Boston University Controlled Substance Program February 2008 PREFACE: The Boston University Office of Environmental Health and Safety (OEHS) is responsible for the establishment and continuing review of an adequate controlled substance program at the University. The purpose of the program is to provide faculty and laboratory directors with the training and resources necessary to obtain federal and state approval required to work with controlled substances, and to ensure that each laboratory properly manages all aspects of the work in compliance with federal, state, and local regulations as well as BU policies. All users of controlled substances must be registered with the Office of Environmental Health and Safety. Ronald Slade, the Assistant Director for the Charles River Campus Office of Environmental Health and Safety, serves as the Controlled Substance Administrator (CSA). The CSA is responsible for providing the services outlined in this program. Copies of the Boston University Controlled Substance Program, as well as the required forms and helpful links, are available through the OEHS at the following web page: www.bu.edu/ehs. Please call the Office of Environmental Health and Safety at 353-9734 with any questions concerning the Controlled Substances Program. Controlled Substance A controlled substance is a drug or other substance that is specifically designated under the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 USC 801 et. seq.). Controlled substances are listed on five separate Drug Enforcement Administration (DEA) lists (Schedules), primarily by the substance’s propensity to become addictive. The DEA also assigns a unique Code Number to each substance. DEA controlled substances schedules are available at: www.deadiversion.usdoj.gov/schedules/schedules.htm Regulations Two regulatory agencies, the United States Drug Enforcement Administration (DEA) and the Massachusetts Department of Public Health, Food and Drug Division (DPH) govern the use of controlled substances for research purposes. Boston University’s controlled substance program is designed to comply with all applicable regulations, found in 21 CFR 1300 (DEA) and 105 CMR 700 (DPH). Copies of these regulations are available in the Office of Environmental Health and Safety (OEHS). Important aspects of the rules include: Controlled substances can only be purchased or obtained by registered users (both the supplier and the purchaser must have State and Federal registrations). Boston University Controlled Substances Program Page 1 of 19 All use and storage must conform to the information reported to the DEA and DPH in the registrant’s application. Use must be at the reported location. Transfers of controlled substances are allowed only between registered parties, and each must be authorized to possess the Schedule that is transferred. For example, a person who is registered for Schedules III through V cannot accept Schedule I or II material from a registered colleague. The BU Office of Environmental Health and Safety must be notified of all purchases and internal transfers. Disposal must be documented, and performed by a DEA authorized entity. BU OEHS will help coordinate disposals. Security and oversight are integral to the process. DEA and DPH inspectors make unannounced inspections. Controlled Substances Registration Process Principal Investigators (PIs) who wish to use controlled substances must apply for and obtain registrations from DEA and DPH. Registrations from each agency must be renewed annually. Regulations require strict adherence to protocol for use of controlled substances in research. OEHS will assist PIs with the application process. Controlled Substances Registration Instructions: Complete all of the following forms and then call the BU OEHS. The OEHS will schedule an appointment with you to review the forms for accuracy prior to submittal of the applications. This will help to avoid common errors that will result in processing delays. Registrants are responsible for maintaining copies of all documentation with their records. 1. INFORMATION FOR DEA CONTROLLED SUBSTANCE APPLICATION This allows OEHS to establish a file for the Controlled Substance user. OEHS will schedule periodic inspections of the lab. This form is available through OEHS at http://www.bu.edu/ehs/cs/pdf/Controlled_Substance_InformationSheet.pdf as well as in Appendix 1. Submit completed forms to OEHS, located at 704 Commonwealth Avenue, 2nd Floor, Boston, MA 02215. Annual updates are required. 2. CONTROLLED SUBSTANCE PROGRAM RELEASE This form must be completed by all lab personnel who will be permitted to have access to controlled substances. Complete this/these form(s) and forward to OEHS. This authorizes Boston University to conduct a background check on employees who have access to controlled substances. This form is available through OEHS at http://www.bu.edu/ehs/cs/pdf/Controlled_Subtance_Program_Release.pdf and in Appendix 2. 3. DEA CONTROLLED SUBSTANCE REGISTRATION APPLICATION (DEA FORM 225) NEW AND RENEWAL These forms are completed on-line, printed and then submitted by mail. Boston University Controlled Substances Program Page 2 of 19 For NEW Applications, go to the web site below and select ‘To Apply for New Applications for Registration On-Line’. Select ‘DEA-225’ from the table for NEW applications. Complete the DEA Form 225 ‘Interactive version’. www.deadiversion.usdoj.gov After OEHS review, send the completed form to DEA with a check for $184.00. For RENEWAL Applications, go to the web site above and select ‘To Apply for Renewal Applications for Registration On-Line’. Select ‘Log-in to Begin Renewal Process’ OEHS need not review your renewal application. Submit the renewal application with a $184.00 fee either by mail or on-line. 4. APPLICATION FOR MASSACHUSETTS CONTROLLED SUBSTANCES REGISTRATION TO USE CONTROLLED SUBSTANCES AND INVESTIGATIONAL NEW DRUGS IN RESEARCH”. This form is available on-line at www.state.ma.us/dph/dcp/dcpmcsr.htm. Go to Quick Links, Registration Application Forms, Applications for Massachusetts Controlled Substances Registration, Researcher or ctrl click on http://www.mass.gov/Eeohhs2/docs/dph/quality/drugcontrol/app_researcher.pdf. Complete the form and submit to OEHS for review. After OEHS review, send the completed form to the Massachusetts Department of Public Health with a check for $150.00. BU OEHS will assist in identifying security needs such as a safe or steel cabinet for Controlled Substance users. You may also refer to the section following on “Security”. Contact Ron Slade, Controlled Substances Administrator at: rslade@bu.edu BU Office of Environmental Health and Safety 704 Commonwealth Avenue, 2nd Floor Phone 617 353-9734 Fax 617 353-5646 Summary of Submittals The following bulleted lists are provided to summarize the documentation that should be prepared and submitted as a part of the registration process: 1. Documentation for the Controlled Substance Administrator, OEHS Information for DEA Controlled Substance Regulation Controlled Substance Program Release Complete DEA initial registration package Complete MDPH initial registration package Initial registration certificates (State and Federal) when received Boston University Controlled Substances Program Page 3 of 19 Annual renewal is the responsibility of the Registrant. A copy of a current State and Federal registration must be attached to each drug order form submitted to OEHS for approval. 2. Documentation for the DEA DEA form 225 Application Check for $184.00 Principal Investigator’s Curriculum vitae (short version) IACUC approval letters (not detailed Protocols) Documentation of method of security (safe or narcotics cabinet) Floor plan showing lab layout and storage location 3. Documentation for the MDPH MDPH Application Check for $150.00 Principal Investigator’s Curriculum vitae (short version) IACUC approval letters (not detailed Protocols) Documentation of method of security (safe or narcotics cabinet) Floor plan showing lab layout and storage location Acquisition Controlled substances must be ordered using either BU’s orange-colored Laboratory Requisition form and include the Registration Holder’s signature. Orders for Schedules I and II substances must also include accurately completed DEA Form 222s. Forms needed to complete a purchase include: BU Controlled Substance Protocol Order Form – Complete and sign (available in Appendix 3 and at http://www.bu.edu/ehs/cs/pdf/Controlled_Substance_Protocol_Order_Form.pdf ) DEA Form 222 – Must be completed for Schedule I and II purchases (sample available in Appendix 4 and at https://www.deadiversion.usdoj.gov/webforms/orderFormsRequest.jsp) Standard BU Requisition Form with PI signature Valid MA DPH and DEA registrations – Copy of each must be included with purchase requisition form All orders must be reviewed and approved by OEHS prior to submission to the Office of Purchasing Services. OEHS will route requests to Office of Purchasing Services. Allow two weeks for order processing. Electronic authorizations are available and will expedite the ordering process. Boston University Controlled Substances Program Page 4 of 19 Internal Transfers Internal transfers of controlled substances between Registration Holders are allowed providing that each holds a current registration with appropriate Schedule. The internal transfer is conducted using the same procedure as a purchase, except that the BU Requisition form is not needed. OEHS will help to coordinate al transfers. Remember: Complete all forms except BU Requisition forms All transfers must be reviewed and approved by BU OEHS Ensure that all inventory records are reconciled upon the transfer by both the sender and receiver DEA Form 222 must be used when transferring Schedule I and II substances. (sample available in Appendix 4 and at https://www.deadiversion.usdoj.gov/webforms/orderFormsRequest.jsp) Security Depending on the quantities and type of controlled substances, security must include a safe or steel cabinet, which follow DEA specifications. Access must be strictly limited. Controlled substances in use must be under the direct supervision of a designated, responsible individual (e.g., Principal Investigator). OEHS will help define specific lab requirements. General requirements include: All controlled substances must be kept in a double locked enclosure. Minimum requirement is a double locked steel cabinet (drug box). Schedule I substances must have 750 lb safe (or safe bolted to floor) with central station alarm Access to storage and use areas must be strictly controlled All controlled substances must be under the control of a designated, responsible individual. Storage cabinet or safe must be adequately sized to maintain stock containers and waste materials. One example of a TL15 compliant safe (resistant to burglary & radiological techniques) is shown below. It is available in sizes from 1 cubic foot of storage (DXE 1212) and larger from Boston Lock and Safe (617-7873400, http://www.bostonlockandsafe.com/ ). This model, or an equivalent, is recommended. Boston University Controlled Substances Program Page 5 of 19 Record keeping Registration holders must maintain the following records in a readily retrievable manner and submit certain records to regulatory agencies as specified below. Records must be available for unannounced inspection. Physical Inventories: o Inventories must be current at all times. o DEA requires biennial inventory reports Standard “Bound Book” Dispensing Log o Numbered pages o List of contents and page numbers o Drug Name, how supplied, date, purpose of use o Quantity on hand, quantity deducted or added to inventory o Signature of individual authorized researcher for each transaction Receipts: o Official order forms (Form 222) for Schedules I and II; invoices from wholesaler/supplier for Schedules III through V. o Blank Form 222s must be kept in safe. Animal Protocols: o Written animal protocols and approval letters from the Institutional Animal Care and Use Committee (IACUC) are required if controlled substance use involves the use of animals. o Otherwise, the Registration Holder or applicant must include a letter justifying the need for the controlled substance in his/her research (included in application materials). Personnel: o Current records of personnel who have access to the security container(s) and personnel who have access only to controlled substances. Disposal Unwanted or outdated controlled substances must be sent to a DEA-registered disposal firm for destruction. Contact OEHS for assistance. Empty containers (using normal means) are disposed of as biohazard waste by OEHS during audits. Registrants are not authorized to dispose of controlled substance containers. Keep your empty containers in security containment until the annual OEHS audit. Make sure inventory is “zeroed” out OEHS will inspect empty containers and documentation prior to defacing the labels and disposing of the containers via the bio-hazardous waste stream. Boston University Controlled Substances Program Page 6 of 19 Termination Registration Holders who wish to terminate registrations must dispose or transfer any controlled substances in inventory, in accordance with applicable regulations, prior to termination. Actions to take include: Notify OEHS Send all remaining blank 222s and registration certificate to DEA Transfer inventory to BU registered user(s) or arrange for disposal Arrange for record retention Reporting Unexplained losses or thefts of controlled substances must immediately be reported to DEA and DPH upon discovery. Contact the OEHS who will assist with the reporting requirement. Learn more here: http://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html Training OEHS will provide training for all current and future registration holders. Training will include an overview and update of the regulatory requirements, including an explanation of each element of the controlled substance program. OEHS will notify all Registrants of scheduled training programs. Audit OEHS performs periodic program audits including visits to each laboratory, interviews with the requisition holders, and a review of recordkeeping. Recommendations for program improvements are developed and implemented. Boston University Controlled Substances Program Page 7 of 19 APPENDIX 1 INFORMATION FOR DEA CONTROLLED SUBSTANCE APPLICATION Boston University Controlled Substances Program Page 8 of 19 INFORMATION FOR DEA CONTROLLED SUBSTANCE APPLICATION 1. Principal Investigator: Full Name: Title: Social Security #: Date of Birth: Mailing Address: Telephone: Home Address: Telephone: 2. Describe where the controlled substances will be secured. a. Address: b. Room No. or Lab Name: c. Floor: d. Describe security to be used (e.g., safe, narcotic control cabinet, other steel cabinet) e. Describe (and attach documentation if possible) of safe and/or cabinet. f. Describe any other security provisions ( e.g., alarm, room locked off master, etc.) 3. Attach floor plan(s), noting location of all security provisions, such as a safe, alarm, etc. 4. List all information below regarding people who will have access to the security container(s): Name Title or Position Local Home Address Social Security (No P.O. Boxes) Number Date of Birth 5. List all information below regarding people who will have access to the controlled substance(s): Name Title or Position Local Home Address Social Security (No P.O. Boxes) Number Date of Birth Boston University Controlled Substances Program Page 9 of 19 6. List for each controlled substance (attach separate sheet if necessary): a. Name of controlled substance b. Purpose or use of controlled substance c. Brief summary of nature of research d. Maximum amount of raw stock to be possessed at any one time e. Maximum amount of any diluted solutions to be possessed at any one time F. the Boston University Institutional Animal Care and Use Committee approved protocol number(s) for the Principal Investigator’s research on (date). g. Grants from support this research. 7. List the source(s) of supply. a. Name of vendor(s) or institution(s) b. Address(es) c. Telephone number(s) d. Name, address and telephone # of person(s) in charge of supplier(s) or point(s) of contact. 8. Attach a copy of the state controlled substance license issued by the Department of Public Health. 9. Signature of DEA license applicant____________________________ Date_______________ Boston University Controlled Substances Program Page 10 of 19 APPENDIX 2 CONTROLLED SUBSTANCE PROGRAM RELEASE Boston University Controlled Substances Program Page 11 of 19 Controlled Substance Program Release Federal and state laws relating to controlled substance licenses encourage employers to take all reasonable steps to reduce the risk of drug security breaches. The United States Drug Enforcement Administration has issued regulations encouraging employers to screen employees with access to controlled substances in order to reduce the risk, or likelihood, of criminal activity or other unauthorized use of controlled substances. Therefore, Boston University requests that you answer the following questions and execute the release set forth below. 1. Within the past five years, have you been convicted of a felony? Yes 2. No Within the past two years, have you been convicted of a misdemeanor? Yes No If the answer to either of Questions 1 or 2 is “Yes,” please furnish the details of the charge or conviction, the offense, the location, the date, and the sentence, if any. Do not include references to any traffic violations, juvenile offenses, or military convictions, except by General Court Martial. Boston University Controlled Substances Program Page 12 of 19 3. Within the past three years, have you ever knowingly used narcotics, amphetamines, or barbiturates, other than those prescribed to you by a physician? Yes No If the answer to Question 3 is “Yes,” please furnish the details of your use of these substances. Release I, [name], authorize Boston University, pursuant to my work in an area where access to controlled substances exists, to make inquiries of courts and law enforcement agencies for charges or convictions, pursuant to 21 C.F.R. § 1301.90 and Massachusetts General Laws, c. 94C § 42. I understand that the information disclosed or discovered as a result of any inquiry will not necessarily preclude employment or continued employment, but will be considered as part of an overall evaluation of my qualifications. I understand that any false information or omission of information will jeopardize my position with Boston University. I recognize that Boston University will treat the results of such inquiries in confidence, consistent with fair employment practices and my right of privacy. Date: By: Boston University Controlled Substances Program Page 13 of 19 APPENDIX 3 BU CONTROLLED SUBSTANCE PROTOCOL ORDER FORM Boston University Controlled Substances Program Page 14 of 19 CONROLLED SUBSTANCE PROTOCOL ORDER FORM (for research only) ONE FORM PER CONTROLLED SUBSTANCE ORDERED This form MUST be typed Date: 1 Principal Investigator (Last name, First name): 2. Department: 3. Building: 4. Phone: 5. Name of Controlled Substance Ordered: 6. Schedule Number: 7. Amount: 8. Reason for use - Describe briefly, in the space below, the reason for ordering (e.g. anesthesia) 9. Grant Title: 10. Place of Storage (Building; Room): 11. Type of Storage (Safe): I am fully knowledgeable of the rules and regulations promulgated by the Drug Enforcement Administration (DEA) pertaining to the safe - keeping of controlled substances scheduled 1,2,3,4, and 5 and agree to abide by them. SIGNATURE OF P.I. ___________________________________________________________ SIGNATURE OF LICENSE HOLDER: ____________________________________________ Send this completed form to the Office of Environmental Health and Safety, 704 Commonwealth Avenue, 2nd Floor, with a completed requisition form (and Form 222, if applicable). Boston University Controlled Substances Program Page 15 of 19 APPENDIX 4 INSTRUCTIONS FOR ORDERING CONTROLLED SUBSTANCES, INCLUDING THOSE THAT REQUIRE A DEA FORM 222 Boston University Controlled Substances Program Page 16 of 19 Boston University Office of Environmental Health and Safety Instructions for Ordering Controlled Substances In order to expedite the delivery of your DEA Controlled Substances, we have created this reference document regarding information necessary to place orders for DEA Controlled Substances. Much of this information was obtained from the 2006-2007 Sigma Catalog, pages 18-20. Orders for controlled substances must be placed in writing on an official purchase order. Please note the "ship to" address must exactly correspond to your name and address on the DEA registration. Your DEA registration number must also be included on your purchase order (on initial order you must submit a copy of your DEA registration for our files). Orders for Schedule I and II DEA items Orders for these items must include a complete DEA Form 222 (see sample below). We are not permitted to fill orders in altered or incomplete order forms. The address on the Form 222 must match the address on your DEA registration certificate. Remember to keep the bottom (blue) copy of Form 222 with your records and follow its instructions. Orders for Schedule III, IV, & V DEA items Orders for these items must include a copy of your DEA registration number with your official purchase order. For All Orders: 1. 2. 3. 4. 5. Complete and sign BU “Controlled Substance Protocol Order Form” Attach completed form 222 for Schedule I and II Attach copies of valid MA DPH and DEA registrations Attach completed standard BU Requisition Form with PI signature Forward to BU Office of Environmental Health and Safety: Ron Slade, Controlled Substances Administrator rslade@bu.edu 617 353-9734 BU Office of Environmental Health and Safety 704 Commonwealth Avenue, 2nd Floor Fax 617 353-5646 Following is a list of the most common reasons that we are unable to process a DEA order upon receipt. Please double check these items before submitting your order to Sigma-Aldrich, Inc. 1. The "No. of lines completed" is not filled out or filled out correctly (Remember it is the number of lines on the form used, not the number of bottles you are ordering.) 2. Two lines on the 222 form are used for 1 product. (Remember you are only to use 1 line per product.) 3. The date is not filled out. 4. DEA and/or DPH registration(s) have expired. (Remember to submit copies of your current registrations to OEHS.) Boston University Controlled Substances Program Page 17 of 19 FORM 222 No order form may be issued for Schedule I and II substances unless a completed application form has been received, (21 CFR 1305.04). See Reverse of PURCHASERS Copy for Instructions TO: (Name of Supplier) CITY and STATE L I N E N o 1 2 3 4 5 6 7 8 9 10 3 OMB APPROVAL No. 1117-0010 STREET ADDRESS DATE TO BE FILLED IN BY SUPPLIER SUPPLIERS DEA REGISTRATION NO. Today's Date TO BE FILLED IN BY PURCHASER No. of Packages Size of Package 1 2 2 250 mg 1g 10 mg NO. OF LINES COMPLETED Date Issued MM/DD/YY Schedules 1, 2, 3, 3N, 4, 5 Registered as a RESEARCHER Name of Item National Drug Code Packages Shipped Cocaine hydrochloride Thebaine Phencyclidine hydrochloride SIGNATURE OF PURCHASER OR HIS ATTORNEY OR AGENT DEA Registration No. Name and Address of Registrant AB1234567 YOUR INSTITUTUON 1 MAIN STREET TOWN, STATE ZIP No. of the Order Form 123456789 DEA Form - 222 (June 1983) U.S. OFFICIAL ORDER FORMS - SCHEDULES I & II DRUG ENFORCEMENT ADMINISTRATION SUPPLIERS COPY 40147948 Instructions appear on the back of the form. Keep blue copy and send the tan and green copy and carbons to supplier. Date Shipped Fill in name and address of supplier Fill in today's date Fill in columns marked "No. of Packages", "Size of Package" and "Name of Item". Use only one line per item ordered. Supplied by the DEA. Do not change Supplied by the DEA. Do not change Sign with your Authorized Signature Do not fill in. For Supplier only. Fill in "No. of lines completed" Boston University Controlled Substances Program Page 18 of 19 Boston University Controlled Substances Program Page 19 of 19