Question & AnswerQ&A (FDA CIRCULAR NO. 2014-011)
The primary purpose of FDA Circular No. 2014-011 is to adopt a Global Trade Item Number (GTIN) or an equivalent unique global product identification number as a requirement for all products seeking registration with the Food and Drug Administration to promote accountability of regulated establishments over registered products.
The components include: (i) each establishment is assigned a unique establishment identification number; (ii) each product is assigned a unique product identification number (Global Trade Item Number or GTIN); (iii) each product identification number is accounted to the proprietary establishment; and (iv) these identification numbers do not expire and are permanently associated with the establishment and the product.
No, the product identification number is not equivalent to a manufacturing batch or lot number. Batch or lot numbers may also be assigned a unique identification number separately by the establishment.
The exterior of the product, including packaging, labels, and/or containers, must bear the product identification number and/or its equivalent identification graphic such as a barcode or Quick Response code, allowing for unaided visual verification and electronic scanning.
Failure to provide a verifiable Global Trade Item Number by itself is sufficient ground for the denial of the application for product authorization.
No, documents are not required to be provided in support of the identification number as part of the authorization process. The FDA has the capability to verify identification numbers through a network that synchronizes global data.
The Circular applies to all FDA-regulated products and establishments.
The Circular took effect on June 30, 2015.
Under Section 5 of Republic Act No. 9711 (Food and Drug Administration Act of 2009), the FDA is empowered to order bans, recalls, and/or withdrawals of any health product found to have caused death, serious illness or injury, or which is imminently injurious, unsafe, dangerous, or grossly deceptive, after due process.
If any provision or term of the Circular is declared invalid, such declaration does not affect the remaining provisions, which continue to be in full force and effect.
Any regulation or provision inconsistent with the terms of FDA Circular No. 2014-011 is repealed or modified accordingly.