Miami Controlled Materials Policies (Research)

Purchase:

All materials that only require an OBP license will be purchased through the Office Research and Innovation. Please contact the Director of the Lab Animal Resources (DLAR) Facility (hembrejl@miamioh.edu) or Neal Sullivan (sullivnh@miamioh.edu) to place orders. The DLAR may already have a stock of the materials. Regulators require a record of all requests with specific information. All orders must be received on the form downloaded using the link below. If you will have future orders, please save a copy to use to facilitate your request.

Download Pharmacy Request Form

For those persons with a DEA registration, they must purchase Schedule II-V personally. The policies for this type of purchase are being developed since there is a prohibition on the use of a Purchase Card to purchase government regulated materials. For the moment, such purchases will be made on a case by case basis using an ORI purchase card (contact Neal Sullivan to make arrangements). The researcher will need to establish an account with the vendor prior to any purchase being possible. This will initially take several days to provide the documents and information they will request. See the list below for vendor recommendations.

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.

Policies are being developed to provide a checks and balances sytem to allow Miami as an institution to be aware of purchases of regulated substances.

Non-Pharmaceutical Grade Materials Policy -

In compliance with the 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

 

 

Receipt and Storage

OBP materials will be received at Roudebush Hall and transferred to the license for the researcher location and secured within the OBP locker or safe assigned to the researcher.

DEA Scheduled materials will be shipped to the address on the registration. The registrant is responsible for receiving and record keeping.


Depletion and Destruction

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). Records must include individual animal use. The sum of the amount used plus the amount remaining must balance with the amount purchased.

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.

Upon receipt, the infomation about the materials must be added to the shared google sheet. Each google sheet basically provides a list of the materials in the locker. When a researcher has more than one locker, information for specific lockers can be distinguished seperately.

Basically, there is an OBP for each of five locations and when materials are moved from one location to another, our records must reflect that. For example, when OBP-only regulated materials are purchased under the Roudebush license, they will be recorded on that google sheet. When they are transferred to the LAR the transfer will be noted on the Roudebush sheet and line item description added to the sheet for the appropriate researcher/locker.

For DEA Scheduled materials, the researcher is responsible for adding the description to the sheet for that reseacher/locker. 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

For standard clinical materials, for OBP materials we will usually use one of four vendors that Miami already has a relationship with, i.e. the vendors require copies of our certifications and other assurances, thus, establishing a relationship with new vendors is not usually cost effective for Miami. If licenses are required, Miami must establish a formal relationship with the company that needs to be renewed annually. Establishment of the relationship will delay the purchase and could result in compliance problems for Miami that could compromise our licenses. Even for vendors with whom we have existing relationships, their oversight agencies (DEA and state) change and additional information may be requested. Thus our policy is to avoid adding vendors to our list of sources.


The current vendors we have an account with are listed below. You may be able to get general information about availability and cost from their websites, but, the authorized purchasers may have access to cost information that a researcher does not.

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.

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.

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, primarily analytical grade materials that are not used in clinical practice, e.g. d-amphetamine. Often these materials are not pharmaceutical grade (not USP designation), an exception must be approved by the IACUC before any use of non-USP materials in live lab animals and cost/convenience is not an acceptable justification.


  Updated   15-Nov-21