FDA Proposes Rule to Amend Foreign and Domestic Drug Establishment Regulations

In addition, the proposed rule would revoke certain registration and listing exemptions currently applicable to foreign manufacturers, foreign repackers, foreign relabelers, and foreign drug product salvagers (foreign establishments). The FDA is also seeking comments on certain proposals that could affect importers, customs brokers, agents, etc.

(FDA sources urge interested parties to read the proposed rule thoroughly as there are a wide range of changes under consideration, including those that could affect importers and customs brokers.)

Highlights of FDA's Proposals

In its proposed rule, the FDA proposes the following changes and seeks comments on the following issues (partial list):

Electronic registration and listing. All registration information and most listing information would be provided to FDA electronically using the electronic drug registration and listing system that FDA intends to develop. FDA believes that the conversion to an electronic system would make the registration and listing processes more efficient and effective for both itself and the industry.

Information concerning importers. The FDA is proposing to make the submission of information concerning importers of drugs and persons who import or offer for import drugs to the U.S. both a registration and a listing requirement. According to the FDA, the Bioterrorism Act requires foreign establishments to submit, among other things, the name of each importer of each drug that is known to the foreign establishment, and the name of each person who imports or offers for import each drug to the U.S.

In its proposed rule, the FDA notes that if the above-described information has been previously provided by the foreign establishment at registration, the foreign establishment would not be required to re-enter that information into the database at listing.

Definition of "person who imports or offers for import". The FDA is proposing to define a "person who imports or offers for import" as an agent, broker, or other entity that the foreign establishment uses to facilitate the import of its drug into the U.S. Among other things, the FDA notes that the terms "broker" or "agent" include customhouse brokers who facilitate importation by filing documents with the U.S. Customs Service, as well as FDA and other Federal agencies responsible for the regulation of imported products.

The FDA's proposed rule would require that the foreign establishment provide the name of each agent, broker, or other entity that the foreign registrant uses to facilitate the import of its drug into the U.S. See FDA's proposed rule for further issues on which FDA is seeking comment with regard to the definition of "person who imports or offers for import."

Removal of two exemptions for foreign establishments. The FDA states that it is proposing to eliminate the two exemptions in current 21 CFR 207.40(a) and (b) from the registration and listing requirements in light of certain statutory changes, such as the Bioterrorism Act, that have occurred since the publication of the final rule on foreign establishment registration and listing. FDA explains that an increased number of foreign establishments could be required to comply with the registration and/or listing requirements as a result of the following proposed revocations:

FTZ exemption. The FDA would revoke the exemption in 21 CFR 207.40(a) relating to foreign establishments whose drugs enter a foreign trade zone (FTZ) and are re-exported from the FTZ without having entered U.S. commerce.

Drug components. The FDA would revoke, in part, 21 CFR 207.40(b) which allows for a component of a drug imported under section 801(d)(3) of the Federal Food, Drug, and Cosmetic Act (21 USC 381(d)(3)) to be imported or offered for import into the U.S. even if the component is not listed and manufactured, prepared, propagated, compounded, or processed at a registered foreign establishment.

NDC numbers would be required, assigned by FDA. The appropriate National Drug Code (NDC) number would be required, with certain exceptions, to appear on drug labels. The appropriate NDC number is the NDC number belonging to the manufacturer, repacker, or relabeler that corresponds to the particular drug.

FDA proposes that all three sections of the NDC number (the labeler code, product code, and package code) be assigned prospectively by the FDA to drugs that have not previously been assigned NDC numbers by a manufacturer, repacker, or relabeler. (Currently, FDA assigns the labeler code, and the registered establishment or private label distributor assigns the product code and package code within certain parameters specified by the FDA).

The FDA notes that the labeler code assigned prospectively by the FDA would be the same as the labeler code (or one of the labeler codes) used by the manufacturer, repacker, or relabeler on its currently marketed drugs. NDC numbers currently assigned to drugs prior to the effective date of the final rule implementing this proposal would remain unchanged, provided those NDC numbers comply with the new regulations as finalized.

-written or electronic comments are due by November 27, 2006; comments on information collection requirements were due September 28, 2006 to the Office of Management and Budget (OMB).

FDA Proposed Rule (D/N 2005N-0403, FR Pub 08/29/06) availableat http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/06-7172.pdf