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CONTROLLED SUBSTANCE OVERVIEW: RECORDS AND INVENTORIES
Controlled substance records and inventories must be maintained in conformance with State of Michigan and federal regulations. All documents related to controlled substances must be readily retrievable and available for immediate inspection. Readily retrievable means certain records are kept in such a manner that they can be separated from all other records in a reasonable time. Registrants must maintain all records at the address listed on one’s state license and DEA registration.
Records must be maintained for a period of two years from the last transaction date recorded. A separate logbook should be kept containing controlled substance information. All records must be stored in a secure location preferably locked in the cabinet or safe containing the controlled substances.
All records of schedules I and II controlled substances must be kept separately from those of schedule III-V substances.
All records of substances in schedules III-V must be kept separately from all other records of the registrant or in such a form that the records are readily retrievable.
The following records must be maintained and readily available:
- State of Michigan controlled substance license
- DEA Certificate of Registration
- Authorized agent screening statement(s)
- Acquisition and ordering invoices
- Signed and dated supplier invoices or packing slips
- DEA Form 222s
- Used, voided and unused Form 222s
- Inventory records
- Usage and administration records
- Transfer records of controlled substances transferred between registrants/licensees
- Disposal records- DEA Form 41
- DEA Form 106- Report of Loss or Theft
The following inventories must be maintained and be readily retrievable:
A copy of the annual inventory must be sent to the State of Michigan. All other inventories should be kept at the registered site.
Inventories must be maintained in a written, typewritten, or printed form at the registered location for two years from the date that the inventory was completed.
Inventories (initial, annual, and biennial) must include the following information:
- Name, address and DEA registration number of the registrant/licensee
- Date and time the inventory was performed (should be at the beginning or the end of the day)
- Signatures of the registrant/licensee or authorized agents responsible for taking the inventory
- For each controlled substance in finished form the inventory must include:
- Name of the substance
- Each finished form of the substance (e.g., 5-mg tablet or 5-mg concentration per fluid ounce)
- Number of units or volume of each finished form in each commercial container (e.g., 100-tablet bottle or 5-mL vial)
- Number of commercial containers of each finished form (e.g., 5 100-tablet bottles or 6 5-mL vials)
- For damaged, defective or impure substances, substances awaiting disposal, substances held for quality control purposes, or substances maintained for extemporaneous compoundings, the inventories must include:
- Name of the substance
- Total quantity of the substance to the nearest metric unit weight or the total number of units of finished form
- Reason for the substance being maintained by the registrant/licensee and whether such substance is capable of use in the manufacture of any controlled substance in finished form
- When determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, do the following:
- If the substance is listed in schedule I or II, make an exact count or measure of the contents
- If the substance is listed in schedules III-V, make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case an exact count of the contents must be made
- Schedule I and II controlled substance inventories must be separated from inventory records of schedule III-V substances
A separate inventory for each location must be performed on the date the registrant/licensee first engages in any activity covered by his or her state license and DEA registration. Initial inventories are usually zero. An initial inventory must be taken for any newly scheduled substance that was not previously listed on any schedule. The substance should then be accounted for on the normal annual/biennial inventories. A specific form is not required for the inventory. The Initial Controlled Substance Inventoriy Form can be used or modified for this purpose.
Annual Inventory – Required by the State of Michigan
The State of Michigan requires a physical inventory of all controlled substances to be conducted on an annual basis. The annual inventory must be performed between April 1 and June 30 of each year per Michigan Public Health Code, Section 333.7321. A specific form is not required for the inventory. The Annual Controlled Substances Inventory Form can be used or modified for this purpose.
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
Biennial Inventory – Required by the DEA
The DEA requires a physical inventory of all controlled substance to be conducted every two years. The inventory may be taken on any date within two years of the previous inventory date. This inventory must be kept at the registered site for two years after it is taken. It is not sent to the DEA. A copy of the State of Michigan annual inventory will satisfy this requirement.
A continuous general inventory is required to track acquisitions, current on-hand stocks, administration, transfers to usage logs, transfers to other registrants/licensees, and transfers of substances for disposal.
- A separate general inventory log should be created for each stock of drug and its associated strength or container size. A sample log can be found in the Controlled Substance section of the EHS web site.
- Schedule I and II records must be separate from schedule III-V records.
- Controlled substance containers should be transferred from the general inventory log to separate usage logs for tracking doses delivered from the same container.
- Individual vials or containers should be assigned a unique number or code upon receipt to assist with tracking
- Registrants/licensees may use their own form provided a substance can be tracked from acquisition to research subject, experimental endpoint, transfer, or disposal.
The registrant/licensee for each registered location must maintain complete, current and accurate purchasing records if controlled substances are stored, delivered or administered at that location.
- The following information should be recorded when receiving a controlled substance shipment:
- Name, address, and DEA registration number of the supplier
- Name, concentration or weight, dosage form, and quantity of controlled substance received
- Signature of the person receiving the shipment (this must be either the registrant/licensee or an authorized agent)
- Date received
- For schedules I and II controlled substances, copy three of DEA Form 222 must be completed and kept on file.
- Invoice and acquisition records of controlled substances listed in schedules I and II must be maintained separately from all other records. Invoice and acquisition records of controlled substances listed in schedule III-V must be maintained either separately from all other records or in a form such that the information is readily retrievable.
- All invoice and acquisition records must be kept for two years from the date of the record.
Controlled substances must be tracked from acquisition to administration. A separate usage form should be used for each unique vial or container. Registrants/licensees may develop their own forms to document usage or use the following forms:
Compounded solutions containing a controlled substance prepared within the laboratory must also be tracked. The solutions should be labeled with the following:
- Name of the controlled substance
- Lot number
- Date vial prepared
- Final concentration and amount per container
- Expiration date