On Thursday, September 22, FDA issued a guidance document, entitled “Self-Identification of Generic Drug Facilities, Sites, and Organizations.” The document was published with the intention of providing generic drug facilities, sites, and organizations with assistance concerning how to comply with the self-identification requirements.
Background
On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law with the goals of speeding “the delivery of safe and effective generic drugs to the public and reduce costs to industry.” In order to do this, GDUFA enables the FDA to collect user fees that are used to support critical and measurable enhancements to FDA’s generic drug program. Among a number of other requirements, GDUFA also mandates generic drug facilities, sites, and organizations to self-identify with FDA and to electronically update this identification information on an annual basis.
Self-identification provides the FDA with an abundance of information, enabling quick, accurate, and reliable surveillance when it comes to the inspection and compliance of generic drugs and their facilities. In its guidance document, FDA states that self-identification is required for the following reasons:
- “It is necessary to determine the universe of facilities required to pay user fees.”
- “It is a central component of an effort to promote global supply chain transparency.”
Most facilities that are required to self-identify are also required to pay an annual facility user fee, which includes “facilities manufacturing, or intending to manufacture, API of human generic drugs and/or finished dosage form (FDF) human generic drugs.” There are also a number of site and organizations that are required to self-identify, but are not subject the annual facility fee. These include:
- Facilities that solely manufacture positron emission tomography (PET) drugs.
- Sites and organizations that only perform testing, repackaging, or relabeling operations.
Self-Identification Requirements Under GDUFA
Who is required to self-identify?
According to GDUFA’s requirements, the following types of generic drug facilities, sites, and organizations are required to self-identify with the Agency:
- “Facilities that manufacture or intend to manufacture, human generic drug APIs or FDFs, or both.”
- “Facilities that package the FDF of a human generic drug into the primary container/closure system and label the primary container/closure system.”
- “Sites that are identified in a generic drug submission and pursuant to a contract with the applicant remove the drug from a primary container/closure system and subdivide the contents into a different primary container/closure system.”
- “Bioequivalence (BE)/bioavailability (BA) sites that are identified in a generic drug submission and conduct clinical BE/BA testing, bioanalytical testing of samples collected from clinical BE/BA testing, and/or in vitro BE testing.”
- “Sites that are identified in a generic drug submission and perform testing of one or more attributes or characteristics of the FDF or the API pursuant to a contract with the applicant to satisfy a current good manufacturing practice (CGMP) testing requirement (excludes sites that are testing for research purposes only).”
What information is required for submission?
1. Data Universal Numbering System (D-U-N-S) Number
A D-U-N-S number is “a unique nine-digit sequence provided by Dun & Bradstreet.” This number is specific to each site, and each distinct physical location (e.g. branch, division, and headquarter) is assigned a different D-U-N-S number.
FDA requires D-U-N-S numbers “for both the facility or site and the registrant owner of the facility or site if the facility or site is in a different location than the registrant owner location.” The FDA states that the D-U-N-S number is required to help the Agency uniquely identify the registrant as well as each of the organization’s physical locations. In addition, the guidance notes that “the site-specific D-U-N-S number is a widely recognized business identification tool and serves as a useful resource for FDA in identifying and verifying certain business information submitted by a user.”
If the facility or site and/or registrant have not been assigned a D-U-N-S number, the business entity may obtain one directly from Dun & Bradstreet at no cost.
2. Facility Establishment Identifier (FEI)
In addition to the D-U-N-S number, FDA also requires facilities to submit an FEI number, which is a unique identifier designated by the Agency to assign, monitor, and track inspections of regulated firms. Organizations that have not previously obtained an FEI number may do so by sending an email request to the Agency.
3. Additional Information
“FDA requests the name and contact information for the registrant owner and facility information, including name, type of business operation, and contact information. Submitters are also asked to indicate whether they manufacture drugs that are not generic drugs.”
What is the process for submitting self-identification information?
The standards and processes governing self-identification are similar to those of other electronic submissions made to FDA. The Agency states that “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 Structured Product Labeling (SPL), and “allows information to be exchanged, searched, and combined with other data sources in a manner that supports health information technology initiatives to improve patient care.”
What is the penalty for failing to self-identify?
GDUFA does not explicitly state any specific penalty for organizations and sites that fail to comply with its self-identification requirement. However, the guidance document states that if a site or organization does fail to comply with the law, it may raise concerns about that site, thus increasing the likelihood of a site inspection prior to approval.
In addition, GDUFA does state that “if a facility fails to self-identify, all FDF or API products manufactured at the facility and all FDFs containing APIs manufactured at the facility will be deemed misbranded.” This is important to note because it is a violation of federal law to ship misbranded products in interstate commerce or to import them into the US, and thus products that are deemed misbranded because of a failure to self-identify may be denied entry into the country.
Are you in the process of developing a generic drug or other FDA-regulated product? Do you manufacture a generic drug in the US? We can help ensure that you are in compliance with these and all other FDA regulations. For additional information about our services and how we can help you, contact us today.
