Drugs
Stay compliant with the latest drug regulations and industry updates for effective market access and continued compliance.
Drugs
Stay compliant with the latest drug regulations and industry updates for effective market access and continued compliance.
Featured Drugs Articles
Secure your proprietary data with Drug Master File submissions to the FDA. Trust Registrar Corp for expert assistance and confidentiality.
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Easily navigate FDA regulations for OTC human drugs with these expert insights into registration, listing, & marketing compliance.
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Latest Drugs Compliance Articles
Understand all 5 FDA DMF types—how to use them, what to avoid, and how to turn confidential submissions into strategic regulatory assets.
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Master DMF submissions with FDA-ready formatting, lifecycle strategy, & sponsor coordination to gain speed, trust, & compliance advantages.
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Learn how to submit, structure, and maintain a Drug Master File (DMF) for FDA compliance, including eCTD formatting and global distinctions.
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Compare the FDA Drug Master File with global equivalents like ASMF, CEP, and J-DMF to streamline regulatory submissions across major markets.
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Learn FDA drug establishment registration and listing rules, FEI use, and how to stay compliant under 21 CFR 207 for U.S. market access.
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Drugs Regulations FAQ
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.