Controlled Substance Record-Keeping and Inventory Management



	Controlled Substance Record-Keeping and Inventory Management Controlled substance records and inventories must be maintained in conformance with State of Michigan and U.S. Department of Justice regulations. All documents related to controlled substances must be readily retrievable and available for immediate inspection (within 48 hours). Readily retrievable means that certain records are kept in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records. By law, inspections may be conducted by DEA Diversion Investigators, State of Michigan Bureau of Health Professions Investigators, and authorized police or law enforcement. Records must be maintained for a period of two years from the last transaction date recorded. Five years is recommended. All records must be stored in a secure location preferably locked in the cabinet or safe containing the controlled substances. The following records must be maintained: DEA Certificate of Registration 223 and State of Michigan controlled substances license Authorized User List Acquisition invoices for Schedule III-V controlled substances DEA Form 222 for ordering Schedule I and II controlled substances Used, voided, and unused DEA 222 Forms must be maintained Power of Attorney for DEA Form 222 Inventory records General inventory Initial inventory Annual inventory State of Michigan - A copy must be mailed each year Biennial inventory - DEA Usage and administration records Disposal records Transfer records of controlled Substances transferred between registrants DEA Form 106 - Report of Loss or Theft Initial Inventory: An initial inventory for each licensed and registered location must be performed on the date the registrant first engages in any activity covered by their Michigan controlled substance research license and DEA researcher registration. Initial Inventory Form The initial inventory must include: Registrant's printed name DEA registration number and registration address Date and time (opening or closing of the day) inventory was performed Names of all controlled substances, dosage forms, dosage strengths, and quantities in possession of the registrant Initial inventories of zero must be documented The inventory form must be signed and dated by the registrant or authorized user and a witness Initial inventory records of Schedule I and Schedule II controlled substances must be kept separate from initial inventory records of Schedule III-V controlled substances An inventory taken by use of an oral recording device must be promptly transcribed The Registrant shall maintain the inventory in a written, typewritten, or printed form An inventory will need to be taken for any new drug(s) or chemical(s), which were not previously listed in any schedule, that were added to a controlled substance schedule by the State of Michigan or the DEA. Afterwards, the substance(s) shall be accounted for on the normal State of Michigan annual inventory date for all controlled substances Principal Investigators currently storing controlled substances acquired from ULAM in their laboratories must not include these agents as part of their initial inventory. These controlled substances are tracked under the ULAM controlled substance general inventory. Once a department or Principal Investigator acquires their DEA researcher registration number only those controlled substances obtained under their registration number can be placed in their general inventory. Initial inventories should be zero for new DEA researcher registrants. The following options exist: Return all controlled substances acquired from ULAM (including expired and partial quantities) to ULAM before an initial inventory is performed and controlled substances are ordered from the UMHS B2 pharmacy or outside vendors (Preferred option) Arrange with the ULAM office to have controlled drugs transferred to the registrant’s inventory Complete a Research Controlled Substance Transfer Request form located on the UCUCA Controlled Substances -Transfer Procedures webpage Schedule II agents will require completion of a DEA Form 222 Once the necessary transfer forms are completed, previously acquired controlled substances from ULAM may be included in the registrant’s initial inventory ULAM can only transfer a limited amount of controlled substances and requests for transfers may be denied Annual Inventory: The State of Michigan requires an annual inventory of all controlled substances. The State of Michigan annual inventory must be performed between April 1st and June 30th of each year per Michigan Public Health Code, Section 333.7321. Annual Inventory Form The annual inventory must include the same information as the initial inventory Annual inventory records of Schedule I and Schedule II controlled substances must be kept and reported separately from annual inventory records of Schedule III-V controlled substances. Annual inventories must be mailed to the following address per Michigan law: State of Michigan Bureau of Health Professions Health and Regulatory Division, Annual Inventory 6546 Mercantile Way, Suite 2 PO BOX 30454 Lansing, MI 48909 For questions regarding annual inventory requirements, contact the Michigan Bureau of Health Professions-Investigation Division at: (517) 373-1737 or bhpinfo@michigan.gov. Biennial Inventory: The DEA requires a physical inventory of all controlled substances to be conducted every two years. The inventory may be taken on any date within two years of the previous inventory date. A copy of the State of Michigan annual inventory will satisfy this requirement. The biennial inventory is maintained at the registrant’s location for two years and is not sent to the DEA. Perpetual or General Inventory: An ongoing current or perpetual inventory is required to track acquisitions, administration, transfers to usage logs, transfers to other registrants, and disposals of controlled substances. General Inventory Log A separate general inventory log should be created for each stock of drug and its associated strength or container size Controlled substance containers should be transferred from the general inventory log to usage logs for tracking doses delivered from the same container Individual vials or containers should be assigned a unique (non-reusable) number or code (date + vial number or other identifier) upon receipt by the registrant to assist with tracking Controlled substances should remain in their original packaging. Compounded controlled substances should be labeled accordingly if purchased from a vendor or compounding pharmacy General inventory records of Schedule I and II controlled substances must be kept separate from general inventory records of Schedule III-V controlled substances Registrants may develop their own inventory forms provided a controlled substance can be tracked from acquisition to research subject or experimental endpoint Usage Logs: Controlled substances must be tracked from acquisition to administration (to a research subject or usage in an in-vitro or chemical process). It is recommended to keep all usage logs in a standard binder. A separate usage form is recommended for each vial or container The following logs can be utilized to assist in tracking: Multiple Dose Usage Log Combination Solution Usage Log Diluted Solution Log Chemical or Powder Usage Log Registrants may develop their own forms or logs to document administration or usage provided a controlled substance can be tracked from acquisition to research subject or experimental endpoint Usage logs and records of Schedule I and II controlled substances must be kept separate from usage logs and records of Schedule III-V controlled substances Compounded solutions containing a controlled substance prepared within the laboratory should be labeled with the following: Name of the controlled substance(s) Lot number(s) Date vial opened or prepared Final concentration(s) and amount(s) per container <7 day expiration date, unless product stability data suggests otherwise Acquisition Records: All supplier invoices, shipping documents, or packing slips must be signed, dated, and kept upon receipt for a period of two years. Schedule III-V controlled substances may be ordered directly with an invoice A DEA Form 222 is required when ordering or transferring a Schedule I or II controlled substance The DEA Form 222 is a triplicate form Copies one and two are sent (attached together) to the supplier with each order The third copy is completed by the registrant when the controlled substance order is received Refer to the UCUCA Controlled Substances- Purchasing/Acquisition webpage for more information regarding DEA 222 Forms The following must be recorded or appear on the invoice when acquiring controlled substances: Name, address, and DEA registration number of supplier Name, concentration, dosage form, and quantity of controlled substance Signature or initials of authorized user receiving the shipment or pickup Date received For Schedule I or II agents, copy 3 of DEA Form 222 must be completed and kept on file with the registrant’s records Acquisition records of Schedules I and II controlled substances must be kept in a separate file from acquisition records of Schedule III-V controlled substances Controlled Substance Routine Record Auditing Registrants or authorized users are encouraged to perform weekly to monthly audits of their controlled substance inventory to accurately track inventory and avoid discrepancies One authorized user and an authorized user witness must complete the inventory audit At the conclusion of the audit, the authorized user shall document the date, their initials, and a statement indicating the records to be accurate Registrants must review records that fail to reconcile in an attempt to identify recording errors or missing transactions. Inventory discrepancies are generally due to: Mathematical errors Non-recorded administration or dispensing transactions Errors in receiving and general inventory update Refer to Loss and Theft section for unaccountable inaccuracies