Controlled Substance Recordkeeping Requirements Checklist
Every record a DEA registrant that dispenses controlled substances is required to keep, grouped by the point in the drug's life it documents, with the regulation it comes from and what an inspector will expect to see. Built for pharmacies and hospital pharmacies; distributors and manufacturers have additional requirements not covered here.
How to read this page. Each row names a record, the federal section it comes from, and what to have ready. Federal rules are a floor. Your state board of pharmacy may require more records, longer retention, a perpetual inventory or shorter reporting deadlines, and those rules control where they are stricter. Citations are to the 2025 annual edition of the Code of Federal Regulations and link to the official text. This is an educational reference, not legal advice.
1 Who keeps records, where, and for how long
| Requirement | What to have ready | Source | |
|---|---|---|---|
| Every registrant maintains the records and inventories required by Part 1304 and files its reports. | A written list of which records your registration requires and who owns each one. | 21 CFR 1304.03(a) | |
| Inventories and records are kept, and available for inspection and copying, for at least two years from the date of the record. | A retention schedule that is at least two years federally and matches any longer state period. | 21 CFR 1304.04(a); 21 U.S.C. 827(b) | |
| Records are kept at the registered location. Financial and shipping records (not executed order forms or inventories) may be kept centrally only after written notice to DEA and a 14-day wait; in-house computer systems need no notice. | If anything is stored off site, the central recordkeeping notice and its receipt. | 21 CFR 1304.04(a)(1), (b), (c) | |
| Separate records for each registered location and each independent activity. | One record set per DEA number, including satellite locations with their own registration. | 21 CFR 1304.21(b), (c) | |
| Pharmacies keep Schedule I and II inventories and records separately from all other records; Schedule III–V records may be separate or “readily retrievable” from ordinary business records. | A Schedule II file that contains nothing else, and a demonstration that III–V records can be pulled out on request. | 21 CFR 1304.04(h)(1), (3) | |
| “Readily retrievable” means an electronic system can separate the records out from all others in a reasonable time, or paper records are asterisked, redlined or otherwise visually marked. | Know which of your records rely on this definition and test the retrieval before an inspector does. | 21 CFR 1300.01 | |
| Dates in records of receipt, transfer or destruction are the dates the event actually happened. | Receiving and destruction posted on the day, not batched. | 21 CFR 1304.21(d) | |
| Hospitals: current and accurate records of the receipt and disposition of all scheduled drugs (Medicare Condition of Participation). | The same record set, plus evidence that it is reviewed as part of pharmacy administration. | 42 CFR 482.25(a)(3) |
2 Inventories
| Requirement | What to have ready | Source | |
|---|---|---|---|
| Initial inventory of all controlled substances on hand on the day the registrant first dispenses; if none on hand, that fact is recorded. | The original initial inventory for the registration, or the zero-stock record. | 21 CFR 1304.11(b) | |
| A new complete inventory at least every two years, on any date within two years of the last one. | The last two biennial inventories and the dates, showing the gap did not exceed two years. | 21 CFR 1304.11(c); 21 U.S.C. 827(a)(1) | |
| Each inventory is a complete and accurate record of everything on hand, in written, typed or printed form, kept at the registered location, and states whether it was taken at opening or close of business. | The opening/close notation on the face of the inventory; the names of the people who counted. | 21 CFR 1304.11(a) | |
| For each substance: name, each finished form and strength, number of units per commercial container, and number of containers. Opened containers of Schedule II: exact count. Opened Schedule III–V: estimate allowed unless the container holds more than 1,000 tablets or capsules. | Inventory lines that show containers and units separately, and exact counts on every opened Schedule II container. | 21 CFR 1304.11(e)(1)(iii), (e)(6) | |
| Damaged, expired or returned stock awaiting disposal is still “on hand” and is inventoried, with the reason it is held. | A separate section of the inventory for quarantined and staged-for-return product. | 21 CFR 1304.11(a), (e)(1)(iv) | |
| When a substance is newly scheduled, an inventory of it on the effective date, and inclusion in every inventory after. | A procedure for tracking scheduling actions and the dated count for each. | 21 CFR 1304.11(d) | |
| No federal requirement for a perpetual inventory. Continuing records must still be complete, accurate and current. | If your state requires a perpetual inventory, the state rule and your reconciliation schedule. See the perpetual inventory guide. | 21 CFR 1304.21(a); 21 U.S.C. 827(a)(3) |
3 Ordering and receipt
| Requirement | What to have ready | Source | |
|---|---|---|---|
| Schedule II paper orders: the purchaser keeps a copy of each executed Form 222 (paper or electronic) and records on it the number of containers received and the dates received. | Every Form 222 copy annotated with received quantity and date, in the purchaser's hand. | 21 CFR 1305.13(a), (e) | |
| Schedule II electronic (CSOS) orders: a record of the quantity of each item received and the date, electronically linked to the original order and archived. | The linked receipt record for each electronic order, retrievable by order. | 21 CFR 1305.22(g) | |
| Form 222 records kept separately from all other records, available for two years, at the registered location printed on the form; electronic copies may be elsewhere if readily retrievable at the registered location. Unaccepted or defective forms are retained with the statement attached. | A Form 222 file containing nothing but order records, including voided and defective forms. | 21 CFR 1305.17(a), (c), (e) | |
| Orders are valid for 60 days; partial shipments must be completed within 60 days of the order date. Shipment goes only to the registered location on the form or tied to the certificate. | No open orders older than 60 days; no deliveries to any other address. | 21 CFR 1305.13(b), (c); 21 CFR 1305.22(e), (f) | |
| A power of attorney for every person who signs Schedule II orders on the registrant's behalf, executed by the registrant, the grantee and two witnesses, kept with the order records for as long as any order they signed, and available for inspection with them. Revocations are signed by the current registration signer and two witnesses. | A power of attorney on file for each current signer, and revocations for each former one. | 21 CFR 1305.05(a), (d), (e) | |
| Schedule III–V receipts: the number of units or containers acquired, the date, and the name, address and registration number of the supplier. | Supplier invoices or packing slips filed so they can be pulled by date and product. | 21 CFR 1304.22(c), applying (a)(2)(iv) |
4 Dispensing and administration
| Requirement | What to have ready | Source | |
|---|---|---|---|
| For each dispensing: the name and address of the person it was dispensed to, the date, the number of units or volume, and the written or typed name or initials of the individual who dispensed or administered it. | Dispensing and administration records that carry all four elements, including the individual's identity. | 21 CFR 1304.22(c) | |
| Paper Schedule II prescriptions in a separate file at the registered location. | The Schedule II prescription file. | 21 CFR 1304.04(h)(2) | |
| Paper Schedule III–V prescriptions in their own file or readily retrievable from the general file, by a red “C” at least one inch high in the lower right corner, unless the pharmacy's computer system can retrieve them by prescriber, patient, drug and date. | Either the stamped prescriptions or a demonstration of the four-way retrieval. | 21 CFR 1304.04(h)(4) | |
| Electronic controlled substance prescriptions kept in an application meeting Part 1311, readily retrievable at the registered location, printable or transferable in a readable format, and sortable by prescriber, patient, drug and date filled. | The application's certification and a sample export sorted each of the four ways. | 21 CFR 1304.04(h)(5) | |
| Partial fills of Schedule II prescriptions: the quantity dispensed noted on the prescription or in the electronic record, with the dispensing record showing each date and dispenser; additional notations when the partial fill is at the patient's or prescriber's request, and the time limits for the remainder. | Partial-fill notations that match the rule for the kind of partial fill. | 21 CFR 1306.13 | |
| Hospitals: Schedule II–V drugs kept locked within a secure area, with access limited to authorized personnel. | The access list for each locked storage area and the date it was last reviewed. | 42 CFR 482.25(b)(2)(ii), (iii) |
5 Waste, return and destruction
| Requirement | What to have ready | Source | |
|---|---|---|---|
| A practitioner disposes of inventory by prompt on-site destruction under Subpart C, delivery to a reverse distributor, return or recall to the supplier or manufacturer, or by requesting DEA assistance on a Form 41. | Your policy naming which method is used for which situation. | 21 CFR 1317.05(a) | |
| Destruction by the registrant is recorded on DEA Form 41, complete and accurate, with the name and signature of the two employees who witnessed it. | A Form 41 for every on-site destruction, with two legible witness signatures. | 21 CFR 1304.21(e) | |
| Two employees handle or observe the drug until it is non-retrievable and personally witness the destruction, whether on site, at a registered location, or at an unregistered destruction site; two employees load and unload any transfer for destruction. | Witness attestations that describe watching the destruction, not signing a form. | 21 CFR 1317.95(a)–(d) | |
| Partial doses left after administration at the registrant's location (the remainder in a vial, tube or syringe) are recorded as dispositions under the dispensing record rule and need not go on a Form 41. | Waste records that capture quantity, date, the person wasting and the witness, linked to the administration record. | 21 CFR 1304.21(e), exception; 21 CFR 1304.22(c) | |
| Returns and transfers to a reverse distributor or supplier are dispositions and are recorded with the date, quantity and the receiving registrant. | Reverse distributor manifests and receipts matched line by line to your own return records. | 21 CFR 1304.22(c), applying (a)(2)(vii), (ix) |
6 Theft, loss and discrepancy records
| Requirement | What to have ready | Source | |
|---|---|---|---|
| Written notice to the local DEA Field Division Office of any theft or significant loss within one business day of discovery. | A copy of each notice, with the date of discovery and the date sent. | 21 CFR 1301.76(b) | |
| A complete and accurate DEA Form 106 filed through DEA's secure online application within 45 days of discovery. | The filed Form 106 and confirmation for each reported loss, matched to its notice. | 21 CFR 1301.76(b) | |
| The significance decision weighs the quantity relative to the business, the specific drug, whether the loss can be tied to individuals or activities, any pattern of losses and the results of efforts to resolve them, the drug's diversion potential, and local trends. | A documented significance analysis for every unresolved discrepancy, whether or not it led to a report. | 21 CFR 1301.76(b)(1)–(6) | |
| Hospitals: abuses and losses reported, in accordance with federal and state law, to the person responsible for pharmaceutical services and, as appropriate, to the chief executive officer. | Evidence of the internal report for each loss. | 42 CFR 482.25(b)(7) | |
| Discrepancy log (practice, not a named federal record): every count difference with drug, location, date, people, size and direction, and the documented cause or “unresolved”, kept with the inventory records it reconciles. | A structured log that can be sorted by drug, shift and person. See the discrepancy guide. | Practice; supports 21 CFR 1304.21(a) and the pattern factor in 1301.76(b)(4) |
7 Security and personnel records an inspector will ask about
| Requirement | What to have ready | Source | |
|---|---|---|---|
| Effective controls and procedures against theft and diversion, judged against the practitioner security sections and the factors DEA may weigh, including key and combination control, supervision of employees with access, visitor procedures, and the system for monitoring receipt and disposition. | Access lists, the access-removal procedure, and the policy describing your monitoring system. See the effective controls guide. | 21 CFR 1301.71(a), (b) | |
| Schedule II–V stored in a securely locked, substantially constructed cabinet, or dispersed through non-controlled stock so as to obstruct theft. | A description of the storage method for each location. | 21 CFR 1301.75(b) | |
| No employee with access to controlled substances who has a felony conviction relating to controlled substances or a DEA registration denied, revoked or surrendered for cause. | The screening step that checks this before access is granted, and its documentation. See employee screening. | 21 CFR 1301.76(a) |
Using this checklist
Work through it once a quarter with someone who does not handle the records day to day. For each row, locate the actual record, not the policy that says it exists. The rows most often found empty are the received quantity and date on Form 222 copies, powers of attorney for people who have left or arrived, witness signatures that attest to a form rather than a destruction, and the one-business-day notice that should sit beside each Form 106.
For what happens when these records are tested, see what a DEA inspection actually looks like. The free assessment scores the controls around these records.
Last reviewed: October 2026 against the 2025 annual edition of the CFR · Educational content, not legal advice. Consult your compliance counsel for organization-specific guidance.
Last reviewed: September 2026 · Content is educational, not legal advice.