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Cosmetics Registration in California and the FDA's Electronic-only Drug Registration
By: David C. Steinberg, Steinberg & Associates
Posted: September 29, 2009, from the October 2009 issue of Cosmetics & Toiletries.
page 5 of 6
Previously, manufacturers of drugs, including OTC drugs such as sunscreens, were annually required to file FDA form 2656, known as the Registration of Drug Establishment/Labeler Code Assignment. Now online, this form is required to be submitted once per manufacturer. A second form, FDA-2657 or the Drug Product Listing, is required for each drug registered. The FDA-2657 must be filed for each formulation and is also used to file updates in June and December, or at the discretion of the registrant when any change occurs. A third form, FDA-2658 or the Registered Establishments’Report of Private Label Distributors, is required when the drug is not made by the manufacturer.
For those filing FDA-2658, the labeler code from FDA-2656 will be required. Like FDA-2657, this form is also used to file updates in June and December, or at the discretion of the registrant when any change occurs.
Manufacturers outside of the United States wishing to register a drug with FDA-2657 must first submit FDA-2656 and include a signed letter designating their representative US address. This letter designates a US liaison address for communications with the FDA and will provide non-US manufacturers with a labeler code. After this address is established, the FDA will send all notifications, communications and infractions to that address. Non-US manufacturers may use distributors, lawyers or consultatants for this purpose; however, the manufacturer should be aware that sales agents at distribution centers may not be able to answer the FDA’s questions.
Complete information for filing electronically can be found online,5 as well as guidance information and the electronic submission gateway. Those companies filing will need a gateway account and a DUNS number—a nine-digit account number that identifies an organization.
Although the system to electronically register drugs with the FDA sounds easy, it is not. As of press, this author was unaware of anyone able to successfully register due to the system’s convoluted instructions. Since the system currently serves as a roadblock to filing and it is the only filing method accepted, it will likely lead to more noncompliance. This system should have been tested before it was released to the industry.