DMF Type III: FDA Requirements for Packaging Materials
What Is a DMF Type III?
DMF Type III is a Drug Master File submitted to the U.S. FDA to provide confidential information about pharmaceutical packaging materials or container-closure systems. It can be used when a packaging manufacturer wants the FDA to review proprietary information without directly disclosing that information to its pharmaceutical customer.
A DMF Type III contains information about packaging materials used with drug products, including their composition, manufacturing information, controls, specifications, and intended use.
FDA does not require packaging information to be submitted in a Type III DMF. A drug manufacturer can instead include the relevant packaging information directly in an NDA, ANDA, BLA, or other applicable submission. A Type III DMF becomes particularly useful when the packaging manufacturer considers certain information proprietary and does not want to disclose it to the applicant or sponsor.
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When Is a Type III DMF Needed?
A Type III DMF may be appropriate when a packaging material manufacturer needs to provide confidential information to FDA in support of a pharmaceutical application. It can cover packaging components and materials of construction, such as bottles, closures, vials, syringes, or other container-closure components. The applicant references the DMF through a Letter of Authorization (LOA), allowing FDA to review the relevant information during application assessment.
What Are the Types of Drug Master Files?
FDA’s current DMF information identifies the following types:
DMF Type | Primary Purpose |
Type II | Drug substance, drug substance intermediate, material used in preparation, or drug product |
Type III | Packaging material |
Type IV | Excipient, colorant, flavor, essence, or related material |
Type V | FDA-accepted reference information |
The FDA’s current public DMF page focuses on Types II through V. The historical 1989 guideline also describes Type I as manufacturing site, facilities, operating procedures, and personnel information.
Type II DMF – Drug Substance
Type II DMFs may contain information about drug substances, intermediates, materials used in their preparation, or drug products.
Type III DMF – Packaging Material
Type III DMFs contain information concerning packaging materials and container-closure systems used with pharmaceutical products.
Type IV DMF – Excipients and Related Materials
Type IV DMFs cover excipients, colorants, flavors, essences, and materials used in their preparation.
Type V DMF – Reference Information
Type V DMFs contain FDA-accepted reference information that does not fall within Types II–IV.
What Information Goes Into a Type III DMF?
FDA’s guidance indicates that Type III DMF information can include details about the packaging material or container-closure system, its components, materials of construction, controls, and intended use. Information about suppliers or fabricators and acceptance specifications may also be included.
A Type III DMF may therefore address:
- General description of the packaging component
- Intended use
- Material of construction
- Composition
- Manufacturing process
- Manufacturing site information
- In-process and release controls
- Acceptance specifications
- Testing and characterization
- Supplier or component information
- Sterilization, washing, coating, or other post-manufacturing operations, where applicable
- Suitability information
- Supporting safety and quality information
The exact information required depends on the packaging material, its intended use, the drug product, and the information being relied upon in the regulatory application.
What Are Primary Packaging Materials?
Primary packaging refers to packaging that directly contacts the pharmaceutical product.
Examples include:
- Bottles
- Vials
- Ampoules
- Blister packs
- Syringes
- Stoppers
- Caps and closures
- Tubes
- Other container-closure components
The packaging must be suitable for its intended use. FDA’s approach considers factors such as protection, compatibility, safety, and performance when evaluating packaging systems.
Primary vs Secondary vs Tertiary Packaging
Packaging Level | Description | Example |
Primary | Directly contacts the drug | Bottle, vial, blister |
Secondary | Protects or groups primary packaging | Carton |
Tertiary | Used for transportation and bulk handling | Shipping container |
For regulatory purposes, the suitability of the container-closure system is particularly important because packaging can affect the quality and safety of the drug product.
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When Should You Consider a Type III DMF?
A Type III DMF may be useful when:
- You manufacture pharmaceutical packaging components.
- Your packaging information contains proprietary manufacturing or composition details.
- Your packaging is used by multiple pharmaceutical companies.
- Your customers need FDA review of your confidential information.
- You want to avoid repeatedly disclosing proprietary information to individual customers.
- Your packaging information will support an NDA, ANDA, BLA, or other applicable submission.
However, a Type III DMF is not automatically required simply because pharmaceutical packaging is involved. FDA specifically states that packaging information can be submitted directly by the applicant or sponsor.
How Does a Type III DMF Work?
The process generally involves these steps:
1. Determine Whether a DMF Is Appropriate
First, determine whether the packaging information should be provided directly to the applicant or maintained confidentially through a Type III DMF.
2. Prepare the Technical Information
Compile information covering the packaging component, materials of construction, manufacturing process, specifications, controls, and relevant suitability information.
3. Submit the DMF to FDA
DMFs are submissions to FDA and are generally prepared and submitted using the applicable FDA submission requirements. FDA provides DMF submission resources, including information on electronic submission and Form FDA 3938.
4. Obtain a DMF Number
After submission and acknowledgment, the DMF is identified by its assigned number.
5. Provide a Letter of Authorization
The DMF holder provides an LOA authorizing FDA to reference the DMF in support of a specific applicant’s submission.
6. Maintain the DMF
The DMF holder should maintain the file and submit appropriate amendments when relevant information changes.
How Operon Strategist Can Help With DMF Type III
Preparing a Type III DMF requires more than compiling documents. The information needs to be organized around the packaging material, its intended use, manufacturing controls, specifications, and the regulatory application it supports.
Operon Strategist can support pharmaceutical and packaging companies with:
- Type III DMF preparation
- Regulatory gap assessment
- Technical documentation review
- Packaging material regulatory strategy
- FDA submission support
- Letter of Authorization documentation
- DMF amendments and lifecycle management
- Regulatory compliance consulting
If you are unsure whether your packaging information should be submitted through a DMF Type III or directly to your pharmaceutical customer, a regulatory assessment can help determine the appropriate approach.
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FAQ's
Is DMF Type III mandatory?
No. FDA does not require packaging information to be submitted in a Type III DMF. It may be used when proprietary packaging information needs to be maintained confidentially while supporting a pharmaceutical application.
Who files a Type III DMF?
Packaging material manufacturers or suppliers that hold proprietary information about packaging components may file a Type III DMF.
What is an LOA in a DMF?
An LOA authorizes FDA to reference the DMF in support of another company’s regulatory submission.
Can packaging information be submitted without a Type III DMF?
Yes. FDA states that applicants or sponsors may include packaging information directly in their regulatory application.
Does FDA approve Type III DMFs?
No. DMFs are not independently approved or disapproved. FDA reviews their technical contents when they are referenced by applicable regulatory submissions.