FDA Sets New Electronic Registration Requirements for Human and Animal Drug Facilities
The Food and Drug Administration is amending its regulations on foreign and domestic drug establishment registration and listing for human drugs, including drugs that are regulated under a biologics license application, and animal drugs. The agency’s final rule (here) sets requirements for all facility registrations to be submitted electronically to FDA, with foreign facilities listing all importers of their covered drugs. Facilities must review and update their registrations annually. FDA’s final rule also makes changes to the National Drug Code (NDC) system.
The final rule comes a decade after FDA first proposed the new electronic registration filing system in 2006 (see 06110320). In the meantime, FDA began requiring electronic registration for human and animal drug facilities in 2009, so “in many cases” these new requirements “will not necessitate changes in a registrant's current registration and listing practices because electronic submission of registration and listing information already takes place, and the information currently collected generally comports with this final rule.” In other cases, the final rule’s new requirements mean “some registrants will need to adjust their registration and listing activities.” The proposed rule’s elimination of registration exemptions for certain foreign-trade zone activities and importation of components for export was not adopted in this final rule.
Though the final rule takes effect Nov. 27, FDA “intends to exercise enforcement discretion” for certain requirements, it said. For human and animal drug facilities, FDA expects “continued electronic submission of registration and listing information” after Nov. 27, though such facilities will have an additional year to comply with changes to the information required by FDA and new registration and listing update requirements. Two years later (i.e., Nov. 27, 2018) FDA will remove from its current electronic database registration and listing information submitted in the past on paper and not updated with a more recent electronic submission. Blood and human cell and tissue facilities will get a grace period of one year to comply with electronic registration and listing requirements, FDA said.
Electronic registration and listing. All registration information and most listing information must be provided to FDA electronically using the appropriate electronic registration and listing system. For foreign drug facilities, registration must occur “before a drug or an animal feed bearing or containing a new animal drug manufactured, repacked, relabeled, or salvaged at the establishment is imported or offered for import.” Private label distributors who do not also manufacture, repack, relabel, or salvage drugs are not required to register, except when it is acting as an authorized agent for another establishment that is required to register. When operations are conducted at more than one establishment under common ownership and control, including combinations of foreign and domestic establishments, the parent, subsidiary or affiliate company may submit registration information for all establishments, FDA said. Facilities will have to update their registrations annually between October and December of each year. Listings must be updated twice per year, in June and December.
Information concerning importers. FDA is finalizing a requirement that foreign facilities submit the name of each importer of their products. However, the agency is making two changes from its 2006 proposed rule. First, though the proposal said the facility must identify all importers known to the establishment, the final rule says the facility must identify all importers, period. Second, FDA is changing its definition of “importer” to exclude customs brokers and downstream customers, as follows: “a person in the United States that is an owner, consignee, or recipient, at the time of entry, of a foreign establishment's [drug, blood or human cell or tissue product] that is imported into the United States.”
FDA’s revised definition of importer is intended to include foreign persons who are primarily responsible for sending a drug to the United States.” In many cases, “the establishment itself will be a person who imports or offers for import,” FDA said. The definition also includes “persons who send a drug to the United States by international mail or other private delivery service.” However, the definition “does not include carriers who merely transport the drug,” nor is it “intended to include persons operating merely as customs brokers.” Also, the term "importer" “should include a U.S. owner, consignee, or recipient at the time of the drug's entry into the United States,” but it “should not include additional subsequent owners, consignees, or recipients of the drug,” FDA said.
Exemptions retained. In a change from its proposed rule, FDA is not eliminating an exemption from current registration and listing requirements for foreign establishments if the drug enters a foreign-trade zone and is re-exported without having entered U.S. commerce. FDA is also retaining an exemption that allows for a component of a drug to be imported even if the component is not listed and manufactured, prepared, propagated, compounded or processed at a registered foreign establishment, as long as the imported articles are exported or destroyed.
(Federal Register 8/31/16)