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Forthcoming Regulations on Drug Imports and Importers to be Focus of July 12 FDA Meeting

Wednesday, June 19, 2013
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration will host a public meeting July 12 in Silver Spring, Md., regarding the implementation of new statutory authorities designed to help the FDA better protect the integrity of the drug supply chain. These authorities, conferred by Title VII of the FDA Safety and Innovation Act, which was enacted in July 2012, increase the FDA’s ability to collect and analyze data to make risk-informed decisions, employ risk-based approaches to facility oversight, partner with foreign regulatory authorities to leverage resources through information sharing and recognition of foreign inspections, and drive safety and quality throughout the supply chain. The FDA states that while implementation of these authorities will accelerate its adaptation to the rapidly changing demands of the global environment, it is also difficult and complex and requires not only the development of new regulations, guidances and reports but also major changes in FDA information systems, processes and policies.

In addition to providing a general overview of Title VII and the FDA’s approach to implementing it, the upcoming meeting will give interested persons an opportunity to provide input that will assist in the development of regulations implementing two sections of Title VII relating to standards for admission of imported drugs and commercial drug importers. Section 713 allows the FDA to require, as a condition of granting admission to a drug imported or offered for import into the United States, that an importer electronically submit information demonstrating that the drug complies with applicable requirements of the Federal Food, Drug and Cosmetic Act. Section 713 also allows the FDA to take into account differences among importers and types of imported drugs and, based on the level of risk posed by the imported drug, to provide for expedited clearance for those importers that volunteer to participate in partnership programs for highly compliant companies and pass a review of internal controls, including sourcing of foreign manufacturing inputs, and plant inspections. Section 714 requires commercial drug importers to register with the FDA and submit a unique identifier for the principal place of business at the time of registration. Drugs imported or offered for import by a commercial importer not duly registered will be deemed misbranded.

In connection with these provisions, the FDA is seeking information on numerous issues, including the following.

- how the regulations should define “importer” and “commercial importer”

- the information that importers should have to submit at the time of entry to demonstrate a drug's compliance with applicable U.S. requirements and country of export regulations

- whether importers should have to submit certificates of analysis as a condition of admission and, if so, how they could demonstrate a COA’s authenticity

- the criteria that should be used to evaluate potential participants in voluntary partnership programs for highly compliant companies and the risk factors that should be considered when determining drug admissibility under such programs

- the benefits and burdens that may be created by requiring drug importers to electronically submit information demonstrating that a drug complies with applicable requirements as a condition of admission

- whether to exempt from the commercial importer registration requirement commercial importers of certain types of drugs, such as inactive ingredients, or the importation of drugs for certain purposes (e.g., research use)

- whether the good importer practices regulations should require commercial importers to establish drug safety management programs to ensure that imported drugs meet the applicable statutory requirements

- whether the GIP regulations should include a requirement for commercial importers to assess whether it is appropriate to import a particular drug from a particular foreign supplier and, if so, the information that commercial importers should be required to consider as part of this assessment

- whether commercial importers should be required to conduct activities to verify that a drug that is offered for import is in compliance with applicable U.S. requirements and is not adulterated or misbranded and, if so, what such activities should be

- whether the GIP regulations should require commercial importers to obtain a COA for each imported drug and, if so, if testing to verify the accuracy of the COA should be required

- whether the GIP regulations should include specific requirements for drugs imported for export

- whether the GIP regulations should require commercial importers to take corrective actions when the drugs they import or offer for import are not in compliance with applicable U.S. requirements and, if so, what such actions should be

- whether the GIP regulations should require commercial importers to list the drugs they import or offer for import and, if so, the information that should be required with listing

- the records that commercial importers should be required to maintain under the GIP regulations

Contact Susan DeMars in the Office of Global Regulatory Operations and Policy at (301) 796-4635 for more information on attending the upcoming meeting.

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