What registering with the FDA actually confers

The phrase that shows up in peptide marketing

FDA registered facility is a phrase that appears across this market. It sounds like a credential. It is a filing.

The rules for that filing sit in title 21 of the Code of Federal Regulations, part 207, whose heading covers establishment registration and listing for human drugs and the National Drug Code.

Most of the part is procedural: who files, when, what fields. One section is not procedural at all, and it is the one worth reading first.

Section 207.77 is headed with a question. What legal status is conferred by registration and listing.

The answer the regulation gives

It is stated in a single sentence, and it is unusually direct for a regulation.

"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."

The next sentence does not stop at describing the limit. It attaches a consequence. "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."

Misbranding is a defined status under federal drug law with its own consequences. The regulation is not saying such a claim is unhelpful. It is saying what the claim makes the product.

The same rule covers the number, the database and the identifier

Paragraph (b) closes the obvious workarounds one at a time.

It names three agency acts: "acceptance of registration and listing information, inclusion of a drug in our database of drugs, or assignment of an NDC." None of them "denote approval of the establishment or the drug or any other drugs of the establishment, nor does it mean that the drug may be legally marketed."

Then it names four specific things a claim might lean on, and treats all of them the same way. A representation is misleading and constitutes misbranding if it creates the impression a drug is approved or legally marketable "because it appears in our database of drugs." The same applies where the claim rests on a drug that "has been assigned or displays an NDC, or the establishment has been assigned an establishment registration number or Unique Facility Identifier."

So a picture of a database entry, a printed registration number and a displayed NDC are all covered by the same sentence.

What registration is evidence of

Paragraph (c) is the part that keeps this honest in the other direction. Registration is not nothing.

It first removes a different misreading: "Neither registration nor listing constitutes a determination by FDA that a product is a drug as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act."

Then it says what the filing can show. "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."

That is a real fact and a useful one. A registration says a named establishment, at a stated address, told the agency it performs stated operations. It says nothing about the quality of what comes out.

Who has to register, and who does not

Section 207.17 sets the duty. Unless exempt, "all manufacturers, repackers, relabelers, and salvagers must register each domestic establishment that manufactures, repacks, relabels, or salvages a drug."

The same sentence extends the duty to foreign establishments whose drugs are imported or offered for import into the United States.

Paragraph (b) carves out a category that matters a great deal for how this market is structured. "Private label distributors who do not also manufacture, repack, relabel, or salvage drugs are not required to register under this part."

That is worth sitting with. A brand that designs a label, sets a price and takes orders, while somebody else makes the product, is not a registrant at all. Its absence from a registration database is what the rule expects, not a finding about it.

The clock, and the annual certification

Section 207.21 sets the timing. A domestic establishment must be registered "no later than 5 calendar days after beginning to manufacture, repack, relabel, or salvage a drug." A foreign establishment must register before its drug is imported or offered for import.

Section 207.25 lists what goes in. Among the eight items are the "Name of the owner or operator of each establishment" and each establishment's "name, physical address, and telephone number(s)." Two more are a Unique Facility Identifier and "All types of operations performed at each establishment."

It also asks for every name the establishment trades under, described as "All name(s) of the establishment, including names under which the establishment conducts business or names by which the establishment is known."

Section 207.29 keeps the file current. Certain changes require an update "no later than 30 calendar days" after they happen, including closing or selling an establishment and changing its name or physical address.

And there is an annual step that explains why a registration listing carries a recent date even when nothing changed. Registrants must review and update annually "during the period beginning on October 1 and ending December 31 of each calendar year." And "If no changes have occurred since the last registration, registrants must certify that no changes have occurred."

What of this is public

Section 207.81 answers that, and the default is broad. Subject to exceptions, "All establishment registration information" is available for public disclosure, along with listing information obtained under several named sections once a drug is marketed.

The exceptions are narrow and specific. One is a direct link into the agency's public information rules. The names of certain inactive ingredients are withheld where "the registrant makes a valid assertion of confidentiality under § 20.61 of this chapter or other provision of law."

FDA may also withhold specific information case by case where it finds that consistent with protecting the public health and the Freedom of Information Act.

The practical effect is that a registration record is a public artifact a reader can look up, while some of what sits behind it is not.

What a reader can do with this

The regulation yields three questions a reader can ask, and none of them requires special access.

First, read what a claim is actually asserting. Registered is a filing status. Approved is a different determination, made through a different process, and the regulation says so in a sentence written for that purpose.

Second, notice what the claim is about. A registration attaches to an establishment and an operation, not to a formulation or a batch.

Third, remember that a private label distributor is not required to register. Where a brand is not the maker, no registration for the brand is the expected outcome, and its absence proves nothing either way.

This page describes what part 207 says. It does not describe any seller's compliance, does not name any seller, and is not legal advice.

Sources

Each document below is named as it names itself, with the date printed on that document rather than the day it was read.

1. Title 21 Code of Federal Regulations section 207.77, What legal status is conferred by registration and listing? — Electronic Code of Federal Regulations, Office of the Federal Register, August 2016
2. Title 21 Code of Federal Regulations section 207.17, Who must register? — Electronic Code of Federal Regulations, Office of the Federal Register, August 2016
3. Title 21 Code of Federal Regulations section 207.21, When must initial registration information be provided? — Electronic Code of Federal Regulations, Office of the Federal Register, August 2016
4. Title 21 Code of Federal Regulations section 207.25, What information is required for registration? — Electronic Code of Federal Regulations, Office of the Federal Register, August 2016
5. Title 21 Code of Federal Regulations section 207.29, What are the requirements for reviewing and updating registration information? — Electronic Code of Federal Regulations, Office of the Federal Register, August 2016
6. Title 21 Code of Federal Regulations section 207.81, What registration and listing information will FDA make available for public disclosure? — Electronic Code of Federal Regulations, Office of the Federal Register, August 2016