2.3 Ordering Controlled Substances & DEA Form 222 (CSOS)

Procurement of Schedule II Substances

The distribution and procurement of Schedule I and II controlled substances require the highest level of security and documentation. Unlike Schedules III-V, which can be ordered via standard invoices, Schedule I and II drugs require a specific, highly controlled order form: the DEA Form 222, or its electronic equivalent, CSOS (Controlled Substance Ordering System).

The DEA Form 222 (Single-Sheet)

Historically, the DEA utilized a triplicate Form 222 (Copy 1, Copy 2, Copy 3). However, to modernize and simplify the process, the DEA introduced a single-sheet format. As of October 30, 2021, the old triplicate forms are no longer valid, and all paper orders must use the new single-sheet Form 222.

Form Characteristics

• The new single-sheet form contains 20 order lines (compared to 10 on the old triplicate form).
• Forms are pre-printed by the DEA with the pharmacy's name, address, DEA number, and authorized drug schedules.
• Forms are serially numbered, and the pharmacy must account for every form issued to them.
• They must be signed and dated by a person authorized to sign a registration application or a person granted Power of Attorney.

Executing the Single-Sheet Form 222

When a pharmacy (the purchaser) wishes to order C-II drugs from a wholesaler (the supplier), the process is as follows:

1. Preparation: The purchaser fills out the form using a typewriter, pen, or indelible pencil. They list the number of packages, size of package, and name of the item. The purchaser must note the total number of lines completed at the bottom of the form.
2. Sign and Date: The authorized individual signs and dates the form.
3. Making a Copy: Before sending the form, the purchaser must make a copy of the original form for their own records. This copy can be a paper photocopy or a scanned electronic copy.
4. Submission: The purchaser sends the original Form 222 to the supplier.
5. Fulfilling the Order: The supplier receives the original form, fills the order, and records on the original form the number of commercial or bulk containers furnished on each item and the date on which the containers are shipped to the purchaser.
6. Supplier Reporting: The supplier retains the original Form 222 for their records and must report the transaction to the DEA's ARCOS system (or submit a copy of the form to the DEA if they are not required to report to ARCOS) by the close of the month during which the order is filled.
7. Receiving the Order: When the pharmacy receives the shipment, an authorized individual (typically a pharmacist) must verify the contents against their retained copy of the Form 222. The purchaser must record on their copy the number of containers received and the date received for each line item.

Rules and Restrictions

• No alterations, erasures, or cross-outs are permitted on a Form 222. If a mistake is made, the form is considered defective. The purchaser must write "VOID" on the form and file it with their retained records. They cannot throw it away.
• If a supplier receives a defective form, they cannot fill it. They must return the original form to the purchaser with a statement explaining why it was not filled. The purchaser retains this returned form and statement with their copy.
• A supplier may partially fill an order if they do not have sufficient stock. The remaining balance must be supplied within 60 days of the date on the order form. If not supplied within 60 days, the balance becomes void.
• A pharmacy can use a Form 222 to transfer C-II drugs to another pharmacy or return them to a reverse distributor. In this case, the receiving entity (the other pharmacy or reverse distributor) acts as the "purchaser" and must issue the Form 222 to the transferring pharmacy (the "supplier").

Controlled Substance Ordering System (CSOS)

CSOS is the DEA's electronic equivalent to the paper Form 222. It allows for secure, electronic transmission of Schedule I-II orders using Public Key Infrastructure (PKI) technology to generate digital certificates.

Advantages of CSOS

• No Line Limits: While the paper Form 222 limits orders to 20 lines, CSOS has no line item limit.
• Faster Processing: Electronic orders are transmitted instantly and can be processed quicker.
• Fewer Errors: Electronic systems reduce the likelihood of manual errors that render paper forms defective.
• Mixed Orders: CSOS allows purchasers to order Schedule II, III, IV, and V drugs, as well as non-controlled drugs, on the same electronic order. (Paper Form 222s can strictly only be used for Schedule I and II).

CSOS Requirements

• The purchaser must enroll with the DEA to obtain a digital certificate.
• Only the DEA registrant or an individual with a specific CSOS Power of Attorney can hold a digital certificate to sign electronic orders.
• If an electronic order is defective (e.g., the digital certificate is expired or invalid), the supplier cannot fill it. The supplier must notify the purchaser and provide a statement of the reason. The purchaser must electronically link this statement of nonacceptance to the original electronic order.
• As with paper forms, when the shipment is received, the purchaser must create an electronic record of the date received and the quantity of each item received, and digitally link this to the original electronic order.

Recordkeeping for Orders

All executed paper Form 222s (purchaser's copies), defective/voided forms, and electronic CSOS receipts must be maintained by the pharmacy for a minimum of two years under federal law. Furthermore, records concerning Schedule II substances must be maintained separately from all other pharmacy records.