Addendum on 7/22: Updated to include a new checklist, to help veterinarians meet DEA’s requirements for tramadol.
Now that tramadol will become a Schedule IV controlled substance effective August 18 (see recent blog post), some veterinarians have questions about what to expect, and how to prepare for the upcoming change, so we’ve compiled some concepts to help veterinarians comply with pending DEA requirements.
First, recognize that DEA registrants must comply with all applicable DEA rules on August 18, including the manufacturers of tramadol products. See our checklist to help you comply with DEA’s requirements. Note that between now and the effective date, any tramadol that veterinarians purchase will likely not be labeled as a controlled substance, because the label “C-IV” is only required by DEA on August 18 and thereafter.
Here are some key actions veterinarians will need to start doing on August 18:
Security: Tramadol will be subject to schedule III–V security requirements, so this means storing it in a securely locked, substantially constructed cabinet. Also remember to secure your tamper-resistant prescription pads, and carefully write your prescription orders. Recall that individuals with certain criminal records or DEA registration revocations should not access controlled substances. See 21 CFR Part 1301 for full requirements.
Inventory: On August 18, DEA registrants will need to take an inventory of all stocks of tramadol on hand. Remember that DEA rules require biennial inventories, so your next federally required inventory will be on or before August 18, 2016. Be sure to check state rules in case your state’s inventory requirements are more stringent. See 21 CFR Part 1304 for more.
Records and Reports: All DEA registrants will need to maintain records on tramadol as of August 18, 2014. The details are in 21 CFR Part 1304 for veterinarians. Be sure to keep tramadol records in your readily retrievable Schedule III-V file (Schedule II records are kept separately) for two years, or longer depending on state rules.
Prescriptions: DEA registrants who prescribe tramadol or products containing tramadol will need to comply with DEA’s rules on August 18 and thereafter. Details within 21 CFR part 1306 are especially applicable for veterinarians. DEA requires controlled substance prescriptions to include the patient’s full name and address; practitioner’s full name, address, and DEA registration number; and drug name, strength, dosage form, quantity, directions for use, and number of authorized refills. You can prescribe tramadol via writing, phone call or fax, depending on state rules. Refills over a 6-month period, and up to 5 refills, are allowed.