China tightens supervision of addictive drugs to curb abuse
China on Monday announced it will ramp up supervision of two addictive pharmaceutical products — oral pregabalin and guaifenesin-containing compounds — in a bid to curb drug abuse.
According to a circular jointly released by the National Medical Products Administration, the Ministry of Public Security and the National Narcotics Control Commission, the country will roll out stringent measures covering the entire industrial chain of these high-risk medications, from manufacturing and distribution to retail.
Under the new rules, provincial-level drug regulators are required to strictly enforce production quotas for these substances, aiming to curb abuse risks at the source.
The circular specifies that online retail or any form of illicit retail sales of these products is strictly prohibited.
At offline pharmacies, the drugs must be stored in designated cabinets, handled by dedicated personnel and dispensed only with a valid prescription. Pharmacies are also required to record detailed transaction information, including the drug name, specifications, quantity sold, manufacturer, batch number, purchase date, and the buyer's name and identification number.
It stressed that prescriptions must be kept on file for future inspection. For over-the-counter versions, single-transaction sales are capped at no more than five minimum packaging units.
Sales to minors are strictly prohibited. Pharmacists and pharmacy staff who detect any suspicious purchasing patterns are required to refuse the sale and immediately report the case to the authorities.
The circular also highlights the implementation of a whole-chain information traceability system for these products and enhanced drug abuse monitoring and early warning capabilities.
Provincial-level drug regulators are required to include pregabalin and guaifenesin-containing products on key drug abuse monitoring lists. Any signs of clustered, regional or trending abuse risks must be promptly investigated and reported to the national-level regulator.
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