As per FD&C act, all domestic and foreign establishments that manufacture, prepare, propagate, compound, or process drug products for commercial distribution in the United States must register regardless the establishment manufacture human drugs, animal drugs, active pharmaceutical manufacturers, or biologics.
Who Must Register
As per FDA establishment registration guidelines, business operations below are required to register with FDA.
- Drug Manufacturers: Facilities producing active pharmaceutical ingredients (APIs), bulk drugs, or finished dosage forms.
- Contract Manufacturers: Third-party organizations that manufacture or process products on behalf of another company.
- Re-packers and Re-labelers: Companies that take bulk drug products, split them into smaller commercial packages, or alter the product labeling.
- Drug Salvagers: Entities that retrieve, recondition, or analyze drugs affected by disasters (e.g., fires or floods) to determine if they are fit for commercial sale.
Foreign facilities exporting drug products to the U.S. market must register their establishments before shipping their goods. They are legally required to appoint a single U.S. Agent who lives or operates a business physically within the United States. This agent serves as the official point of communication between the FDA and the foreign firm.
The FDA exempts certain entities from registration if they manage drugs in the ordinary course of their local business operations.
- Pharmacies, hospitals, clinics, and licensed practitioners dispensing or administering drugs directly to patients.
- Research facilities utilizing drug products solely for teaching, analysis, or scientific research without commercial sale.
- Private label distributors (PLDs) who market drugs under their own brand name but utilize a registered third-party facility to oversee the actual manufacturing, repacking, or relabeling.
- Storage and transport facilities that only hold or move drug products without altering the product or its packaging.
All registered establishment must submit the list of drugs manufactured in their facility with a unique National Drug code (NDC).
Initial drug listings must be submitted within 3 days after registration of the establishment via Structured Product Labeling (SPL) format.
Establishment registration must be renewed annually between October 1 and December 31.
Liberty Management Group Ltd, provides assistance with drugs establishment registration, NDC labeler code request, Drug listings and US agent service to foreign facilities.
Sudha S
Regulatory Consultant
Email : office@libertymanagement.us