In this edition of the Weekly Compliance Digest, we cover a final rule by the U.S. FDA that specifies the data that must be submitted electronically for FDA-regulated products imported into the U.S.
Submission of Food and Drug Administration Import Data in the Automated Commercial Environment
What is it?
On November 29, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other Electronic Data Interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP). ACE is a single access point where industry can electronically submit all data required by various government agencies involved in international trade. The final rule specifies which data must be submitted in ACE when an FDA-regulated product is offered for import into the U.S.
The rule also includes technical revisions to certain sections of FDA regulations:
- The owner or consignee of an FDA-regulated product is now defined as the importer of record. This brings FDA regulations up to date with previous revisions to customs laws.
- FDA will now directly provide a notice that an FDA-regulated product is to be sampled, rather than having to go through CBP to provide that notice.
- FDA may now provide written notices electronically to the importer of record about FDA actions to refuse FDA-regulated products and/or subject certain drug products to administrative destruction.
- FDA can reject an entry for failure to provide through ACE the complete and accurate information required by the rule.
Who is affected?
The final rule affects companies that want to import any of the following items into the U.S.:
- Food contact substances
- Drugs (human and animal)
- Biological products
- HCT/Ps (human cells, tissues, and cellular or tissue-based products)
- Medical devices
- Radiation-emitting electronic products
- Tobacco products
What are the requirements?
When filing an entry in ACE, a company that wants to import any of the affected products must submit the following information:
- Product identifying information for the article that is being imported or offered for import. This consists of:
- FDA Country of Production, which is the country where the article was last manufactured, processed, or grown (including harvested, or collected and readied for shipment to the U.S.). The FDA Country of Production for an article that has undergone any manufacturing or processing is the country where that activity occurred provided that the manufacturing or processing had more than a minor, negligible, or insignificant effect on the article.
- Complete FDA Product Code, which must be consistent with the invoice description of the product.
- Full Intended Use Code.
- Importer of record contact information, which is the telephone and email address of the importer of record.
The rule also includes specific data submission requirements for each of the product types mentioned in the previous section. For example, for human drugs, importers must include: 1) Drug Registration Number, 2) Drug Listing Number, 3) Drug Application Number, and 4) Investigational New Drug Application Number. Finally, low-acid canned food and acidified food also have data submission requirements, but they are different from the other product types.
Failure to provide complete and accurate information through ACE can result in a rejection by the FDA of an import filing.
What is next?
The final rule was published in the Federal Register on November 29, 2016, and it will be effective on December 29, 2016.
The Weekly Compliance Digest will take a break for the holidays. The next post of the series will be on Friday January 13, 2017. Until then, Happy Holidays!
To learn more about EHS, Sustainability and Risk trends, we encourage you to read the NAEM 2016 Trends Report: Planning for a Sustainable Future, which presents the ideas and issues that will shape EHS and Sustainability Management.