How Often Do Controlled Substances Have to Be Counted?
DEA requires a full inventory at least every two years and accurate records in between. It does not set a daily or shift count. Those intervals come from your state and your own policy, and this page shows which is which.
The short answer
Federal DEA rules require a complete inventory when you start handling controlled substances and a new one at least every two years after that. Between inventories they require accurate records of everything received and disposed of. They do not require a daily, shift or weekly count, and they say in so many words that no registrant has to keep a perpetual inventory.
Shift counts, daily counts, cabinet cycle counts and perpetual inventories come from somewhere else: your state's pharmacy rules, your accreditor's expectations, or your own policy. Which of those applies to you depends on your state and your setting. There is no single national answer.
What federal rules fix
| Requirement | What the rule says | Source |
|---|---|---|
| Initial inventory | An inventory of all controlled substances on hand on the first day you dispense them. If you have none, you record that. | 21 CFR 1304.11(b) |
| Biennial inventory | A new inventory “at least every two years”, on “any date which is within two years of the previous biennial inventory date.” | 21 CFR 1304.11(c) |
| Opening or close | The inventory may be taken as of the opening or the close of business, and must say which. | 21 CFR 1304.11(a) |
| How exact | Opened containers: an exact count for Schedule II; an estimate for Schedules III to V unless the container holds more than 1,000 tablets or capsules. | 21 CFR 1304.11(e)(6) |
| Newly scheduled drugs | An inventory of the drug on the day the scheduling rule takes effect. | 21 CFR 1304.11(d) |
| Between inventories | “A complete and accurate record” of each substance received or disposed of, “except that no registrant shall be required to maintain a perpetual inventory.” | 21 CFR 1304.21(a) |
| Keeping the records | Inventories and other required records kept and available for inspection “for at least 2 years”. | 21 CFR 1304.04(a) |
| Hospitals | “Current and accurate records must be kept of the receipt and disposition of all scheduled drugs.” | 42 CFR 482.25(a)(3) |
The CFR sets no count interval shorter than two years. Accurate records between inventories are still required, and a count is the usual way to show they are accurate.
Where your shorter intervals come from
Your state. State pharmacy rules can be stricter than DEA's. Depending on the state, they may require an inventory more often, a perpetual inventory for some schedules, or a new inventory when the pharmacist in charge changes. Read your state board of pharmacy's current rules for your setting. A hospital pharmacy and a community pharmacy in the same state can fall under different sections.
Your accreditor. Accreditation standards on medication security and management apply on top of the law. Check the current manual from your accreditor rather than a summary of it.
Your own policy. Most count intervals in a hospital are set here: change-of-shift counts for manually stocked areas, cabinet cycle counts, vault counts. In a 2024 survey of 66 hospital pharmacy respondents in 31 states, the most common interval for auditing vault inventory was monthly, reported by 73.3% of health systems and 61.1% of single facilities (Bastow et al., 2024). That describes what respondents do, not what any rule requires.
For best practice rather than law, the ASHP Guidelines on Preventing Diversion of Controlled Substances (2022) are the usual reference for health systems.
What your count policy should settle
Whatever intervals you choose, a surveyor or investigator will ask whether the policy says what you do and whether you do it. A count policy should answer:
- which stock is counted, and how often: vault, cabinets, manual stock, compounding area;
- who counts, whether a second person counts independently, and whether counts are blind (the counter does not see the expected number);
- what triggers an extra count, such as a discrepancy, a change in pharmacist in charge, or a staff member leaving;
- how quickly a discrepancy must be resolved, and who it goes to if it cannot be;
- who reviews discrepancies over time, and how often.
What to do when a count does not match is covered in controlled substance discrepancies: resolve each one, then look for the pattern.
Sources
- 21 CFR 1304.04, 1304.11 and 1304.21; 42 CFR 482.25. 2025 annual edition.
- Bastow SS, Borrelli EP, Lucaci JD, Nelkin H, Graves A, Hays A. Insights from a National Survey on Controlled Substance Diversion Practices in U.S. Hospital Pharmacies. Pharmacy. 2024;12(6):183.
- Clark J, Fera T, Fortier C, et al. ASHP Guidelines on Preventing Diversion of Controlled Substances. Am J Health Syst Pharm. 2022;79(24):2279-2306.
Read on October 16, 2026. Educational content, not legal advice; check your state's current rules before relying on an interval.
Further reading
Counts and discrepancies
Running the count, and what to do when it does not match.
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Controlled Substance Discrepancies: Resolve Each One, Then Look for the Pattern
What to do when a count does not match, and how to trend every discrepancy by drug, shift and person so that a pattern of small losses is seen.
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Why Controlled Substance Count Reconciliation Stops Diversion Early
Unexplained count discrepancies — even small ones — can signal diversion. Review controlled substance count records daily and investigate…
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Closing the Loop on Return-to-Stock Discrepancies
When a returned dose is credited back to inventory without a second verifier confirming vial, quantity, and condition match the original di…
Inventory and records
The biennial inventory and the records behind it.
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Controlled Substance Inventory Requirements: DEA Rules for Pharmacies Explained
DEA biennial inventory requirements, what must be counted, when to count, and how to keep the records audit-ready.
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Controlled Substance Recordkeeping: Every Document a DEA Audit Checks
The complete recordkeeping framework for controlled substances — inventory records, receiving/dispensing logs, transfer records, and the two-year retention rule.
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Compliance Tools & Calculators
DEA 106 deadline calculator, controlled substance discrepancy calculator, and waste percentage calculator
Other topics
Check your count and inventory controls
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