UNIVERSITY of HOUSTON MANUAL OF ADMINISTRATIVE POLICIES AND PROCEDURES SECTION: AREA: Safety Specific Area Guidelines Number: 06.04.01 SUBJECT: Clinical and Research Use of Controlled Substances and Dangerous Drugs I. Formatted: Indent: Left: 0", Hanging: 1", Tab stops: Not at 1.5" POLICY AND SCOPE A. A. The University of Houston strives to provide every opportunity for its employees and students to attain excellence in their educational and employment experiences, and thereby further the mission of the institution. The university recognizes that to help employees and students realize these goals, it must provide safe environments conducive to employment and educational activities. The university shall seek ways to minimize the hazards of working with controlled substances and dangerous drugs in the university’s clinical and non-clinical settings while meeting federal and state laws. Formatted: Numbered + Level: 1 + Numbering Style: A, B, C, … + Start at: 1 + Alignment: Left + Aligned at: 0.5" + Indent at: 0.75" Formatted: Indent: Left: 0.75", First line: 0" B. It is the policy of the University to prohibit the unlawful purchase, manufacture, distribution, possession, selling, storing, or use of a controlled substance or dangerous drug, in or on premises or property owned or controlled by the University. II. B. Nothing in this policy is to be construed as authorizing any individual to engage in any act that such individual is not authorized or permitted to do under federal or state laws or rules. Compliance with this policy is not to be construed as compliance with all applicable federal or state laws or rules. C. Personal medication is exempt from the requirements of this guide if the drug was obtained in accordance with the Texas Health and Safety Code, chapters 481 and 483. D. University registrants who use controlled substances and dangerous drugs in the university’s clinical and non-clinical settings must obtain and keep current federal United States Drug Enforcement Administration (DEA) and Texas Department of Public Safety (DPS) registrations, unless exempted by law. Registrants are responsible for procuring, maintaining security, keeping records, and disposing of controlled substances and dangerous drugs in accordance with federal and state regulations and rules. The registrant may not allow the permit to lapse until all controlled substances are spent, disposed of, or transferred to another registered person. DEFINITIONS A. Clinical setting: A setting where a controlled substance or dangerous drug is used in a medical application. B. Controlled substances: A Substance, including a drug, an adulterant, and a dilutant, listed in Schedules I-V or Penalty Groups 1, 1-A, 2 through 4 of the Texas Health and Safety Code, chapter 481. The term includes the aggregate weight of any mixture, solution, or other substance containing a controlled substance. C. Dangerous drug: Device or drug that is unsafe for self-medication and that is not included in schedules I-V or penalty groups 1-4 of the Texas Health and Safety Code, Chapter September 20, 1999; Revised August 31, 2006December 13, 2010 Page 1 of 17 Formatted: Numbered + Level: 1 + Numbering Style: A, B, C, … + Start at: 1 + Alignment: Left + Aligned at: 0.5" + Indent at: 0.75" Clinical and Research Use of Controlled Substances and Dangerous Drugs MAPP 06.04.01 Formatted: Font: (Default) Arial, Bold 481. The term includes a device or a drug that bears, or is required to bear, either of the following labels: III. 1. “Caution: Federal law prohibits dispensing without prescription” or “Rx only” or another label that complies with federal law; or 2. “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.” D. DEA: Federal United States Drug Enforcement Administration. E. DPS: Texas Department of Public Safety. F. Non-Clinical settings: A setting where a controlled substance or dangerous drug is used in research or education which is not a clinical usage of the controlled substance or dangerous drug. G. Registrant: Practitioner, physician, dentist, nurse, veterinarian, scientific investigator, or other person licensed, registered, or otherwise permitted to distribute, dispense, analyze, conduct research with respect to, or administer a controlled substance in the course of professional practice or research in Texas. PROCEDURES University faculty or staff members who work with controlled substances and dangerous drugs must obtain and keep current DEA and DPS registrations, unless exempted by law. Registrants are also responsible for procuring, securing, maintaining records, and disposing of controlled substances and dangerous drugs in accordance with federal and state guidelines. A. Registration Process 1. 1. A university faculty or staff member who qualifies as a registrant must obtain a DEA registration application by calling (713) 693-3660, or 1-800-743-0595 or visit the website below for more information:. http://www.deadiversion.usdoj.gov/drugreg/index.html Formatted: Numbered + Level: 1 + Numbering Style: 1, 2, 3, … + Start at: 1 + Alignment: Left + Aligned at: 1" + Indent at: 1.25" Formatted: Indent: Left: 1.25", First line: 0" 2. Apply for a DEA registration number using DEA Form 225. The certifying signature on the form must be the registrant’s supervisor. The business address should be listed. The link to the application is found at the following web site: http://www.deadiversion.usdoj.gov/drugreg/reg_apps/225/225_instruct.htm Formatted: Left Formatted: Font: (Default) Arial, 10 pt Formatted: Font: (Default) Arial, 10 pt Dr. ______________ (Registrant) Environmental Health and Risk Management University of Houston 4211 Elgin, Room 183 Houston, Texas 77204-1005 1.3. After receipt of a DEA registration number, apply for a DPS Registration. 2. 3. a. Application forms for a DPS registration may be obtained from: 4. 5. Department of Public Safety 6. Controlled Substances Registration Section 7. P.O. Box 4087 8. Austin, Texas 78773-0001 September 20, 1999; Revised August 31, 2006December 13, 2010 Page 2 of 17 Formatted: List Paragraph, Left, No bullets or numbering Formatted: Indent: Left: 1.25", No bullets or numbering Formatted: Strikethrough Formatted: Indent: Left: 1", No bullets or numbering Formatted: Indent: Left: 1.25", No bullets or numbering Formatted: Indent: Left: 2", No bullets or numbering Clinical and Research Use of Controlled Substances and Dangerous Drugs 9. 10. 11. c. MAPP 06.04.01 Formatted: Font: (Default) Arial, Bold (512) 424-2188 E-mail: tppcsr@txdps.state.tx.us b. Registrants must furnish their DEA registration numbers on the DPS application. Apply for a DPS registration using DPS Form NAR-77. The certifying signature on the form must be the registrant’s supervisor. The business address should be listed. Please visit the following web site for additional information: http://www/txdps.state.tx.us/criminal_law_enforcement/narcotics/narccsr.htm 12. The proposed business address for non-clinical settings should be listed as: 13. 14. Dr. ______________ (Registrant) 15. Environmental Health and Risk Management 16. University of Houston 17. 4211 Elgin, Room 183 18. Houston, Texas 77204-1005 19. 20. 5. Provide copies of current registrations, and subsequence renewal registrations from DEA and DPS to the university’s Environmental Health and Risk Management Department at EHRM 1005. Schedule an inspection by the university’s Environmental Health and Risk Management Department (EHRM) for the location where controlled substances or dangerous drugs are to be stored/used. EHRM will provide the registrant written confirmation when adequate security controls are in place. Individuals inspecting for security measures will be trained in what constitutes adequate controls. 2. A university faculty or staff member who qualifies as a registrant must obtain a DEA registration application by calling (713) 693-3660 or visit the website below for more information. http://www.deadiversion.usdoj.gov/drugreg/index.html 3. Apply for a DEA registration number using DEA Form 225. The certifying signature on the form must be the registrant’s supervisor. The proposed business address for non-clinical settings should be listed as: Formatted: Indent: Left: 1.25", No bullets or numbering Formatted: Indent: Left: 1.25", Hanging: 0.5", No bullets or numbering Field Code Changed Formatted: Indent: Left: 1.25", No bullets or numbering Formatted: Numbered + Level: 1 + Numbering Style: 1, 2, 3, … + Start at: 1 + Alignment: Left + Aligned at: 1" + Indent at: 1.25" Formatted: Indent: Hanging: 0.5" Dr. ______________ (Registrant) Environmental Health and Risk Management University of Houston 4211 Elgin, Room 183 Houston, Texas 77204-1005 4. B. Procurement Process 1. For non-clinical settings 1. a. Registrant must use a DEA Form 222 to order controlled substances in schedules I & II. A DEA Form 222 is issued only to a registrant who has a DEA registration number, and can be obtained from the local DEA office. Drug Enforcement Administration 1433 W. Loop South, Suite 600 Houston, TX 77027 September 20, 1999; Revised August 31, 2006December 13, 2010 Page 3 of 17 Formatted: Indent: Left: 1", Hanging: 0.5", Numbered + Level: 1 + Numbering Style: 1, 2, 3, … + Start at: 1 + Alignment: Left + Aligned at: 1.75" + Indent at: 2" Clinical and Research Use of Controlled Substances and Dangerous Drugs MAPP 06.04.01 Formatted: Font: (Default) Arial, Bold (713) 693-3660 The List of Controlled Substances and Schedules can be reviewed at http://www.deadiversion.usdoj.gov/schedules/index.html. 2. b. A DEA Form 222 is not required to order controlled substances in schedules III – V. 3. c. Complete university purchasing documents and DEA form 222 if required. The certifying signature on DEA Form 222 must be the registrant’s supervisor. Fax or forward these documents and copies of current DEA and DPS registrations to EHRM 1005 for approval. EHRM will verify information, approve and then return these documents to the registrant or registrant’s business office. Registrant must order through the Purchasing Department per UH MAPP 04.01.01. d. Formatted: Indent: Left: 2", First line: 0" Formatted: Indent: Left: 1", Hanging: 0.5", Numbered + Level: 1 + Numbering Style: 1, 2, 3, … + Start at: 1 + Alignment: Left + Aligned at: 1.75" + Indent at: 2" Formatted: Indent: Left: 1", Hanging: 0.5", Numbered + Level: 1 + Numbering Style: 1, 2, 3, … + Start at: 1 + Alignment: Left + Aligned at: 1.75" + Indent at: 2" Verify the delivery address on the purchase order is Dr._______________ (Registrant) Environmental Health and Risk Management University of Houston 4211 Elgin, Room 183 Houston, TX 77201-1005 e. EHRM will receive all controlled substances and contact the registrant to schedule delivery. EHRM will ensure items are properly logged in and out. f. 4. The package will be delivered to the registrant by EHRM. The registrant will be required to show one form of photo proof of identification. The registrant will then verify the contents and sign for their controlled substances order. g. A Dispensing Record Form (sample provided in Addendum B) must be used as the controlled substance is dispensed. A copy of this form must be sent to EHRM 1005 once the controlled substance is depleted or expired/disposed. h. 2. Dangerous Drugs, prescription drugs that are non-controlled substances, can be ordered by registrants through routine purchasing procedures. For clinical setting a. Registrant must use a DEA Form 222 to order controlled substances in schedules I & II. A DEA Form 222 is issued only to a registrant who has a DEA registration number, and can be obtained from the local DEA office. Drug Enforcement Administration 1433 W. Loop South, Suite 600 Houston, TX 77027 (713) 693-3660 b. A DEA Form 222 is not required to order controlled substances in schedules III – V. September 20, 1999; Revised August 31, 2006December 13, 2010 Page 4 of 17 Formatted: Indent: Left: 1", Hanging: 0.5", Numbered + Level: 1 + Numbering Style: 1, 2, 3, … + Start at: 1 + Alignment: Left + Aligned at: 1.75" + Indent at: 2" Clinical and Research Use of Controlled Substances and Dangerous Drugs C. MAPP 06.04.01 c. Registrants must order controlled substances in schedules I – V through the Purchasing Department per UH MAPP 04.01.01. d. Dangerous drugs, prescription drugs that are non-Controlled Substances, can be ordered by registrants through routine purchasing procedures. Security Controls Registrants are responsible for establishing and maintaining effective controls and procedures to safeguard against controlled substances and dangerous drugs being diverted from legitimate sources to the illicit market. Controlled substances and dangerous drugs may only be used for a legitimate purpose as authorized by appropriate university official(s). Registrants are directly responsible for: 1. Establishing adequate security to prevent unauthorized access to controlled substances and dangerous drugs. 2. Establishing adequate security to prevent the diversion of controlled substances and dangerous drugs. 3. Not allowing any unauthorized individual access to controlled substances and dangerous drugs storage areas. 4. Storing controlled substances listed in schedules I-V in a locked office and in a securely locked, substantially constructed cabinet, or security cabinet (i.e. not easily broken into or moved; see 21 CFR 1301.71). a. A “substantially constructed cabinet” is a structure of wood or metal so constructed as to resist easy entry by simple tools such as screwdrivers, crowbars, tire tools, or pry bars. i. Hinges should not be mounted with bolts or screws on outside of doors, and the locking devices should be installed internally as deadbolt type, or the device should be of a type that has protected mounting screws or bolts to make removal difficult. ii. The cabinet should be permanently constructed or attached to the building structure or fixtures so as to prevent the cabinet from being physically removed from the premises. iii If the cabinet is a metal file cabinet type, it should be permanently attached to prevent easy removal and have an external locking bar that secures the drawers. b. A “substantially constructed security cabinet” is a security cabinet or safety cabinet equivalent in construction to a Class 6 Mosler Government Sales Security filing cabinet or a Class 5 Mosler Government Sales safe. c. A cabinet less substantially constructed may meet security requirements provided the cabinet is located in a room or an area where the entrance has been so constructed that the hinge mounting inhibits removal and a limited number of employees have keys or combinations to the locking device. If combination locks are used, the combination must be changed upon termination of employees who have knowledge of the combination. September 20, 1999; Revised August 31, 2006December 13, 2010 Page 5 of 17 Formatted: Font: (Default) Arial, Bold Clinical and Research Use of Controlled Substances and Dangerous Drugs MAPP 06.04.01 Formatted: Font: (Default) Arial, Bold Note: EHRM generally requires a small non-removable safe in a secure area to comply with these regulations. An alternate security cabinet may be required for refrigeration consideration or other special situation 5. The 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. The registrant shall also complete, and submit to local DEA office, DEA Form 106 regarding the loss or theft. Thefts must be reported whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action taken against them. Note: The registrant is also required to notifymust first send copies of all correspondence reports regarding the incident to the University of Houston Department of Public Safety (UH-DPS) and EHRM for review prior to notification of DEAof the theft or loss of any controlled substances and dangerous drugs. This does in no way supersede notification to DEA. 6. D. Dangerous Drugs must be secured in a locked area per 21 CFR 1301.71. InventoryMaintenance of Records of Inventories Records and inventories are required to be maintained as part of the registration requirements as detailed in 21 CFR Section 1304.04 and Section 1304.11. Every inventory and other records required to be kept under this part must be kept by the registrant and available, for at least two years from the date of such inventory or records, for inspections and copying by authorized employees of the DEA, UH-DPS, Internal Auditing, DPS, or appropriate state regulatory agency. 1. Controlled substances schedules I-V a. The registrant shall take an initial inventory of all stocks of controlled substances on hand on the date he/she starts newly registered storage location. Each registrant must then complete an inventory of all Controlled Substances (schedules I-V) every six months after the initial inventory is taken, using the EHRM EHS Inventory Form. in Addendum A. EHRM will send out a notice with the form when the inventory is due. The university University Health Center pharmacy will follow Texas State Board of Pharmacy regulations. b. The regulations require that an inventory of controlled substances must be conducted on a biennial basis for each registered location. Biennial inventories of all controlled substances schedules I-V must be kept by each registrant, and must include the following information: i. The name of the substance; ii. Each formulation of the substance (e.g., liquid, tablet), and iii. The number of units or volume of each formulation in each commercial container. Note: This requirement is fulfilled by the six months EHRM inventory. September 20, 1999; Revised August 31, 2006December 13, 2010 Page 6 of 17 Formatted: Indent: Left: 1" Formatted: Font: (Default) Arial, 10 pt, No underline, Font color: Auto Formatted: Font: (Default) Times New Roman, 12 pt, No underline, Font color: Auto Clinical and Research Use of Controlled Substances and Dangerous Drugs c. d. 2. MAPP 06.04.01 Inventories of controlled substances schedules I and II require an exact count or measurement of contents. Schedules III, IV, and V can be estimatedrequire an estimated count or measure of contents, if unless the commercial container holds fewer than 1,000 tablets or capsules. Inventory records must be kept for two years from the date of the inventory in accordance with the regulations outlined in the Texas Controlled Substances Act, Health and Safety Code, Chapter 481. Dangerous Drugs Each registrant must conduct and maintain an inventory of all dangerous drugs annually, using EHRM the sample inventory Form form in Addendum A or any other form deemed acceptable. The university University Health Center pharmacy will follow Texas State Board of Pharmacy regulations. E. Records 1. Persons registered under the Federal and Texas Controlled Substances Acts to manufacture, distribute, analyze, or dispense controlled substances or dangerous drugs, or to conduct research with controlled substances or dangerous drugs must keep and maintain inventories and records required for two years from the date such inventories and records are made. A “record” is any notification, order form, statement, invoice, prescription, inventory information, or other document for the acquisition or disposal of controlled substances or dangerous drugs in conformance with record keeping and inventory requirements of federal law and the Texas Controlled Substances Act. 2. Inventories and records shall be available for inspection and copying by authorized employees of EHRM, UH-DPS, Internal Auditing, DPS, DEA, or appropriate state health regulatory agency. 3. Registrants must also maintain complete and accurate records of purchases (to include samples received from pharmaceutical manufacturer representatives), transfers, and disposals of controlled substances listed in schedules I-V and dangerous drugs. 4. Records of purchases, transfers, acquisitions, and disposals of controlled substances and dangerous drugs must include the following information: a. Name, quantity, and strength of drug; b. Invoice number or purchase order number; c. d. Date of purchase or acquisition; Date and quantity administered or disposed or transferred; and e. substance. 5. Reason for administering, or disposing or returning of the controlled Records of purchases, acquisitions, transfers, and disposals of dangerous drugs are to be maintained by the registrant for two years beyond acquisition or disposal September 20, 1999; Revised August 31, 2006December 13, 2010 Page 7 of 17 Formatted: Font: (Default) Arial, Bold Formatted: No underline, Font color: Auto Formatted: No underline, Font color: Auto Clinical and Research Use of Controlled Substances and Dangerous Drugs MAPP 06.04.01 Formatted: Font: (Default) Arial, Bold The records must be maintained in a bound record book, ledger, or other device equal in durability and capacity to record the required data. The record-keeping device shall have a numbered page for each drug, by drug strength. Formatted: Indent: Left: 1" 6. Records of purchases, acquisitions, transfers, and disposals of dangerous drugs are to be maintained by the registrant for two years beyond acquisition or disposal. Formatted: Indent: Left: 1", First line: 0" Record keeping requirements and reporting requirements are detailed in 21 CFR 1304.21 and 22. F. Formatted: Font: (Default) Arial, 10 pt, No underline, Font color: Auto Disposal Process The registrant is responsible for the return or disposal of controlled substances and dangerous drugs within 30 days of the expiration datein accordance with procedures listed in Title 21, Section 1307.21 of the regulations. Registrants requiring disposal of controlled substances and dangerous drugs may request assistance from the Special DEA Agent in the Houston area. A listing of controlled substances on DEA Form 41 is required of registrants and the Special Agent may recommend disposal through any of the following: Formatted: Indent: First line: 0" i. Formatted: Numbered + Level: 1 + Numbering Style: i, ii, iii, … + Start at: 1 + Alignment: Left + Aligned at: 1" + Indent at: 1.5" ii. iii. iv. 1. Transfer to person registered under the Act and authorized to possess the substance. Destruction in the presence of an agent of the Administration or other authorized persons; or By such other means as the Special Agent in Charge may determine to assure that the substance does not become available to unauthorized persons. The registrant must document the disposal of controlled substances and a copy of DEA Form 41 must be maintained with the registrant’s records to provide accountability for the disposal of these controlled substances and dangerous drugs. There are two disposal options: a. Expired or unusable controlled substances and dangerous drugs may be returned to the supplier. i. Contact the supplier for specific details on returning expired or unusable controlled substances and dangerous drugs. ii. The supplier signs for the controlled substance and arranges expired or unusable doses to be destroyed by an enforcement agency. (The supplier may require an assay of the dose prior to issuing a receipt.) iii. The receipt is maintained as proof of disposal and an entry is made in the controlled substance record on the appropriate page indicating the date, strength, and disposed amount of the expired or unused drug. September 20, 1999; Revised August 31, 2006December 13, 2010 Page 8 of 17 Formatted: Numbered + Level: 1 + Numbering Style: i, ii, iii, … + Start at: 1 + Alignment: Left + Aligned at: 1" + Indent at: 1.5" Clinical and Research Use of Controlled Substances and Dangerous Drugs b. G. MAPP 06.04.01 Formatted: Font: (Default) Arial, Bold Expired or unused controlled substances and dangerous drugs may be placed in a container and submitted for appropriate disposal by EHRM. Currently, the university conducts onsite destruction of controlled substances and dangerous drugs as approved by DEA, which meet environmental waste disposal laws. i. The UH-DPS oversees the disposal of controlled substances and dangerous drugs. ii. EHRM documents the disposal of the controlled substance and dangerous drugs using DEA Form 41. iii. A copy of DEA Form 41 will be given to the registrant by EHRM after disposal. This form must be maintained with the registrant’s records to provide accountability for the disposal of these controlled substances and dangerous drugs. 2. Incidents in which controlled substances and dangerous drugs are destroyed accidentally and cannot be recovered must be documented in detail and cosigned by a witness to the destruction. The documentation must indicate the date, name, strength, amount of substances destroyed, and method of disposal. This documentation must be attached to the log record. 3. Wasted controlled substances and dangerous drugs are to be handled in the same manner as accidentally destroyed controlled substances and dangerous drugs. 4. Registrants who plan to leave the university’s employment must first complete a checkout procedure conducted by EHRM. The department chair or equivalent is responsible for notifying EHRM when a registrant terminates their employment with the university so that the laboratory checkout procedure may begin. At this time, EHRM will coordinate, with UH-DPS, the disposal of all controlled substances and dangerous drugs, which have not been transferred by the registrant. Failure to comply with this section will result in the controlled substances and dangerous drugs being appropriately disposed by EHRM as approved by the DEA for disposal, with a written explanation of the incident and parties involved. Compliance ReviewEmployee Screening Procedure The registrant is responsible for managing the controlled substances in accordance with the requirements of the regulations including inventory, record keeping and security provisions. However, agents of the registrant may engage in approved activities under the direction of the registrant in which case the registrant is required to screen those employees prior to authorization. One questionnaire is required for each employee (nonpractitioner) who is authorized by the registrant to handle DEA controlled substances under his or her direction. Formatted: Indent: First line: 0" Formatted: Font: (Default) Arial, 10 pt, No underline, Font color: Auto A questionnaire which includes the following questions in 21 CFR 1301.90 must be completed for each non-practitioner having access to DEA controlled substances as part of the screening process: • Within the past five years, have you been convicted of a felony, or within the past two years, of any misdemeanor or are you presently formally charged with September 20, 1999; Revised August 31, 2006December 13, 2010 Page 9 of 17 Formatted: Indent: Left: 1", Hanging: 0.5", Bulleted + Level: 1 + Aligned at: 0.75" + Indent at: 1", Tab stops: 1.5", Left Clinical and Research Use of Controlled Substances and Dangerous Drugs MAPP 06.04.01 committing a criminal offense? (Do not include any traffic violations, juvenile offenses or military convictions, except by general court-martial). If the answer is yes, furnish details of conviction, offense, location, date, and sentence. • H. In the past three years, have you knowingly used narcotics, amphetamines, or barbiturates other than those prescribed to you by a physician? If the answer is yes, furnish details. 2. VI. VII. The Environmental Health and Risk ManagementSafety Department will may conduct periodic reviews of each registrant to verify compliance with regulations and the provisions of this policy. A list of all registrants will be requested annually. Any changes to researcher status can be reported to Environmental Health and Safety at 713-743-5858. The UH Internal Auditing Department will may perform periodic reviews to ensure compliance with the provisions of this policy. Also, other institutional committees may impose additional requirements on the use of controlled substances and dangerous drugs in a manner that will not jeopardize the institutional requirements and personnel safety. REVIEW AND RESPONSIBILITY Responsible Party: Associate Assistant Vice President for Plant OperationsPublic Safety Review: Every three years, on or before August 1 APPROVAL John Rudley Executive Vice President for Administration and Finance Jay Gogue President Effective Date: August 31, 2006December, 2010 VIII. Formatted: Font: (Default) Arial, 10 pt, No underline, Font color: Auto Formatted: Font: (Default) Arial, 10 pt Formatted: Bulleted + Level: 1 + Aligned at: 0.75" + Indent at: 1" Formatted: Font: (Default) Arial, 10 pt, No underline, Font color: Auto Compliance Review 1. Formatted: Font: (Default) Arial, Bold REFERENCES Title 21 Code of Federal Regulations - Part 1300 Food and Drugs; Texas Health and Safety Code, chapters 481 and 483 Title 37 of Texas Administrative Code, Part 1, Chapter 13 – Controlled Substances September 20, 1999; Revised August 31, 2006December 13, 2010 Page 10 of 17 Formatted: Indent: First line: 0" Formatted: No underline, Font color: Auto Clinical and Research Use of Controlled Substances and Dangerous Drugs Index Terms: MAPP 06.04.01 Clinical Settings Controlled substances Dangerous drugs Drug Enforcement Administration Non-Clinical settingsTexas Department of Public Safety Registrant September 20, 1999; Revised August 31, 2006December 13, 2010 Page 11 of 17 Formatted: Font: (Default) Arial, Bold Clinical and Research Use of Controlled Substances and Dangerous Drugs MAPP 06.04.01 Formatted: Font: (Default) Arial, Bold Formatted: Font: 12 pt, Bold, No underline, Font color: Auto REVISION LOG Formatted: Font: 12 pt, Bold Revision Number Approved Date Description of Changes 1 09/22/1999 Initial version Formatted: Left 2 10/25/2004 Removed “In Non-Clinical Settings” from title of MAPP. Applied new MAPP template. Emphasis is made throughout the document when a non-clinical setting is part of the procedure. Added definition for Clinical Setting and removed definition for SRM. Organization change from Safety and Risk Management (SRM) Department to Environmental Health and Risk Management (EHRM) throughout document. In Section III.B.1, registrants must order a controlled substance through the Purchasing Department. A copy of DEA Form 222 is sent to EHRM for non-clinical settings. Section III.B.6 was removed. Schedules III – V controlled substances and dangerous drugs must be ordered through the Purchasing Department. In Section III.E.1, an inventory is performed every year using the EHRM Inventory Form (Attachment A). In Section III.G.8, a more detailed procedure was documented for registrants leaving university employment and the laboratory checkout procedure with UH DPS and EHRM. EHRM conducts periodic reviews of each registrant to verify compliance with regulations and MAPP 06.04.01, in addition to the Internal Auditing Department. Review schedule was changed from two years to three years. Responsible party was changed to AVP for Plant Operations Formatted: Left 3 01/28/2005 In Section III.B, #6 was added to indicate that for clinical settings, the registrant will use the normal procurement process. Formatted: Left 4 08/31/2006 The definition for controlled substances was expanded in Section II.A. The “caution” labels in Section II.B were quoted and expanded. In Section II.A.2, a website for DEA registration was added. The DPS Registration forms address removed “Registration Section” and Narcotics Service.” Section III.A.4.c added information on applying for DPS registration using DPS Form NAR-77. Section III.A.5 added details on copies of current registrations and subsequent renewal registrations from DEA and DPS being provided to EHRM at mail code EHRM 1005. Section III.B was changed to emphasize non-clinical setting and clinical setting procurement processes for all controlled substances, removing a specific section for a procurement process for schedules III-V substances and dangerous drugs. A note was added to Section III.C.4.c on EHRM requirements for a small non-removable safe in a secure area to comply with all documentation in Section III.C.4. The formatting of information was changed in Section III.C.5, and Section III.C.6 was added to indicate that dangerous drugs must be secured in a locked area. Section III.D was expanded to emphasize controlled substances in schedules I-V, and dangerous drugs. Section III.F was documented to emphasize Formatted: Left September 20, 1999; Revised August 31, 2006December 13, 2010 Formatted Table Page 12 of 17 Clinical and Research Use of Controlled Substances and Dangerous Drugs Revision Number Approved Date MAPP 06.04.01 Formatted: Font: (Default) Arial, Bold Formatted Table Description of Changes the disposal process for all controlled substances and dangerous drugs. Addendum B, UH Controlled Substances and Dangerous Drugs Dispensing Record, was added. 5 03/10/2010 A note was added to the beginning of the procedure to indicate that the document was being revised to comply with U.S. Drug Enforcement Agency Regulations Formatted: Left 6 TBD Added statement in Section I to prohibit unlawful possession of a controlled substance or dangerous drug on property owned or controlled by the University. Updated the registration process and procurement process with web site forms and revised examples in Addendums A and B. Removed information on security cabinet specifications. Added information on maintenance of inventory and records. Removed information on record keeping, referencing 21 CFR 1304.21 and 22. Updated the disposal process to current operating practices. Replaced compliance review with employee screening procedure. Changed the responsible party, and added a reference to Title 37 of the Texas Administrative Code, Part 1, Chapter 13. Updated Index terms Formatted: Left September 20, 1999; Revised August 31, 2006December 13, 2010 Page 13 of 17 Cliniical and Re esearch Use e of Controlled Substa ances and D Dangerous Drugs MAPP 06.0 04.01 Formatted: Font: (Deffault) Arial, Bold Adden ndum A Formatted: Font: 12 pt, p No underline e, Font color: Autto Septtember 20, 1999; Revis sed Augustt 31, 2006D December 13 3, 2010 Page 14 of 17 Cliniical and Re esearch Use e of Controlled Substa ances and D Dangerous Drugs MAPP 06.0 04.01 Formatted: Font: (Deffault) Arial, Bold Formatted: Font: 12 pt, p No underline e, Font color: Autto Septtember 20, 1999; Revis sed Augustt 31, 2006D December 13 3, 2010 Page 15 of 17 Cliniical and Re esearch Use e of Controlled Substa ances and D Dangerous Drugs MAPP 06.0 04.01 Formatted: Font: (Deffault) Arial, Bold Adden ndum B Formatted: Font: (Deffault) Arial, 12 pt, Bold, No underrline, Font colorr: Auto Septtember 20, 1999; Revis sed Augustt 31, 2006D December 13 3, 2010 Page 16 of 17 Cliniical and Re esearch Use e of Controlled Substa ances and D Dangerous Drugs MAPP 06.0 04.01 Formatted: Font: (Deffault) Arial, Bold Formatted: Font: (Deffault) Arial, 12 pt, Bold, No underrline, Font colorr: Auto Septtember 20, 1999; Revis sed Augustt 31, 2006D December 13 3, 2010 Page 17 of 17