INVENTORY REQUIREMENTS

Question 1

An “inventory” is

Answer 1

a complete and accurate list of all stocks and forms of controlled substances in the possession of the registrant as determined by an actual physical count for schedule II controlled substances.

Question 2

With respect to inventories of a schedule III, IV, or V controlled substance, the registrant may, with respect to an open bottle which contains no more than how many tablets, make an estimated count or measure of the contents, unless the container holds more than how many tablets or capsules in which case they must

Answer 2

1,000 tablets, unless the container holds more than 1,000 tablets or capsules in which case an exact count of the contents must be made.

Question 3

The CSA also requires that all inventory records be maintained at the registered location for how long?

Answer 3

at least two years for copying and inspection.

Question 4

In addition, the inventory records of schedule II

controlled substances must be kept ________ from all other records of the pharmacy.

Answer 4

separate

Question 5

The inventory records of schedules III, IV, and V controlled substances must be maintained either

Answer 5

must be maintained either separately from all other records of the pharmacy or in such form that the information required is readily retrievable from ordinary business records of the pharmacy.

Question 6

When issued a DEA registration, a registrant must take an initial inventory, which is what?

Answer 6

which is an actual physical count of all controlled substances in their possession.

Question 7

If there are no stocks of controlled substances on hand when doing an initial inventory, the registrant should what?

Answer 7

the registrant should make a record showing a zero inventory.

Question 8

Is there a requirement to submit a copy of the inventory to DEA?

Answer 8

No

Question 9

The initial inventory shall include:

Answer 9

1. The date of the inventory,
2. Whether the inventory was taken at the beginning or close of business,
3. The name of each controlled substance inventoried,
4. The finished form of each of the substances (e.g., 10 milligram tablet),
5. The number of dosage units or volume of each finished form in the commercial container (e.g., 100 tablet bottle or 3 milliliter vial),
6. The number of commercial containers of each finished form (e.g., four 100 tablet bottles), and
7. The total count of the substance.

Question 10

Although the it is not required by law, DEA recommends that registrants keep an inventory record that includes what?

Answer 10

the name, address, and DEA registration number of the

registrant, and the signature of the person or persons responsible for taking the inventory.

Question 11

After the initial inventory, the registrant is required to take a new inventory at least every ____ years, which requires what?

Answer 11

two years, which requires the same information as the initial inventory of all controlled substances on hand.

Question 12

Is there a requirement to submit a copy of the inventory to DEA?

Answer 12

No

Question 13

Newly Scheduled Controlled Substance Inventory. When a drug not previously listed as a controlled substance is scheduled, the drug must be inventoried as of

Answer 13

the effective date of scheduling, if possessed by the registrant.

Question 14

For damaged, defective, or impure substances awaiting disposal, substances held for quality control purposes, or substances maintained for extemporaneous compoundings, the inventories, must include:

Answer 14

1. The name of the substance;
2. The total quantity of the substance to the nearest metric unit weight or the total number of units of finished form; and
3. 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.