Lachman 撰文解答 FDA 药品企业注册常见疑问及年度再注册要点

FDA requires registration of facilities for everything from animal/veterinary and human drugs, medical devices, cosmetics, food, tobacco, radiation-emitting products, and vaccines, blood, and biologics. This blog focuses on the Drug Establishment Registration (DER) requirements.

On September 25, 2026, a whirlwind of emails came through to those of us in the pharmaceutical world proclaiming that the period from October 1, 2026 – December 31, 2026 is the Annual DER and Drug Listing Certification period. This is the time of the year when drug establishments registered with the FDA must confirm that there are no changes to how they are registered and that all their NDCs are still active. This time of year often brings assorted questions regarding drug listings and establishment registrations to the Regulatory team at Lachman Consultants, but today’s focus is on the DER requirements alone. DERs directly impact the User Fees, so getting the facility information input in FDA’s system with the correct business operations and qualifiers chosen correctly is critical to not having unwanted surprises arise when a facility is invoiced or generates a user fee cover sheet for payment of user fees. Therefore, we thought it might be a good idea to provide some feedback on commonly asked questions and often misunderstood topics related to DER while the window to recertify is still open.

1. Which facilities are required to register?
In general, this is a fairly straightforward answer. According to the FDA site for Registration and Listing, “Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA.” This applies to establishments for human and animal drugs, including over-the-counter (OTC) drugs.

2. What is the difference between repackaging and re-labeling?
Repacker/Repackagers, as defined here, eCFR :: 21 CFR 207.1 — What definitions and interpretations of terms apply to this part? refers to a person who owns or operates an establishment that repacks a drug or drug package. Repackaging is defined as the act of taking a finished drug product or unfinished drug from the container in which it was placed for commercial distribution and placing it into a different container without manipulating, changing, or affecting the composition or formulation of the drug.

Relabeling is the act of changing the existing label or labels on a drug or drug package, or a change or alteration in the existing labeling for a drug or drug package, without repacking the drug or drug package. This does not include the addition or modification of information affixed solely for purposes of delivery to a customer, customer identification, and/or inventory management.

3. When do facilities need to register?
According to 21 CFR § 207.21, each domestic establishment needs to be registered no later than 5 calendar days after beginning to manufacture, repack, relabel, or salvage a drug or animal feed bearing or containing a new human or animal drug at such establishment.

Each foreign establishment must be registered before a drug or an animal feed bearing or containing a new animal drug manufactured, repacked, relabeled, or salvaged before it is imported or offered for import into the US.

Annual registration renewal must be done between October 1 and December 31 each year.

4. Do sites that package “kits” have to register?
First, we think it’s prudent to define what a “kit” is – a kit is when two or more products are co-packaged into one larger container for convenience or marketing purposes. This may be a drug and device, two or more drugs, or two or more devices. An example that can be found on the store shelf frequently is a day and night cold medicine, which are also sold individually, are also packaged into one carton for convenience for the consumer treating their cold round the clock. First-aid kits are another example, as they often combine devices and drugs into one convenient package.

This can be a complicated topic. Keep watch for a future blog on drug listing which will include some additional information on kits and multi-product packaging as it relates to drug listing requirements.

5. If I’m a Contract Manufacturing Organization (CMO), how do I make sure that role is selected on my establishment registration?
For each Type of Business Operation (each establishment can have multiple business operations), a Business Operation Qualifier must be added. If you are a CMO, you should choose the option that includes the term “Contract manufacturing”. This is important to you, as a facility, as the user fees are often different for manufacturers versus contract manufacturers and often the CMO fees are much less than for manufacturers so this distinction is important.

6. What do I do if my facility is no longer operating or has a change to the business operations?
If your facility is no longer operating, you can de-register the site on FDA Direct. You should change the document type to “establishment de-registration” or “out of business notification”, as appropriate, and submit the DER file.

If you need to change the business operations, create a new version of the DER file and make the appropriate changes before submitting the DER that reflects the updates.

Whenever you make a change, and when you do your annual re-registration, check the Drug Establishments Current Registration Site (DECRS) 1 day after you’ve made the submission to make sure your registration is accurate and shows the correct expiration date. Updates can and should be made to your DER at any time, if you find an error, or whenever you have an update.

Still have questions? Lachman can help you with your Drug Establishment Registration, please reach out to the LCS team at [email protected] or if you have a contact already, reach out to your friendly neighborhood Lachman Regulatory Consultant!

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