FDA drug establishment registration and listing, explained

On Oct. 1, 2026, FDA's annual registration window opened for every plant that makes drugs for the US market. Each establishment that manufactures, repacks, relabels or salvages drugs has until Dec. 31 to renew or confirm its registration. A plant that files in that window stays registered through the end of the following year, and one that misses it drops out of FDA's public registration database, according to the agency¹.

That database, and the drug listings that go with it, are the closest thing the US has to a census of where its medicines are made. At the end of fiscal 2025, FDA's curated inventory of active human drug manufacturing sites held 5,953 sites worldwide, 57 percent of them in the United States, the agency reported in its FY2025 Report on the State of Pharmaceutical Quality³.

Registration sounds like paperwork, and mostly it is. It also feeds FDA's inspection planning, recall work and shortage monitoring, and it is easy to misread. This explainer covers who has to register, what the rules in 21 CFR part 207 require and when, what FDA's public databases show, and what a registration number does not mean.

Who has to register

Unless exempt, "all manufacturers, repackers, relabelers, and salvagers must register each domestic establishment" that handles a drug, and each foreign establishment whose drug "is imported or offered for import into the United States," 21 CFR 207.17⁴ says. The part defines manufacturer broadly, covering contract manufacturers, contract packers and labelers, and laboratories that test drugs for another registered establishment. A company that only puts its name on a product made by others, a private label distributor, does not register but must still obtain a labeler code to list the product.

Some groups are exempt from registration and listing. Under 21 CFR 207.13⁵, they include pharmacies that operate under state law and do not manufacture, repack or relabel beyond the regular course of dispensing, along with hospitals, clinics and other health care entities that meet similar conditions. Compounding outsourcing facilities register under a separate section of the law and are left out of FDA's registration database¹, as are wholesale distributors, which report their licensure to FDA each year under the Drug Supply Chain Security Act instead. Our explainers on 503A and 503B compounders and drug wholesalers cover those groups.

The rules and the calendar

Part 207, rewritten in 2016, sets deadlines for each step. The table pulls them together from the regulation.

Registration information includes the owner's name, each site's address and trade names, a unique facility identifier and the types of operations performed at each site. Drug listing adds the product side, with an NDC for every finished product and unfinished ingredient, which is how the National Drug Code system connects to a physical plant. Everything is submitted electronically in structured product labeling, the same format behind the labels on DailyMed (our guide to looking up a drug on DailyMed shows it from the reader's side). FDA's registration and listing page² says the agency relies on this information for "inspections, postmarket surveillance, recalls, supply chain resiliency, counterterrorism and more."

What FDA's databases show

Two public products come out of this system. The Drug Establishments Current Registration Site (DECRS) lists every currently registered establishment and is "updated each business day." A site disappears from it when its registration expires or is deregistered, or when FDA inactivates it after a compliance case. The second is the NDC Directory, which shows what each registrant has listed. GxRadar tallied the openFDA copy of the directory¹¹ as of Nov. 2, 2026, by marketing category.

Generic listings outnumber brand listings almost seven to one. FDA's own product inventory shows the same tilt; at the end of fiscal 2025 it held 14,753 approved generic applications, 3,640 brand and other new drug applications and 422 biologics, plus 141,664 NDCs for products sold without an approved application, the quality report says. Our approvals page charts generic approvals by year.

FDA does not treat the raw registration file as a count of working factories. Its Site Catalog, the 5,953-site figure, is a vetted subset limited to sites "legally manufacturing human drugs for the U.S. market." It fell 1 percent from 5,999 in fiscal 2021. Some of the churn came from hand sanitizer makers that registered during the COVID-19 emergency and later deregistered. FDA also prunes foreign sites with no recent shipments and sites that deregistered after fees under the over-the-counter monograph user fee program. Of the 5,953, 1,704 make medical gases, nearly all in the US, and 2,755 make only products sold without an approved application. Our explainer on where drug ingredients come from looks at the foreign side of the supply chain.

Registration also drives inspections. FDA counted 1,248 drug quality assurance inspections in fiscal 2025, 702 in the US and 546 abroad, up from 972 the year before. Our guide to FDA inspections and warning letters explains what follows a bad one.

What a registration number does not mean

A registration is a notice to FDA, and the regulation says so in plain terms. Registration "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," 21 CFR 207.77¹⁰ states. Any claim that suggests otherwise "is misleading and constitutes misbranding." The same goes for having an NDC or appearing in FDA's drug database. FDA's registration page² repeats the point, saying registration and listing do not show "that FDA has verified the information provided."

That matters for anyone checking a supplier, a website or an unfamiliar product. A product can carry a valid-looking NDC and still be unapproved, as the 2,242 "unapproved drug, other" listings in the directory suggest. The marketing category on the listing, and the application number for approved drugs, are the more useful fields.

Gaps in the data

The newest requirement is the least complete. The CARES Act of 2020 told registrants to report each year how much of each listed drug they made, so FDA could spot shortages earlier. For calendar 2024, reporting rates for active products were 84 percent for biologics, 81 percent for brand drugs, 80 percent for generics and 52 percent for OTC monograph products, up from 72, 72, 61 and 45 percent a year earlier, FDA's quality report shows. Our explainer on why drug shortages happen covers why that volume data matters.

A May 2025 executive order, EO 14293¹², directed FDA to improve enforcement of that reporting duty, "including consideration of publicly displaying the list of facilities, including foreign facilities, that are not in compliance." The next registration deadline is Dec. 31, 2026. Sites that have not renewed by then lose their current status in FDA's database at the start of 2027.