Posted by kiddo on March 19, 2002, at 20:17:54
In reply to ANSWER: Legality of Importing Meds from Overseas » PhoenixGirl, posted by fachad on March 19, 2002, at 19:26:52
http://www.fda.gov/ora/import/ora_import_system.htmlFDA's IMPORT PROGRAM / GENERAL PROCEDURES (1st Paragraph)
To ensure that FDA is notified of all regulated products imported into the United States, the importer, or his/her representative, must file an entry notice and an entry bond with the U.S. Customs Service (Customs) pending a decision regarding the admissibility of the product. FDA inspection and enforcement procedures for imports rely on coordination with Customs with whom FDA has an excellent working relationship. For specific information on U.S. Customs procedures, requirements, forms, etc., contact your local Customs office.FDA is notified by Customs of the entry and makes a decision as to the article's admissibility. If FDA does not wish to examine the entry, the product is allowed to proceed into United States commerce.
(3rd paragraph under "Additional Forms")
Although it is not a requirement for foreign drug firms to register their establishments, their products must be listed with the FDA. Forms required to obtain a labeler code (FD 2656) and drug list their product (FD 2657) should be requested from the Center for Drug Evaluation and Research, Product Information Management Branch (HFD-058), 5600 Fishers Lane, Rockville, MD 20857.
Drugs are restricted from importation unless they are covered under an Investigational New Drug Exemption (IND) or by an approved New Drug Application (NDA). Information on regulations covering INDs or NDAs and application forms should be requested from CDER Executive Secretariat (HFD-8), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857.
There are several forms that are required to be filed with FDA prior to the importation of medical devices into the United States.
A premarket notification or 510(k) submission is required when the following occurs: (a) a foreign manufacturer intends to export a medical device to the U.S. that the firm has never before shipped to the U.S.; (b) either the foreign manufacturer or initial distributor changes the intended uses of devices that are legally being marketed in the U.S.; or (c) changes or modifications to a legally marketed device that could significantly affect its safety or effectiveness. Detailed information regarding the premarket notification process can be obtained from the following documents: Premarket Notification: 510(k), Regulatory Requirements for Marketing a Device, and 510(k) Review Program.
Firms are required to submit a properly completed form FDA 2892 (Medical Device Listing) before their medical device can be imported into the United States. Although, it is not a requirement for foreign medical device firms to register their establishments, it is requested that they do so. This can be done by submitting a properly completed form FDA 2891 (Initial Registration of Medical Device Establishment). Form FDA 2877 (Declaration for Radiation Standard) is required for radiation-emitting electronic products entering the United States.
To obtain these above forms, or information concerning premarket notification, radiation control standards, or Drug and Device Listing and Establishment Registration contact the Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance (DSMICA), (HFZ-220), 1350 Piccard Drive, Rockville, MD 20850-4307, (800) 638-2041).
poster:kiddo
thread:98860
URL: http://www.dr-bob.org/babble/20020318/msgs/98890.html