Q.01

Who has to register a drug establishment with the FDA?

Under 21 CFR 207.17, every manufacturer, repacker, relabeler and salvager of drugs has to register each establishment where it carries out those operations, unless an exemption applies. That covers domestic sites, and foreign sites whose drugs are imported or offered for import into the US. It also covers sites handling animal feed that bears or contains a new animal drug.

Approach: The datasets I can search hold the FDA's list of currently registered drug establishments, but not the text of 21 CFR Part 207. So these findings come from search snippets of the eCFR and FDA's registration pages, not from a full reading of the rule.

Who must register (21 CFR 207.17)

  • Who: manufacturers, repackers, relabelers and salvagers of human drugs (including drugs regulated under a biologics license application) and of animal drugs. Animal feed bearing or containing a new animal drug is included.
  • Which sites: each domestic establishment that does any of these four activities, and each foreign establishment whose drug or medicated feed is imported or offered for import.
  • Groups of companies: if several establishments are under common ownership and control, the parent, subsidiary or affiliate company may register all of them.
  • Private label distributors: they don't have to register under Part 207 unless they also manufacture, repack, relabel or salvage drugs.

Who is exempt (21 CFR 207.13, under FD&C Act section 510(g))

  • Pharmacies that operate under local law, regularly dispense prescription drugs on valid prescriptions, and only manufacture, repack, relabel or salvage drugs in the regular course of their business.
  • Hospitals, clinics, other health care entities and public health agencies under the same conditions, where these activities stay within their regular pharmacy practice.
  • Licensed practitioners who manufacture, repack, relabel or salvage drugs only for use in their own professional practice.
  • Research, teaching or chemical analysis: anyone who makes or handles drugs only for these purposes and not for sale.
  • Makers of harmless inactive ingredients that become drug components, such as excipients, colorings, flavorings, emulsifiers, lubricants, preservatives and solvents.
  • Carriers that receive, carry, hold or deliver drugs in the usual course of their carrier business.
  • Registered outsourcing facilities that compound drugs in line with FD&C Act section 503B. These are registered with the FDA as outsourcing facilities instead of under Part 207.

The exemptions apply to both registration and drug listing. If useful, I can look up whether a particular firm or site is currently registered, and which operations it is registered for, in the FDA's register of drug establishments.

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Q.02

How often do you renew it?

You renew every year. Under 21 CFR 207.29, each registered establishment has to review and update all of its registration information annually, between October 1 and December 31. Today is October 7, 2026, so the window for this year is open now.

Approach: The datasets I can search hold the FDA's register of currently registered drug establishments, but not the text of 21 CFR Part 207. These findings come from search snippets of the eCFR, govinfo and FDA pages, not from a full reading of the rule.

Annual review and update (21 CFR 207.29)

  • Every year: you review and update all the registration information required under § 207.25 for each establishment, between October 1 and December 31.
  • First year: if you first register before October 1, your first annual update is due between October 1 and December 31 of that same year.
  • What to report: the update has to reflect every change since the last annual review.
  • How long it covers you: if you submit your first or annual registration between October 1 and December 31, the establishment counts as registered until the end of the following calendar year. If you miss the window, the registration lapses after that.

Changes you report within 30 days (21 CFR 207.29) You can't wait for the annual window for these. Update the registration within 30 calendar days if you:

  • close or sell an establishment
  • change an establishment's name or physical address
  • change the name, mailing address, phone number or email of the official contact or the US agent

I can check the FDA's register to see whether a particular site is currently registered, if that would help.

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Q.03

Do I need to list my drugs too?

Yes. Under 21 CFR 207.41, every registrant has to list each drug it manufactures, repacks, relabels or salvages for commercial distribution. The listing for drugs already in commercial distribution is due within 3 calendar days of first registering the establishment. After that, you review and update the listings every June and December.

Approach: The datasets I can search include the FDA's register of drug establishments and the NDC Directory, but not the text of 21 CFR Part 207. These findings come from search snippets of the eCFR and FDA pages, not from a full reading of the rule.

Who lists what (21 CFR 207.41)

  • Scope: each drug you manufacture, repack, relabel or salvage for commercial distribution. What you submit depends on which of those activities you do for that drug (§§ 207.49, 207.53 and 207.54).
  • Private label products: if you make, repack or relabel a drug sold under a private label distributor's name, you list it using an NDC that includes that distributor's labeler code. This applies to both human and animal drugs.
  • Human drugs only: you also have to list each human drug under an NDC that includes your own labeler code. This applies whether the drug is sold under your label or a private label distributor's.
  • Groups of companies: if several establishments are under common ownership and control, the parent, subsidiary or affiliate company may submit the listings for all of them.
  • Exemptions: the 21 CFR 207.13 exemptions from my first answer (pharmacies, practitioners, research use, carriers and so on) cover listing as well as registration.

When to list (21 CFR 207.45)

  • At initial registration: submit listings for drugs already in commercial distribution no later than 3 calendar days after you first register the establishment.

Keeping listings current (21 CFR 207.57)

  • Twice a year: review and update your listings every June and December.
  • What to report:
    • any drug you haven't listed yet
    • the date you stopped making a listed drug, with the expiry date of the last lot
    • the date you started making a discontinued drug again
    • any material change to information you submitted before
  • No changes: for listings that haven't changed, you can make one blanket "no changes" certification during your annual registration update (the October to December window). It covers all your unchanged listed drugs.
  • Updating early: the FDA encourages you to update a listing as soon as something changes, rather than waiting for June or December.

I can look up your products in the FDA's NDC Directory to see how they are currently listed, if that would help.

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Q.04

How do I search the FDA's list of registered drug sites?

The FDA's list of registered drug sites is the Drug Establishments Current Registration Site (DECRS), which the FDA publishes on its website. I can search it for you. Give me a firm name, an FEI number, a site's DUNS number, a country, or a registered operation, and I'll tell you whether the site is currently registered and what it is registered to do.

Approach: I searched the FDA's DECRS current registrations file. I didn't check the search functions on the FDA's own DECRS web page, so this answer covers what the register contains and how to search it through me.

Ways to search

  • Firm name: partial names work. For example, "LNK International" returns each registered site of LNK International, Inc. in Hauppauge, New York [1][2].
  • DUNS number: this is the most exact way to find one physical site, because every site has its own DUNS. Both LNK addresses share FEI 2432212 but have different DUNS numbers (038154464 and 967626305) [1][2].
  • FEI number: this is the FDA Establishment Identifier. It can be the 10-digit form or the older 7-digit form, and has to be given exactly as the FDA holds it.
  • Country: for example, all registered sites in India.
  • Registered operation: for example ANALYSIS, MANUFACTURE, API MANUFACTURE, PACK or LABEL. These can be combined with a country, such as testing laboratories in India [3].

What each entry shows

  • Firm name, full site address and country
  • FEI and DUNS numbers
  • Registered operations, such as "ANALYSIS; API MANUFACTURE" for a Zydus Lifesciences site in Ankleshwar [4]
  • Establishment contact, and the registrant (parent company) with its DUNS number and contact
  • The US agent, for foreign sites [3]
  • Registration expiry date. The entries I checked all show 12/31/2026 [1], which fits the October to December annual update window from my last answer.

Limits to keep in mind

  • DECRS lists current registrations only. A site that isn't in it may never have registered, or its registration may have lapsed.
  • DECRS covers drug establishments only. Medical device sites are on a separate FDA register (CDRH establishment registration and device listing), which I can also search.

Send me the firm name, FEI or DUNS of the sites you're interested in and I'll check their current status.

Q.05