Introduction
Controlled substances are drugs that federal law regulates because they can be abused or diverted. Diversion means a drug leaves its legal path, for example when it is stolen or used by staff. Opioids, ketamine, benzodiazepines, phenobarbital and euthanasia solutions are all controlled, and a busy practice handles them every day. The veterinarian holds the DEA registration, but the technician usually orders, receives, draws up, logs, counts and helps dispose of these drugs. One sloppy entry can put the registration, the practice and your credential at risk.
This guide covers the five federal schedules with veterinary examples, registration, ordering with DEA Form 222, records and logs, the biennial inventory, theft and loss reports, storage and disposal. It ends with what to do when the count does not match the log.
Key facts
- There are five schedules. Schedule I drugs have no accepted medical use; Schedules II to V have an accepted medical use and fall in abuse potential from II down to V.2
- Hydrocodone combination products moved from Schedule III to Schedule II on October 6, 2014. Tramadol became Schedule IV on August 18, 2014.78
- Schedule I and II drugs are ordered only on DEA Form 222 or its electronic equivalent (CSOS). Schedule III to V drugs need no official order form.214
- Every controlled drug, Schedules II to V, must be stored in a securely locked, substantially constructed cabinet.9
- The biennial inventory covers all controlled substances on hand, at least every two years. Opened Schedule II containers need an exact count; Schedule III to V may be estimated unless the container holds more than 1,000 tablets or capsules.12
- Controlled substance records and inventories are kept for at least 2 years.11
- Theft or significant loss: written notice to the DEA Field Division Office within one business day of discovery, then DEA Form 106 within 45 days.10
- Schedule II prescriptions can never be refilled. Schedule III and IV prescriptions may be refilled up to five times within six months.2
How the VTNE tests this
- Maintain controlled drug inventory, related logbooks and medical records (Domain 1 Task E).1
- Store, handle and safely dispose of pharmacological agents (Domain 1 Task G), and know the legal requirements for acquiring, storing, dispensing, documenting and disposing of them (K10).1
- Classify: name the schedule of a common veterinary drug, or pick the drug that belongs in a given schedule.
- Match the form to the job: Form 222 for ordering, Form 106 for theft or loss, Form 41 for destruction, Form 224 for registration.
- Choose the next step in a scenario: a count that does not match, a broken vial, expired stock, or a client who brings back leftover tablets. Pharmacy and Pharmacology carries 20 of the 150 scored items (13%).1
Core concepts
The five schedules
The Controlled Substances Act places drugs in five schedules. Schedule I drugs have a high potential for abuse, no currently accepted medical use in the United States and no accepted safety under medical supervision, so they cannot be prescribed, administered or dispensed. Examples are heroin, LSD and marijuana.2 Schedule II drugs also have a high abuse potential, but they have an accepted medical use. Abuse may lead to severe psychological or physical dependence.2 Schedule III drugs have less abuse potential than I or II, and abuse may lead to moderate or low physical dependence or high psychological dependence. Schedule IV is lower again, and Schedule V is lowest. Schedule V consists mainly of preparations with limited amounts of certain narcotics.2
A schedule is a legal category, not a measure of how strong a drug is clinically. Butorphanol is an opioid, yet it is Schedule IV; the Schedule II opiate listing excludes it by name.35 The same molecule can also sit in two schedules. Pentobarbital alone is Schedule II, but a product that combines pentobarbital with another active ingredient not listed in any schedule is Schedule III.34 That is why Euthasol (pentobarbital with phenytoin) carries a CIII label.26
| Schedule | Abuse potential and use | Veterinary examples | How it is ordered | Federal refill rule |
|---|---|---|---|---|
| I (CI) | High; no accepted medical use | None in practice (heroin, LSD, marijuana) | Form 222 or CSOS, research only | Cannot be prescribed |
| II (CII) | High; accepted use; severe dependence | Morphine, hydromorphone, oxymorphone, methadone, fentanyl, hydrocodone (including combination products), single-ingredient pentobarbital | DEA Form 222 or CSOS | No refills |
| III (CIII) | Less than II; moderate or low physical, high psychological dependence | Ketamine, tiletamine-zolazepam (Telazol), buprenorphine (Simbadol), pentobarbital combination products (Euthasol), anabolic steroids such as testosterone, boldenone and stanozolol | Purchase order; keep invoice and receiving record | Up to 5 refills within 6 months |
| IV (CIV) | Low relative to III | Butorphanol, diazepam, midazolam, lorazepam, phenobarbital, alfaxalone, tramadol | Purchase order; keep invoice and receiving record | Up to 5 refills within 6 months |
| V (CV) | Low relative to IV; limited narcotic preparations | Codeine cough preparations (up to 200 mg per 100 mL), low-dose diphenoxylate with atropine, pregabalin, lacosamide | Purchase order; keep invoice and receiving record | No federal limit; must be for a medical purpose |
Sources: DEA Practitioner's Manual; 21 CFR 1308.12 to 1308.15; 2014 DEA final rules on hydrocodone and tramadol; DailyMed labels for Telazol, Simbadol, Euthasol, Alfaxan and Torbugesic.23456782223242526
Registration
Any practitioner who handles Schedule II to V drugs must register with the DEA, and a state license is needed first.2 A separate registration is needed for each location where controlled substances are stored, administered or dispensed. New registrations use DEA Form 224, and renewals use Form 224a every three years, online.2 The Veterinary Medicine Mobility Act of 2014 added a further exception to the separate-registration rule for veterinarians.2 A DEA registration depends on the state veterinary license. In two recent cases the DEA refused or revoked a veterinarian's registration after a state board suspended the license.20
Technicians do not hold their own registration. An agent or employee of a registrant who acts in the usual course of employment is exempt from registering, and works under the registrant's authority.19 Federal rules also bar a registrant from giving controlled substance access to anyone convicted of a felony involving controlled substances.10
The closed system of records
DEA records follow each drug from manufacturer to patient. Practitioners must keep complete and accurate records, on a current basis, of every controlled substance received, stored, dispensed or disposed of.2 Schedule I and II inventories and records are kept separate from all other records. Schedule III to V records are kept either separately or in a form that is readily retrievable from ordinary business records.11 Every inventory and record is kept for at least 2 years and must be available for DEA inspection.11
For each dispensing, the record must show the drug and its finished form, the number of units or volume dispensed, the name and address of the person it was dispensed to, the date, and the name or initials of the person who dispensed or administered it.13 Medical record rules apply to the log too. Never erase or obliterate an entry. Draw a single line through a mistake, then write "error", your name, the reason and the date.32
| Form or record | Used for | Key rules |
|---|---|---|
| DEA Form 224 / 224a | Practitioner registration and renewal | One registration per location; renew every 3 years online |
| DEA Form 222 (or CSOS) | Ordering Schedule I and II drugs | One item per numbered line; one supplier per form; valid 60 days; altered forms cannot be filled; purchaser keeps a copy 2 years, separate from other records |
| Invoice and receiving record | Ordering Schedule III to V drugs | Record date received, drug, finished form, units per container and number of containers |
| Dispensing and administration log | Every dose given or sent home | Drug and form, amount, name and address of recipient, date, initials of the person who gave it |
| Initial and biennial inventory | Physical count of all controlled stock | Every 2 years at most; note opening or close of business; exact count for CII; estimate for CIII to V unless the container holds more than 1,000 tablets or capsules |
| DEA Form 41 | Recording destruction | Practice lists drugs on Form 41 for disposal other than by reverse distributor; reverse distributor completes it when it destroys them |
| DEA Form 106 | Theft or significant loss | Filed online within 45 days, after written notice within 1 business day |
| Power of attorney | Lets a named person sign Form 222 | Signed by the registrant, the person granted it and two witnesses; filed with executed Forms 222, not sent to DEA |
Sources: DEA Practitioner's Manual; 21 CFR 1301.76, 1304.04, 1304.11, 1304.22, 1305.12 and 1305.13.2101112131530
Procedure or technique
Ordering and receiving a Schedule II drug
- Confirm who may sign. Form 222 is signed by the registrant or by someone the registrant has given a power of attorney.230
- Fill in the form with a typewriter, printer or pen. Enter one item per numbered line, list only one supplier, and note how many lines you completed.30
- Check the form before it goes. A supplier must not fill a form with any alteration or erasure, and a defective form cannot be corrected. It must be replaced with a new one.2
- Make a copy for the practice, paper or electronic, then send the original to the supplier.15
- When the order arrives, record on your copy the number of containers received for each item and the date received.15 File the copy with the other Schedule II records.
For Schedule III to V drugs, record the date received, the drug name, its finished form, the units in each container and the number of containers.2
Giving a dose and logging it
- Check the written order: patient, drug, dose and route.
- Remove the vial or tablets from the locked cabinet and lock it again straight away.
- Draw up the dose and record it at once: date, patient, owner name and address, drug and strength, amount, your initials and the new balance.13 Late documentation is a recognized red flag for diversion.21
- Waste any leftover drug in the syringe and record it. DEA requires practitioners to record the destruction of wastage, the drug left in a vial, syringe or patch after a dose.2 Wastage does not go in a client collection receptacle.2 If your practice requires a witness, have a second person watch and co-sign. This mirrors the two-employee rule for on-site destruction of stock.17
- Check that the remaining volume in the vial matches the new balance.
Taking the biennial inventory
- Pick a date within two years of the last inventory, and note whether you count at the opening or the close of business.12
- Include every controlled substance on hand, Schedules II to V, including expired stock waiting for disposal.12
- For each item, record the name, finished form (such as 10 mg tablet), units per container and number of containers.2
- Opened Schedule II containers: exact count or measure. Opened Schedule III to V containers: an estimate is allowed, unless the container holds more than 1,000 tablets or capsules.12
- Keep it at the registered location for at least 2 years. DEA recommends, but does not require, that the people who took the inventory sign it.2
A new practice takes an initial inventory on the day it first handles controlled substances. If it has none, it records a zero inventory.2
Disposing of stock
A practice may dispose of out-of-date or unwanted stock in four ways. It can destroy it promptly on site. It can deliver it to a reverse distributor, a DEA registrant that receives drugs for destruction. It can return it to the supplier or manufacturer, or ask the local DEA Special Agent in Charge for help using Form 41.16 A reverse distributor is the usual choice. For Schedule II drugs, the reverse distributor issues a Form 222 to the practice. For Schedule III to V, the practice records the date, manner of disposal, the recipient's name, address and registration number, and the quantity.2 Any destruction must leave the drug non-retrievable.18 On-site destruction needs two employees to handle the drug and witness the destruction.17 Until it leaves the building, expired stock stays in the locked cabinet and on the inventory.912
Flowchart: the count does not match the log
Use this when a physical count and the log balance disagree. The technician's job is to stop, recheck, document and report. Reporting to DEA is the registrant's duty.
DEA lists factors for judging whether a loss is significant: the amount lost for the type of practice, which drug it is, whether the loss links to particular people or activities, a pattern of losses over time, and how likely the drug is to be diverted.10 Form 106 is not for "balancing the books". Minor discrepancies that are not due to theft are not reported. If the practice is unsure, it files the form. A continuing pattern of small losses is always treated as significant.2 DEA also advises notifying local law enforcement and state regulatory agencies, although federal rules do not require it.2 If investigation later shows no theft or loss occurred, Form 106 is not needed, but DEA advises writing to explain why.2 A breakage or spill that someone witnessed is not a loss, because the drug is accounted for. If the drug cannot be recovered, record what happened in the inventory records and have the two people who saw it sign.2
Species differences
The rules are the same for every species. What changes is the product, its label and its record.
- Cats: Simbadol (buprenorphine 1.8 mg/mL) is a CIII product labelled for subcutaneous use in cats. It comes in a 10 mL multidose vial. Its label gives two in-use limits for a broached vial: discard after 28 days in one section, and use within 56 days of first puncture in the storage section. Date the vial when you first puncture it and follow the practice's policy.22 Alfaxan Multidose (CIV) is labelled for cats and dogs, and the vial is discarded 56 days after first puncture.24 Record the discarded volume so the log balance closes at zero.
- Dogs: Telazol (CIII) is labelled for dogs and cats.23 Euthasol (CIII) is labelled for canine euthanasia only.26
- Horses: Torbugesic (butorphanol, CIV) is labelled for colic pain in adult horses and yearlings.25 Ambulatory practices must still keep stock locked and logged.
- Food animals: Euthasol must not be used in animals intended for food, and its label warns that birds and mammals that feed on treated carcasses may be killed. Carcass disposal is part of the job.26
- Zoo and wildlife: the ultra-potent opioids etorphine, carfentanil and thiafentanil, and the reversal agent diprenorphine, must be stored in a safe or steel cabinet equal to a U.S. Government Class V security container.9
Calculation
Worked example: running balance with waste (cat, buprenorphine). A Simbadol vial (1.8 mg/mL) shows a log balance of 8.6 mL.22 You draw up 0.5 mL, give the cat 0.4 mL and waste 0.1 mL with a witness.
- Volume removed from the vial: 0.4 mL given + 0.1 mL wasted = 0.5 mL.
- New balance: 8.6 mL - 0.5 mL = 8.1 mL. Write 8.1 mL in the balance column.
- Dose in mg for the medical record: 0.4 mL x 1.8 mg/mL = 0.72 mg (mL cancels).
- Waste in mg: 0.1 mL x 1.8 mg/mL = 0.18 mg.
Check: if the vial holds about 8.1 mL, the count matches. If the log said 8.6 mL after the dose, someone forgot to subtract the waste. That is a documentation error, so fix it with a dated, initialled correction, not a new number written over the old one.
Safety, legal and client education
- Label warning. A Schedule II, III or IV drug dispensed to a patient must carry: "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."31
- State law can be stricter. California requires Schedule II inventories at least every three months. Alabama, North Dakota and Georgia list propofol as Schedule IV. Gabapentin is Schedule V in Alabama, Kentucky, North Dakota, Tennessee, Virginia and West Virginia. Florida lists xylazine as Schedule I, and several other states schedule it too.20 Some states let technicians administer but not dispense controlled drugs.20 Always follow the stricter rule.
- Diversion. Red flags include rising discrepancies, missing overfill or tampered vials, waste errors, patients still in pain after adequate doses, late documentation and drugs removed without an order.21 Report suspected diversion to the veterinarian or practice manager. DEA's stated position, written in the rules for non-practitioner registrants such as distributors, is that an employee who knows a coworker is diverting drugs should report it, and the employer must keep that employee's identity confidential.29
- Client returns. Only DEA-authorized collectors and law enforcement may collect controlled drugs from clients for disposal.33 Veterinarians are not eligible to register as collectors, so the practice does not take them back.2 Direct clients to a drug take-back site or prepaid mail-back envelope. If neither is available, check the FDA Flush List.28
- Fentanyl patches. Used patches still contain enough drug to harm children and pets. A client who removes a patch at home should fold it in half, sticky sides together, and flush it. Never put it in household trash, where children or pets can find it.27
Common mistakes and exam traps
- Hydrocodone combination products are Schedule II, not III. The change took effect in October 2014.7
- The biennial inventory covers all schedules, not only Schedule II. Only the counting method differs: exact for II, estimated for III to V unless the container holds more than 1,000 tablets or capsules.12
- Form 222 orders. Form 41 records destruction. Form 106 reports theft or significant loss. Form 224 registers. Do not mix them up.2
- Form 106 is not used to balance minor discrepancies, and a witnessed breakage is not a loss.2
- "Locked" is not enough. The cabinet must be securely locked and substantially constructed, and the rule applies to Schedules II to V.9
- Two years is the federal minimum for records. Check state rules too, because they can be stricter than federal rules.1120
Quick review
- Schedule I: no accepted medical use. Schedules II to V: accepted use, with abuse potential falling from II to V.
- CII: morphine, hydromorphone, methadone, fentanyl, hydrocodone, pentobarbital alone.
- CIII: ketamine, tiletamine-zolazepam, buprenorphine, pentobarbital combinations, anabolic steroids.
- CIV: butorphanol, benzodiazepines, phenobarbital, alfaxalone, tramadol.
- Each practice location needs its own DEA registration, renewed every 3 years.
- Form 222 or CSOS for Schedule I and II orders; invoices for III to V.
- Store Schedules II to V in a securely locked, substantially constructed cabinet.
- Log date, recipient's name and address, drug and form, amount and initials for every dose.
- Biennial inventory: all schedules; exact count for opened CII containers.
- Keep all records at least 2 years; CII records separate.
- Theft or significant loss: notify DEA in writing within 1 business day, Form 106 within 45 days.
- Disposal by reverse distributor or witnessed on-site destruction to a non-retrievable state.