Overview
- Regulators confirmed the move on June 22 and said the reclassification to Fracción III of Article 226 takes effect on July 14, 2026.
- Under Fracción III, pharmacies must demand and retain an original medical prescription that shows the prescriber's professional ID and institution and must log every Tramadol sale in control books.
- Pharmacies may dispense the same prescription up to three times according to the doctor’s treatment plan, must seal each delivery with date and quantity, and must keep the prescription after the third dispensing.
- COFEPRIS said the change responds to new scientific evidence and to concerns about addiction and misuse while stressing it aims to keep access for patients who need supervised treatment.
- The shift will raise administrative work for prescribers, pharmacies and manufacturers, who must update labels and distribution practices, and could prompt closer clinical follow-up for patients who use Tramadol regularly.