A DEA controlled substance recordkeeping program is the set of written procedures, inventories and continuing records that a DEA registrant keeps to meet 21 CFR Part 1304. Integral Healthcare Solutions (IHS) drafts the recordkeeping procedures, inventory worksheets, record templates and a mock inspection checklist for pharmacies, clinics, hospitals and other registrants.
The registrant counts the stock, signs the inventories and answers DEA. IHS never handles controlled substances. IHS is a consulting firm, not a law firm.
Last updated: November 2026
What does 21 CFR Part 1304 require of a DEA registrant?
Part 1304 requires every registrant, including collectors, to keep the records and inventories and file the reports the part requires, except as section 1304.03 exempts. The rest of the part sets where records are kept, for how long, how often stock is counted and what each record shows. Section 1300.01 defines the Administration as the Drug Enforcement Administration (DEA).
Source note: IHS read these sections in Title 21 Volume 9 of the GovInfo eCFR bulk data, opened November 4 and re-checked November 5, 2026 (file built November 4). Section links go to the eCFR reader copy. IHS also searched every Federal Register issue from October 1 through November 4, 2026. None contains a final or proposed rule that amends Part 1304, section 1300.01 or Part 1317. Later rules are not covered; check the current eCFR text before relying on this page.
| Section | What it requires | What IHS drafts for it |
|---|---|---|
| 1304.03 Who keeps records | Every registrant, including collectors, keeps records and inventories, except as the section exempts. An individual practitioner keeps records of Schedule II through V substances dispensed, other than by prescribing or administering in the lawful course of professional practice. | Records-scope memo by registration type. |
| 1304.04 Keeping records | Records are kept and available for DEA inspection and copying for at least 2 years from the date of the inventory or record. Paragraphs (a)(1) and (a)(2) allow central locations for some records. | Retention table and filing map. |
| 1304.11 Inventory | An inventory when a person first engages in manufacture, distribution or dispensing, then a new one at least every two years. A separate inventory for each registered location and each independent activity registered, except as (e)(4) provides. | Initial and biennial inventory worksheets. |
| 1304.21 Continuing records | A current, complete and accurate record of each substance manufactured, imported, received, sold, delivered, exported or otherwise disposed of, except that no perpetual inventory is required. A DEA Form 41 record of destruction when the registrant destroys on site (1317.95(d)) or causes destruction at a non-registered location (1317.95(c)), with one exception. | Continuing-record templates and destruction workflow. |
| 1304.22 Dispenser records | The acquisition and distribution details the section lists, plus units dispensed, recipient, date and who dispensed or administered them. | Dispensing-record field checklist. |
This program covers those five sections. Emergency medical services agencies add section 1304.27, which requires a record for each dose of a controlled substance administered or disposed of (final rule effective March 9, 2026, 91 FR 5216).
Who needs it and what triggers it?
Any pharmacy, clinic, hospital or other registrant that holds a DEA registration needs these records. These events usually start the work.
- An expected or recent DEA inspection. Records must be available for inspection and copying by authorized DEA employees (1304.04(a)).
- A new registered location, which needs its own inventory (1304.11(a)) and its own continuing records, except as the central-records provisions in 1304.04(a) allow (1304.21(b)).
- A practice that begins dispensing, not only prescribing (1304.03(b)).
- A new registrant, whose initial inventory falls on the date it first engages in manufacture, distribution or dispensing (1304.11(b)), or a biennial inventory coming due (1304.11(c)).
- A newly scheduled substance. When a rule under 1308.45, 1308.46 or 1308.47 adds a substance that was not on any schedule the day before, each registrant required to keep records who possesses it takes an inventory of its stock on the effective date (1304.11(d)). DEA's October 30, 2026 interim final rule placing centanafadine in Schedule III (91 FR 68470, comments due November 30, 2026) amends Part 1308. Its text does not describe an effective-date inventory, and IHS has not determined whether 1304.11(d) applies to it. Your counsel confirms.
- A retail pharmacy with automated dispensing registrations at long term care facilities. It may keep all Part 1304 records for those additional sites at the pharmacy or another approved central location (1304.04(a)(2)).
- An emergency medical services agency preparing for the dose-level records in 1304.27.
How IHS helps
IHS assesses your records and inventories against the sections above, maps each record type to its location and keeper, drafts what is missing and runs a mock inspection. Thomas G. Goddard, JD, PhD, IHS founder and former URAC Chief Operating Officer and General Counsel, leads the work. This program sits in Compliance Services, one of three IHS practice lines, with compliance program development as the program-build companion.
What IHS drafts
- Procedures by registration type and location.
- Initial and biennial inventory worksheets with the on-hand and count rules.
- Continuing-record templates and a dispensing-record field checklist.
- A DEA Form 41 destruction workflow.
- A retention table, a filing map and a mock inspection checklist built from the sections above.
What you supply
You supply the physical counts, your pharmacist's or practitioner's clinical judgments, your DEA registration, the signer of each inventory and any central recordkeeping notice.
The real limit
The sections contain no inspection checklist, so the mock checklist is IHS work product. IHS does not contact DEA, does not submit anything to it and does not guarantee an inspection outcome.
What to have ready
Each ties to Part 1304 as read November 4 and 5, 2026.
- A list of every registered location and every independent activity registered (1304.11(a)).
- Your initial inventory and its date, or the record that you began with no stock (1304.11(b)).
- Your latest biennial inventory and the date the next one is due (1304.11(c)).
- Your written definition of stock on hand: anything in your possession or control, including customer returns, items ordered by a customer but not yet invoiced, stock in a warehouse on your behalf, and employee-held stock intended for distribution as complimentary samples (1304.11(a)).
- Your count method for opened containers: exact for Schedule I or II, estimated for Schedule III through V unless the container holds more than 1,000 tablets or capsules (1304.11(e)(6)).
- Continuing records by substance for each location (1304.21(a), (b)).
- Dispensing records with the fields 1304.22(c) lists.
- Your separate filing for Schedule I and II records, the separate Schedule II paper prescription file for pharmacies, and your method for Schedule III through V records: separate, or readily retrievable from ordinary business records (1304.04(f), (g), (h)).
- DEA Form 41 records for destruction under 1317.95(c) or (d), with the two witnesses, and your rule for the immediate-administration exception (1304.21(e)).
- Any central recordkeeping notice you sent and the date DEA received it (1304.04(a)(1)).
How it compares
| Option | What the text says | Note |
|---|---|---|
| All records at the registered location | The starting rule in 1304.04(a). | Executed order forms and inventories stay at each registered location (1304.04(b)(1)). |
| Central location for financial and shipping records | Financial and shipping records, such as invoices and packing slips but not executed order forms, if the registrant has notified DEA by registered or certified mail, return receipt requested, in triplicate, to the Special Agent in Charge. Central records may start 14 days after receipt unless permission is denied (1304.04(a)(1)). | The registrant agrees to deliver records to the registered location within two business days of a written DEA request, or let DEA inspect them at the central location (1304.04(b)(3)). |
| Records on an in-house computer system | No notice to the Special Agent in Charge and no central recordkeeping approval is needed (1304.04(c)). | Central recordkeeping is the route that needs a notice. |
For the prescriber side of controlled substances, see DEA telemedicine controlled substance prescribing compliance.
What it costs
The Part 1304 sections above state no fee. DEA links its registration fee categories and fee rule on its Registration page, opened November 4, 2026. Verify current fees with DEA.
Cost depends on your registered locations and activities, Schedule II files to separate, how complete your records are and whether you use central recordkeeping. IHS scopes each engagement after a free introductory call.
What this is not
- It is not legal advice. IHS is a consulting firm, not a law firm.
- It is not a guarantee of any DEA inspection outcome.
- IHS does not contact, submit to or correspond with DEA. The registrant files notices and answers DEA.
- This page covers records and inventory under Part 1304, not DEA registration, physical security, theft or loss reporting or order forms. This page covers federal Part 1304 only. State law can add record or retention duties and is not covered.
Frequently asked questions
What does 21 CFR Part 1304 cover?
Part 1304 covers the records and reports that DEA registrants must keep. Section 1304.03 says every registrant, including collectors, shall maintain the records and inventories and file the reports the part requires, except as that section exempts.
How long must DEA records be kept, and can they be kept centrally?
At least 2 years from the date of the inventory or record (1304.04(a)). The central-records provisions in (a)(1) and (a)(2) change where some records may be kept. Financial and shipping records, such as invoices and packing slips but not executed order forms, may be kept centrally if the registrant has notified DEA. Inventories and executed order forms stay at each registered location, and records on an in-house computer system need no notice.
How often is a controlled substance inventory required?
Once at the start, then at least every two years. Section 1304.11(b) requires an initial inventory on the date a person first engages in manufacture, distribution or dispensing, and a business that starts with no stock records that fact. Section 1304.11(c) allows the biennial inventory on any date within two years of the previous one.
Do I need a perpetual inventory?
No. Section 1304.21(a) requires a current, complete and accurate record of each substance received, sold, delivered or otherwise disposed of, “except that no registrant shall be required to maintain a perpetual inventory.”
How is destruction of controlled substances recorded?
When a registrant destroys a controlled substance at its registered location (1317.95(d)), or causes destruction after transporting it to a location that is not registered (1317.95(c)), the record is a DEA Form 41 that includes the name and signature of the two employees who witnessed the destruction (1304.21(e)). The exception is a substance dispensed by a practitioner for immediate administration at the practitioner’s registered location when it is not fully exhausted. That record is made under 1304.22(c) and need not be on a Form 41. Destruction procedures in the rest of Part 1317 are outside this page.
What must a pharmacy keep separate?
A pharmacy keeps Schedule I and II inventories and records apart from all other pharmacy records (1304.04(h)(1)) and paper Schedule II prescriptions in a separate file at the registered location (1304.04(h)(2)). Schedule III through V records may be kept separately or in a form readily retrievable from ordinary business records (1304.04(h)(3)). Practitioners and institutions follow the same two-part rule (1304.04(f), (g)).
Does a practice that only prescribes need these records?
Generally not for what it prescribes. Except as 1304.06 provides, a registered individual practitioner need not keep records of Schedule II through V substances prescribed in the lawful course of professional practice, unless they are prescribed in the course of maintenance or detoxification treatment (1304.03(c)). Records are required for substances dispensed, other than by prescribing or administering in the lawful course of professional practice (1304.03(b)). Your counsel or compliance lead confirms which applies.
What does IHS draft, and does IHS deal with DEA?
IHS drafts the procedures, worksheets, templates, destruction workflow and mock inspection checklist. The registrant counts the stock, signs the inventories and holds the registration. IHS does not contact, submit to or correspond with DEA, and any central recordkeeping notice goes from the registrant.