE: See additional procedures on below regarding orders for Schedule I controlled substances that are not commercially available.

To obtain DEA Form 222, go to:

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

NOTE: The registrant must personally order and receive any Schedule I or II controlled substances. The registrant may not delegate this duty to another employee.

To place an order:

Additional Instructions

Further instructions regarding completing DEA Form 222 are available at:

http://www.deadiversion.usdoj.gov/faq/dea222.htm

Schedule I Substance That is Not Commercially Available

To obtain a Schedule I controlled substance that is not commercially available, the registrant must submit a request to the National Institute on Drug Abuse (NIDA); by telephone to 301-443-1124; or through the National Institute on Drug Abuse website at:

http://www.drugabuse.gov/

Select the NIDA Drug Supply Program link.

Schedule III - V

University registrants may order Schedule III-V controlled substances using WSU's normal purchasing procedures and documentation.

In accordance with University policies and procedures, registrants may use Department Orders (see 70.07) or Departmental Requisitions (see 70.10) to place orders for Schedule III-V controlled substances. Registrants are not to purchase controlled substances with purchasing cards (see 70.08.)

The registrant must ensure that DEA registration numbers for both the supplier and the recipient are included on the order documentation and the invoice.

All invoices for controlled substances must be identified with a red letter “C”, no less than one inch high on the bottom right corner of the invoice document. The required order and invoice documents are described below.

RECORDKEEPING REQUIREMENTS

The following records should be maintained at the registrant's location (as identified on the registration).

If the registrant wishes to maintain controlled substance records at a central location other than the registered location, he or she must send a notification to the DEA. Requirements regarding the information that must be submitted in the notification is available in the Code of Federal Regulations, 21 CFR 1304.04.

Retention Requirements

For minimum retention requirements for controlled substance records, see the All-University Records Retention Schedule: Safety Records table on 90.01.49-53.

For further information regarding University records retention and disposition, see 90.01. For minimum retention requirements for other applicable University records, refer to the other All-University Records Retention Schedule tables at the end of 90.01.

Controlled Substance Tracking

Registrants must maintain the following in a separate, bound and sequentially numbered tracking document for each controlled substance. Each tracking document must include:

The registrant must maintain records for Schedule I and II controlled substances separately from records for Schedule III-V controlled substances.

See the sample controlled substance tracking record in the PDF version of 45.75.9.

NOTE: It is a felony for a registrant to provide a controlled substance to a person who is not registered with the DEA or is not one of the registrant's authorized users. A transfer of controlled substances may occur between two DEA registrants only. A transfer of Schedule I or II controlled substances must be accompanied by a DEA Form 222 (Official Order Form) completed by the registrant receiving the substances.

Inventory Procedures

Each registrant must complete an inventory annually as required by the Washington Board of Pharmacy. The registrant must:

Inventory Record Form

To obtain copies of the Controlled Substance Inventory Record, complete and/or print the PDF master form on 45.75.14.

Required Inventory Data

The inventory is to include the following information, based upon the types of controlled substances maintained.

Commercially Purchased

For commercially-purchased controlled substances, i.e., controlled substances obtained in a finished form, the inventory records must include the following:

NOTE: Schedule I and II substances must be separated from other substances on the inventory.

Damaged, Defective, Impure, or Not Commercially Purchased

For damaged, defective, or impure substances, and/or substances that were not commercially purchased, the inventory records must include an exact count of the dosage units or the container must be graduated to reflect its content. Such inventory records must also include the following:

SECURITY

Theft or Loss

If there is a theft or loss of controlled substances, the registrant must notify the Washington State University Police (or the local police department, if no University Police department is available at the location). The notification must occur as soon as the theft or loss is discovered.

The registrant must notify the area DEA Field Office in writing within one business day of the discovery of the theft or loss. The registrant must also complete and submit a DEA Form 106 (Report of Theft or Loss of Controlled Substances) to the area DEA Field Office and send a copy of the completed form to the Washington State Board of Pharmacy. (21 CFR 1301.76; WAC 246-887-020)

To obtain DEA Form 106, go to:

http://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html

Storage

Storage locations must be consistent with the locations identified on the registrant licenses. Registrants are generally permitted to keep controlled substances in substantially constructed, double-locked cabinets or safes, as described below. Narcotics cabinets are strongly recommended, to ensure that the registrants' storage complies with regulations.

It is unacceptable for a registrant to leave the keys to the cabinet in the laboratory. Keys allowing access to controlled substances must be in the possession of the registrant.

Schedules III-V

For Schedules III-V, registrants must keep controlled substances in a substantially constructed, double-locked cabinet or safe.

Schedules I and II

For Schedules I and II, registrants must keep the controlled substances in a substantially constructed, double-locked cabinet that cannot be easily forced open, with the cabinet secured to a wall or otherwise not removable.

For specific information regarding physical security requirements, see 21 CFR 1301.71 to -.76.

DISPOSAL

When a DEA registrant has a controlled substance that is expired or unwanted, the registrant must contact Environmental Health and Safety (EH&S) at WSU Pullman for the disposal of the substance. WSU Pullman EH&S is the University's registered DEA reverse distributor. (See also SPPM 5.66.)

EH&S disposes of the controlled substances using DEA- and DOH-approved procedures.

For additional assistance or questions about controlled substance disposal, contact EH&S; telephone 509-335-3041.

ABANDONED CONTROLLED SUBSTANCES

Under no circumstances is a DEA registrant to abandon controlled substances.

Faculty are to follow the procedures in 60.38 prior to termination of employment to ensure that materials are properly disposed of or transferred.

If controlled substances are abandoned, contact the Office of the Campus Veterinarian for assistance. Substances are to be disposed or transferred. The Office of the Campus Veterinarian determines the applicable procedures on a case-by-case basis.

See the PDF forms:
45.75.13: Authorized User Questionnaire
45.75.14: Controlled Substance Inventory Record
Complete and/or print as needed.