UNIVERSITY HOUSTON

advertisement
UNIVERSITY of HOUSTON
MANUAL OF ADMINISTRATIVE POLICIES AND PROCEDURES
SECTION:
AREA:
Safety
Specific Area Guidelines
Number: 06.04.01
SUBJECT: Clinical and Research Use of Controlled Substances and Dangerous
Drugs
I.
Formatted: Indent: Left: 0", Hanging: 1",
Tab stops: Not at 1.5"
POLICY AND SCOPE
A. A. The University of Houston strives to provide every opportunity for its employees and
students to attain excellence in their educational and employment experiences, and thereby
further the mission of the institution. The university recognizes that to help employees and
students realize these goals, it must provide safe environments conducive to employment
and educational activities. The university shall seek ways to minimize the hazards of working
with controlled substances and dangerous drugs in the university’s clinical and non-clinical
settings while meeting federal and state laws.
Formatted: Numbered + Level: 1 +
Numbering Style: A, B, C, … + Start at: 1 +
Alignment: Left + Aligned at: 0.5" + Indent at:
0.75"
Formatted: Indent: Left: 0.75", First line: 0"
B. It is the policy of the University to prohibit the unlawful purchase, manufacture, distribution,
possession, selling, storing, or use of a controlled substance or dangerous drug, in or on
premises or property owned or controlled by the University.
II.
B.
Nothing in this policy is to be construed as authorizing any individual to engage in any act
that such individual is not authorized or permitted to do under federal or state laws or
rules. Compliance with this policy is not to be construed as compliance with all applicable
federal or state laws or rules.
C.
Personal medication is exempt from the requirements of this guide if the drug was
obtained in accordance with the Texas Health and Safety Code, chapters 481 and 483.
D.
University registrants who use controlled substances and dangerous drugs in the
university’s clinical and non-clinical settings must obtain and keep current federal United
States Drug Enforcement Administration (DEA) and Texas Department of Public Safety
(DPS) registrations, unless exempted by law. Registrants are responsible for procuring,
maintaining security, keeping records, and disposing of controlled substances and
dangerous drugs in accordance with federal and state regulations and rules. The
registrant may not allow the permit to lapse until all controlled substances are spent,
disposed of, or transferred to another registered person.
DEFINITIONS
A.
Clinical setting: A setting where a controlled substance or dangerous drug is used in a
medical application.
B.
Controlled substances: A Substance, including a drug, an adulterant, and a dilutant, listed
in Schedules I-V or Penalty Groups 1, 1-A, 2 through 4 of the Texas Health and Safety
Code, chapter 481. The term includes the aggregate weight of any mixture, solution, or
other substance containing a controlled substance.
C.
Dangerous drug: Device or drug that is unsafe for self-medication and that is not included
in schedules I-V or penalty groups 1-4 of the Texas Health and Safety Code, Chapter
September 20, 1999; Revised August 31, 2006December 13, 2010
Page 1 of 17
Formatted: Numbered + Level: 1 +
Numbering Style: A, B, C, … + Start at: 1 +
Alignment: Left + Aligned at: 0.5" + Indent at:
0.75"
Clinical and Research Use of Controlled Substances and Dangerous Drugs
MAPP 06.04.01
Formatted: Font: (Default) Arial, Bold
481. The term includes a device or a drug that bears, or is required to bear, either of the
following labels:
III.
1.
“Caution: Federal law prohibits dispensing without prescription” or “Rx only” or
another label that complies with federal law; or
2.
“Caution: Federal law restricts this drug to use by or on the order of a licensed
veterinarian.”
D.
DEA: Federal United States Drug Enforcement Administration.
E.
DPS: Texas Department of Public Safety.
F.
Non-Clinical settings: A setting where a controlled substance or dangerous drug is used
in research or education which is not a clinical usage of the controlled substance or
dangerous drug.
G.
Registrant: Practitioner, physician, dentist, nurse, veterinarian, scientific investigator, or
other person licensed, registered, or otherwise permitted to distribute, dispense, analyze,
conduct research with respect to, or administer a controlled substance in the course of
professional practice or research in Texas.
PROCEDURES
University faculty or staff members who work with controlled substances and dangerous drugs
must obtain and keep current DEA and DPS registrations, unless exempted by law. Registrants
are also responsible for procuring, securing, maintaining records, and disposing of controlled
substances and dangerous drugs in accordance with federal and state guidelines.
A.
Registration Process
1. 1. A university faculty or staff member who qualifies as a registrant must obtain a
DEA registration application by calling (713) 693-3660, or 1-800-743-0595 or visit the
website
below
for
more
information:.
http://www.deadiversion.usdoj.gov/drugreg/index.html
Formatted: Numbered + Level: 1 +
Numbering Style: 1, 2, 3, … + Start at: 1 +
Alignment: Left + Aligned at: 1" + Indent at:
1.25"
Formatted: Indent: Left: 1.25", First line: 0"
2. Apply for a DEA registration number using DEA Form 225. The certifying signature
on the form must be the registrant’s supervisor. The business address should be
listed. The link to the application is found at the following web site:
http://www.deadiversion.usdoj.gov/drugreg/reg_apps/225/225_instruct.htm
Formatted: Left
Formatted: Font: (Default) Arial, 10 pt
Formatted: Font: (Default) Arial, 10 pt
Dr. ______________ (Registrant)
Environmental Health and Risk Management
University of Houston
4211 Elgin, Room 183
Houston, Texas 77204-1005
1.3. After receipt of a DEA registration number, apply for a DPS Registration.
2.
3.
a.
Application forms for a DPS registration may be obtained from:
4.
5.
Department of Public Safety
6.
Controlled Substances Registration Section
7.
P.O. Box 4087
8.
Austin, Texas 78773-0001
September 20, 1999; Revised August 31, 2006December 13, 2010
Page 2 of 17
Formatted: List Paragraph, Left, No bullets or
numbering
Formatted: Indent: Left: 1.25", No bullets or
numbering
Formatted: Strikethrough
Formatted: Indent: Left: 1", No bullets or
numbering
Formatted: Indent: Left: 1.25", No bullets or
numbering
Formatted: Indent: Left: 2", No bullets or
numbering
Clinical and Research Use of Controlled Substances and Dangerous Drugs
9.
10.
11.
c.
MAPP 06.04.01
Formatted: Font: (Default) Arial, Bold
(512) 424-2188
E-mail: tppcsr@txdps.state.tx.us
b. Registrants must furnish their DEA registration numbers on the DPS
application.
Apply for a DPS registration using DPS Form NAR-77. The certifying
signature on the form must be the registrant’s supervisor. The business
address should be listed. Please visit the following web site for additional
information:
http://www/txdps.state.tx.us/criminal_law_enforcement/narcotics/narccsr.htm
12. The proposed business address for non-clinical settings should be listed as:
13.
14. Dr. ______________ (Registrant)
15. Environmental Health and Risk Management
16. University of Houston
17. 4211 Elgin, Room 183
18. Houston, Texas 77204-1005
19.
20. 5.
Provide copies of current registrations, and subsequence renewal
registrations from DEA and DPS to the university’s Environmental Health and Risk
Management Department at EHRM 1005.
Schedule an inspection by the university’s Environmental Health and Risk
Management Department (EHRM) for the location where controlled substances or
dangerous drugs are to be stored/used. EHRM will provide the registrant written
confirmation when adequate security controls are in place. Individuals inspecting for
security measures will be trained in what constitutes adequate controls.
2.
A university faculty or staff member who qualifies as a registrant must obtain a
DEA registration application by calling (713) 693-3660 or visit the website below
for more information. http://www.deadiversion.usdoj.gov/drugreg/index.html
3.
Apply for a DEA registration number using DEA Form 225. The certifying
signature on the form must be the registrant’s supervisor. The proposed business
address for non-clinical settings should be listed as:
Formatted: Indent: Left: 1.25", No bullets or
numbering
Formatted: Indent: Left: 1.25", Hanging:
0.5", No bullets or numbering
Field Code Changed
Formatted: Indent: Left: 1.25", No bullets or
numbering
Formatted: Numbered + Level: 1 +
Numbering Style: 1, 2, 3, … + Start at: 1 +
Alignment: Left + Aligned at: 1" + Indent at:
1.25"
Formatted: Indent: Hanging: 0.5"
Dr. ______________ (Registrant)
Environmental Health and Risk Management
University of Houston
4211 Elgin, Room 183
Houston, Texas 77204-1005
4.
B.
Procurement Process
1.
For non-clinical settings
1.
a.
Registrant must use a DEA Form 222 to order controlled substances in
schedules I & II. A DEA Form 222 is issued only to a registrant who has a DEA
registration number, and can be obtained from the local DEA office.
Drug Enforcement Administration
1433 W. Loop South, Suite 600
Houston, TX 77027
September 20, 1999; Revised August 31, 2006December 13, 2010
Page 3 of 17
Formatted: Indent: Left: 1", Hanging: 0.5",
Numbered + Level: 1 + Numbering Style: 1, 2,
3, … + Start at: 1 + Alignment: Left + Aligned
at: 1.75" + Indent at: 2"
Clinical and Research Use of Controlled Substances and Dangerous Drugs
MAPP 06.04.01
Formatted: Font: (Default) Arial, Bold
(713) 693-3660
The List of Controlled Substances and Schedules can be reviewed at
http://www.deadiversion.usdoj.gov/schedules/index.html.
2.
b.
A DEA Form 222 is not required to order controlled substances in
schedules III – V.
3.
c.
Complete university purchasing documents and DEA form 222 if
required. The certifying signature on DEA Form 222 must be the registrant’s
supervisor. Fax or forward these documents and copies of current DEA and DPS
registrations to EHRM 1005 for approval. EHRM will verify information, approve
and then return these documents to the registrant or registrant’s business office.
Registrant must order through the Purchasing Department per UH MAPP
04.01.01.
d.
Formatted: Indent: Left: 2", First line: 0"
Formatted: Indent: Left: 1", Hanging: 0.5",
Numbered + Level: 1 + Numbering Style: 1, 2,
3, … + Start at: 1 + Alignment: Left + Aligned
at: 1.75" + Indent at: 2"
Formatted: Indent: Left: 1", Hanging: 0.5",
Numbered + Level: 1 + Numbering Style: 1, 2,
3, … + Start at: 1 + Alignment: Left + Aligned
at: 1.75" + Indent at: 2"
Verify the delivery address on the purchase order is
Dr._______________ (Registrant)
Environmental Health and Risk Management
University of Houston
4211 Elgin, Room 183
Houston, TX 77201-1005
e.
EHRM will receive all controlled substances and contact the registrant to
schedule delivery. EHRM will ensure items are properly logged in and
out.
f.
4.
The package will be delivered to the registrant by EHRM. The registrant
will be required to show one form of photo proof of identification. The
registrant will then verify the contents and sign for their controlled
substances order.
g.
A Dispensing Record Form (sample provided in Addendum B) must be
used as the controlled substance is dispensed. A copy of this form must be sent
to EHRM 1005 once the controlled substance is depleted or expired/disposed.
h.
2.
Dangerous Drugs, prescription drugs that are non-controlled substances,
can be ordered by registrants through routine purchasing procedures.
For clinical setting
a.
Registrant must use a DEA Form 222 to order controlled substances in
schedules I & II. A DEA Form 222 is issued only to a registrant who has
a DEA registration number, and can be obtained from the local DEA
office.
Drug Enforcement Administration
1433 W. Loop South, Suite 600
Houston, TX 77027
(713) 693-3660
b.
A DEA Form 222 is not required to order controlled substances in
schedules III – V.
September 20, 1999; Revised August 31, 2006December 13, 2010
Page 4 of 17
Formatted: Indent: Left: 1", Hanging: 0.5",
Numbered + Level: 1 + Numbering Style: 1, 2,
3, … + Start at: 1 + Alignment: Left + Aligned
at: 1.75" + Indent at: 2"
Clinical and Research Use of Controlled Substances and Dangerous Drugs
C.
MAPP 06.04.01
c.
Registrants must order controlled substances in schedules I – V through
the Purchasing Department per UH MAPP 04.01.01.
d.
Dangerous drugs, prescription drugs that are non-Controlled
Substances, can be ordered by registrants through routine purchasing
procedures.
Security Controls
Registrants are responsible for establishing and maintaining effective controls and
procedures to safeguard against controlled substances and dangerous drugs being
diverted from legitimate sources to the illicit market. Controlled substances and
dangerous drugs may only be used for a legitimate purpose as authorized by appropriate
university official(s). Registrants are directly responsible for:
1.
Establishing adequate security to prevent unauthorized access to controlled
substances and dangerous drugs.
2.
Establishing adequate security to prevent the diversion of controlled substances
and dangerous drugs.
3.
Not allowing any unauthorized individual access to controlled substances and
dangerous drugs storage areas.
4.
Storing controlled substances listed in schedules I-V in a locked office and in a
securely locked, substantially constructed cabinet, or security cabinet (i.e. not
easily broken into or moved; see 21 CFR 1301.71).
a.
A “substantially constructed cabinet” is a structure of wood or metal so
constructed as to resist easy entry by simple tools such as screwdrivers,
crowbars, tire tools, or pry bars.
i.
Hinges should not be mounted with bolts or screws on outside of
doors, and the locking devices should be installed internally as
deadbolt type, or the device should be of a type that has
protected mounting screws or bolts to make removal difficult.
ii.
The cabinet should be permanently constructed or attached to
the building structure or fixtures so as to prevent the cabinet from
being physically removed from the premises.
iii
If the cabinet is a metal file cabinet type, it should be
permanently attached to prevent easy removal and have an
external locking bar that secures the drawers.
b.
A “substantially constructed security cabinet” is a security cabinet or
safety cabinet equivalent in construction to a Class 6 Mosler Government
Sales Security filing cabinet or a Class 5 Mosler Government Sales safe.
c.
A cabinet less substantially constructed may meet security requirements
provided the cabinet is located in a room or an area where the entrance
has been so constructed that the hinge mounting inhibits removal and a
limited number of employees have keys or combinations to the locking
device. If combination locks are used, the combination must be changed
upon termination of employees who have knowledge of the combination.
September 20, 1999; Revised August 31, 2006December 13, 2010
Page 5 of 17
Formatted: Font: (Default) Arial, Bold
Clinical and Research Use of Controlled Substances and Dangerous Drugs
MAPP 06.04.01
Formatted: Font: (Default) Arial, Bold
Note: EHRM generally requires a small non-removable safe in a secure area to
comply with these regulations. An alternate security cabinet may be required for
refrigeration consideration or other special situation
5.
The registrant shall notify the local DEA office, in writing, of the theft or significant
loss of any controlled substances within one business day of discovery of such
loss or theft. The registrant shall also complete, and submit to local DEA office,
DEA Form 106 regarding the loss or theft. 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.
Note: The registrant is also required to notifymust first send copies of all
correspondence reports regarding the incident to the University of Houston
Department of Public Safety (UH-DPS) and EHRM for review prior to notification
of DEAof the theft or loss of any controlled substances and dangerous drugs.
This does in no way supersede notification to DEA.
6.
D.
Dangerous Drugs must be secured in a locked area per 21 CFR 1301.71.
InventoryMaintenance of Records of Inventories
Records and inventories are required to be maintained as part of the registration
requirements as detailed in 21 CFR Section 1304.04 and Section 1304.11. Every
inventory and other records required to be kept under this part must be kept by the
registrant and available, for at least two years from the date of such inventory or records,
for inspections and copying by authorized employees of the DEA, UH-DPS, Internal
Auditing, DPS, or appropriate state regulatory agency.
1.
Controlled substances schedules I-V
a.
The registrant shall take an initial inventory of all stocks of controlled
substances on hand on the date he/she starts newly registered storage
location. Each registrant must then complete an inventory of all
Controlled Substances (schedules I-V) every six months after the initial
inventory is taken, using the EHRM EHS Inventory Form. in Addendum
A. EHRM will send out a notice with the form when the inventory is due.
The university University Health Center pharmacy will follow Texas State
Board of Pharmacy regulations.
b.
The regulations require that an inventory of controlled substances must
be conducted on a biennial basis for each registered location. Biennial
inventories of all controlled substances schedules I-V must be kept by
each registrant, and must include the following information:
i.
The name of the substance;
ii.
Each formulation of the substance (e.g., liquid, tablet), and
iii.
The number of units or volume of each formulation in each
commercial container.
Note: This requirement is fulfilled by the six months EHRM inventory.
September 20, 1999; Revised August 31, 2006December 13, 2010
Page 6 of 17
Formatted: Indent: Left: 1"
Formatted: Font: (Default) Arial, 10 pt, No
underline, Font color: Auto
Formatted: Font: (Default) Times New Roman,
12 pt, No underline, Font color: Auto
Clinical and Research Use of Controlled Substances and Dangerous Drugs
c.
d.
2.
MAPP 06.04.01
Inventories of controlled substances schedules I and II require an exact
count or measurement of contents. Schedules III, IV, and V can be
estimatedrequire an estimated count or measure of contents, if unless
the commercial container holds fewer than 1,000 tablets or capsules.
Inventory records must be kept for two years from the date of the
inventory in accordance with the regulations outlined in the Texas
Controlled Substances Act, Health and Safety Code, Chapter 481.
Dangerous Drugs
Each registrant must conduct and maintain an inventory of all dangerous drugs
annually, using EHRM the sample inventory Form form in Addendum A or any
other form deemed acceptable. The university University Health Center
pharmacy will follow Texas State Board of Pharmacy regulations.
E.
Records
1.
Persons registered under the Federal and Texas Controlled Substances Acts to
manufacture, distribute, analyze, or dispense controlled substances or
dangerous drugs, or to conduct research with controlled substances or
dangerous drugs must keep and maintain inventories and records required for
two years from the date such inventories and records are made. A “record” is any
notification, order form, statement, invoice, prescription, inventory information, or
other document for the acquisition or disposal of controlled substances or
dangerous drugs in conformance with record keeping and inventory requirements
of federal law and the Texas Controlled Substances Act.
2.
Inventories and records shall be available for inspection and copying by
authorized employees of EHRM, UH-DPS, Internal Auditing, DPS, DEA, or
appropriate state health regulatory agency.
3.
Registrants must also maintain complete and accurate records of purchases (to
include samples received from pharmaceutical manufacturer representatives),
transfers, and disposals of controlled substances listed in schedules I-V and
dangerous drugs.
4.
Records of purchases, transfers, acquisitions, and disposals of controlled
substances and dangerous drugs must include the following information:
a.
Name, quantity, and strength of drug;
b.
Invoice number or purchase order number;
c.
d.
Date of purchase or acquisition;
Date and quantity administered or disposed or transferred; and
e.
substance.
5.
Reason for administering, or disposing or returning of the controlled
Records of purchases, acquisitions, transfers, and disposals of dangerous drugs
are to be maintained by the registrant for two years beyond acquisition or
disposal
September 20, 1999; Revised August 31, 2006December 13, 2010
Page 7 of 17
Formatted: Font: (Default) Arial, Bold
Formatted: No underline, Font color: Auto
Formatted: No underline, Font color: Auto
Clinical and Research Use of Controlled Substances and Dangerous Drugs
MAPP 06.04.01
Formatted: Font: (Default) Arial, Bold
The records must be maintained in a bound record book, ledger, or other device equal in
durability and capacity to record the required data. The record-keeping device
shall have a numbered page for each drug, by drug strength.
Formatted: Indent: Left: 1"
6.
Records of purchases, acquisitions, transfers, and disposals of dangerous drugs
are to be maintained by the registrant for two years beyond acquisition or
disposal.
Formatted: Indent: Left: 1", First line: 0"
Record keeping requirements and reporting requirements are detailed in 21 CFR 1304.21
and 22.
F.
Formatted: Font: (Default) Arial, 10 pt, No
underline, Font color: Auto
Disposal Process
The registrant is responsible for the return or disposal of controlled substances and
dangerous drugs within 30 days of the expiration datein accordance with procedures
listed in Title 21, Section 1307.21 of the regulations.
Registrants requiring disposal of controlled substances and dangerous drugs may
request assistance from the Special DEA Agent in the Houston area. A listing of
controlled substances on DEA Form 41 is required of registrants and the Special Agent
may recommend disposal through any of the following:
Formatted: Indent: First line: 0"
i.
Formatted: Numbered + Level: 1 +
Numbering Style: i, ii, iii, … + Start at: 1 +
Alignment: Left + Aligned at: 1" + Indent at:
1.5"
ii.
iii.
iv.
1.
Transfer to person registered under the Act and authorized to possess the
substance.
Destruction in the presence of an agent of the Administration or other authorized
persons; or
By such other means as the Special Agent in Charge may determine to assure
that the substance does not become available to unauthorized persons.
The registrant must document the disposal of controlled substances and a copy
of DEA Form 41 must be maintained with the registrant’s records to provide
accountability for the disposal of these controlled substances and dangerous
drugs.
There are two disposal options:
a.
Expired or unusable controlled substances and dangerous drugs may be
returned to the supplier.
i.
Contact the supplier for specific details on returning expired or
unusable controlled substances and dangerous drugs.
ii.
The supplier signs for the controlled substance and arranges
expired or unusable doses to be destroyed by an enforcement
agency. (The supplier may require an assay of the dose prior to
issuing a receipt.)
iii.
The receipt is maintained as proof of disposal and an entry is
made in the controlled substance record on the appropriate page
indicating the date, strength, and disposed amount of the expired
or unused drug.
September 20, 1999; Revised August 31, 2006December 13, 2010
Page 8 of 17
Formatted: Numbered + Level: 1 +
Numbering Style: i, ii, iii, … + Start at: 1 +
Alignment: Left + Aligned at: 1" + Indent at:
1.5"
Clinical and Research Use of Controlled Substances and Dangerous Drugs
b.
G.
MAPP 06.04.01
Formatted: Font: (Default) Arial, Bold
Expired or unused controlled substances and dangerous drugs may be
placed in a container and submitted for appropriate disposal by EHRM.
Currently, the university conducts onsite destruction of controlled
substances and dangerous drugs as approved by DEA, which meet
environmental waste disposal laws.
i.
The UH-DPS oversees the disposal of controlled substances and
dangerous drugs.
ii.
EHRM documents the disposal of the controlled substance and
dangerous drugs using DEA Form 41.
iii.
A copy of DEA Form 41 will be given to the registrant by EHRM
after disposal. This form must be maintained with the registrant’s
records to provide accountability for the disposal of these
controlled substances and dangerous drugs.
2.
Incidents in which controlled substances and dangerous drugs are destroyed
accidentally and cannot be recovered must be documented in detail and cosigned by a witness to the destruction. The documentation must indicate the
date, name, strength, amount of substances destroyed, and method of disposal.
This documentation must be attached to the log record.
3.
Wasted controlled substances and dangerous drugs are to be handled in the
same manner as accidentally destroyed controlled substances and dangerous
drugs.
4.
Registrants who plan to leave the university’s employment must first complete a
checkout procedure conducted by EHRM. The department chair or equivalent is
responsible for notifying EHRM when a registrant terminates their employment
with the university so that the laboratory checkout procedure may begin. At this
time, EHRM will coordinate, with UH-DPS, the disposal of all controlled
substances and dangerous drugs, which have not been transferred by the
registrant. Failure to comply with this section will result in the controlled
substances and dangerous drugs being appropriately disposed by EHRM as
approved by the DEA for disposal, with a written explanation of the incident and
parties involved.
Compliance ReviewEmployee Screening Procedure
The registrant is responsible for managing the controlled substances in accordance with
the requirements of the regulations including inventory, record keeping and security
provisions. However, agents of the registrant may engage in approved activities under
the direction of the registrant in which case the registrant is required to screen those
employees prior to authorization. One questionnaire is required for each employee (nonpractitioner) who is authorized by the registrant to handle DEA controlled substances
under his or her direction.
Formatted: Indent: First line: 0"
Formatted: Font: (Default) Arial, 10 pt, No
underline, Font color: Auto
A questionnaire which includes the following questions in 21 CFR 1301.90 must be
completed for each non-practitioner having access to DEA controlled substances as part
of the screening process:
•
Within the past five years, have you been convicted of a felony, or within the past
two years, of any misdemeanor or are you presently formally charged with
September 20, 1999; Revised August 31, 2006December 13, 2010
Page 9 of 17
Formatted: Indent: Left: 1", Hanging: 0.5",
Bulleted + Level: 1 + Aligned at: 0.75" +
Indent at: 1", Tab stops: 1.5", Left
Clinical and Research Use of Controlled Substances and Dangerous Drugs
MAPP 06.04.01
committing a criminal offense? (Do not include any 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.
•
H.
In the past three years, have you knowingly used narcotics, amphetamines, or
barbiturates other than those prescribed to you by a physician? If the answer is yes,
furnish details.
2.
VI.
VII.
The Environmental Health and Risk ManagementSafety Department will may
conduct periodic reviews of each registrant to verify compliance with regulations
and the provisions of this policy. A list of all registrants will be requested
annually. Any changes to researcher status can be reported to Environmental
Health and Safety at 713-743-5858.
The UH Internal Auditing Department will may perform periodic reviews to ensure
compliance with the provisions of this policy. Also, other institutional committees
may impose additional requirements on the use of controlled substances and
dangerous drugs in a manner that will not jeopardize the institutional
requirements and personnel safety.
REVIEW AND RESPONSIBILITY
Responsible Party:
Associate Assistant Vice President for Plant OperationsPublic Safety
Review:
Every three years, on or before August 1
APPROVAL
John Rudley
Executive Vice President for Administration and Finance
Jay Gogue
President
Effective Date: August 31, 2006December, 2010
VIII.
Formatted: Font: (Default) Arial, 10 pt, No
underline, Font color: Auto
Formatted: Font: (Default) Arial, 10 pt
Formatted: Bulleted + Level: 1 + Aligned at:
0.75" + Indent at: 1"
Formatted: Font: (Default) Arial, 10 pt, No
underline, Font color: Auto
Compliance Review
1.
Formatted: Font: (Default) Arial, Bold
REFERENCES
Title 21 Code of Federal Regulations - Part 1300 Food and Drugs; Texas Health and
Safety Code, chapters 481 and 483
Title 37 of Texas Administrative Code, Part 1, Chapter 13 – Controlled Substances
September 20, 1999; Revised August 31, 2006December 13, 2010
Page 10 of 17
Formatted: Indent: First line: 0"
Formatted: No underline, Font color: Auto
Clinical and Research Use of Controlled Substances and Dangerous Drugs
Index Terms:
MAPP 06.04.01
Clinical Settings
Controlled substances
Dangerous drugs
Drug Enforcement Administration
Non-Clinical settingsTexas Department of Public Safety
Registrant
September 20, 1999; Revised August 31, 2006December 13, 2010
Page 11 of 17
Formatted: Font: (Default) Arial, Bold
Clinical and Research Use of Controlled Substances and Dangerous Drugs
MAPP 06.04.01
Formatted: Font: (Default) Arial, Bold
Formatted: Font: 12 pt, Bold, No underline,
Font color: Auto
REVISION LOG
Formatted: Font: 12 pt, Bold
Revision
Number
Approved
Date
Description of Changes
1
09/22/1999
Initial version
Formatted: Left
2
10/25/2004
Removed “In Non-Clinical Settings” from title of MAPP. Applied
new MAPP template. Emphasis is made throughout the
document when a non-clinical setting is part of the procedure.
Added definition for Clinical Setting and removed definition for
SRM. Organization change from Safety and Risk Management
(SRM) Department to Environmental Health and Risk
Management (EHRM) throughout document. In Section III.B.1,
registrants must order a controlled substance through the
Purchasing Department. A copy of DEA Form 222 is sent to
EHRM for non-clinical settings. Section III.B.6 was removed.
Schedules III – V controlled substances and dangerous drugs
must be ordered through the Purchasing Department. In
Section III.E.1, an inventory is performed every year using the
EHRM Inventory Form (Attachment A). In Section III.G.8, a
more detailed procedure was documented for registrants
leaving university employment and the laboratory checkout
procedure with UH DPS and EHRM. EHRM conducts periodic
reviews of each registrant to verify compliance with regulations
and MAPP 06.04.01, in addition to the Internal Auditing
Department. Review schedule was changed from two years to
three years. Responsible party was changed to AVP for Plant
Operations
Formatted: Left
3
01/28/2005
In Section III.B, #6 was added to indicate that for clinical
settings, the registrant will use the normal procurement
process.
Formatted: Left
4
08/31/2006
The definition for controlled substances was expanded in
Section II.A. The “caution” labels in Section II.B were quoted
and expanded. In Section II.A.2, a website for DEA registration
was added. The DPS Registration forms address removed
“Registration Section” and Narcotics Service.” Section III.A.4.c
added information on applying for DPS registration using DPS
Form NAR-77. Section III.A.5 added details on copies of
current registrations and subsequent renewal registrations from
DEA and DPS being provided to EHRM at mail code EHRM
1005. Section III.B was changed to emphasize non-clinical
setting and clinical setting procurement processes for all
controlled substances, removing a specific section for a
procurement process for schedules III-V substances and
dangerous drugs. A note was added to Section III.C.4.c on
EHRM requirements for a small non-removable safe in a
secure area to comply with all documentation in Section III.C.4.
The formatting of information was changed in Section III.C.5,
and Section III.C.6 was added to indicate that dangerous drugs
must be secured in a locked area. Section III.D was expanded
to emphasize controlled substances in schedules I-V, and
dangerous drugs. Section III.F was documented to emphasize
Formatted: Left
September 20, 1999; Revised August 31, 2006December 13, 2010
Formatted Table
Page 12 of 17
Clinical and Research Use of Controlled Substances and Dangerous Drugs
Revision
Number
Approved
Date
MAPP 06.04.01
Formatted: Font: (Default) Arial, Bold
Formatted Table
Description of Changes
the disposal process for all controlled substances and
dangerous drugs. Addendum B, UH Controlled Substances
and Dangerous Drugs Dispensing Record, was added.
5
03/10/2010
A note was added to the beginning of the procedure to indicate
that the document was being revised to comply with U.S. Drug
Enforcement Agency Regulations
Formatted: Left
6
TBD
Added statement in Section I to prohibit unlawful possession of
a controlled substance or dangerous drug on property owned
or controlled by the University. Updated the registration
process and procurement process with web site forms and
revised examples in Addendums A and B. Removed
information on security cabinet specifications. Added
information on maintenance of inventory and records.
Removed information on record keeping, referencing 21 CFR
1304.21 and 22. Updated the disposal process to current
operating practices. Replaced compliance review with
employee screening procedure. Changed the responsible
party, and added a reference to Title 37 of the Texas
Administrative Code, Part 1, Chapter 13. Updated Index terms
Formatted: Left
September 20, 1999; Revised August 31, 2006December 13, 2010
Page 13 of 17
Cliniical and Re
esearch Use
e of Controlled Substa
ances and D
Dangerous Drugs
MAPP 06.0
04.01
Formatted: Font: (Deffault) Arial, Bold
Adden
ndum A
Formatted: Font: 12 pt,
p No underline
e, Font
color: Autto
Septtember 20, 1999; Revis
sed Augustt 31, 2006D
December 13
3, 2010
Page 14 of 17
Cliniical and Re
esearch Use
e of Controlled Substa
ances and D
Dangerous Drugs
MAPP 06.0
04.01
Formatted: Font: (Deffault) Arial, Bold
Formatted: Font: 12 pt,
p No underline
e, Font
color: Autto
Septtember 20, 1999; Revis
sed Augustt 31, 2006D
December 13
3, 2010
Page 15 of 17
Cliniical and Re
esearch Use
e of Controlled Substa
ances and D
Dangerous Drugs
MAPP 06.0
04.01
Formatted: Font: (Deffault) Arial, Bold
Adden
ndum B
Formatted: Font: (Deffault) Arial, 12 pt, Bold,
No underrline, Font colorr: Auto
Septtember 20, 1999; Revis
sed Augustt 31, 2006D
December 13
3, 2010
Page 16 of 17
Cliniical and Re
esearch Use
e of Controlled Substa
ances and D
Dangerous Drugs
MAPP 06.0
04.01
Formatted: Font: (Deffault) Arial, Bold
Formatted: Font: (Deffault) Arial, 12 pt, Bold,
No underrline, Font colorr: Auto
Septtember 20, 1999; Revis
sed Augustt 31, 2006D
December 13
3, 2010
Page 17 of 17
Download