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SFDA Issues New Rules for Drug Excipients

Jul. 31, 2012

The SFDA has issued a draft for the new regulations governing the purity and safety of excipients, the pharmacologically inactive substances that drug-makers add to stabilize or deliver a drug’s active ingredients. The new rules, which go into effect on October 1, 2012, place responsibility for the safety of the excipient on the drug company that uses it. The regulations also require excipient makers to test their products and prove they meet all specifications.