Controlled Materials Policies (Research)
DEA Controlled Substances vs.
Ohio Board of Pharmacies (OBP) Regulated Materials:
Substances include, but are not limited to morphine, Vicodin, cocaine,
methamphetamine, methadone, hydromorphone (Dilaudid), meperidine
(Demerol), oxycodone (OxyContin), fentanyl, Dexedrine, Adderall,
and Ritalinketamine, anabolic steroids, testosterone Xanax, Soma,
Darvon, Darvocet, Valium, Ativan, Talwin, Ambien, Tramadol. A full
list can be found here: DEA
Web Site or CS.pdf (current July
OBP: Any other material that is used in clinical
practice or research that require OBP licensing information to obtain.
This includes DEA Controlled Substances and materials not meeting
DEA criteria. Examples include isoflurane, carprofen, xylazine,
injectable saline and dextrose, antibiotics (any non "over-the-counter"
pharmaceutical grade material).
Non-DEA Clinical-Use Materials:
All materials that only require an OBP license
must be purchased through the Office Research and Innovation.
Please contact the Director of the Lab Animal Resources (DLAR) Facility,
Jazzminn Hembree (firstname.lastname@example.org)
or Neal Sullivan (email@example.com)
to place orders. The DLAR may already have a stock of the materials.
All orders must be received on the form downloaded using the link
below. Regulators require a record of all requests with specific
information. If you will have future orders, please save a copy
to use to facilitate your request.
Pharmacetical Request Form
of Procedures (OBP Materials) (pdf)
DEA Regulated Materials (Controlled
Substances, Schedule I-V): For materials requiring a DEA
registration to acquire, the individual registration holder
must make purchases through Buyway personally. That is,
you must establish Banner/Buyway account access and submit Buyway
purchase requisitions using that account. The task must not be performed
by anyone other than the registration holder to ensure compliance
with regulations and policy (this policy addresses the legal accountability
of the registration holder). Information about how to navigate the
Buyway system will be provided to persons authorized to make purchases
(contact Neal Sullivan).
of Procedures for Buyway Process
(for persons authorized to place orders, departmental admininstrators
are not authorized)
- All purchase requisitions submitted through
Buyway are subject to internal approvals prior to the order being
sent to the vendor (financial and research compliance approval).
The compliance approving authority (Neal Sullivan: firstname.lastname@example.org)
must be notified with a brief description of the request if it
is a new or unusual type of purchase when a requistion has been
submitted. This will help avoid delays.
- Shipping and Receipt: All materials will
be shipped to the address on the specific license and registrations.
Upon receipt, the requestor will be notified by the receiver.
- All regulated materials (OBP and DEA Schedule
II-V) must be stored in the LAR controlled access room in the
locker(s) assigned to the researcher. Note: Schedule I materials
are stored elsewhere.
As most materials are purchased for use
in research in the Animal Facility, billing for OBP-only materials
is handled through the monthly billing from the facility. Miami
account information for other users will be requested. Individuals
holding a DEA registration and ordering DEA materials should use
indix codes managed by their home department.
Non-Pharmaceutical Grade Materials Policy -
In compliance with NIH and USDA regulations
, non-pharmaceutical grade drugs are to be used in live animals
only when there is no pharmaceutical grade alternative available
unless there is a scientific justification approved by the IACUC.
Information about the IACUC USP policy
Depletion and Destruction
Records must include individual animal use. The sum of the amount
used plus the amount remaining must balance with the amount purchased.
Expired materials must be stored in a secure location and easily distinguishable
from usable materials (e.g. in a prominantly marked box within the
assigned locker). Expired OBP materials or those not needed must be
returned to the LAR director for disposal or re-allocation (desctruction
events will occur quarterly).
expired DEA controlled substances (Sched II-V), the registrant is
responsible for record keeping and destruction per DEA regulations.
State, Federal, and Miami regulations
and policies require documentation to provide an accurate record of
current inventory and document the fate of the acquired materials
(use or destruction). The information must be available for unannounced
An overall inventory will be maintained
by the DLAR based on received materials. The facility inventory will
indicate which researcher to whom the materials has been transferred.
Subsequent use/depletion records must be maintained by the researcher.
A google sheet will provide a list of the materials in the locker.
When a researcher has more than one locker, information for specific
lockers can be distinguished on the same google sheet though specific
lockers must be indicated.
For DEA Scheduled materials, the researcher
is responsible for adding the description to the sheet for that reseacher/locker.
A pharmaceutical request form must be submitted upon receipt to ensure
the material is added to the overall inventory records. Note: we will
have knowledge and can track what has been ordered, but may not be
notified when it is received. The Schedule II-V materials fall under
two jurisdictions: 1) the DEA registration with the registrant named
as the responsible person, and 2) the OBP license listing the Director
of the Research Ethics and Integrity Office (Neal Sullivan) as the
responsible person. Therefore, the google sheet/inventory is shared
with the OBP license holder. An OBP inspection would include all of
The vendors listed below are approved for obtaining clinical
materials using Buyway. Establishment of relationships with
new vendors will delay the purchase. Miami policy is to avoid
adding vendors to our list of sources as small cost savings
will be more than offset by greater administrative costs.
Researchers may be able to
get general information about availability and cost from vendor
websites. Individuals may establish an account with the vendor
for catalog research, but should not make purchases outside
Observations: fast service, some items are only available
in bulk purchases, pharmaceutical grade materials only,
the website might not reflect the available inventory (you
wil receive a notice of backorder status).
b. Midwest Veterinary Supply (https://www.midwestvetsupply.com/products/)
Observations: fast service, items are often available in
small quantities (by the vial), competitive pricing, pharmaceutical
grade materials only. The online catalog is accurate (e.g.
when an item is in low supply, there will be a note to contact
customer service to check availability)
c. Henry Schein Medical
This vendor is geared toward human use. Some clinical materials
are available from this vendor. Observations:
sometimes materials can only be ordered in bulk, items on
the website that indicate "available" may be back-ordered
in actuality (and they may not notify you of this).
d. MillaporeSigma (https://www.emdmillipore.com/US/en)
Observations: typically slower, often analytical grade materials
that are not used in clinical practice, e.g. d-amphetamine.
Often these materials are not pharmaceutical grade (not
USP, BP designation), an exception must be approved by the
IACUC before any use of non-USP materials in live lab animals.
Cost/convenience is not an acceptable justification.
of Procedures (OBP Materials) (pdf)
of Procedures for Buyway Process (authorized purchasers)
| Updated 6-Jul-22