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(Sandler, Travis & Rosenberg, P.A.)
The Food and Drug Administration recently issued proposed regulations that could severely jeopardize the continued
competitiveness of the United States as a global distribution hub for both prescription and non-prescription drugs. The rule would substantially revise the current regulatory requirements concerning
facility registration and drug listing and would affect foreign as well as domestic drug establishments. Public comments on this rule must be submitted to the FDA by Nov. 27.
Current Law:
Under FDA regulations, facilities that manufacture, process, relabel or repack drugs must register with the FDA and provide it with a listing of all of the drugs they manufacture, process, relabel or repack for distribution in the U.S. If a drug product is not listed it cannot be distributed or entered into the U.S. In addition, private label distributors may list their own branded goods, even if they are manufactured by a third-party registrant.
There are several exemptions from the registration and listing requirements. Drugs imported or entered into a foreign-trade zone for subsequent export are not required to be listed and the
foreign manufacturers of those products do not need to be registered. An "import for export" provision for drug components intended to be further processed into finished goods that are then
exported excludes such components from the registration and listing requirements for finished goods distributed within the U.S.
Proposed Rule:
The proposed rule would adopt many provisions involving significant changes from current practice, including the following, and would impose new compliance burdens.
- Private label
distributors will no longer be able to list their own branded products for distribution within the United States.
- Foreign manufacturers and other facilities will no longer be exempt from
the registration and listing requirements in connection with products passing through FTZs for export to other countries.
- Facilities that intend to import into the United States components
of finished drug products will be subject to registration and listing requirements, even if those components are entered only for further processing or manufacturing into products to be exported.
- National Drug Code numbers will be required on all drug labeling and all components of NDC numbers will be assigned by the FDA instead of designated by the relabeler or manufacturer itself.
- Foreign establishments will need to designate a U.S. agent as part of the registration process in order to facilitate FDA inspection of such facilities.
- Foreign establishments will be
required to advise the FDA at the time of registration of known entities that are authorized to facilitate the importation of their products into the United States.
- Contract or toll
manufacturers will have to register with the FDA and separately list applicable products processed at their facilities, even if pre-existing registered manufacturers are relied upon for ingredient
acquisition, product distribution, quality control or other processes.
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