Biennial Inventory
A biennial inventory is the DEA-required physical count of all controlled substances that must be conducted by every registrant (pharmacy, hospital, practitioner) at least once every two years to account for Schedule II-V drugs on hand.
Exam Tip
Biennial = every 2 years. Schedule II requires EXACT counts. Schedules III-V allow estimated counts (unless container has >1,000 units). Records kept for 2 years minimum.
What Is a Biennial Inventory?
A biennial inventory is a complete physical count of all controlled substances that a DEA registrant must perform every two years (biennially) as required under the Controlled Substances Act (21 CFR 1304.11). This inventory helps the DEA track controlled substance distribution and detect diversion.
Biennial Inventory Requirements
| Requirement | Details |
|---|---|
| Frequency | Every 2 years from the date of the initial inventory |
| Who must conduct | All DEA registrants (pharmacies, hospitals, practitioners, manufacturers) |
| Substances covered | All Schedule II through Schedule V controlled substances |
| Record retention | Must be kept for at least 2 years |
| Timing | Can be taken on any date within 2 years of the previous inventory |
Counting Methods
| Schedule | Counting Method |
|---|---|
| Schedule II | Exact count required (every unit must be counted) |
| Schedules III-V | Estimated count allowed unless container holds >1,000 units (then exact count required) |
What Must Be Recorded
- Drug name, dosage form, and strength
- Number of units or volume on hand
- Date and time of inventory
- Whether inventory was taken at opening or close of business
- Name and signature of the person conducting the inventory
Initial vs. Biennial Inventory
| Type | When Performed |
|---|---|
| Initial inventory | On the day the registrant first engages in controlled substance activity |
| Biennial inventory | Every 2 years thereafter |
| Perpetual inventory | Optional ongoing record (some states require for Schedule II) |
Exam Alert
The biennial inventory falls under the Overview and Laws/Regulations domain (25% of ExCPT). Key points: Schedule II requires exact counts, Schedules III-V allow estimates, and records must be kept for 2 years.
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Related Terms
Controlled Substance Schedules
Controlled substance schedules are the DEA's five-tier classification system (Schedule I through Schedule V) that categorizes drugs based on their accepted medical use, abuse potential, and likelihood of causing dependence.
DEA Number
A DEA number is a unique identifier assigned by the Drug Enforcement Administration to healthcare providers and pharmacies authorized to handle controlled substances, used to track prescribing and dispensing activity.
OBRA-90 (Omnibus Budget Reconciliation Act of 1990)
OBRA-90 is a federal law that mandated prospective drug utilization review (DUR), patient counseling by pharmacists, and maintenance of patient medication profiles for all Medicaid prescription recipients.
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