Miami Controlled Materials Policies (Research)

DEA Controlled Substances vs. Ohio Board of Pharmacies (OBP) Regulated Materials:

DEA: Controlled 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 2022).

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).

Purchase:

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 (hembrejl@miamioh.edu) or Neal Sullivan (sullivnh@miamioh.edu) 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.

Download Pharmacetical Request Form

Outline 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).

Outline of Procedures for Buyway Process
(for persons authorized to place orders, departmental admininstrators are not authorized)

Security:

    • 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: sullivnh@miamioh.edu) 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.

Billing:

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.

More 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).

For expired DEA controlled substances (Sched II-V), the registrant is responsible for record keeping and destruction per DEA regulations.


Record Keeping

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 inspections.

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 materials.

 

Vendor Information

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 Buyway.

a. COVETRUS (https://northamerica.covetrus.com/)  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 (https://www.henryschein.com/us-en/medical/default.aspx?did=medical&stay=1).  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.


Resources:

vid

Outline of Procedures (OBP Materials) (pdf)

Outline of Procedures for Buyway Process (authorized purchasers)

 


  Updated   6-Jul-22