![]() you can download the referenced sections of the act or the regulations by using this link to the act: Federal Food, Drug, and Cosmetic Act and this link to the regulations: Code of Federal Regulations. the following information on imports/exports contains references to the act and regulations set forth at title 21, code of federal regulations (cfr) (regulations of the food and drug administration). that lack required fda approval is available. A draft guidance, Unapproved Drugs - Compliance Policy Guide (PDF - 66KB), on current agency policy regarding drugs marketed in the u.s. can be found on the CDER Small Business and Industry Assistance (CDER SBIA) website. Information about how drugs are approved in the U.S. Information can be obtained at the USDA Veterinary Services Import and Export website. Also, the United States Department of Agriculture (USDA) has certain requirements for the importation and exportation of animal-derived products, such as biological drugs. Information can be obtained at the DEA Office of Diversion Control website. The importation and exportation of controlled substances requires compliance with provisions enforced by the U.S. For example, without evidence that specific drugs sought to be imported have been manufactured pursuant to an approved new drug application or abbreviated new drug application, in the manufacturing facility permitted under the application, the drugs might appear to be unapproved new drugs. Under the Act, FDA may refuse admission to any drug that "appears" to be unapproved, misbranded, or adulterated, placing the burden on the importer to prove that specific drugs sought to be imported are not in violation of the Act. They must be brought into compliance, destroyed, or re-exported. Shipments not found to comply with the law are subject to detention. Bureau of Customs & Border Protection (Customs). Imported products regulated by the FDA are subject to inspection at the time of entry by the U.S. approved drugs-that have not been manufactured in accordance with FDA approval. Unapproved new drugs include any drugs-including foreign-made versions of U.S. Thus, the importation of new drugs that lack FDA approval, whether for personal use or otherwise, violates the Act. The Federal Food, Drug, and Cosmetic Act (Act) prohibits the interstate shipment (which includes importation and exportation) of unapproved new drugs.
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