The State Food and Drug Administration (SFDA) announced on November 30, 2006, a clarification on the application of the standard non-prescription drug insert sheet and labeling over both the non-prescription drug by the State listing (which means the drug is on the non-prescription drug list prepared by the State) and those by registration (which means the drug is registered as nonprescription by the pharmaceutical manufacturer). The SFDA circulated on October 20, 2006, a standard non-prescription drug insert sheet guidance for both chemical drugs and Chinese Proprietary medicines by the Detailed Specification for Non-Prescription Drug Insert Sheet (the Specification). It is required that all non-prescription drug manufacturers shall modify their current insert sheet and labeling according to the standard form, and the newly revised insert sheet and labeling shall be submitted to the provincial food and drug administration no later than June 1, 2007, for approval.
The Notice to Strengthen the Administration of the Insert Sheet and Labeling for Non-prescription Drugs (the “Notice”) clarifies that the standard non-prescription drug insert sheet be applied to both non-prescription drugs as listed as well as those being registered as non-prescription according to the Administrative Measures for Drug Registration (SFDA Order No. 17). With respect to the registered non-prescription drugs whose name, category, specification, or dosage is not completely identical to those as listed, the manufacturing enterprises of those drugs shall draft or modify the insert sheet of that drug in accordance with the standard form as referred to. As for those registered as both prescription and non-prescription drug alike, the drug insert sheet and labeling of both prescription and nonprescription types should be used at the same time. And the packaging for non-prescription drugs shall be distinguishable from those for prescription drugs.
The labeling of the non-prescription drug should be printed according to the Administrative Regulation on Drug Insert Sheet and Labeling (SFDA Order No. 24) as well as the Notice on Regulating the Publishing of the Exclusive Non-Prescription Drug Labeling and the Administrative Regulation (SDA Order No. 399 (1999)), and it shall contain the warning “please read the insert sheet carefully and use according to the instruction or after consulting with physicians or pharmacists.”
The Notice further states that all information contained in the insert sheet and the labeling shall be strictly restricted to the approved on-label use for such drug.