4.3 Schedule II Ordering: Single-Sheet DEA Form 222 & Electronic CSOS
Key Takeaways
- Schedule I and Schedule II controlled substances must be ordered using the single-sheet DEA Form 222 or electronically via the Controlled Substances Ordering System (CSOS) pursuant to 21 CFR Part 1305.
- The single-sheet DEA Form 222 has 20 order lines; the purchaser keeps a copy, sends the original to the supplier, and records the number and date of containers received on its copy.
- The supplier fills the order, records the number of containers shipped and the date shipped on the original Form 222, and reports the transaction to the DEA's Automation of Reports and Consolidated Orders System (ARCOS) or submits a copy to the DEA by the close of the month.
- If a supplier cannot fill an entire order, they may partially fill it and ship the remaining balance within 60 calendar days from the date the Form 222 was executed.
- Power of Attorney (POA) to execute Form 222 or CSOS orders may be granted to any designated individual (pharmacist or non-pharmacist) by the registrant; the POA document is retained on file in the pharmacy and is NOT submitted to the DEA.
Schedule II Ordering: Single-Sheet DEA Form 222 & Electronic CSOS
The procurement and transfer of Schedule I and Schedule II controlled substances are subject to the strictest paper and electronic audit trails in pharmacy jurisprudence. Under 21 CFR Part 1305 and Miss. Admin. Code Title 30, Part 3001, transfer of Schedule II medications between registrants (e.g., wholesaler to pharmacy, pharmacy to reverse distributor, or pharmacy-to-pharmacy emergency loans) requires either an official DEA Form 222 or an authenticated electronic order via the Controlled Substances Ordering System (CSOS).
1. The Single-Sheet DEA Form 222
In September 2019, the DEA issued a final rule transitioning from the legacy three-part carbon-interleaved (triplicate) Form 222 to a modern single-sheet Form 222. The transition period concluded on October 30, 2021; use of the old triplicate form is now strictly prohibited.
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| SINGLE-SHEET DEA FORM 222 WORKFLOW (21 CFR PART 1305) |
| |
| [PURCHASER / PHARMACY] |
| 1. Completes 20-line single-sheet Form 222 (Supplier name/address, drug details, package count).|
| 2. Makes a legible COPY (paper photocopy or scanned electronic copy) for pharmacy files. |
| 3. Transmits the ORIGINAL single-sheet Form 222 to the supplier. |
| | |
| v (Original Form Sent) |
| [SUPPLIER / WHOLESALER] |
| 4. Receives original Form 222 and verifies signature/POA authorization. |
| 5. Fills order and records: Commercial containers shipped + Date shipped on original form. |
| 6. Retains the original Form 222 for required retention period (2 yrs federal / 6 yrs MS). |
| 7. Reports shipment data to DEA via ARCOS or submits copy/file to DEA by end of month. |
| | |
| v (Shipment Delivered) |
| [PURCHASER RECEIVING VERIFICATION] |
| 8. Unpacks shipment and inspects containers. |
| 9. Records on RETAINED COPY: Number of containers received + Date received for each line item. |
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Form 222 Specifications & Execution Rules
- Order Line Capacity: The single-sheet Form 222 contains 20 order lines (an increase from the 10 lines on the legacy triplicate form). Only one item may be entered per line.
- Required Entry Data: The purchaser must enter the name, strength, dosage form, package size, and number of commercial containers ordered, along with the supplier's name and physical address.
- Prohibition of Alterations: DEA Form 222 must be completely legible and free of alterations, erasures, correction fluid (white-out), or crossed-out text. Any alteration renders the form legally void. If an error is made during execution, the purchaser must mark the form 'VOID' and file it in the pharmacy's Form 222 records; the form cannot be thrown away.
Supplier Partial Fills & 60-Day Validity Window
If a supplier cannot fill the entire quantity requested on a DEA Form 222 (e.g., the pharmacy ordered 10 bottles of oxycodone 30 mg, but the wholesaler only has 6 bottles in stock):
- The supplier may ship the partial quantity (6 bottles) immediately.
- The supplier has 60 calendar days from the date the Form 222 was executed by the purchaser to ship the remaining balance (4 bottles).
- If the balance is not shipped within 60 calendar days, the remaining unfilled balance is void, and a new Form 222 or CSOS order is required for subsequent shipments.
Endorsement of Form 222 to Another Supplier
A supplier that is unable to fill any part of a DEA Form 222 order may endorse the entire original Form 222 to a second supplier. Only the first supplier may endorse the form; partial endorsements are prohibited.
2. Power of Attorney (POA) for Schedule II Ordering
Under 21 CFR § 1305.05, the primary individual authorized to execute DEA Form 222 or sign electronic CSOS orders is the person who signed the most recent DEA registration or renewal application.
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| POWER OF ATTORNEY (POA) RULES & CHARACTERISTICS |
| |
| Parameter Statutory Requirement |
| =============================================================================================== |
| Who May Grant POA? The individual who signed the most recent DEA registration/renewal. |
| Who May Receive POA? ANY designated individual (pharmacists, technicians, managers). |
| *Pharmacist designation is recommended professional best practice.* |
| Witness Requirements Must be signed by the grantor, the POA grantee, and TWO witnesses. |
| Submission to DEA? NO. POA documents are NOT submitted to the DEA. They are retained |
| on file in the pharmacy alongside Form 222 / CSOS records. |
| Revocation May be revoked at any time by executing a formal Notice of Revocation|
| signed by the current registrant and two witnesses. |
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[!CAUTION] Common Exam Trap: Non-Pharmacist POA: MPJE questions frequently test whether a non-pharmacist (such as a registered pharmacy technician, pharmacy intern, or business manager) can legally sign a DEA Form 222. Under federal law (21 CFR § 1305.05), a Power of Attorney may be granted to any competent individual, including a non-pharmacist. However, a person cannot sign Form 222 merely by virtue of their employment—a formal, executed POA document must be on file.
3. Unaccepted, Defective & Lost Form 222 Procedures
Defective or Refused Forms (21 CFR § 1305.15)
A supplier must refuse to accept a DEA Form 222 if:
- The form is incomplete, illegible, or not properly signed.
- The form shows signs of alteration, erasure, or overwritten text.
- The purchaser's DEA registration is inactive or does not authorize the requested schedule.
When refusing an order, the supplier returns the original single-sheet Form 222 to the purchaser accompanied by a written explanation of the refusal. The purchaser must attach the returned original and the explanation to their retained copy and preserve both in the pharmacy's controlled substance files. The supplier cannot alter or correct the form on behalf of the purchaser.
Lost or Stolen Form 222 in Transit (21 CFR § 1305.16)
If a completed Form 222 is lost or stolen in transit between the pharmacy and the supplier:
- The purchaser must execute a second Form 222 to reorder the medications.
- The purchaser must attach a written statement to the second form containing:
- The unique serial number of the lost Form 222.
- The date of the lost Form 222.
- A statement verifying that the drugs ordered on the first form were never received.
- The purchaser retains a copy of the second form and the written statement with the copy of the first lost form.
- If the supplier subsequently receives the original lost form, the supplier must mark it 'Not Accepted' and return it to the purchaser for filing.
4. Electronic Controlled Substances Ordering System (CSOS)
Under 21 CFR Part 1305, Subpart C, the DEA's Controlled Substances Ordering System (CSOS) permits electronic ordering of Schedule I and II controlled substances without paper Form 222s.
| Feature | Single-Sheet Paper Form 222 | Electronic CSOS |
|---|---|---|
| Eligible Schedules | Schedule I and Schedule II ONLY | Schedules I, II, III, IV, and V (+ Non-controlled) |
| Order Line Limit | Maximum 20 lines per form | No line limits (Unlimited items per electronic order) |
| Authentication Method | Manual wet ink signature of registrant/POA | PKI Digital Certificate issued by DEA Certification Authority |
| Order Turnaround | Postal/courier transit (several days) | Near instantaneous electronic data interchange (EDI) |
| DEA Reporting | Supplier submits copy/ARCOS by month end | Supplier transmits electronic report to DEA within 2 business days |
| Defective Order Handling | Supplier returns original form with statement | Supplier issues electronic refusal notice; no edits permitted |
CSOS Digital Certificates & Administrative Roles
- CSOS Coordinator: An individual designated by the registrant to manage digital certificate applications, renewals, and revocations for the organization.
- CSOS Subscriber: An individual who has undergone identity verification and holds a unique private cryptographic signing key to execute electronic controlled substance orders.
- Certificate Revocation: If a CSOS subscriber leaves employment or is relieved of ordering duties, the CSOS coordinator must request certificate revocation within 6 hours of the change.
A community pharmacy in Southaven, Mississippi submits a single-sheet DEA Form 222 to a pharmaceutical wholesaler for 10 commercial bottles of hydromorphone 4 mg. The wholesaler currently has only 7 bottles in stock. Under 21 CFR § 1305.13, how long does the wholesaler have to ship the remaining 3 bottles before the order expires?
A new retail pharmacy owner signs the initial DEA Form 224 registration application. The owner wishes to authorize the staff pharmacist and lead certified pharmacy technician to sign single-sheet DEA Form 222 orders. Which of the following procedures is legally required to execute this Power of Attorney (POA) under 21 CFR § 1305.05?
While filling out a single-sheet DEA Form 222 for methylphenidate 20 mg tablets, a pharmacist accidentally writes the wrong package size on line 3, draws a single line through the error, writes the correct package size above it, and initials the change. How must the supplier handle this Form 222 under 21 CFR § 1305.15?
A Mississippi pharmacy uses CSOS to acquire controlled substances. How long does Article XXIII require it to maintain acquisition records?