Importation of Drugs Outline
Drugs products imported or offered for import into the USA must comply with all the applicable requirements under the Federal Food, Drug, and Cosmetic Act (the Act) and the pertinent regulations found in Title 21 of the Code of Federal Regulations (21 CFR). These include pre-market approvals; i.e. new drug or abbreviated new drug applications (NDA/ANDAs), labeling, firm registration and drug listing, and they must be manufactured in accordance with Current Good Manufacturing Practices (CGPM).
For prescription (Rx) and non-prescription or over-the-counter (OTC) drugs that require NDA or ANDA approval, the NDA or ANDA must be filed with and approved by the Center for Drug Evaluation and Research (CDER) prior to the importation of such product as required by section 505(a) of the Act and 21 CFR 314.
Foreign manufacturers whose drugs are imported or offered for import into the U.S. are required to register with FDA and submit a listing of every product in commercial distribution in the U.S. as required by Section 510 of the Act and 21 CFR 207. These requirements apply to all manufacturers, repackers, relabelers, and control laboratories involved in the manufacture, preparation, propagation, compounding, processing or testing of human or veterinary drugs and human biological products, including the manufacturer of active pharmaceutical ingredients. Drug products must be listed with FDA before they may be imported for commercial distribution in the U.S., and the foreign manufacturer is required to register with FDA within 5 days of the submission of a NDA or an ANDA. In addition, these regulations require importers to identify a U.S. Agent. The necessary registration and listing forms can be found on FDA’s Internet web site at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/default.htm. Please note that registration of a drug establishment or drug wholesaler, or assignment of a registration number, or drug listing, or assignment of a NDC number does not in any way denote approval of the firm or its products (see 21 CFR 207.39).
Section 501 of the Act requires that all drugs, including drug components, distributed in the U.S. be manufactured in accordance with good manufacturing practices (GMPs). Finished drug products must specifically comply with the GMP regulations under 21 CFR Parts 210 and 211. The failure to follow GMP requirements causes a finished drug product or drug component to be adulterated under Section 501(a)(2)(B) of the Act. Facilities that manufacture drug products and drug components for importation into the U.S. are subject to FDA inspection to determine conformance with these requirements.
FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Manufacturers must make sure that product label information is truthful and not misleading. More information on guidance, compliance, regulatory information, and importing dietary supplements go to the following website: http://www.fda.gov/Food/DietarySupplements/GuidanceComplianceRegulatoryInformation/RegulationsLaws/default.htm).
This is not intended to be an all inclusive list of the requirements of the Act and regulations applicable to the importation of drug products. Due to the agency's limited resources, we are unable to provide extensive consultative services. It is the responsibility of each person marketing drug products to comply with all of the requirements of the Act and regulations. Should you have further questions concerning the manufacturing, labeling, approval requirements, etc. of any drug products you are interested in importing into the US, we recommend that you retain the services of an attorney or consultant with expertise regarding the Act and its implementing regulations, especially those affecting OTC drugs.