Annual Inventory Instructions

The State of Michigan requires an annual inventory of controlled substances to “be conducted and submitted to the administrator not more than 30 days before May 1, but shall be conducted and submitted to the administrator not later than 60 days after May 1” (see the regulation: 333.7321). If there are no controlled substances in stock at the registered location at the time of the annual inventory, the licensee/registrant must still report a zero inventory.

Complete the Inventory

1. The inventory shall contain a complete and accurate record of all controlled substances in the possession or control of the licensee on the date the inventory is taken as follows:

  • If the substance is listed in schedule 1 or 2, then the licensee shall make an exact count or measure of the contents.
  • If the substance is listed in schedule 3, 4, or 5, then the licensee shall make an estimated count or measure of the contents, but if the container holds more than 1,000 dosage units, such as tablets or capsules, then the licensee shall make an accurate account of the contents.

2. 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); and
  • The number of commercial containers of each such finished form (e.g. four 100-tablet bottles or six 3-milliliter vials).

3. For each controlled substance not in finished form (e.g., damaged, defective or impure substances awaiting disposal, substances held for quality control purposes, or substances maintained for extemporaneous compounding) 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; and
  • 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.

4. A licensee/registrant shall indicate on the inventory record whether the inventory was taken as of the opening or closing of the day that the inventory is taken.

5. A licensee/registrant shall maintain the inventory in a written, typewritten, or printed form. The inventory taken by use of an oral recording device shall be promptly transcribed.

6. A licensee/registrant shall sign and date the inventory record.

7. A licensee's/registrant’s printed name, address, and DEA number shall be recorded on the inventory.

8. Schedule 2 drugs shall be separated on the inventory from all other drugs.

*see the regulations: R 338.3151; 21 CFR 1304.11

 

Keep a copy of the inventory

You are no longer required to send a copy of the annual inventory to the State of Michigan.  You do need to keep a copy of the inventory with your other controlled substance records.  This will meet the requirements of the State of Michigan's annual inventory and the federal regulations for a biennial inventory (see the regulation: 21 CFR 1304.11). 

Tips

  • A sample inventory form is available on the EHS website. There is no specific form that must be used. The form can be used as is or modified for your use. 
  • If there are no controlled substances in stock at the registered location at the time of the annual inventory, the licensee/registrant must still report a zero inventory.
  • Additional information regarding annual inventories and other record-keeping requirements can be found on Controlled Substance section of the EHS website.

Controlled Substances