§ 200.30 - Sterilization of drugs by irradiation.

There is a current interest in the utilization of newly developed sources of radiation for the sterilization of drugs. Prior to the marketing of a drug sterilized by such means, it is necessary in the interest of protecting the public health to establish by adequate investigations that the irradiation treatment does not cause the drug to become unsafe or otherwise unsuitable for use. Accordingly, all drug products, including injections, ophthalmic solutions, surgical sutures, and surgical dressings sterilized by means of irradiation are regarded as new drugs within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act. An effective new-drug application pursuant to section 505 of the act is therefore a prerequisite to interstate shipment of such articles, except as provided by section 505(i).