Records and Reports of Registrants
The recordkeeping and reporting obligations of DEA registrants: inventories, receipt and distribution records, retention periods, and the reporting of losses and thefts.
What this does not cover
stated in the document's own scope- Governs controlled-substance records and reports for diversion control, not GMP batch records or quality documentation under 21 CFR 211.
- Sits within the DEA framework under the Controlled Substances Act, outside ICH / PIC/S GMP harmonisation.
- Covers records and reports; the registration and physical-security obligations are set separately in 21 CFR Part 1301.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
21 CFR Part 1304 sets the recordkeeping and reporting obligations of DEA registrants who handle controlled substances. It requires an initial and biennial inventory of stocks on hand, and complete, accurate records of every receipt, distribution, dispensing, and disposal, kept in a form that allows controlled substances to be accounted for. It specifies which records must be maintained, how long they must be retained, and the reporting of losses and thefts. Together these requirements create the audit trail that lets the DEA reconcile what a registrant received against what it distributed or used.
Scope & applicability
All DEA registrants. Records must be maintained per registered location and be readily retrievable, which shapes how a controlled-substance inventory system must be designed.
Legal basis & how it acquires force
Part 1304 is a binding federal regulation in Title 21 CFR, issued by the DEA under the Controlled Substances Act, and complements the registration and security rules of Part 1301. Its recordkeeping and reporting duties are legal obligations. Like the rest of the DEA framework it sits outside the GMP and international harmonisation systems — its purpose is diversion control, ensuring controlled substances can be traced and accounted for, rather than assuring product quality, which remains the province of FDA GMP.
Document structure
| Part | Covers |
|---|---|
| Persons required to keep records | Which registrants must maintain records and reports and the general inventory requirements |
| Inventory requirements | The initial and biennial inventories of controlled substances on hand |
| Continuing records | Records of receipt, distribution, dispensing, and disposal by schedule |
| Retention and availability | How long records must be kept and their availability for inspection |
| Reports of registrants | Required reports, including manufacturing and distribution reporting to DEA systems |
| Loss and theft reporting | Reporting significant losses or thefts of controlled substances |
Key requirements
- Complete receipt-to-disposition records for controlled substances
- Inventories taken and documented at the required intervals
- Loss and theft reporting to DEA
- Records retained for the required period and readily retrievable
Implementation tips
- Reconcile controlled-substance inventory on a defined cycle with a documented discrepancy escalation path — DEA discrepancies are reportable, not merely investigable
- Map DEA record requirements against your GMP records explicitly; assume gaps until proven otherwise
- ALCOA+ thinking applies here even though DEA does not use the term
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Part 1304 is read together with Part 1301 (registration and security), Part 1305 (order forms for Schedule I and II substances), and Part 1307 (disposal), as the recordkeeping backbone of the DEA controlled-substances framework under the Controlled Substances Act. Its documentation duties are separate from, and additional to, the GMP recordkeeping required by 21 CFR 211 — a controlled-substance manufacturer keeps both sets of records for different purposes.
21 CFR Part 1304: frequently asked questions
Quick answers to common questions about 21 CFR Part 1304.
What records does 21 CFR Part 1304 require?
An initial and biennial inventory of controlled substances on hand, plus complete records of receipt, distribution, dispensing, and disposal by schedule, kept so that stocks can be accounted for, along with reporting of losses and thefts.
How does Part 1304 relate to Part 1301?
Part 1301 covers DEA registration and physical security; Part 1304 covers the records and reports those registrants must keep. Together they form the core of the DEA controlled-substances framework.
Are DEA records the same as GMP batch records?
No. DEA records under Part 1304 exist for diversion control — tracing and accounting for controlled substances — and are separate from and additional to the GMP records required by 21 CFR 211.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.