(A)
Policy
statement
The United States drug enforcement
administration ("DEA") and the state of Ohio board of pharmacy regulate the use
of controlled substances and dangerous drugs. The university of Toledo
("UToledo") and its employees will comply with the federal and state laws and
regulations that pertain but are not limited to ordering, storing, dispensing,
recording and destruction of controlled substances and dangerous drugs used in
animal and in-vitro research.
To obtain, synthesize, and use
controlled substances in UToledo institutional animal care and use committee
("IACUC") approved animal or in-vitro research, an investigator must be either
a registrant or authorized agent.
(B)
Purpose of
policy
The purpose of this policy is to
facilitate a general understanding of the steps necessary to comply with
federal and state laws and regulations governing controlled substances and
dangerous drugs in UToledo animal or in-vitro research and to ensure safe
handling and security of controlled substances and dangerous
drugs.
(C)
Scope
This policy applies to all UToledo
faculty, students and staff using controlled substances or dangerous drugs in
animal and in-vitro research.
(D)
Definitions
(1)
"Registrant":
UToledo employee who holds both a current DEA registration and a state of Ohio
board of pharmacy terminal distributor of dangerous drugs ("TDDD")
license.
(2)
"Authorized agent": UToledo employee or student who is
authorized to act on behalf of or at the direction of the registrant with
respect to controlled drug access, use, receipt, and disposal.
(3)
"Controlled
substances": drugs regulated by U.S. government including illegal and
prescription drugs. List of controlled substances found online at
https://www.deadiversion.usdoj.gov/schedules/orangebook/a_sched.alpha.pdf.
(4)
"Controlled
substance schedules": classification of controlled substances used by the DEA.
An updated list of schedules may be found online at
https://www.deadiversion.usdoj.gov/schedules/.
(5)
"Dangerous
drugs": as defined by section
4729.01 of the Revised Code; any
drug with a label prohibiting dispensing or use without a prescription or by
order of a licensed veterinarian, and drugs that may be dispensed only upon a
prescription; any drug intended for administration by injection into the human
body other than through a natural orifice of the human body. These are also
known as "pharmaceutical grade" drugs. This does not include substances known
as "chemical grade" or "reagent grade."
(6)
"DEA": U.S. drug
enforcement administration, the U.S. department of justice law enforcement
agency.
https://www.deadiversion.usdoj.gov/(7)
"IACUC" The
UToledo IACUC or an IACUC authorized in writing by the UToledo office of
research and sponsored rograms ("RSP").
(8)
"List I and list
II chemicals": chemicals specifically designated by the DEA and used in
manufacturing a controlled substance.
(E)
Management of use
and disposal
Controlled substances and/or dangerous
drugs obtained or manufactured pursuant to this policy may only be used for
UT-authorized scientific research purposes. When using controlled substances
and/or dangerous drugs in research on animals, UToledo registrants may do so
only pursuant to an IACUC-approved research protocol, which defines the
specific agent(s), dosage(s), and method(s) of administration of controlled
substances and/or dangerous drugs used in the research protocol.
Registrants, TDDDs and authorized
agents are responsible for compliance with all applicable laws, rules and
regulations regarding controlled substances and dangerous drugs obtained or
manufactured as part of UToledo animal or in-vitro research, including details
not set forth in this policy and updates that occur after the effective date of
this policy.
(1)
Licensing and registration requirements
(a)
Before initiating
the acquisition of controlled substances, UToledo researchers proposing such
use in their research must inform the office of research and sponsored programs
("RSP") via email to the IACUC project administrator
(Elaine.Joseph@utoledo.edu)and disclose the
mechanism under which they will obtain controlled substances:
(i)
As a current
registrant;
(ii)
As a new registrant with an intent to apply for a new
license and registration, specifying the type of license and
registration;
(iii)
As an authorized agent, identifying the specific
UToledo registrant under whose license they will be receiving controlled
substances.
(b)
Before initiating the acquisition of dangerous drugs,
UToledo researchers must disclose the mechanism under which they will obtain
dangerous drugs:
(i)
As a current registrant;
(ii)
As new
registrant with an intent to apply for a new license and registration,
specifying the type of license and registration;
(iii)
As an
authorized agent, identifying the specific UToledo registrant under whose
license they will be receiving dangerous drugs.
(c)
Prior to applying
for a controlled substance license, terminal distributer of dangerous drugs
("TDDD"), and DEA registration, the UT researcher must first provide written
notification in the form of the university of Toledo controlled substance
registrant registration form to their department chair and dean, and vice
president for research ("VPR"). This form contains the following
information:
(i)
Type of DEA registration (i.e., researcher vs
practitioner)
(ii)Identification of DEA controlled substance
schedule(s)
(iii)
Location of controlled substance
storage
(iv)
List of anticipated controlled substances to be
manufactured or used in research project
(v)
Project or usage
summary
(vi)
Signatures of the UToledo researcher, chair, dean or
provost, and VPR
(d)
The UToledo
researcher should forward the signed controlled substance registrant
registration form to the IACUC administrator, who will inform the UToledo
researcher of the appropriate type of license and registration for which he/she
should apply.
(2)
Purchasing controlled substances and dangerous
drugs
The purchase of controlled substances
must be in accordance with 21 C.F.R. 1305 and rule
3364-40-15 of the Administrative
Code (procurement policy). Purchase of dangerous drugs must be in accordance
with rule
3364-40-15 of the Administrative
Code (procurement policy).
(a)
The registrant must be an authorized purchaser with a
current TDDD license and DEA registration.
(b)
Controlled
substances must be purchased pursuant to rule
3364-40-15 of the Administrative
Code (procurement policy).
(c)
Purchases of
"Schedule I" or" II" controlled substances must be made in conformance with
21 C.F.R.
1305.13 (completion of DEA form 222).
(3)
Manufacturing controlled substances
The manufacture/synthesis of controlled
substances and the use of list I or list II chemicals must be done through a
DEA researcher registration in accordance with
21
C.F.R. 1301.13, 1309.71 - 1309.73 and this
rule.
(a)
Purchasing and use records of list I chemicals (only
those used in manufacture of controlled substances) must be kept and maintained
by the registrant for a period of at least three years after the conclusion of
the research project or protocol.
(b)
List I chemicals
must be securely stored to prevent unauthorized access.
(i)
Each registrant
must survey, record and reconcile the relevant list I chemical inventory
contained in his/her possession annually, by the thirty-first day of
January.
(ii)
The registrant must provide a copy of relevant
inventory records to their department chair and college dean's office
annually.
(c)
Prior to, or at any time during commencement of
research and/or manufacture of controlled substances, RSP or UToledo office of
environmental health and radiation safety staff may inspect the laboratory in
which such manufacture will occur.
(4)
Storage and
security controls for controlled substances and dangerous drugs, in accordance
with rules
4729-13-05,
4929-9-05,
4729-9-11
of the Administrative Code, and
21
C.F.R. 1301.72:
(a)
All controlled
substances must be kept under lock and key in a securely locked, substantially
constructed cabinet with access given only to authorized users.
Schedule I and II substances must be
kept in a securely locked, substantially constructed cabinet that is bolted to
the floor or wall with access given only to authorized
users.
(b)
Criminal background checks must be obtained by the
registrant through the UT police department for all personnel who will be
manufacturing or handling schedule I or II controlled substances.
Personnel with criminal backgrounds may
be banned from participating in research that involves manufacturing or
handling scheduling I and II controlled substances.
(c)
All dangerous
drugs must be stored in an area secured by a physical barrier with locks to
deter and detect unauthorized access.
(5)
Controlled
substance accountability
According to
21 C.F.R.
1304.04,
1304.11
and rules
4729-13-04
and 4729:5:3-07 of the Administrative Code
and this rule, the registrant is responsible for recordkeeping and maintenance
of records for a period of at least three years after the conclusion of the
research project or protocol.
(a)
The registrant
must keep a list of authorized agents through the use of the
controlled substance authorized agent list form.
(b)
The registrant must sign for receipt of purchase of
controlled substances and keep purchasing/receipt logs.
(c)
Record keeping
must include details regarding use of the controlled substance by registrant,
any authorized agent(s), students, and staff.
(d)
Each registrant
must survey, record and reconcile the relevant controlled substances' inventory
contained in his/her possession annually, by the thirty-first day of
January.
The registrant must provide a copy of
relevant inventory records to their department chair and college dean's office
annually
(6)
Dangerous drug accountability
According to rules
4729-13-04,
4729-9-14,
and
4729-9-22
of the Administrative Code and this rule, the registrant is responsible for
recordkeeping and maintenance of records for a period of at least three years
after the conclusion of the research project or protocol.
(a)
Record keeping
must include details regarding use of the dangerous drugs (i.e., use logs with
administration information) by registrant, any authorized agent(s), students,
and staff.
(b)
Each registrant must survey, record and reconcile the
relevant dangerous drugs' inventory contained in his/her possession annually,
by the thirty-first day of January.
(7)
Disposal/destruction
(a)
Disposal of
controlled substances must be performed pursuant to 21 C.F.R. 1307.05,
1317.90
and rule
4729:5-3-01
of the Administrative Code. See the UT controlled substance in research
website
(https://www.utoledo.edu/research/rsp/RC/controlled-substances-and-dangerous-drugs/)for instructions.
(b)
Disposal of
dangerous drugs must be performed pursuant to rule 4729.5 -3-06 of the
Administrative Code. See the UToledo controlled substance in research website
(https://www.utoledo.edu/research/rsp/RC/controlled-substances-and-dangerous-drugs/)for instructions.
(c)
Prior to disposal
or destruction of controlled substances and dangerous drugs, Registrant must
ensure that all records are complete and up-to-date, and the controlled
substances and dangerous drugs are stored securely until disposal or
destruction.
(8)
Report of loss, theft or unauthorized use
(a)
The registrant
must notify the field division office of the DEA administration in his or her
area, in writing, of any significant loss or theft of any controlled substance
within one business day of discovery of the theft or loss ( 21 C.F.R. 1304.74,
1301.76,
and rule
4729:5-3-02
of the Administrative Code). The registrant must also report such loss or theft
to their department chair and dean, the IACUC office (or RSP), UT police
department, and the Ohio board of pharmacy.
(b)
Upon discovery,
the registrant must report any significant loss or theft of dangerous drugs to
the Ohio board of pharmacy (rule
4729:5-3-02
of the Administrative Code). The registrant must also report such loss or theft
to their department chair and dean, the IACUC office (or RSP), and the UT
police department (section
2921.22 of the Revised
Code).
(9)
Inspections/audits
(a)
UToledo IACUC
administrator, UToledo department of internal audit and compliance, RSP staff,
Ohio state board of pharmacy and the DEA may inspect and audit laboratories and
records at any time to ensure compliance according to
21 C.F.R.
1316.03,
4729.54 of the Revised Code,
rule
4729:5-3-03
of the Administrative Code and this rule.
(b)
UToledo
environmental health and radiation safety perform laboratory inspections
routinely and may assess controlled substance handling during these
inspections.
(c)
All registrants and authorized agents may be audited by
UToledo IACUC administrator or RSP designee to ensure compliance with DEA and
board of pharmacy regulations and this policy.
(F)
Non-compliance or misuse of controlled substances or
dangerous drugs
(1)
Failure of registrants and authorized agents to follow
the requirements of this policy may result in personal civil and criminal
liability under state and federal law. Failure may also result in university
disciplinary action under applicable university policies and/or rules,
including loss or limitation of privileges to conduct animal or laboratory
research at the university, or termination of employment.
(2)
When issues of
non-compliance are identified, the college and/or department of the registrant,
in consultation with applicable university units, will be responsible for
determining the corrective action plan and/or disciplinary actions to be taken.
Corrective action plans may include, but are not limited to, re-training of
faculty, staff, and students; purchasing ability limitations; and laboratory
shutdown.
(3)
Purchases made with grant or outside funding that are
not in compliance with this policy will be re-allocated to either the
appropriate person or appropriate department account.
Resources:
Ohio state board of pharmacy 614-
466.4143
http://pharmacy.ohio.gov
U.S. drug enforcement administration
-
http://www.usdoj.gov/dea/index.htm
U.S. DEA diversion control
http://www.deadiversion.usdoj.gov
Replaces: 3364-70-27
