Kelley Detweiler is a DEA and regulatory compliance expert who provides controlled-substances risk-management consulting solutions to veterinarians and the health care industry via her partnership with Dr. Peter Weinstein in Simple Solutions For Vets. She is the co-author of “Safeguarding Controlled Substances,” published by AAHA Press. She may be emailed at firstname.lastname@example.orgRead Articles Written by Kelley Detweiler
Maintaining a constant supply of controlled substances can be challenging. Between supply chain issues and reductions in manufacturer quotas, combined with the human health care market receiving priority, veterinary clinics don’t always obtain controlled substances in a timely manner. If your hospital hasn’t run out yet, inevitably, you will. When it happens, what will you do?
Drug Transfers 101
Veterinary professionals may transfer controlled substances to another DEA-registered colleague if they do it appropriately and carefully to avoid putting either party at risk. Specific rules and processes must be followed.
Let’s look at the following scenario:
- Dr. A: “I ran out of morphine. I’ll gladly pay you Tuesday if you can give me some morphine today. Can I meet you in the 7-Eleven parking lot at 2:30 for the handoff?”
- Dr. B: “Works for me. I can’t be there, but I’ll send one of my animal caretakers to make the exchange.”
- Dr. A: “That’s great. Let me know how you want me to pay you, or I can just restock your inventory when I get some in.”
- Dr. B: “Restocking would be great, or we could use some buprenorphine. Why not just make a trade?”
That’s the wrong way to go about it. Controlled substances cannot be shared, borrowed, traded, gifted or donated. Even if a consolidator group owns your practice, you cannot “give” controlled substances to another clinic within the group. The Drug Enforcement Administration allows only the “transfer” of controlled substances from one DEA registrant to another. In other words, between a “transferor registrant” and a “receiving registrant.”
The Receiving Registrant
The receiving registrant initiates the transfer process. If Schedule II controlled substances are involved, the receiver must submit DEA Form 222 to the transferor registrant. Before submitting the form, the receiver should make a copy and keep it on file.
Form 222 may not be used with Schedule III, IV or V controlled substances. Instead, the transfer must be documented in writing. (I recommend using a purchase order). Make sure to include the:
- Controlled substance’s name.
- Dosage form.
- Date of transfer.
The names, addresses and DEA registration numbers of both registrants must be on the paperwork. In addition, the purchase order should be signed and dated by someone with power of attorney or an individual authorized by the DEA registrant to handle controlled substances.
On the date of receipt, the receiving registrant and authorized witness must inspect the controlled substances for accuracy. Once the receiver and witness verify the transfer, they must inventory the drugs. The controlled substances must be logged and placed in a secure storage area, and the receiver and authorized witness must sign and date the transfer documents and the transfer inventory. If the drugs fall under Schedule II, the receiving registrant must complete Section 5 of Form 222.
Upon receipt of Form 222 or a purchase order from the receiving registrant, the transferor registrant must verify the controlled substances before fulfillment. The paperwork must be signed and dated by the transferor registrant and an authorized witness. The transferor registrant must retain the original purchase order or Form 222 at the registered location and send a copy to the receiving registrant. On the transfer day, the transferor registrant must conduct an initial inventory of the controlled substances, documenting the drug name, dosage form, strength, quantity and date. It serves as the transferor registrant’s final inventory and the receiver’s initial inventory.
Upon the receipt of Form 222 or purchase order, the transferor registrant must generate an invoice showing:
- The name, address and DEA registration of the receiving and transferor registrants.
- The name, strength, form and quantity of the controlled substances.
- Transfer date.
Even if no money changes hands, an invoice must be generated and indicate, “No cost.” The transferor registrant and authorized witness must sign and date the invoice and send a copy to the receiver.
In addition, both registrants must keep all transfer records for a mininum of two years, according to federal law (or longer if required by state regulations). For organizational purposes, clinics should create a folder specifically for controlled substance transfers and keep it with all other DEA-required records.
The Method of Transfer
How you physically transfer controlled substances matters. The DEA requires them to be stored securely at all times, including during transit. If the transfer involves commercial shipping, choose a carrier that offers insurance and tracking. Ensure that nothing on the shipping package indicates that the contents are controlled substances. Also, make sure the shipment gets to the receiving registrant by requiring a signature upon delivery.
If the transfer does not involve a commercial shipper, the controlled substances must be securely stored during transit. If by vehicle, all controlled substances should be packaged to prevent breakage or leakage and placed inside a lockbox affixed to the vehicle.
The 5% Rule
How many controlled substances may be transferred between DEA registrants falls under what’s called “the 5% Rule.” Without having to acquire a distributor registration, individuals with a DEA practitioner registration may transfer only up to 5% of the annual total controlled substances that were ordered.
Because the 5% Rule is based on a calendar year, a practitioner might not be aware of a violation until the following year, resulting in potential citations and fines. For that reason, I strongly recommend initiating transfers significantly below the 5% mark.
At the end of the day, the DEA will assess how well your records reflect the lifecycle of a controlled substance from acquisition to disposition. So, make sure your transfer records tell the right story.
Remember the following when you conduct a controlled substance transfer:
- Don’t forget the 5% Rule, and aim to stay well below the limit.
- Maintain a separate folder for DEA transfer records.
- Securely store controlled substances during transit.
- Utilize an authorized witness during transfers, and make sure the person signs and dates the paperwork.
- If a transfer is done at no charge, “No cost” should be noted on the invoice.
- Monitor the movement of any controlled substance shipped, and confirm the delivery.