On December 17, 2008, the State Food and Drug Administration (SFDA) issued the Circular on Further Standardizing the Operation of Pharmaceutical Retail Enterprises. The Circular’s purposes are to further standardize drug retail enterprises and crack down on illegal and criminal activities related to the sale of counterfeit drugs.
The Circular is intended to further implement the Special Regulations on Strengthening the Supervision and Management of the Safety of Food and Other Products, issued by the State Council on July 26, 2007. While some of the provisions stipulated in the Circular are included in the Special Regulations, the Circular specifically governs pharmaceutical retail enterprises.
The Circular requires pharmaceutical retail enterprises to establish and implement a mechanism to check and verify the products sold in the pharmacy (especially non-pharmaceutical products). In particular, these enterprises must confirm their supplier’s business qualifications, product quality certificates and product labeling. Furthermore, the enterprises must create files for the products they purchase and accurately record each product’s name, specifications, quantity, supplier and its contact information, and purchase time. Under the Circular, a pharmaceutical retail enterprise mustalso issue sale vouchers indicating the name, specifications, quantity, manufacturer and price of the product, and establish similar files for the products it sells. The purchase and sale files must be saved for at least two years.
Moreover, the Circular forbids pharmaceutical retail enterprises from selling products without an approval certificate, quality certificate, product name, Chinese label of the manufacturer, or production address. It also prohibits the sale of non-pharmaceutical products with similar packaging, names, or descriptions of their therapeutic functions.
Finally, the Circular requires all levels of food and drug supervising departments to strengthen the administration and inspection of pharmaceutical retail enterprises’ operation. In serious cases, an enterprise’s Drug Operation License may be revoked according to the law.