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STATE OF MARYLAND

DHMH

Maryland Department of Health and Mental Hygiene

201 W. Preston Street · Baltimore, Maryland 21201

Martin O'Malley, Governor ­ Anthony G. Brown, Lt. Governor ­ John M. Colmers, Secretary

Division of Drug Control

4201 Patterson Avenue, Baltimore, MD 21215

410-764-2890, Fax 410-358-1793 Controlled Dangerous Substances (CDS) Researcher Questionnaire The highlighted text below is an EXAMPLE of what can be written, not a template. The Fee is $120 for 2 years Applicant Name ______________________________________________________ Facility Name ________________________________________________________ Address _____________________________________________________________ Telephone ______________________________ Fax. _________________________ Facility Maryland CDS Registration Number __PENDING___________ Exp. Date__________ Facility DEA Registration Number __PENDING___________________ Exp. Date__________ M-F ______ Sat. _______ Sun. ______ Hol. _______ (Hours that your lab is open e.g. M-F 8a-5p. Closed Sat/Sun/Holidays)

1. Brief description of the research/testing that will be conducted and list of controlled dangerous substances ("CDS") that will be used to conduct research/testing and approximate quantities per year. Anesthetize/sedate animals for various research procedures and provide analgesia. You don't need to describe your specific research unless the controlled drugs are used as part of the research and not just for sedation/analgesia. List drugs you will use and approximate bottle numbers

2. Who is the primary responsible person that supervises use of controlled substances at the facility? The "Responsible Person" must be a principal investigator or have a faculty-rank appointment (i.e., faculty or administrative professional). This person is ultimately responsible for obtaining approval to use a controlled substance, and is responsible for the safe use, secure storage, and record keeping requirements of that controlled substance. The Responsible Person certifies that the legally required records of receipts and disbursements of the controlled substances listed on this application will be maintained for inspection, and that drug security measures will meet those required by federal and state law.

3. Who are "individuals with access"? Individuals with access are defined as persons that will handle the controlled substances, and all persons having access to the locked storage unit containing those substances.

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4. What is the exact location where CDS will be stored? ­ Location/name of the building, room number This would ideally be the address on the DEA license.

5. How will CDS for research be obtained? ­ Name, address, phone number, and DEA number of supplier(s) If you are looking for pharmaceutical grade drugs such as ketamine, buprenorphine, Telazol, we suggest one of the following companies: You will just need to put one company on this form.

MWI 651 Stratford Dr. Meridian ID 83642 DEA: RM0310540 Penn Veterinary Supply 53 Industrial Circle Lancaster, PA 17601 DEA: PP0236352

(Penn Vet doesn't carry pentobarbital) Dr. Robert Adams' veterinary license is already on file at each place, you will just need to use your own DEA.

6. What are the policies and procedures for disposal of outdated/unwanted CDS? The expired drugs will be poured into a drain with two people present. The amount will be recorded into the log book and initialed by both people. Another alternative will be to inject the expired drugs into an expired animal with two people present. Both will initial the log book.

7. Are there procedures for delivery and receipt of CDS? Will items be hand-delivered to the person responsible for the order or an individual designated by the responsible person. How are your supplies normally delivered to your lab? Typically they are hand delivered to someone approved to have access to the drugs (hand delivered by FedEx, UPS, however it is delivered).

8. What kind of record keeping will be maintained for controlled substances? RECOMMENDED- Complete record keeping is required at the site of storage for controlled substances. This includes an inventory logbook showing: · Dates, quantity, and description of each controlled substance received, total quantity ON HAND along with initials of receiving individual. · Dates, quantity, and description of each controlled substance removed from inventory with description of use, total quantity ON HAND and initials of individual removing from inventory. · Logbook will show total quantity of each controlled substance ON HAND before removal from inventory and quantity of each controlled substance ON HAND following removal from inventory. · Logbook to be maintained under security (lock and key) with the controlled substances and made available for responsible person and regulatory officials.

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As described above

9. How will controlled substances be stored? Controlled substances, by DEA Regulations, are to be kept under secure conditions at all times and are to be accessible to approved users ONLY. Secure conditions include "under lock and key at all times except when receiving inventory or removing inventory for use": · In a locked safe, · In a locked drawer or cabinet within a room behind a locked door, · Key or combination to safe, cabinet, or drawer lock accessible to approved users ONLY. · In Regard to FIELD USE: The responsible person must be notified in advance and approve if controlled substances are to be used in a location away from primary location listed in the application.

PLEASE READ AND INITIAL THE FOLLOWING REQUIREMENTS AND RECOMMENDATIONS

Take a inventory of all CDS items prior to the opening of the business. If no CDS products are present, state "No CDS products at opening of business". [21 CFR 1304.11] (initial__________) You are required to take a biennial CDS inventory, which is a physical inventory of all controlled substances on hand that is taken at least every two years. The biennial inventory may be taken on any date which is within two years of the previous biennial or opening inventory date. [21 CFR 1304.11] (initial__________) It is recommended that you keep a perpetual inventory of CDS products, which serves as an up to date record of all CDS products on hand. (initial__________) Invoices for schedule III-V must be dated upon receipt. It is recommended that these invoices by filed separately. [21 CFR 1304.21] (initial__________) DEA Form 222, which must be used to order schedule I-II products, must be signed by the DEA Registrant. Power of Attorney may be executed by the registrant to allow others to sign the DEA 222 form. [21 CFR 1005.05] (initial__________) When schedule I-II orders are received, the quantity and date received must be recorded for each line item on DEA Form 222. [21 CFR 1305.13(e)] (initial__________) Executed DEA 222 Forms must be maintained separately from other records and kept readily available for 2 years. [21 CFR 1305.17] (initial__________) Any significant loss or theft of CDS product must be reported immediately upon discovery, within one business day, in writing to DEA and the Division of Drug Control. A DEA Form 106 must be completed for any unresolved loss, with the original sent to DEA and a copy sent to DDC. [COMAR 10.19.03.12A(1)] (__________)

Signature of Applicant __________________________________

Date ____________________

Division of Drug Control · 4201 Patterson Avenue · Baltimore, Maryland 21215-2222 410-764-2890 · Fax 410-358-1793 · TTY for Disabled - Maryland Relay Service 1-800-735-2258

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Toll Free 1-877-4MD-DHMH ·

Web Site:www.dhmh.state.md.us/drugcont/

Rev. 11/09

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STATE OF MARYLAND

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