DEA Form 222 vs CSOS: Which Method Should You Use to Order Schedule I–II Drugs?

When ordering Schedule I and II controlled substances, you need to use either DEA Form 222 or its electronic equivalent called CSOS (Controlled Substance Ordering System). DEA Form 222 is a paper-based triplicate order form, while CSOS allows you to transmit controlled substance orders electronically without paper forms. Both methods serve the same purpose of tracking and securing controlled substance orders, but they work in different ways.

Understanding the differences between these two ordering methods helps you choose the right system for your practice. The DEA designed CSOS to modernize the ordering process and reduce the paperwork burden on registrants. However, you can still use paper Form 222 if that better fits your needs.

This guide explains how each system works, what makes them different, and which option might be best for your situation. You will also learn about common mistakes to avoid and what to expect during DEA inspections.

Purpose Of DEA Form 222 And CSOS

DEA Form 222 and CSOS both serve the same core function: they create a secure paper trail for ordering Schedule I and II controlled substances. These systems help the DEA track high-risk medications from manufacturers to pharmacies and prevent diversion into illegal markets.

Why Schedule I–II Drugs Require Enhanced Controls

Schedule I and II controlled substances have the highest potential for abuse and dependence. Schedule I drugs have no accepted medical use, while Schedule II drugs include medications like oxycodone, fentanyl, and morphine.

The DEA requires special ordering procedures for these substances to prevent theft and illegal distribution. Every transaction must be documented and traceable. When you order these drugs, you must verify your identity and authorization.

This tracking system helps law enforcement identify suspicious patterns. If someone tries to order unusual quantities or frequencies, the documentation makes it visible. The controls also ensure that only properly registered entities can purchase these substances.

Overview Of Paper Vs Electronic Ordering

DEA Form 222 is a paper-based triplicate form that requires a handwritten signature. You must submit the original copy to your supplier, who keeps one copy and sends another to the DEA.

Paper forms take 1-3 days for delivery when using express mail, or 3-7 days through regular mail. Errors like missing signatures or transposed numbers can delay your order significantly.

CSOS uses digital signatures and Public Key Infrastructure technology to transmit orders electronically. You receive a digital certificate from the DEA that verifies your identity and registration status.

The electronic system processes orders instantly and reduces common errors. You don’t need to worry about forms getting lost in the mail or weather delays. CSOS also works for Schedule III-V substances, while Form 222 only covers Schedule I and II drugs.

What Is DEA Form 222?

DEA Form 222 is a single-page official order form used to purchase or transfer Schedule I and II controlled substances. The form links to a specific DEA registration number, meaning each registered location must use its own designated forms.

When DEA Form 222 Is Required

You must use DEA Form 222 whenever you purchase or transfer Schedule I or II controlled substances. These are the most strictly regulated drugs under federal law.

The form is mandatory for all transactions involving these high-risk medications. Even transfers between your own locations require proper documentation if the locations have different DEA registration numbers.

As of October 30, 2021, only two ordering methods are authorized by the DEA for Schedule II drugs: the Single Sheet 222 Form and CSOS electronic ordering. No other ordering methods meet federal requirements.

Who May Execute DEA Form 222

Only authorized individuals can sign and execute DEA Form 222. Your facility must designate specific people who have the legal authority to complete these forms.

The person executing the form takes on significant responsibility. They verify the accuracy of the order and ensure compliance with federal regulations.

You cannot share forms between different DEA registrations. If you operate multiple locations with separate registration numbers, each location needs its own set of forms that correspond to its unique DEA number.

Distribution And Use Of DEA Form 222

The DEA issues Form 222 with built-in security features to prevent fraud and unauthorized use. You must store blank forms securely to prevent theft or misuse.

Each form contains multiple copies for record-keeping purposes. You keep one copy, the supplier keeps one, and the DEA may request copies during audits or inspections.

If you lose or have a form stolen, you must execute a new DEA Form 222. You need to attach a statement that includes the original form number, date, and confirmation that you never received the goods. This protects you from liability and maintains an accurate paper trail.

What Is CSOS?

CSOS is the DEA’s electronic system that lets you order Schedule I-V controlled substances digitally without paper forms. The system uses digital certificates to verify your identity and keep orders secure.

What CSOS Is And How It Works

CSOS stands for Controlled Substance Ordering System. The DEA created it to replace paper DEA Form 222 with secure electronic orders.

You can use CSOS to order any controlled substance in Schedules I through V. The system sends your orders electronically to suppliers who can fill them without receiving paper forms.

CSOS works through digital signatures that verify both you and your supplier. When you place an order, the system encrypts it and sends it directly to the supplier. Your supplier receives the order, verifies it, and can begin processing it right away.

The system eliminates the need to mail physical forms or wait for them to arrive. You can track your orders electronically and keep digital records instead of paper files.

Digital Certificates And Authentication

You need a CSOS digital certificate to use the system. The DEA issues these certificates after you enroll and verify your identity.

Your certificate works like a digital signature that proves you are authorized to order controlled substances. Each certificate links to your specific DEA registration number.

The system uses Public Key Infrastructure (PKI) to keep orders secure. Both you and your supplier must have valid certificates to complete transactions. Your certificate encrypts the order so only the intended supplier can read it.

You must protect your certificate like you would a password. If someone else gets access to it, they could place unauthorized orders under your DEA registration.

Who May Use CSOS

You can use CSOS if you have a valid DEA registration. The system is available to:

• Pharmacies
• Hospitals
• Drug manufacturers
• Distributors and wholesalers
• Researchers with DEA authorization

Your supplier must also be enrolled in CSOS to accept electronic orders. If your supplier does not use CSOS, you will need to order from them using paper Form 222 instead.

You are not required to use CSOS. You can choose to continue ordering with paper forms if you prefer.

Key Differences Between DEA Form 222 And CSOS

The paper DEA Form 222 and electronic CSOS system differ in processing speed, accuracy rates, storage requirements, and how suppliers handle orders. Understanding these differences helps you choose the right ordering method for your pharmacy or facility.

Speed And Efficiency

CSOS processes orders faster than paper DEA Form 222. Electronic orders typically take 1-2 business days to complete, while paper forms take 2-5 business days.

The speed difference comes from how each system works. With CSOS, your order reaches the supplier instantly through secure electronic transmission. Paper forms require physical handling, mail delivery, and manual data entry.

CSOS lets you place orders any time without waiting for office hours. You can submit multiple orders quickly without filling out separate paper forms. The system has no line item limit, so you can order as many products as needed in a single transaction.

Faster processing means you can keep smaller inventories and order supplies closer to when you need them. This just-in-time ordering reduces storage costs and helps prevent product expiration.

Error Reduction And Accuracy

CSOS significantly reduces ordering mistakes compared to paper forms. The electronic system eliminates problems caused by unclear handwriting, incorrect calculations, and missing information.

When you use CSOS, the system validates your order details automatically before submission. This catches errors immediately rather than after the supplier receives your form. Digital signatures cannot be forged or misread like handwritten signatures.

Paper DEA Form 222 creates more opportunities for mistakes. You must fill out each line carefully with a pen or indelible pencil. Any cross-outs or corrections can invalidate the entire form.

Suppliers can process CSOS orders with greater accuracy because they receive standardized electronic data. They don’t need to interpret handwriting or manually enter information from paper forms. This accuracy reduces order rejections and delays.

Recordkeeping And Audit Considerations

Your recordkeeping requirements differ between the two methods. CSOS maintains electronic records automatically in the system. You can access past orders quickly and search by date, supplier, or product.

Paper DEA Form 222 requires you to keep physical copies of all forms for two years. You must store Copy 3 of each completed order in a separate file from other records. This takes physical storage space and makes retrieval slower during audits.

CSOS simplifies audits because records are organized electronically. Auditors can review your ordering history without sorting through paper files. The system tracks all order details including dates, quantities, and digital signatures.

You still need to maintain proper records with CSOS, but the format is more manageable. Electronic storage reduces the risk of lost or damaged forms that could cause compliance issues.

Supplier Participation Requirements

Not all suppliers accept both ordering methods. Most major controlled substance distributors now support CSOS, but some smaller suppliers may only accept paper DEA Form 222.

Before switching to CSOS, verify that your regular suppliers can process electronic orders. Contact each supplier to confirm they have CSOS capability and understand their specific requirements.

Suppliers must also enroll in CSOS and obtain digital certificates to receive electronic orders. This means newer or smaller distributors might not have completed the setup process yet.

You can use both methods simultaneously. Keep paper DEA Form 222 available for suppliers who don’t accept CSOS. This flexibility ensures you can always order needed medications regardless of supplier capabilities.

Common Mistakes Registrants Make

Registrants often make preventable errors when ordering Schedule I and II controlled substances, whether using paper DEA Form 222 or CSOS. These mistakes can delay orders, create compliance issues, and result in rejected transactions.

Improper Execution

One of the most common errors occurs when you fail to properly sign or validate orders. With paper DEA Form 222, you must use an original handwritten signature from an authorized person. Photocopied or stamped signatures are not acceptable and will result in order rejection.

For CSOS orders, you need a valid digital certificate issued by DEA. Your order will be rejected if you attempt to use an expired or revoked certificate. The digital certificate must belong to someone who signed the most recent DEA registration application, a person authorized to sign a registration application, or someone granted power of attorney by the registrant.

You also need to complete all required data fields. Missing information such as the supplier name, drug name, quantity, or strength will cause the supplier to reject your order. Under 21 CFR 1305.25(a), a supplier cannot fill an electronic order if required fields are incomplete or if the digital certificate fails validation.

Missing Or Incomplete Records

You must keep proper records of all controlled substance orders for two years. This requirement applies to both accepted and rejected orders. When a supplier refuses your electronic order, you need to electronically link the statement of non-acceptance to your original order and retain both documents.

Many registrants fail to maintain voided orders correctly. If a supplier voids your entire electronic order, you must retain the electronic copy marked “void.” For partially voided orders, your records should show which items were not shipped.

You cannot correct a defective order after submission. If your order has errors, you must issue a completely new order. Attempting to modify or reuse a rejected order violates DEA regulations.

Assuming CSOS Eliminates All Form 222 Obligations

Some registrants mistakenly believe that using CSOS removes all paper-based requirements. CSOS is optional, and you can continue using paper DEA Form 222 if you prefer. The DEA will not force you to adopt electronic ordering.

You still need to follow the same ordering rules regardless of which method you choose. Both systems require proper authorization, complete information, and two-year record retention. The main difference is the format, not the underlying regulatory requirements.

If you use CSOS, you must appoint a CSOS coordinator who serves as your recognized agent for certificate issues. This person handles certificate issuance, revocation, and changes under your DEA registration. Failing to designate a coordinator can create problems when you need to manage digital certificates for your staff.

Which Option Is Right For Your Practice?

Your choice between DEA Form 222 and CSOS depends on your order volume, staff resources, and operational setup. Smaller practices often benefit from the simplicity of paper forms, while high-volume operations gain efficiency from electronic ordering.

Small Or Low-Volume Registrants

If you order Schedule II controlled substances infrequently, paper DEA Form 222 might be your best option. You won’t need to invest time in enrolling staff members or learning new software systems.

Paper forms work well when you have limited administrative staff or minimal technical infrastructure. The process is straightforward: fill out the form, send it to your supplier, and file your copy. You don’t need digital certificates, special software, or additional training.

Paper forms are ideal if you:

• Order Schedule II substances less than once per month
• Have a single location with one or two authorized purchasers
• Prefer familiar processes over new technology
• Want to avoid enrollment and certificate management

Keep in mind that paper forms take longer to process and ship. You’ll also need to maintain physical storage for your records. But for low-volume practices, these drawbacks are often minor compared to the simplicity of sticking with paper.

High-Volume Or Multi-Location Registrants

CSOS becomes more valuable as your order frequency increases. Electronic ordering cuts processing time significantly, which matters when you place multiple orders each week or manage several locations.

You’ll save time on order entry and record keeping. The system reduces errors because it validates information before submission. Your suppliers receive orders instantly, which speeds up delivery times.

CSOS benefits high-volume operations through:

• Faster order processing and delivery
• Automatic record keeping and electronic storage
• Reduced paperwork and filing requirements
• Better tracking across multiple locations

The initial setup requires effort. Each authorized purchaser must enroll with the DEA and obtain a digital certificate. You’ll also need compatible software from your supplier or a third-party vendor. However, practices that order frequently recover this time investment within a few months.

Using Both Systems Together

You’re allowed to use both ordering methods simultaneously. This flexibility lets you choose the best option for each situation.

Many registrants keep paper forms as a backup. If your CSOS certificate expires or technical issues arise, you can still place urgent orders. Some suppliers also don’t accept electronic orders yet, so paper forms remain necessary for those vendors.

A mixed approach works well during transition periods. You can start with CSOS for your most frequent suppliers while using paper forms for occasional orders. This lets your staff learn the electronic system gradually without disrupting your operations.

DEA Inspection And Audit Considerations

The DEA conducts unannounced inspections to verify compliance with controlled substance regulations, whether you use paper DEA Form 222 or CSOS for ordering. Your records must be accurate, complete, and immediately accessible during these audits.

What Inspectors Commonly Review

DEA Diversion Investigators examine your controlled substance ordering records to ensure proper documentation and compliance. They verify that all Schedule I and II orders match your inventory records exactly.

Key items inspectors check include:

• All executed DEA Form 222s or CSOS electronic records
• Inventory counts for Schedule I and II substances
• Proper storage and security of controlled substances
• Documentation of any discrepancies or losses
• Registration certificates and authorization credentials

Inspectors compare your ordering records against received shipments. They look for missing forms, incomplete documentation, or unexplained inventory gaps. Any inconsistencies between what you ordered and what your inventory shows raises red flags.

Record Accessibility Expectations

You must maintain all executed DEA Form 222s and CSOS records for at least two years. These records need to be available for immediate inspection when DEA investigators arrive unannounced.

Paper Form 222s should be filed separately from other business records. Keep executed copies organized by date or supplier for quick retrieval. Unexecuted forms must also be stored securely and accounted for during inspections.

CSOS users need to ensure electronic records are readily accessible. You should be able to pull up transaction histories, digital certificates, and order confirmations without delay. System backups and audit trails must be maintained throughout the required retention period.

Frequently Asked Questions

DEA Form 222 and CSOS each have specific requirements for ordering, enrollment, and compliance that affect how you purchase controlled substances. Understanding these differences helps you choose the right method for your practice.

How do Controlled Substance Ordering System (CSOS) transactions differ from those made with DEA Form 222?

CSOS transactions happen electronically through a secure system that uses digital certificates instead of paper forms. You submit orders online, and they get signed with your digital signature rather than a handwritten one.

Paper DEA Form 222 requires you to manually fill out a three-part form and physically sign it. You keep one copy, send one to the supplier, and the supplier keeps another copy after filling the order.

Electronic orders through CSOS process faster because they go directly to the supplier without mail delays. The system automatically validates your digital certificate and order information before transmission.

With CSOS, you can track your orders electronically and maintain digital records instead of storing paper copies. Both methods let you order Schedule I and II controlled substances, but CSOS extends to Schedule III-V substances as well.

What are the requirements for enrolling in the DEA’s CSOS program?

You need an active DEA registration to enroll in CSOS. Only the person who signed your most recent DEA registration or renewal application can apply for a digital certificate.

Your organization must appoint a CSOS coordinator who manages certificate issues for your DEA registration. This coordinator serves as your recognized agent for certificate issuance, revocation, and changes.

You must obtain a digital certificate from the DEA’s Certification Authority using Public Key Infrastructure technology. This certificate allows you to sign electronic orders legally.

The enrollment process requires you to download and complete the Diversion PKI CSOS Enrollment document. You can access enrollment materials and instructions at the DEA E-Commerce Program website.

Can DEA Form 222 be used for ordering all schedules of controlled substances?

DEA Form 222 only works for ordering Schedule I and II controlled substances. You cannot use this form for Schedule III, IV, or V substances.

Schedule III through V controlled substances require different ordering procedures. You can order these through regular purchase orders or invoices without DEA Form 222.

CSOS provides more flexibility because it handles all controlled substance schedules from I through V. This makes electronic ordering more versatile than the paper form system.

What is the process for renewing CSOS certificates?

Your CSOS digital certificate stays valid until your DEA registration expires. When you renew your DEA registration, you need to obtain a new digital certificate.

You must contact the DEA’s support line or use the online system to request certificate renewal. The process requires verification of your current registration status and authorization.

The DEA may revoke your certificate before expiration if you lose authorization to sign Schedule II orders. Your certificate also gets revoked if the information it contains changes or if it gets compromised, stolen, or lost.

You should start the renewal process before your current certificate expires to avoid disruption in ordering. The DEA E-Commerce Program support line operates from 8:00 a.m. to 5:50 p.m. Eastern Time, Monday through Friday at 1-877-332-3266.

How do electronic orders with CSOS comply with DEA regulations?

CSOS orders must include all required data fields and get signed with a valid digital certificate issued by DEA. The system validates your certificate and order information before transmission to confirm compliance.

Your digital certificate must be current and not expired or revoked at the time you sign the order. The purchaser’s public key must validate the digital certificate for the order to go through.

You must keep electronic records of all orders for two years. This includes accepted orders, rejected orders, and any linked statements of non-acceptance or voiding.

Suppliers can refuse orders if required fields are missing, the digital certificate is invalid, or the order fails validation. When this happens, the supplier must notify you and explain the reason for rejection.

What steps are involved in transitioning from paper DEA Form 222 to electronic CSOS ordering?

You need to enroll in CSOS by obtaining a digital certificate from the DEA’s Certification Authority. Start by designating a CSOS coordinator for your organization.

Download the enrollment documents from the DEA E-Commerce Program website and complete the application process. The person who signed your DEA registration must be the one to apply for the certificate.

Train your staff on using the CSOS system before you stop using paper forms. Your supplier must also accept CSOS orders, so confirm their capability before transitioning.

You can use both methods during the transition period since CSOS enrollment is optional. This lets you test the electronic system while maintaining your paper ordering process as backup.