Controlled Substance Inventory Requirements
The registrant for each registered location must maintain complete, current, and accurate inventory records if controlled substances are stored, delivered, or administered at that location.
Refer to Title 21 CFR, Part 1304.11: Inventory Requirements for additional information.
Refer to Michigan CS Administrative Rules R 338.3151 Inventories for additional information.
Inventories and records of controlled substances listed in Schedules I and II shall be maintained separately from all of the records of the registrant.
Inventories and records of controlled substances listed in Schedules III, IV, and V shall be maintained either separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant.
All inventory records must be maintained for at least 2 years from the date of such inventory or records and be readily retrievable for immediate inspection and copying by authorized employees of the DEA and Michigan Bureau of Health Investigations. Five years is recommended for record retention.
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.
All inventory records must be stored in a secure location at the registered site preferably locked in a cabinet or safe.
The following inventory records must be maintained and be readily retrievable:
- Initial Inventory
- Annual Inventory – State of Michigan (A copy must be mailed to MBHP each year)
- Biennial Inventory - DEA
- Perpetual or General Inventory
A copy of the annual inventory is mailed to the State of Michigan. All other inventories (initial, biennial, and general or perpetual) remain at the registered location.
An initial inventory must be performed upon receipt of a new DEA registration
**Do not include current quantities of controlled substances previously acquired from ULAM in an initial inventory. See the Ordering/Purchasing Transfers: ULAM to New DEA Registrants for additional information. **
- Registrants shall take an inventory for each licensed location of all stocks of controlled substances on hand on the date he/she first engages in the manufacture, distribution, or dispensing of controlled substances.
- In the event a person commences business with no controlled substances on hand, he/she shall record this fact as the initial inventory.
- Initial laboratory controlled substance inventories for new registrations should be zero.
- 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 at the registered location for at least two years from the date that the inventory was conducted.
- 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
Initial, State of Michigan annual, or DEA biennial inventory must include:
- Name, address and DEA registration number of the registrant
- Date and time (opening or closing of the day) inventory was performed
- Signatures of the registrant or authorized users responsible for taking the inventory
- For each controlled substance in finished form 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)
- For controlled substances that are damaged, defective or impure substances awaiting disposal, substances held for quality control purposes, or substances maintained for extemporaneous compoundings) the inventories shall include:
- The name of the substance
- The total quantity of the substance to the nearest metric unit weight or the total number of units of finished form (all controlled substances in powder form must be weighed)
- The reason for the substance being maintained by the registrant and whether such substance is capable of use in the manufacture of any controlled substance in finished form
- In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the dispenser shall do as follows:
- 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 Schedule III, IV or V, make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case he/she must make an exact count of the contents.
- Schedule I and Schedule II controlled substances must be separated from inventory records of Schedule III-V controlled substances.
State of Michigan Annual Inventory
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.
The State of Michigan Bureau of Health Professions does not mandate a specific form be used to satisfy this requirement. The following form can be used or modified for the annual inventory requirement:
State of Michigan Annual Inventory Form
- The annual inventory must include the same information as the initial State of Michigan inventory and DEA inventory.
- Schedule I and Schedule II controlled substances must be listed separately from Schedule III-V controlled substances on the State of Michigan controlled substances annual inventory form
The State of Michigan controlled substance licensee - DEA registrant must report a zero inventory to the Michigan Bureau of Health Professions if there are no controlled substances in stock at the registered laboratory location at the time of the annual inventory.
Annual inventories must be mailed to the following address:
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 firstname.lastname@example.org.
DEA Biennial Inventory
After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date, which is within two years of the previous biennial inventory date.
DEA Biennial Inventory Form
- The biennial inventory requires the same information as the initial inventory of all controlled substances on hand.
- The biennial inventory is maintained at the registrant’s location for two years and is not sent to the DEA.
Perpetual or General Inventory
Title 21 CFR, Section 1304.22: Records for manufacturers, distributors, dispensers, researchers, importers and exporters
A continuous general or perpetual inventory is required to track acquisitions, current on-hand stocks, direct administration, transfers to usage logs, transfers to other registrants, and transfers of controlled substances for disposal.
The DEA prefers one central storage location at each registered site with a single general or perpetual inventory.
A registrant is responsible for maintaining complete and accurate inventories for all controlled substance inventories when controlled substances are stored or administered in multiple rooms at the same registered location.
The State of Michigan annual inventory and DEA biennial inventory must include the total inventory of all storage areas under the registrant’s DEA registration.
General Inventory Log
- A separate general inventory log should be created for each stock of drug and its associated strength or container size. 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 (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.
- Registrants may develop their own inventory forms provided a controlled substance can be tracked from acquisition to research subject, experimental endpoint, transfer, or disposal.