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UAMS ADMINISTRATIVE GUIDE
NUMBER: 16.1.13 DATE: 12/14/2009
REVISION: PAGE: 1 of 10
SECTION: RESEARCH
AREA: RESEARCH ADMINISTRATION
SUBJECT: NON-HUMAN RESEARCH USE OF DEA CONTROLLED
SUBSTANCES
PURPOSE
The purpose of the UAMS Non-Human Research Use Controlled Substances Policy is to ensure
compliance with state and federal regulations governing the use of Drug Enforcement Agency
(DEA) controlled substances.
SCOPE
This policy covers all UAMS research faculty operating on the UAMS campus.
POLICY
1. Scope of Use
The Controlled Substance Act (CSA) places all substances which were in some manner regulated
under existing federal law into one of five schedules. The placement is based upon the
substance’s medical use, potential for abuse, and safety or dependence liability. UAMS requires
that all individuals conducting non-human research activities with DEA controlled substances
be registered with the DEA and Arkansas Department of Health Pharmacy Services and Drug
Control (ADH) and comply with state and federal regulations regarding the acquisition, storage,
use and disposal of those substances.
2. Responsibilities
Each principal investigator or faculty* conducting non-human research with DEA controlled
substances will be responsible for registering with the DEA and ADH and for assuring
compliance with applicable state and federal regulations. The registrant may not allow the
permit to lapse until all controlled substances are spent, disposed of, or transferred to another
registered person.
*NOTE: “Department” registration is acceptable if one member of a Department is willing to
obtain the registration and assume responsibility for all use of the controlled substances approved
under the registration.
Occupational Health and Safety will be responsible for assisting individuals in complying with
applicable rules and regulations. This will include educating researchers about the requirements,
assisting them as necessary during implementation, and providing regular oversight to insure
compliance is being maintained.
GENERAL INFORMATION & PROCEDURES
1. Registration
All investigators conducting non-human research with DEA controlled substances must be
registered with the DEA and ADH. Investigators requesting to use controlled substances on
laboratory animals must also submit a written request and receive approval from the Institutional
Animal Care and Use Committee (IACUC) for this use.
DEA Schedule http://www.deadiversion.usdoj.gov/schedules/schedules.htm
ADH Schedule http://www.healthyarkansas.com/rules_regs/controlled_substances_list_2006.pdf
Registration Instructions - DEA
Every person conducting research activities with a controlled substance is required to register
with the Drug Enforcement Agency (21 CFR 1301.11). Re-registration is required annually.
State employees are exempt from the registration fee (see 21 CFR 1301.21 or instructions on
application Form 225).
For Schedule II, Schedule III, Schedule IV and Schedule V Substances, complete and submit
DEA Form 225.
For Schedule I substances, in addition to DEA Form 225, the applicant is required to submit 3
copies of the research protocol (see 21 CFR 1301.18 or instructions on application Form 225). It
is recommended that any individual or Department planning to use Schedule I and II substances
in their research contact the local DEA office to request a site visit to discuss required security
measures before acquiring the Schedule I and/or II substances.
Medical Physician “Practitioners” may also conduct research and instructional activities under
their dispensing and instructing registration. DEA Form 224 should be used to register with the
DEA. Re-registration is required every three (3) years.
DEA Forms http://www.deadiversion.usdoj.gov/
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Registration Types (Excerpt from Chart in 21 CFR 1301.13)
Type Schedule Application Expires Approved for
Form In
iv) Dispensing or Schedules II- New--224 3 years May conduct research and instructional activities
instructing (includes V Renewal--224a with those substances was granted, except that a mid-level
Practitioner) practitioner may conduct such research only to the extent
expressly authorized under state statute.
(v) Research Schedule I New--225 1 year A researcher may manufacture or import the basic class of
Renewal--225a substance or substances for which registration was issued,
provided that such manufacture or import is set forth in the
protocol required in Sec. 1301.18 and to distribute such class to
persons registered or authorized to conduct research with such
class of substance or registered or authorized to conduct
chemical analysis with controlled substances.
(vi) Research Schedules II- New--225 1 year May conduct chemical analysis with controlled substances in
V Renewal--225a those schedules for which registration was issued; manufacture
such substances if and to the extent that such manufacture is
set forth in a statement filed with the application for registration
or re-registration and provided that the manufacture is not for
the purposes of dosage form development; import such
substances for research purposes; distribute such substances
to persons registered or authorized to conduct chemical
analysis, instructional activities or research with such
substances, and to persons exempted from registration
pursuant to Sec. 1301.24; and conduct instructional activities
with controlled substances.
Registration Instructions – ADH
In addition to the DEA registration, individuals in the state of Arkansas conducting research
activities with controlled substances must also register with the Arkansas Department of Health
Pharmacy Services and Drug Control (ADH).
ADH Forms For Application for Controlled Substances Registration contact ADH at
501-661-2325.
ADH Regulations
http://www.healthyarkansas.com/rules_regs/controlled_substances_july_2
005.pdf
Notes
• For investigators using Schedule I substances in animal research, a copy of the DEA
Application and research protocol must be submitted to the IACUC. Following review, the
IACUC will provide institutional approval as appropriate.
• DEA Form 222 must be used for procurement of Schedule I and II substances. DEA Form
222 is available on the web at
https://www.deadiversion.usdoj.gov/webforms/orderFormsRequest.jsp Note: these forms are
issued specifically to each DEA registrant and includes registration specific information.
• A separate registration is required for each principal place of business or professional
practice at one general physical location where controlled substances are manufactured,
distributed, imported, exported, or dispensed by a person. (21 CFR 1301.12)
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2. Employee Screening Procedure
Agents of the registrant may engage in approved activities under the direction of the registrant.
The registrant is required to screen those employees prior to authorization. As part of the
screening process, a questionnaire which includes the following questions (21 CFR 1301.90)
must be completed for each non-practitioner having access to DEA controlled substances:
• 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 3 years, have you knowingly used narcotics, amphetamines, or barbiturates other
than those prescribed to you by a physician?
Fill out one questionnaire for each employee (non-practitioner) who is authorized by the
registrant to handle DEA controlled substances under his or her direction. The registrant should
maintain this documentation for the duration of the employee’s employment.
In the event an employee provides a “YES” response on the questionnaire, the registrant
(investigator) is advised to contact the UAMS Office of Human Resources to discuss how to
proceed.
3. Investigator Responsibilities
As a DEA and ADH registrant for controlled substances each investigator is responsible for
managing the controlled substances in accordance with the requirements of the regulations
including inventory, record keeping, security, and disposal provisions.
Initial Inventory [21 CFR 1304.11(e)(4)]
[Note 21 CFR 1304.11(e)(4) refers back to 1304.11(e)(1)(iii) and (iv)]
Initial (at time of receipt) and biennial (two year) inventories are required for controlled
substances. Initial inventories must be performed each time a new controlled substance is added
to the inventory. An initial inventory shall include [1304.11(e)(1)(iii)]:
• Name of each substance
• Each finished form of the substance (e.g., 10 mg tablet or 10 mg concentration/mL)
• Number of units or volume of each finished form in each container.
• Number of containers of each finished form (e.g., six 3-mL vials).
Damaged, defective, expired, or impure substances awaiting disposal must also be inventoried
including name, total quantity, and the reason why the substance is being maintained. [21 CFR
1304.11(e)(1)(iv)]
After the initial inventory, a new inventory must be taken at least every two years. The biennial
inventory date must be within two years of the last inventory. Inventories and records for
schedule I & II substances are required to be maintained separately from all other records
of the registrant. Records and inventories of all controlled substances must be maintained at the
registered location.
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Real-Time Inventory (Continuing Record Use Log) [21 CFR 1304.22(c)]
[Note 21 CFR 1304.22(c) refers back to 21 CFR 1304.22(a)(2)(i), (ii), (iv), (vii) and (ix)]
To ensure accountability, a complete and accurate continuing record (e.g., real-time inventory) is
required for each substance and must be maintained on a current basis. It is the investigators’ or
his/her designee’s responsibility to audit the controlled substances on a day of use basis.
Continuing records should be kept for 2 years after the substance is spent. It should include:
• Date of receipt
• Name of the substance
• Each finished form of the substance (e.g., 10 mg tablet or 10 mg concentration/mL)
• Number of units or volume of each finished form in each container.
• Number of containers of each finished form (e.g., six 3-mL vials).
• Date of dispensing, units or volume dispensed, units or volume remaining in container, name
or initials of the individual who dispensed or administered the substance.
• If substance is acquired from, or distributed to another person, their name, address and DEA
registration number must be recorded along with date and number of units acquired or
distributed.
• If substance is disposed of, include date, manner of disposal, and quantity of substance
disposed. Keep disposal records for at least two years. (Note: Substances must be disposed
via ADH Pharmacy Services only. UAMS onsite disposal is not approved. Contact OHS
regarding disposal of expired or unused substances.)
Note: Example Inventory Form and Continuing Record Use are available for use. These forms
are not required forms but examples; they may be used to remain in compliance with
recordkeeping requirements.
Record Keeping Requirements
Inventories (biennial and real-time/continuing records) and other records including copy of
certificate of registration, purchase orders, copy of DEA Form 222 (if applicable), loss records,
and screening questionnaires must be kept at the registered location and made available to OHS
and IACUC if requested during a compliance audit review.
4. Labeling
If controlled substances are removed from their original packaging and compounded, diluted or
combined, each new container must be labeled and tracked. The label must include: the name of
the controlled substance, the lot number (or tracking number), the date opened, the final
concentration, the amount per container and the expiration date.
5. Security
Registrants shall provide effective controls to guard against the theft or diversion of controlled
substances. Substances are required to be stored under double-lock security in a substantially
5
constructed permanently mounted cabinet or safe (See Arkansas State Board of Health’s
Rules and Regulations pertaining to Controlled Substances, Section III, Security Requirements).
Registrants are required to report any significant loss or thefts to the local DEA office (Little
Rock) by using DEA Form 106. Immediate notification must also be made to ADH by calling
501-661-2325 and faxing DEA Form 106 to 501-661-2769. Thefts must be reported whether or
not the controlled substances are subsequently recovered and/or the responsible parties are
identified and action taken against them.
DEA Form 106 https://www.deadiversion.usdoj.gov/webforms/dtlLogin.jsp
Registrants must also be aware of the requirements of 21 CFR 1301.91 Employee responsibility
to report drug diversion. This regulation states: “Reports of drug diversion by fellow employees
is not only a necessary part of an overall employee security program but also serves the public
interest at large. It is, therefore, the position of DEA that an employee who has knowledge of
drug diversion from his employer by a fellow employee has an obligation to report such
information to a responsible security official of the employer. The employer shall treat such
information as confidential and shall take all reasonable steps to protect the confidentiality of the
information and the identity of the employee furnishing information. A failure to report
information of drug diversion will be considered in determining the feasibility of continuing to
allow an employee to work in a drug security area. The employer shall inform all employees
concerning this policy.”
6. Disposal
All DEA controlled substances must be accounted for upon their disposal. Empty syringes and
vials may be discarded in laboratory sharps containers. All unused or expired substances must be
surrendered to ADH Pharmacy Services. Form PHA:DC-1 Report of Drugs Surrendered must
be completed and must accompany the drugs when surrendered in person to ADH Pharmacy
Services at 4815 West Markham, Little Rock, AR. Contact OHS for the form. Keep all disposal
records for at least two years.
7. Audits
Compliance with applicable rules and regulations will be reviewed during the semi-annual
laboratory audits conducted by the Institutional Animal Care and Use Committee (IACUC) as
well as the routine semi-annual laboratory audits conducted by Occupational Health and Safety
(OHS).
OHS will issue notifications of noncompliance for Research Compliance. Responses to the items
of noncompliance will be submitted to OHS with OHS performing follow-up audits as necessary.
In the event a response is not submitted within 30-days or an item is not corrected, OHS will
notify the registrant’s Department Chair, Dean, or Vice Chancellor to request their assistance in
obtaining a response or correction of the item of noncompliance. Consequences for continued
noncompliance will be determined by the Department Chair, Dean or Vice Chancellor.
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DEA PHONE NUMBERS & CONTACTS
501-217-6500 Ph
Little Rock, AR:
501-217-6597 Fax
New Orleans Field Division 504-840-1100 Ph
Metairie, LA 70002 504-840-1076 Fax
Washington, D.C.: 1-800-882-9539
ADH PHARMACY SERVICES NUMBERS & CONTACTS
4815 W. Markham, Slot 25 501-661-2346
Little Rock, AR72205
Date: January 14, 2010
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UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES
NON-HUMAN USE OF CONTROLLED SUBSTANCES
NON-PRACTITIONER EMPLOYEE SCREENING QUESTIONNAIRE
Instructions: A separate questionnaire must be filled out by the registrant and for each
employee (non-practitioner) who is authorized by the registrant to handle DEA controlled
substances under his or her direction.
The Drug Enforcement Agency requires that any non-practitioner who will have access to controlled
substances under the direction of the registrant as a result of his or her status as an employee or agent of
the University of Arkansas for Medical Sciences answer the following questions. Any false information
or omission of information may jeopardize your position with respect to employment. Information
revealed by this questionnaire will not necessarily preclude employment, but will be considered as part of
an overall evaluation of your qualifications. The responses to this questionnaire will be held in strictest
confidence.
1. In the past five years have you been convicted of a felony or within the past two years of any
misdemeanor or are you presently charged with committing a criminal offense? (Do not include
traffic violations, juvenile offenses or military convictions, except by general court-martial.) If
the answer is yes, furnish details of conviction, offense, location, date, and sentence.
Yes _____ No _____
2. In the past three years, have you ever knowingly used any narcotics, amphetamines or
barbiturates, other than those prescribed to you by a physician? If the answer is yes, furnish
details.
Yes _____ No _____
_____________________________________ ____________________________________
Signature (Employee) Name (Print)
_____________________________________ ____________________________________
Signature (Registrant - Principal Investigator) Name (Print)
_____________________________
Date
UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES
NON-HUMAN USE OF CONTROLLED SUBSTANCES
CONTROLLED SUBSTANCES INVENTORY FORM
Principal Investigator/Researcher: ____________________________ Department: _____________________________
DEA License #: ______________________ Expiration Date: ______________ AR License #: _________________
Date: ___________________________ Initial Inventory (at time of receipt) ____ Biennial Inventory ____
[Columns 1-5 and 9] [Columns 1-9]
1 2 3 4 5 6 7 8 9
Controlled Strength Quantity Number Tracking Expected Actual Inventory Discrepancy Initials
Or Or of Quantity Or Volume Amount*
Substance Containers Number Amount
Dosage Volume From Use Log/ On Hand
Name 10 mg tablet 50 tablets Continuing
10 mg/ml 50 mg Record
Opened Unopened
*Explain all discrepancies between Expected Amount and On-hand Amounts. If necessary report loss/theft.
Page ____ of ____
UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES
NON-HUMAN USE OF CONTROLLED SUBSTANCES
CONTROLLED SUBSTANCES CONTINUING RECORD USE LOG
Drug Name: ____________________________ Lot/Serial # _______________ Schedule (I-V): __________ Expiration Date: _________________
Form: ___________________ Strength/Dosage: __________ Initial Quantity/Volume _________ Lab Assigned Tracking # _________________
One log sheet must be completed for each container of Controlled Substance. If the material is converted or diluted, start a new log form to track that usage,
reference the original container’s lot or serial # and original lab assigned tracking #.
Date Quantity Quantity Balance Initials If Wasted Notes
Dispensed Wasted Secondary
Verification
Initials
*Explain all discrepancies between Expected Amount and On-hand amounts. If necessary report loss/theft.
Page ____ of ____
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