Controlled Substance Training Manual

Transcription

1 Controlled Substance Training Manual Last updated Aug2018

2 Table of Contents I. Purpose... 3 II. Responsibilities... 3 III. DEA Registration... 3 IV. Storage... 4 V. Handling and Transport... 4 VI. Recordkeeping Receipt of Controlled Substances Usage and Disposition Mixtures and Dilutions Transfer Inventory Reconciliation Loss or Theft... 8 VII. Disposal... 8 VIII. Terminating CS Usage... 8 IX. Associated Forms... 9

3 I. Purpose This manual serves as a companion manual to the CS Program Procedures, covering technical aspects of applying for DEA registration, establishing storage location and security, maintaining records, and complying with DEA regulations for CS use. It is to be referenced in conjunction with the CS Program Procedures document, which supports the UO Safety Policy Questions about the program can be directed to Hallie Hoskins, Controlled Substance Program Manager. II. Responsibilities Please take a moment to review the Authority and Responsibilities section of the CS Program Procedures document. Since the shift from an institutional UO CS registration to individual registrations, more responsibility falls to the DEA Registrant to obtain, track, and secure controlled substances. The change in registration requirements arises from the DEA s desire to have a more direct relationship with the users of controlled substances. They will be visiting the lab to meet with you and learn about your logbooks and security measures. EHS will support your program in providing training, processing background checks, following up with DEA registrants and authorized users at UO, conducting audits, and reviewing records. Template forms are provided on the EHS website, which contain required information listed in 21 CFR If you choose not to use these forms, please work with EHS to make sure your forms conform with DEA requirements. DEA Registrants are permitted to name Authorized Users within their lab groups. These individuals must have a need to access the CS storage location, not just simply administering the drugs. An authorized user must be a direct supervisory report of his/her DEA Registrant. When identifying authorized users within your group, please minimize those who have access to the storage areas. Registrants should not employ as an agent or employee who has access to CS: Any person who has been convicted of a felony offense related to CS Any person who has been denied a DEA registration Any person who has had a DEA registration revoked Any person who has surrendered a DEA registration for cause III. DEA Registration The first step in beginning research with CS is to contact EHS to initiate background clearances. The CS Program Procedures document details this process for both DEA Registrants and Authorized Users. Once the forms are submitted to EHS, training should be scheduled to review important aspects of the CS Program.

4 After EHS has been notified of cleared background checks, the Controlled Substance Program Manager will notify the DEA Registration Applicant, who is now permitted to proceed with the DEA application. Instructions for submitting the application are found on the EHS website. A copy of the DEA certificate must be provided to EHS. Your DEA registration must be renewed annually. Renewal can be conducted online and is relatively straightforward. Generally the DEA will contact you ahead of time as a reminder, but please do not count on this! If your registration is allowed to expire and you possess controlled substances, you will be out of compliance and you may not use them, dispose of them, or transfer them until DEA has been contacted and they issue instructions. Obtaining a Letter of Exemption from the Oregon Board of Pharmacy While Federal DEA does not require state registration in order to grant a Controlled Substance license, Oregon s Board of Pharmacy does require registration. UO researchers qualify for exemption from this registration requirement, but a Letter of Exemption is still required. Once the DEA license has been obtained, please submit a letter to the Oregon Board of Pharmacy as instructed in the Procedures manual. IV. Storage Before the DEA registration application can be submitted, a storage location must be identified. Most Registrants currently working with CS at UO have this in place. Please take a moment to ensure your storage location meets DEA s requirements, as they will inspect this area during their site visit. Title 21, CFR Section (a), requires that all registrants provide effective controls and procedures to guard against theft and diversion of CS. Depending on the facility s existing security controls and public access to the building, the DEA may determine that additional controls are needed. At a minimum, researchers are required to store stocks of Schedule II through V CS in a securely locked, substantially constructed cabinet. A safe is not required, but if a safe or other freestanding unit is used, it must weigh at least 750 lbs. Ideally the storage cabinet is bolted to the floor or infrastructure, or contained within the facility s laboratory bench. EHS can advise on suitable storage conditions. V. Handling and Transport Another process to establish prior to submitting the DEA registration application is ordering and delivery of CSs. The mailing address you provide on the DEA application must be the address to which CS are shipped; vendors will not ship to any other address. Please identify the most appropriate shipping address so that any CS delivery will be accepted by a trustworthy person and handed directly to the DEA registrant or authorized user for that CS. CS deliveries can never be left in an office or otherwise unattended!

5 VI. Recordkeeping When a CS is received from a manufacturer or vendor, the accompanying paperwork (order form, shipping documents, and invoices) must be retained as part of the CS official record. Template forms provided on the EHS webpage meet DEA criteria for information captured. You must maintain records with the CS in the storage location. Records must be kept for at least two years past the last recorded entry. Forms must be filled out deliberately and thoughtfully; do not rush. Write neatly in pen. Errors must be crossed out one time and the entry initialed. Whiteout is not allowed. Records must be in written, printed, or typewritten form (not maintained electronically). When a delivery of CS is received from a vendor, it must be issued an internal inventory number. The following numbering convention must be used for consistency within UO and to avoid accidental duplications: MMDDYY of receipt + First & Last Initials of DEA Registrant (Example: a receipt of Ketamine for a DEA Registrant named Howard Hughes on February 14, 2016 would be listed as HH.) Beyond this convention, you have leeway with further distinguishing the substance. For instance, an order of 10 vials of one CS may more easily tracked by issuing inventory numbers such as HH-A, HH-B, etc. The inventory number must be clearly and indelibly marked on the vial itself. A label-making machine is ideal; if a marker is used please write legibly and ensure it will not erase with alcohol. A Controlled Substance Disposition Log shall be initiated for the substance, immediately upon receipt. Because the Disposition Log also serves as a chain of custody, this will track the CS s initial receipt and possession. In the example above, if 10 vials are received, it may be most logical to initiate 10 separate Disposition Logs, one for each vial. The following fields must be filled out on the Disposition Log for each CS received: DEA Registrant Name (Full name of individual possessing a DEA certificate) DEA Registration Number (Number appearing on the certificate issued by DEA)

6 Storage Location (Building and Room Number) Department (UO Department or Institute under which the work is conducted) Receipt Date (Month, Day, Year of initial CS receipt into the Registrant s possession) Controlled Substance (Name of CS as it appears in the DEA List) Volume Received (Initial volume of unopened bottle/vial) Form ( finished form, meaning units of measure) Concentration (Initial concentration of stock solution, as received from manufacturer) Expiration Date (Manufacturer s expiration date as printed on bottle) Internal Inventory # (Issued per numbering convention described in this document) This form is to be used for all withdrawals or usages of CS from the bottle/vial to which it is issued. The table must be completed as follows: Date (Date of transaction, e.g., receipt, transfer, administration) Description of use (Detailed description of reason for withdrawing) Protocol # (Applicable IACUC protocol or equivalent) # of Animals x Dose amount = Amount Used (Total) Balance Remaining (Previous balance minus amount used) Signature of person conducting the transaction The form is two-sided. Additional copies of page 2 may be made if more entry lines are needed. Any comments may be recorded at the bottom of page 2 (for instance, if the vial broke and contents were lost). Mixtures and dilutions of CS should be issued a new internal inventory number consisting of the original (parent) inventory number plus a suffix. Following is the recommended method of identification: MMDDYY of receipt + First & Last Initials of DEA Registrant +.01 (Example: a dilution of Ketamine in the Howard Hughes lab, which produced ten more vials, could be identified as HH.01, HH.02, HH.10, etc.) A fresh Disposition Log should be created to pair with each vial created. Transfer of Schedule II CS must be conducted using DEA Form 222. This form may be requested at the DEA website: The form is not available online, but must be requested using the Official Order Form. A Form 222 must be

7 completed for every Schedule II transfer of ownership. The current owner should be listed as the supplier on the form. The form is in triplicate; one copy stays with the supplier, one goes to the recipient, and the third must be mailed to the DEA. Transfer of Schedule III-V CS can be conducted between DEA Registrants within UO only. Please complete the Schedule III-V Transfer Form to initiate this: The Transferor (current Registrant possessing the CS) must enter his/her: Full name DEA-issued registration certificate number Current storage location Date of transfer Signature (electronic is permissible) The transferor should fill out the table for each CS to be transferred to the listed recipient. The CS Schedule and 4-digit National Drug Code number can be found on the DEA Controlled Substance List. The Recipient should then enter his/her: Full name DEA-issued registration certificate number New storage location Date of transfer Signature (electronic is permissible) A copy of the completed form should be maintained in each Registrant s file for at least two years. The Transferor should write an entry in the current Disposition Log indicating the transfer transaction, and update the Balance Remaining column accordingly. The Recipient must initiate a fresh Disposition Log to track usage of the material from the transfer going forward. A complete and accurate inventory reconciliation of the CS within each DEA Registrant s laboratory must be recorded when he or she first receives a DEA license and then at least biennially thereafter. The inventory can be taken either as of the opening of business or the close of business on the inventory date and this, along with the date, should be noted on the inventory. Any product that is in the lab at that time must be inventoried, even if it has not been in the lab's possession for the full two years. The type, strength, and quantity of all controlled substances must be recorded at this time in the manner prescribed in DEA regulations. All Schedule II CS must be physically measured or counted during the inventory. If no drugs are on hand during the inventory (e.g., when conducted upon first receiving a DEA license), indicate none on hand on the form.

8 For each CS, the inventory shall include: The name of the substance Each finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) The number of units or volume of each finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial) The number of commercial containers of each such finished form (e.g., four 100-tablet bottles or six 3-milliliter vials) The DEA Registrant conducting the inventory must sign the record. This biennial inventory must be retained on the laboratory premises for at least two years from the date of inventory, and be readily available for regulatory review if requested. A copy of each completed inventory reconciliation should be submitted to EHS. If any CS has been stolen, misplaced, or lost from the lab s control, it must be reported to EHS, UOPD, the DEA (DEA Form 106, Drug Theft/Loss ), and any other relevant authorities. This includes required reporting for unauthorized uses and unauthorized destruction of CS. Lab staff must also document any discrepancies for losses of the product on the disposition sheets for the bottle. VII. Disposal The DEA will only allow researchers to dispose of leftover, expired, or otherwise unwanted CS through a reverse distributor, who is authorized by DEA to receive shipments of CS for disposal. A list of DEA-approved reverse distributors is available on the EHS website. Schedule I and II CS should be transferred via the DEA Form 222, while Schedule III-V CS may be transferred via invoice. To document the disposal, complete DEA Form 41 and file with your CS records (it does not need to be submitted to DEA unless requested to do so). The Registrant is responsible for contacting a reverse distributor, arranging for shipment of materials to the reverse distributor, and paying associated expenses. Empty vials are allowed to be disposed in the standard lab waste stream, after defacing the label. VIII. Terminating CS Usage If work involving CS is anticipated to end, the Registrant should contact EHS immediately. CS may be transferred to another UO DEA Registrant or disposed through a reverse

9 distributor. It is your responsibility to UO and the DEA to properly terminate the work, including revoking all CS in possession and notifying DEA of intent to cancel the CS registration. IX. Associated Forms New Registrant Application Background Check Permission Form Authorized User Screening Form Disposition Record (UO template) DEA Form 222 for transfer of Schedule I and II drugs DEA Form 41 for documenting disposal/destruction DEA Form 106 for documenting drug theft/loss Schedule III-V Transfer Form (UO template) Inventory Log (UO template)