May 2010 Rhonda Dash, MPH Director, Research Compliance

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1 May 2010 Rhonda Dash, MPH Director, Research Compliance

2 Introduce the new Director of Research Compliance Review Applicable Federal Regulations Review Applicable State Regulations Review UNTHSC new Policies and Procedures for Controlled Substance in Research

3 I provide oversight for research compliance. My focus is to ensure that research at UNTHSC is performed in accordance with strict ethical standards, in compliance with federal and state regulations, and institutional policies. My goal is to help protect the research subject, the research data, the researcher & their staff, and the institution. I strive to meet this goal primarily through audits and education. I am committed to the highest standards of quality and integrity in all areas of research. REMEMBER I are not out to get you and I am not the police. I am on your side!

4 Internal Audit No dated 2009 A comprehensive uniformed program Access to controlled substance is not limited Records are not complete and accurate Outdated substances have not been disposed of in the last ten years

5 Drug Enforcement Administration Office of Diversion Control Controlled Substance Act May 1971 Closed system for distribution Trace: manufacture dispensed ultimate user Registration Reduced Diversion CFR Title 21 Part Divided into five (5) schedules Schedules II-V have an accepted medical use in the US

6 Texas Department of Public Safety Texas Controlled Substances Act 1973 Controlled Substances Registration Program Health and Safety Code, Title 6. Food, Drugs, Alcohol, and Hazardous Substances, Subtitle C. Substance Abuse Regulation and Crimes, Chapter 481. Texas Controlled Substance Act (HSC Title 6, Subtitle C, Chapter 481) TAC Title 37, Part I, Chapter 13

7 CSA Sec. 822 Persons Required to Register the term practitioner is defined as a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital,.in which the practitioner practices or performs research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research. Every person or entity that handles controlled substances must be registered with DEA or be exempt by regulation from registration.

8 It is the responsibility of each individual Principal Investigator to obtain appropriate license and registration. Shall not allow license and registration to lapse until all controlled substances are spent or disposed Submit a copy of each license to the Director of Research Compliance, CBH 333 Remainders Identify

9 1. DEA Application 2. TX DPS Application orcement/narcotics/narccsr.htm Annual Registration

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11 Each PI must notify the DEA and TXDPS before the seventh day after any changes in name, address, telephone, schedules, or any information required on the application, registration, or permit (TAC ).

12 No individual who has been convicted of a felony for any State or Federal law regarding controlled substances should be allowed access to controlled substances (21CFR ).

13 Controlled substances must be ordered on-line using UNTHSC procurement system (EPro). Miller Veterinary Supply Co, Inc ( ) Butler Schein Animal Health ( ) Stocks of controlled substances must be kept to the smallest quantity needed. Category Code =

14 Factors 1. Type of activity (Processing, packaging, labeling) 2. Type & form of controlled substances (Bulk liquids, dosage units, nonusable powders) 3. Location 4. Type of building 5. Type of vault, safe, secure enclosures, or storage system 6. Type of closure (Built-in combination locks, key locks, padlocks, self closing ) 7. Key and lock control (Adequacy, accountability, routine changing, issuance and control procedures, logging, combination security ) 8. alarm systems (Adequacy supervision, method of signal transmission, maintenance and testing, signal & response time) 9. Public access / perimeter fencing 10. Supervision of employees (Access control, control of & accountability identification, responsibilities) 11. Guest / visitor procedures 12. Local police / security force (availability, legal obligation to respond, frequency of patrol, size of force, alarm response time, training) 13. Adequacy of internal systems for monitoring controlled substances (storage security, common or contract carrier security ) 14. The quantity of controlled substances handled

15 All Principal Investigators authorized to use controlled substances are responsible for establishing and maintaining effective controls and procedures against unauthorized access to controlled substances. All controlled substances shall be stored in a substantially constructed, securely locked, cabinet (safe) as per Federal regulations. The cabinet should be permanently constructed or attached to a building structure to prevent physical removal. Access to locked rooms and locked storage cabinets containing controlled substances shall be restricted to limited authorized personnel. 21 CFR ;

16 All controlled substances shall be kept locked in their storage location except for the actual time required for authorized staff to remove, legitimately work with, and replace them. The storage and handling of controlled substances must adhere to all applicable state and federal laws. 21 CFR ;

17 All controlled substance shipments must be processed and stored in a security cabinet as soon as possible after receipt. Open the package and verify the contents. All inventories should be entered into the Scheduled Drug Inventory log book. This book is available from the Director of Research Compliance. Schedule I and II compounds shall be stored different from Schedule III-V substances, in a lockable room separate from the laboratories. 21 CFR ;

18 There shall be a limited number of authorized personnel which have keys and / or combination codes to operate locking devices. Principal Investigators shall rekey a key lock if a key is lost or upon termination of an employee having possession of a key. Principal Investigators shall change a combination lock code if a record of the combination is lost or stolen or upon termination of an employee having knowledge of the combination. TAC

19 Bulk controlled substance in solid or pure form shall not be removed from the lockable room with the safe at any time. At least two authorized persons shall co-sign for initial storage of a sealed vial of bulk compound and subsequent laboratory use. I am available to assist in evaluating and making recommendations regarding site security.

20 All containers of controlled substances must be properly labeled. If the laboratory re-packages, compounds or dilutes controlled substances, appropriately label the re-packaged, compounded or diluted substance and store it in the safe. The label on diluted or combined controlled substances that will be stored at least overnight in the safe must include the following information: Name of controlled substance Final concentration of controlled substance Volume per container Expiration date no more than 30 days after dilution

21 A researcher may dispose of out-of-date, damaged, or otherwise unusable or unwanted controlled substances by transferring them to a registrant who is authorized to receive such materials. These registrants are referred to as "Reverse Distributors. Schedule I and II controlled substances should be transferred via the DEA Form 222, while Schedule III V compounds may be transferred via invoice. The registrant should maintain copies of the records documenting the transfer and disposal of controlled substances for a period of two years.

22 Expired or unused product(s) must be labeled, separated, and stored under lock and key until ready for disposal. You should contact the Office of Research Compliance, Ext # 2458, to request disposal of controlled substances. You must provide a copy of your DEA license for disposal.

23 Disposal of controlled substances will be documented in the spiral bound binder labeled as Scheduled Drug Inventory Record Year All additional records documenting disposal must also be maintained.

24 Drug accountability records shall be completed upon receipt of controlled substances, after each use, disposal, or loss. PIs must maintain complete and accurate inventory records for all controlled substances. Records shall be kept separately from all other records, in or near the primary work area, and be available for inspection. All records shall be maintained for at least two years from the date of the last recorded transaction.

25 Receipt of Controlled Substance: Each receiving record must be verified, signed, and dated upon receipt by the authorized person receiving the controlled substance (21 CFR ). Use of Controlled Substance: A separate and current record for the use of each controlled substance, indicating the name of substance, strength, date dispensed, dispensed to whom, laboratory building/room, reason for, total balance on hand, amount used, authorized user s signature, and authorized witness s signature must be documented in the Scheduled Drug Inventory Record Year spiral bonded log book (21 CFR ).

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29 Initial Inventory When issued a DEA registration, a registrant shall take an initial inventory, which is an actual physical count of all controlled substances in their possession. **The registrant should make a record showing a zero inventory upon receipt of license. Inventory means a complete and accurate list of all stocks and forms of controlled substances in the possession of the registrant as determined by an actual physical count.

30 After an initial inventory is taken, the registrant shall take a new inventory of all controlled substances on hand at least every two years. Record must state Biennial Inventory The inventory of Schedule II controlled substances must be kept separate from those for all other controlled substances.

31 If the substance is listed in Schedule II, make an exact count or measure of the contents, or If substance is listed in Schedule III-V, make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules then make exact count of the contents

32 Disposal of Controlled Substance (III-V) via authorized Reverse Distributor: Current record indicating the number of commercial containers, quantity per container, date of disposal, how disposed, name, address, and registration number of person to whom distributed (21 CFR ). Inventory of Controlled Substance: A complete and accurate inventory of the stock of controlled substances within each authorized registrant s laboratory must be performed initially upon receipt of DEA license. ** You must record zero inventories at this time on the Research Control Substance Biennial Inventory Record. The authorized person conducting the inventory and authorized witness must also sign the Research Control Substance Bi-Annual Inventory Record (21 CFR ).

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34 BiennialInventory: After the initial inventory is taken, a new inventory of all stocks of controlled substances on hand should be conducted every two years. The inventory date and opening or close of business, drug name, strength, quantity, drug form (tablet, capsule, etc), number of units/volume, total quantity, expiration date, name of Principal Investigator, and location must be recorded on the Research Control Substance Biennial Inventory Record at this time. The authorized person conducting the inventory and authorized witness must also sign the Research Control Substance Biennial Inventory Record (21 CFR ).

35 Authorized Users Signature Log as designated by PI: date signed, printed name, title, signature, initials, and date departed.

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37 Registrant shall notify the local DEA office, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft DEA Form 106

38 Factors of Significant Loss of any controlled substances Actual quantity lost in relation to type of business Specific Whether associated with access to controlled substances by specific individual(s) or whether loss can be attributed to unique activities that may take place involving controlled substances Pattern of losses over a specific time period, whether losses appear random, & results of efforts taken to resolve the losses Whether specific controlled substances are likely candidates for diversion Local trends and other indicators of the diversion potential of the missing controlled substance

39 Must notify in writing of: Discrepancy in amount of an item ordered and the amount received, if not back ordered Loss of theft during shipment from a source Loss or theft from current inventory DPS Form NAR-91 Copy of DEA Form 106

40 Authorized personnel must be alert and attentive to the disappearance of any controlled substances. Thefts, suspected thefts, unauthorized uses, or any significant loss of controlled substances must be immediately reported (within the next business day) to the Office of Research via the Director of Research Compliance and the University Police upon the discovery of the loss. In addition, the DEA requires that theft or significant loss of controlled substances be reported on DEA Form 106 Report of Theft or Loss of Controlled Substances. The form is available at

41 The TXDPS requires notification via DPS Form NAR-91 of the following: (1) Discrepancy in amount of an item ordered and the amount received, if not back ordered; (2) Loss of theft during shipment from a source; and (3) Loss or theft from current inventory. If a container of a controlled substance is inadvertently broken or damaged, document this on the disposition record and have an authorized witness sign and date it. Complete a DEA Form 41 for the amount of the substance lost and write "unintentional destruction" on the form. This form is available at Signatures of the authorized person who broke the bottle, the authorized witness and the Registrant are required on Form 41. Mail the original to the DEA and file a copy with your controlled substance records.

42 Reports of drug diversion by fellow employees is not only a necessary part of an overall employee security program but also serves the public interest at large. It is, therefore, the position of DEA that an employee who has knowledge of drug diversion from his employer by a fellow employee has an obligation to report such information to a responsible security official of the employer. The employer shall treat such information as confidential and shall take all reasonable steps to protect the confidentiality of the information and the identity of the employee furnishing information.

43 An employee who has knowledge of a drug diversion associated with the actions of a fellow employee, supervisor, or Principal Investigator has an obligation to report such information to the Office of Research or the EthicsLine at You may also report on-line at The Texas Whistleblower Act protects anyone who, in good faith, reports unlawful activity from retaliation for making such a report.

44 Schedule II Schedule III & IV Schedule V Registration Required Required Required Ordering Receiving Records Daily Use Inventory Security Theft or Significant Loss UNTHSC Epro (Miller Vet Butler Schein) Order Forms (DEA Form-222) Sign and Date Spiral Bound Logbook Initially Update Every 2 Yrs Locked Drawer or Safe Report and complete DEA Form 106 UNTHSC EPro (Miller Vet Butler Schein) Invoice Sign and Date Spiral Bound Logbook Initially Update Every 2 Yrs Locked Drawer or Safe Report and complete DEA Form 106 UNTHSC EPro (Miller Vet Butler Schein) Invoice Sign and Date Spiral Bound Logbook Initially Update Every 2 Yrs Locked Drawer or Safe Report and complete DEA Form 106 Disposal Reverse Distributor Reverse Distributor Reverse Distributor

45 Annually Updates for chemicals and schedules

46 1. State / Federal Sanctions Loss of License and Registration Prison Fines ( Documentation discrepancies up to $10K ) 2. Disciplinary action per UNTHSC Faculty Handbook 3. Media 4. Career

47 Audit, Monitor, and Report (Details/Specifics) Training and Education Polices and Procedures Compliance Roles and Responsibilities Key Point: Policies, procedures, and practices must be aligned!

48 RHONDA DASH, MPH, CHRC DIRECTOR OF RESEARCH COMPLIANCE CBH

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