For Drug Establishments, who must register?
Domestic or foreign owners or operators of establishments that manufacture, prepare, propagate, compound, or process a drug or drugs and are not considered exempt must register their facility with FDA, according to the Code of Federal Regulations. In general, exemptions include pharmacies, professional licensed practitioners, researchers, teachers, analysts, and distributors.
What information is required for drug establishment registration?
Information you must submit as part of your FDA facility registration with your Structured Product Labeling (SPL) file includes:
- Company Name and full address of each establishment
- Name, address, phone number, and email address of official contact
- Type of operation(s) performed at each establishment
- DUNS number
- Facility Establishment Identifier (when assigned)
Non. U.S. establishments must also include:
- Name designated U.S. Agent
- Name of each importer known to the establishmentName of each agent, broker, or other entity, other than a carrier used to facilitate the import of their drug into the U.S.
- Include DUNS number, phone number and email address for each entry.
See Title 21 of the Code of Federal Regulations for a complete list.
Who must provide drug listings?
All drug establishments that are not considered exempt and must register with FDA must also submit initial listing information for all drugs in commercial distribution at the time of their original FDA facility registration, according to the Code of Federal Regulations.
In general, exemptions include pharmacies, professional licensed practitioners, researchers, teachers, analysts, and distributors.
What information is submitted for a drug listing?
Information you must submit as part of your FDA drug listing includes:
- Name of establishment(s) manufacturing or processing the listed drug and the type of operation(s) performed
- DEA schedule
- Route(s) of administration
- Dosage Form
- Ingredients (active with strength amounts and inactive)
- Marketing information (e.g., category, start/stop date)
- Information related to the application (e.g., type and year of approval) or OTC monograph citation number
- Package size and type
- NDC Product Code for a source drug repacked or relabeled
- Unique Ingredient Identifiers (UNII) and other code sets
- Distinctive Characteristics of certain listed drugs
- Labeling artwork
- National Drug Code (NDC) number
What is a master file?
A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), or the National Medical Products Association (NMPA) in China.