The U.S. Food and Drug Administration (FDA) is expected to issue new regulations for U.S. drug importers by July 9, 2015. Section 714 of the Food and Drug Administration Safety and Innovation Act (FDASIA) directs FDA to:
- Require U.S. drug importers to register with FDA
- Establish a Unique Facility Identifier (UFI) system for registrants
- Establish Good Importer Practices (GIPs)
Once the rules become effective, it will be a prohibited act for a drug importer to fail to register with FDA. Drugs imported by an unregistered importer will be deemed misbranded.
GIPS are intended to ensure that drugs imported into the U.S. are in compliance with FDA regulations. Under section 714, FDA must discontinue a drug importer’s registration if the importer fails to comply with GIP requirements. In FDA’s 2009 draft guidance, GIPs are organized under four guiding principles. Below are only a few of FDA’s suggestions.
1. Establishing a product safety management program.
Importers should conduct activities such as assigning responsibility for product control to specific individuals, ensuring those individuals have proper training, developing systems for communication, and clearly documenting the policies for certain product safety procedures.
2. Knowing the product and applicable U.S. requirements.
Importers should know all significant details about the products they import, such as their packaging, quantity, and composition. The importer should know which FDA regulations apply to each product they import and should identify potential hazards associated the products.
3. Verifying product and company compliance with U.S. requirements throughout the supply chain and product life cycle.
Importers should monitor the compliance history of their suppliers and the products they import, be aware of all preventive controls the supplier has in place, and establish methods of verifying compliance of products before importing the products into the United States.
4. Taking corrective and preventive action when the imported product is not in compliance with U.S. requirements.
Importers should establish plans for corrective actions, including plans to investigate sources of non-compliance. When an importer becomes aware that a supplier or its products are not in compliance, the importer should either help the supplier become compliant or discontinue working with the supplier.
Once FDA issues the final rule, Registrar Corp will update the industry on specific requirements and exemptions. Registrar Corp assists drug companies with U.S. FDA compliance. Our Regulatory Specialists can register drug importers with FDA and help their suppliers obtain compliance with FDA regulations. Registrar Corp’s FDA Compliance Monitor allows importers to monitor the FDA compliance status of FDA-regulated companies around the world.
For questions about or assistance with FDA regulations for drug companies, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.