Generic drug manufacturers and certain others are subject to a new reporting requirement. It is perhaps buried in the Generic Drug User Fee Amendment (GDUFA), which was a part of the Food and Drug Administration Safety and Innovation Act (FDASIA) passed on July 9, 2012. Accordingly, FDA published a Federal Register announcement implementing this new requirement on October 2, 2012. This new requirement takes on a new urgency because the report is due 60 days after that announcement or by December 3, 2012. Failure to self-identify will cause all Final Drug Forms or API products manufactured at the facility to be misbranded. Shipping misbranded product is a prohibited act under Federal law and could subject the product to seizure or result in the prosecution of those responsible or an injunction. Foreign product would be subject to being denied entry into the United States.
The types of facilities that are required to “self-identify” include:
- Facilities manufacturing or intending to manufacture (i.e., identified in pending or approved generic drug submission) a finished dosage form (FDF) or active pharmaceutical ingredient (API). They will be required to pay an annual user fee. All others will not be required to pay the user fee.
- Sites and organizations that package the FDF of a human generic drug into the primary container/closure system and label the primary container/closure system.
- Generic drug repackagers.
- Both clinical or in vitro bioequivalence (BE)/bioavailability (BA) study sites.
- Sites that perform contract testing of attributes or characteristics of the FDF or the API to satisfy a current good manufacturing practice testing requirement (excluding sites that are testing for research purposes only).
- Manufacturers of positron emission tomography (PET) drugs solely, or in addition to other drugs.
Type of information required:
- Name and contact information for both the registrant owner and facility if they are different.
- Type of business operation.
- What the facility manufactures, i.e., whether the facility manufactures FDFs, APIs, PET drugs, or a combination of all, and whether the facility manufactures drugs that are not generic drugs.
- If applicable, the Data Universal Numbering System (DUNS), a nine-digit number provided by Dun & Bradstreet. Contact Dun & Bradstreet to obtain or verify a number. If you pay an expedited service fee, you can receive the number in approximately 10 business days; otherwise, it may take 30 business days.
- Facility Establishment Identifier (FEI), a number supplied by the FDA to track regulated firms. An FEI is assigned when the business first registers with the FDA.
This new process will be familiar to firms who have submitted information electronically to FDA. Self-identification files should be formatted in the same electronic messaging standard used for drug registration and listing information and for the content of labeling for abbreviated new drug applications (ANDAs). This standard is known as Health Level Seven SPL. The eSubmitter tool is available on FDA’s website (instructions). There are several sources of the software to generate the self-identification SPL file. Once generated, transmit the SPL file to FDA through the Electronic Submission Gateway (ESG).
FDAImports.com assists drug manufacturers all over the world with FDA regulatory compliance consulting. Contact us for assistance with GDUFA and FDASIA compliance, GMPs, labeling, compounding or bulk ingredient questions or issues.
Source
www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm320942.htm
