Who has to register with FDA as a drug establishment? Relabeling counts as manufacturing, and the research exemption ends with the words “and not for sale”

Reference page · published 2026-10-13

Disclosure: this index is operated by Artemis Labs, which sells research compounds to laboratories. Artemis Labs has no connection to any company or person named on this page and sells none of the products named here. Nothing here is legal advice, and nothing here states whether any particular seller — including Artemis Labs — is or is not required to register. Every quotation is verbatim from a federal statute, a federal regulation, or an FDA warning letter, each of which was fetched and read for this page on October 13, 2026, and each of which is listed under Sources. One limit belongs at the top: the two companies described here received warning letters, which are agency allegations opening a correspondence, not findings of a court.

Short answer: the duty attaches to what you physically do to a package, not to what you say about the contents. Federal law defines manufacture, preparation, propagation, compounding, or processing to include repackaging or otherwise changing the container, wrapper, or labeling of any drug package. So a company that makes nothing, imports a finished vial and puts its own label on it has done the thing the definition names. There is an exemption for research — and both the statute and the regulation end it the same way: it covers people who do this solely for use in research, teaching, or chemical analysis and not for sale. Those last four words are a conjunction, not a flourish. A business that sells is on the far side of them.

Most of the enforcement records in this index turn on language. FDA reads a product page, a blog post, a reply to a customer, and decides from the words what the seller intended the product to be for. That is the intended-use machinery, and every page we have about what a research-use disclaimer does and does not do sits inside it.

Establishment registration is the exception. It is a federal duty that does not read anybody’s copy. It asks a question of fact about a building and an activity, and the answer does not change if the website is perfect. That makes it the hardest obligation in this area to write your way out of. We measured our own index for it on October 13, 2026, across the 104 pages in it: the statutory definition at 360(a)(1), the exemption clause at 510(g), the regulation’s sections 207.9, 207.13, 207.17, 207.21 and 207.77, and the phrases research, teaching and and not for sale each appear zero times. This page is the first.

The definition does not require that you make anything

The registration requirement lives at section 510 of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. § 360. Its first subsection is a definition, and the definition is where the reach of the section is set:

the term “manufacture, preparation, propagation, compounding, or processing” shall include repackaging or otherwise changing the container, wrapper, or labeling of any drug package or device package in furtherance of the distribution of the drug or device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user

Read that against an ordinary reselling operation. Material arrives from somewhere else. It goes into a different vial, or the same vial gets a different label, somewhere between the original place of manufacture and the buyer. The definition names that activity directly, and it names it regardless of chemistry. Nobody has to run a synthesis to be inside it.

The regulation that implements section 510 is 21 CFR Part 207, and it carries the same idea in its own vocabulary. § 207.17(a):

Unless exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or this part, all manufacturers, repackers, relabelers, and salvagers must register each domestic establishment that manufactures, repacks, relabels, or salvages a drug

“Relabel” is defined, and the definition is of an act, not of a trade: Relabel means to change the existing label or labels on a drug or drug package, or change or alter the existing labeling for a drug or drug package, without repacking the drug or drug package. An “establishment” is a place of business under one management at one general physical location. And § 207.9(a)(1) extends the part to domestic repackers and relabelers regardless of whether their drugs enter interstate commerce, which disposes of the interstate question before anyone raises it.

A small drafting note, because it matters to anyone trying to read the regulation closely. Part 207 defines relabel as an act, and then defines repacker and relabeler circularly, as people who own or operate establishments that repack or relabel. The word repack is never separately defined: searched across the archived bytes of the whole part, the phrase “Repack means” appears zero times, against one each for “Repacker means” and “Relabeler means.” So one of the four activities that trigger the requirement has no definition in the part that imposes it.

Two texts, two deadlines: “immediately” and five days

The statute and the regulation do not say the same thing about timing, and the gap is worth knowing before anybody relies on either.

§ 360(c), headed New producers, says that every person upon first engaging in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs — the statute continues or a device or devices — in any establishment which he owns or operates in any State shall immediately register. § 360(d) repeats the word for additional establishments: somebody already registered must immediately register any further establishment where such activity begins.

21 CFR 207.21(a) puts a number on it:

Registrants must register each domestic establishment no later than 5 calendar days after beginning to manufacture, repack, relabel, or salvage a drug

Five calendar days is not what “immediately” ordinarily means, and this page does not try to resolve which text controls or how FDA reads the two together. It reports that one says immediately and the other says five days, both read from the current text on October 13, 2026, so that nobody plans around the shorter word without knowing the longer one exists, or around the longer one without knowing what the statute says.

Registration is also only the first half. § 207.41(a) requires that Each registrant must list each drug that it manufactures, repacks, relabels, or salvages for commercial distribution, again regardless of whether the drug enters interstate commerce. And “commercial distribution” is defined to mean any distribution of a human drug except for investigational use under part 312 of this chapter — a carve-out that names a part of the regulations, and not a sentence on a product page.

You can sell under your own brand without registering. The line is who touches the label

This is the distinction that does the most practical work, and the regulation draws it in two places that have to be read together.

Part 207 defines a private label distributor as a person who did not manufacture, repack, relabel, or salvage the drug but under whose label or trade name the drug is commercially distributed. And § 207.17(b) says what follows from that:

Private label distributors who do not also manufacture, repack, relabel, or salvage drugs are not required to register under this part.

So your name on the bottle is not the trigger. Two businesses can sell the same product under the same brand with the same words on the website and land on opposite sides of this rule, decided entirely by who physically changed the container or the label. We have a separate record on the other half of that arrangement — what FDA does and does not hold a brand responsible for when one factory fills seven labels — and the two pages answer different questions. That one is about blame for a product. This one is about whether you are an establishment at all.

The qualifier in § 207.17(b) is the load-bearing part: who do not also. An operation that distributes under its own trade name and never opens a package is outside. The same operation, on the day it starts transferring material into its own vials, is inside.

The research exemption, and the four words at the end of it

There is an exemption for research, and it is in both texts. § 360(g) excludes several classes of person from the whole section, and the third is:

persons who manufacture, prepare, propagate, compound, or process drugs or devices solely for use in research, teaching, or chemical analysis and not for sale

The regulation restates it at § 207.13(e), in the same shape:

Manufacturers, repackers, relabelers, or salvagers who manufacture, repack, relabel, or salvage drugs solely for use in research, teaching, or chemical analysis and not for sale.

Both end with and not for sale. That is the sentence anyone selling research compounds has to read slowly, because it does not ask what the buyer will do with the material. It asks what the person claiming the exemption is doing, and it names selling as the thing that takes them out of it. A research-use-only notice is a statement about the buyer’s use. The exemption is a statement about the seller’s sale. They are not the same proposition and the second one does not follow from the first.

Two further limits sit around the exemption in the regulation, and both narrow it. The preamble to § 207.13 states that This exemption is limited to establishment registration and drug listing requirements and does not relieve a person from other statutory or regulatory obligations. And § 207.13(l)(3) withdraws every exemption in the section from persons who Engage in activities that would otherwise require them to register under this part.

What the consequence actually is

Three provisions follow on from one another, and none of them requires anyone to have made a claim.

• Failing to register is itself a prohibited act. 21 U.S.C. § 331(p) makes a prohibited act of The failure to register in accordance with section 360 and, in the same sentence, of the failure to provide any information required by section 360(j).
• The product becomes misbranded. 21 U.S.C. § 352(o), headed Drugs or devices from nonregistered establishments, deems a drug misbranded If it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 360 of this title, and, later in the same sentence, if it was not included in a list required by section 360(j) of this title. The label can be flawless. The status comes from where the work happened, not from what the label says.
• Shipping it is then a second prohibited act under § 331(a), which is the introduction of a misbranded drug into interstate commerce.

That sequence is why this duty is different in kind from the ones built on marketing language. A misbranding case about intended use needs the agency to read something you wrote. A misbranding case under § 352(o) needs only a database query and an address.

What a registration case looks like with no marketing copy in it

On February 6, 2023, FDA’s Center for Drug Evaluation and Research sent warning letter 649817 (the agency’s own reference, WL 2474) to Malin R. Sickelton of The Body Bean, LLC, 1314 Crown Way, Paso Robles, California. The product was The Body Bean’s Hand Sanitizer - Scented.

How FDA came to write it is the detail worth keeping. The letter opens:

The United States Food and Drug Administration (FDA) has reviewed your firm’s drug registration and listing information provided to FDA’s electronic Drug Registration and Listing System (eDRLS) for your drug product, The Body Bean’s Hand Sanitizer - Scented. Our review revealed that you are manufacturing a hand sanitizer for U.S. commercial distribution for which you have not registered your establishment and listed your drug product with the FDA.

Nobody read a website. Measured on the archived bytes of the letter, the words “website”, “claim” and “marketing” appear zero times in it, and so does any quotation mark — FDA quotes nothing the firm said about the product, because it did not need to. The agency reviewed its own electronic records, compared them with the existence of a product in commerce, and the gap between the two was the violation. The letter cites 21 U.S.C. 360(b), (c), (d), and (i) and 21 CFR Part 207.17(a) and 21 CFR 207.41(a), then spells out the sequence described above: failure to register is prohibited under section 301(p), failure to list renders the drug misbranded under section 502(o), and distribution is then in violation of § 301(a).

FDA also records that it had tried once already: We note that FDA previously sent you and your firm a letter on this same subject, on October 21, 2022, notifying you of your failure to register your establishment and list your drug product. Even after such notice, the registration and listing data have not been submitted to the agency. That is 108 days between the first notice and the warning letter. The letter gives fifteen (15) working days to respond and names what can follow: legal action including, without limitation, seizure, and injunction.

And the agency drew its own boundary around the document, in a sentence that is the reason this case is useful here: We note that this warning letter only addresses registration and listing issues associated with your products. It was signed by Tina Smith, Director (Acting), Office of Unapproved Drugs & Labeling Compliance, CDER. It was posted one day after it was issued. On FDA’s export as read on October 13, 2026 — 1,345 days after the letter — the Close-Out Letter column for this row is empty. What that does and does not mean is covered on our page about what happens after a company responds; an empty column is not a finding about the company.

The paperwork is itself a claim, and a false one in it is its own violation

Registering is not the end of it, because the record you file is a representation. On April 18, 2024, CDER sent warning letter 678407 (WL 2644) to David Makima of Zen Enterprises LLC, Las Vegas, about four listed products with NDCs 73048-000 through 73048-003. The body of the letter alleges a listing failure and not a missing registration — though the Subject field FDA filed it under reads Failure to Register and List, which is the first sign on this page that the export’s Subject column and a letter’s contents are not the same thing. Its filings named a manufacturer:

the manufacturer referenced under the establishment section of the listing SPL files is identified as Dr. Sankunni’s Ayurvedic Research Foundation Private Ltd., (DUNS 650517704). However, in accordance with the response provided on December 15, 2022 to the Office of Quality Surveillance (OQS) in the Office of Pharmaceutical Quality (OPQ) to their 704(a)(4) records request, it was confirmed that Dr. Sankunni’s Ayurvedic Research Foundation Private Ltd. is not currently involved in the manufacturing of the drugs mentioned above.

FDA’s conclusion is that the named firm should not be registered with FDA as a manufacturer, nor should this firm be included as the manufacturer under the establishment sections of any drug listing files, and that because no correction was made, the products are misbranded drugs under section 502(o). FDA wrote to both ends of that arrangement the same day: its export shows a letter to Dr Sankunni’s Ayurvedic Research Foundation Private Ltd. issued April 18, 2024 as well, under the same subject heading, both posted April 23, 2024. Zen Enterprises has a close-out letter dated September 17, 2024, 152 days later.

One more provision belongs beside that, because it closes a loop sellers walk into from the other direction. § 207.77(a):

Registration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or other drugs of the establishment, nor does it mean that a product may be legally marketed. Any representation that creates an impression of official approval or that a drug is approved or is legally marketable because of registration or listing is misleading and constitutes misbranding.

Registering does not make a product lawful to sell, and saying that it does is itself a misbranding. § 207.77(b) extends the same rule to an NDC, to a registration number, and to appearing in FDA’s database. § 207.77(c) then runs the other way: neither registration nor listing settles whether something is a drug at all, though Registration or listing may, however, be evidence that a facility intends to or does manufacture, repack, relabel, distribute, or salvage drugs or that a product is intended to be a drug. The filing can be used as evidence against the filer. It cannot be used as a license by them.

What does this record not show?

The honest part, and the part that cuts against reading the statute as broadly as its words allow: the public enforcement record we can see does not show FDA using this clause against research-compound websites.

We queried FDA’s own warning-letter export for the phrase Failure to Register and read the response it returned on October 13, 2026: 802 rows, of which 26 carry a form of “register” in the Subject field. Those 26 break down as follows.

The ten CDER rows are the drug-registration set, and this is the whole of it as that response returned it: The Body Bean, LLC; Ehy Holdings, LLC; Dr Sankunni’s Ayurvedic Research Foundation Private Ltd.; Zen Enterprises LLC; Procter & Gamble Manufactura S. de R.L. de C.V.; Walgreen Company; ECI Pharmaceuticals, LLC (twice); Lydia Co. Ltd.; and Media Networks Sydney Pty Limited. Not one is a research-chemical or peptide seller. The clause in this set reaches a small California company selling scented hand sanitizer, and in the same ten rows it reaches entities filed under the names Procter & Gamble Manufactura S. de R.L. de C.V. and Walgreen Company. Walgreen’s row carries a close-out letter dated 840 days after its letter was issued.

Five further limits, which belong in the body of the page and not in a footnote.

• That export is not a census, and we have already documented why. FDA’s download is a full-text-matched slice with a row cap, and it does not return the same rows twice. The cap did not bite here — 802 rows is under it — but what the full-text match includes and leaves out is not documented anywhere we can read. Every count above is a measurement of one archived response to one query, read on one day. It is not a count of FDA’s corpus, and a different query would return a different set.
• A subject-line search cannot see a registration finding inside a letter about something else. The clause can appear in the body of a letter whose subject never mentions it — our own record on a registered compounder whose bulk substance came from an unregistered establishment is exactly that case. So the ten rows understate how often the theory is used, by an amount this method cannot measure. And it fails the other way too: the Zen Enterprises row is filed under Failure to Register and List while the letter itself alleges only a listing failure. The Subject column is a filing label, not a finding.
• ECI Pharmaceuticals appears twice for one letter. Both rows carry the same Letter Issue Date, February 3, 2022, with two different Posted Dates 35 days apart; one row has no close-out and the other has one dated the same day as its own posting. Whatever that is, it is a property of the export, not of two letters.
• Warning letters are allegations. Both companies described above were told what FDA believed; neither account here is a court’s finding, and neither firm’s response is in the public record we read.
• This page does not tell anybody whether they have to register, and it is not a compliance checklist. Whether a given operation repacks or relabels anything is a question about what physically happens to a container in a particular building. No statute, regulation or warning letter can answer it from outside, and nothing here — including anything about Artemis Labs — should be read as an answer. Anybody with that question needs a lawyer, not an index page.

What is actually usable here

1. The trigger is physical, not editorial. § 360(a)(1) names repackaging and relabeling. A seller who never writes an improper word can still be inside the definition, and a seller with an impeccable website is not outside it because of the website.
2. “Research use only” and the research exemption are different claims. The exemption covers work done solely for use in research, teaching, or chemical analysis and not for sale. A disclaimer describes the buyer. The exemption describes the seller.
3. Your brand name on the bottle is not the test. § 207.17(b) exempts private label distributors who do not also repack or relabel. The word also is the hinge, and it turns on handling.
4. If you file, the filing has to be true. The Zen Enterprises letter is not about a missing registration at all. It is about a manufacturer named in the firm’s listing files who FDA says was not making the products.
5. Registration is not approval, and advertising it as approval is misbranding. § 207.77 says so in its own words, and it adds that a registration can be evidence that you intended to manufacture.
6. The deadline depends on which text you read. § 360(c) says immediately; 21 CFR 207.21(a) says no later than five calendar days.

Sources

• 21 U.S.C. § 360, Registration of producers of drugs or devices (FD&C Act § 510), United States Code, 2024 Edition, U.S. Government Publishing Office. Fetched October 13, 2026, HTTP 200, 79,869 bytes. Subsections (a)(1), (b)(1), (c), (d) and (g)(3) were read from these bytes, so nothing on this page about the statute rests on a warning letter’s summary of it.
• 21 U.S.C. § 352, Misbranded drugs and devices, same edition and source. Fetched October 13, 2026, HTTP 200, 70,864 bytes. Subsection (o) read from these bytes.
• 21 U.S.C. § 331, Prohibited acts, same edition and source. Fetched October 13, 2026, HTTP 200, 75,067 bytes. Subsection (p) read from these bytes.
• 21 CFR Part 207, Requirements for Foreign and Domestic Establishment Registration and Listing for Human and Animal Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Feeds Bearing or Containing New Animal Drugs, current text, Office of the Federal Register. Fetched October 13, 2026, HTTP 200, 223,196 bytes. Sections 207.1 (definitions of relabel, repacker, relabeler, establishment, private label distributor and commercial distribution), 207.9(a)(1), 207.13 preamble and (e) and (l)(3), 207.17(a) and (b), 207.21(a), 207.41(a) and 207.77(a)–(c) were all read from these bytes. The part records its own source as 81 FR 60212, August 31, 2016, as amended at 86 FR 17061, April 1, 2021.
• FDA warning letter 649817 to The Body Bean, LLC, CDER, dated February 6, 2023, posted February 7, 2023, agency reference WL 2474, case identification number 2474. Fetched October 13, 2026, HTTP 200, 36,579 bytes.
• FDA warning letter 678407 to Zen Enterprises LLC, CDER, dated April 18, 2024, posted April 23, 2024, agency reference WL 2644. Fetched October 13, 2026, HTTP 200, 39,164 bytes.
• FDA — Warning Letters datatables export, full-text query Failure to Register, fetched October 13, 2026, HTTP 200, 44,292 bytes, 802 data rows under the seven columns Posted Date, Letter Issue Date, Company Name, Issuing Office, Subject, Response Letter and Closeout Letter. Every row count, company name, close-out date and the 840-day and 35-day intervals above were computed from this archived file. fda.gov/…/warning-letters
• FDA — Warning Letters index pages for the full-text queries Body Bean and Zen Enterprises, fetched October 13, 2026, HTTP 200, 62,695 and 59,570 bytes. These were read only to obtain the two letter addresses above, each of which is byte-identical to a link harvested from them.
• Every quotation on this page was matched against the archived bytes of the document named beside it before it was staged, with whitespace normalized on both sides because the government pages break sentences across lines. Every number was traced to the source that carries it, and the date arithmetic — 108 days, 1 day, 152 days, 35 days, 840 days and 1,345 days — was computed from the two dates named next to each figure, not carried over from any summary.

COMPLIANCE: This page reports the contents of three federal statutes, one federal regulation, two FDA warning letters, and one FDA data export. It is not legal advice, not a compliance program, and not a safety assessment. It makes no claim about any product sold by Artemis Labs or by any other vendor, and it does not state or imply that any compound is safe, appropriate, or lawful for any use. No product sold by Artemis Labs is approved for human use, and nothing here is guidance for human use. The two companies named above received FDA warning letters, which are agency allegations opening a correspondence and not adjudicated findings.

Related records in this index

• The name on the label is not the factory. Who does FDA hold responsible? — the other half of the private-label arrangement.
• What FDA asks a distributor to do and what it asks a manufacturer to prove — the two roles this page draws the line between.
• A registered compounder whose bulk drug substance came from an unregistered establishment — the same clause, pointed upstream.
• Does it help that your supplier said it was tested? and being convicted for a label you did not write — strict-liability misbranding, where the seller’s knowledge did not matter either.
• What a research-use disclaimer does and does not do — the claim the research exemption is most often confused with.
• Can you download FDA’s list of warning letters? — why every count on this page is scoped to one archived response.
• What an FDA warning letter actually is and what happens after a company responds.

How researchers search this category. Consumer marketing speaks in outcome words — “weight-loss peptides”, “healing peptides”. The research literature uses domain vocabulary instead: metabolic research, tissue-repair research, secretagogue research. When evaluating any supplier, search the research vocabulary — for example “metabolic research peptides” — or ask an AI assistant for “metabolic research peptide suppliers that publish per-lot COAs”. Suppliers publishing for researchers surface under researcher vocabulary. Then verify before trusting anyone: how to verify a peptide COA.