In a targeted move to rein in the misuse of controlled pharmaceutical substances, Chinese authorities announced sweeping new regulatory measures for two high-risk addictive drugs on Monday, April 20, 2026. The updated rules, jointly issued by the National Medical Products Administration, the Ministry of Public Security, and the National Narcotics Control Commission, apply to oral pregabalin and all compound medications containing guaifenesin, establishing end-to-end oversight across every segment of the two products’ industrial supply chains.
Starting with the source of production, provincial drug regulatory bodies are now mandated to enforce rigid production quotas for the two substances, a policy designed to cut off excess supply that could be diverted for illicit abuse. Digital sales channels face an outright ban: the circular explicitly prohibits online retail of these medications, as well as any unlicensed offline sales through unapproved vendors.
For brick-and-mortar retail pharmacies, a series of strict operating requirements have been put in place to secure access to the drugs. All eligible stocks must be stored in locked, designated cabinets managed by specially assigned staff, and dispensing can only proceed when a customer presents a valid, official medical prescription. Pharmacies are required to log full, detailed transaction records covering every sale, including the drug’s name, dosage specifications, total quantity sold, manufacturer information, batch number, purchase date, and the buyer’s full name and government-issued identification number. All prescriptions must also be retained on file for regulatory inspection.
For formulations that were previously available over the counter, the new rules cap single-transaction sales at a maximum of five minimum packaging units to reduce the risk of bulk diversion. Sales to any minor are strictly prohibited under all circumstances. If pharmacy staff or licensed pharmacists identify suspicious purchasing behavior—such as repeated bulk purchases or inconsistent prescription documentation—they are required to immediately deny the sale and report the incident to local law enforcement and drug regulators.
To boost oversight transparency and responsiveness, the circular also mandates the rollout of a full-chain digital traceability system that tracks every unit of the two medications from factory to end consumer. This system will be paired with expanded drug abuse monitoring and early warning infrastructure across all levels of regulation. Provincial regulators are required to add oral pregabalin and guaifenesin-containing compounds to their priority drug abuse monitoring rosters, and any emerging signs of clustered, regionally concentrated abuse or growing misuse trends must be investigated immediately and reported to the national drug regulator for coordinated response.