[ NATIONAL · US ]

United States

Statutory requirements written directly into federal regulation, enforced by inspection and by published enforcement action.

What this page does not claim

SPEQ synthesis for orientation. It does not determine what applies to a specific product, and an adopted version can move without this page moving with it. Confirm the instrument in force with the authority before relying on it.

Who regulates here (6)

NORTH AMERICA

Food and Drug AdministrationUS federal regulator; issues the 21 CFR parts and FDA guidance that set cGMP, data-integrity, and clinical expectations for the US market.United States PharmacopeiaCompendial standards body; its General Chapters carry the force of law under the FD&C Act.Drug Enforcement AdministrationUS controlled-substance regulator; registration, security, and recordkeeping obligations that run alongside cGMP for any site handling scheduled drugs.State Boards of PharmacyThe primary regulators of 503A compounding pharmacies — licensing, inspection and discipline sit at state level, not with FDA.Centers for Medicare & Medicaid ServicesUS administrator of the CLIA program (42 CFR Part 493) — the certification regime every US laboratory testing human specimens operates under, separate from FDA's regulation of the tests themselves.U.S. Environmental Protection AgencyUS environmental regulator; runs the non-FDA GLP regime — 40 CFR Part 160 under FIFRA (and its TSCA twin, Part 792) — for the safety studies behind pesticide and chemical registrations.

What makes a requirement binding here

The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §301 et seq. The hook that makes current good manufacturing practice binding is §501(a)(2)(B), which deems a drug adulterated where the methods, facilities or controls used in its manufacture, processing, packing or holding do not conform to current good manufacturing practice — a status that attaches to the process, so a batch that passes every finished-product specification is still adulterated if it was made outside cGMP. The regulations themselves sit at 21 CFR Parts 210 and 211 for finished pharmaceuticals and, for devices, at 21 CFR Part 820, retitled the Quality Management System Regulation and incorporating ISO 13485:2016 by reference with effect from 2 February 2026. Biological products are licensed under §351 of the Public Health Service Act, 42 U.S.C. §262 — a separate statute from the FD&C Act, which is why a BLA is not an NDA with different paperwork.

Through inspection and enforcement against a registered establishment, not through a site licence — and that is the structural difference from almost every other jurisdiction on this axis. Establishments register and list under §510 of the Act (21 CFR Part 207 for drugs, Part 807 for devices), FDA inspects under its §704 authority, and §501(j) deems a drug adulterated where an owner or operator delays, denies, limits or refuses inspection. What follows a finding is an escalating enforcement ladder rather than a licence action: Form FDA 483 observations, a Warning Letter, then import alert, seizure, injunction or a consent decree. Products reach the market by application — NDA under §505(b), ANDA under §505(j), BLA under PHS Act §351, and for devices 510(k), De Novo or PMA.

WHAT TRANSFERS

Inspection outcomes transfer in one direction under a specific instrument; approvals do not transfer at all. The US–EU Mutual Recognition Agreement covers GMP inspections of human medicines and lets each side rely on the other’s inspection reports for capable authorities, which removes duplicate inspection — it does not make an EU manufacturing authorisation a US permission, and it does not touch marketing applications. A product approved in the European Union has no US status until FDA approves an application for it. Conversely, an FDA establishment inspection classification is a fact about the site’s cGMP record, not a certificate a customer can rely on the way an EU GMP certificate is used: FDA issues no equivalent of one.

Operating here

Registration is not approval, and saying otherwise is misbranding

21 CFR §207.77 is explicit: registration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or any other drug of the establishment, and does not mean the product may legally be marketed. Any representation creating an impression of official approval on the strength of registration is misleading and constitutes misbranding — so an “FDA registered” claim on a label, a website or a supplier’s certificate is a compliance problem rather than a marketing flourish.

The device rulebook changed on 2 February 2026

21 CFR Part 820 is now the Quality Management System Regulation and incorporates ISO 13485:2016 by reference, with FDA-specific requirements retained in the supplemental subparts. A quality system built against the old Quality System Regulation’s clause structure still needs mapping to the standard the regulation now points at; conformity to ISO 13485 alone does not discharge the supplemental requirements FDA kept.

Two statutes, not one

Drugs are regulated under the FD&C Act; biological products are licensed under §351 of the Public Health Service Act. The practical consequences are real — the application, the licensing concept and parts of the post-approval regime differ — and treating a BLA as an NDA variant is a recurring source of wrong references in submissions and in supplier agreements.

Refusing an inspection is itself an adulteration finding

§501(j) means delay, denial, limitation or refusal of an inspection deems the drug adulterated without any finding about the product. Sites that treat inspection logistics as negotiable — access, translation, records production — are exposed to a statutory outcome rather than to a discretionary one.

What practitioners get wrong

  • There is no US manufacturing licence. Registration under §510 creates an obligation and a public record; it confers nothing, and 21 CFR §207.77 says so in terms.
  • cGMP non-conformity adulterates the product on its own — passing release testing is not a defence, because §501(a)(2)(B) addresses the methods and controls, not the result.
  • “FDA approved facility” is not a thing. FDA approves applications and classifies inspections; it does not approve or certify establishments.
  • The US–EU MRA covers GMP inspections of human medicines. It is not mutual recognition of marketing authorisations, and it does not extend to every product class.

Questions about United States

Does the United States issue a manufacturing licence like the EU or UK?

No. Establishments register and list under §510 of the FD&C Act — 21 CFR Part 207 for drugs, Part 807 for devices — and FDA inspects them under §704. There is no site licence to hold. 21 CFR §207.77 states that registration and listing do not denote approval of the establishment or the drug, and that representing otherwise is misleading and constitutes misbranding.

What makes cGMP legally binding in the United States?

§501(a)(2)(B) of the FD&C Act, which deems a drug adulterated where the methods, facilities or controls used in its manufacture, processing, packing or holding do not conform to current good manufacturing practice. Because the provision addresses the process rather than the result, a batch meeting every finished-product specification is still adulterated if it was not made in conformity. The detailed requirements are at 21 CFR Parts 210 and 211.

What changed for medical devices in February 2026?

21 CFR Part 820 became the Quality Management System Regulation, incorporating ISO 13485:2016 by reference with effect from 2 February 2026 and retaining FDA-specific requirements in its supplemental subparts. It replaces the former Quality System Regulation’s standalone clause structure, so an existing quality system needs mapping to the standard rather than a change of title.

Does an EU GMP certificate satisfy FDA?

Not as a permission. The US–EU Mutual Recognition Agreement covers GMP inspections of human medicines and allows each authority to rely on the other’s inspection reports where it has recognised that authority’s capability, which avoids duplicate inspection. It does not make an EU manufacturing authorisation a US permission and it has no effect on marketing applications — a product still needs an approved NDA, ANDA, BLA, 510(k), De Novo or PMA to be marketed in the United States.

ADOPTED, AT A PINNED VERSION

What binds here, and which edition

SPEQ has not decoded a pinned adoption edge here yet. That is a gap in this catalog, not a finding about United States: requirements still arrive through the authorities below, and the edition in force is theirs to state.

What influences it

Participation changes which evidence transfers, and which edition of a harmonized guide the local instrument is likely to pin.

Standards SPEQ decodes here (66)

21 CFR Part 211Current Good Manufacturing Practice for Finished Pharmaceuticals21 CFR Part 11Electronic Records; Electronic Signatures21 CFR Part 210Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs — General21 CFR Part 820Quality Management System Regulation (QMSR) — 21 CFR Part 820FDA Aseptic Processing GuidanceGuidance for Industry — Sterile Drug Products Produced by Aseptic ProcessingFDA Process Validation Guidance (2011)Guidance for Industry — Process Validation: General Principles and PracticesUSP <1116>Microbiological Control and Monitoring of Aseptic Processing EnvironmentsUSP <1117>Microbiological Best Laboratory PracticesUSP <1058>Analytical Instrument QualificationUSP <61>/<62>Microbiological Examination of Nonsterile Products21 CFR Part 312Investigational New Drug Application (IND)21 CFR Part 50Protection of Human Subjects (Informed Consent)21 CFR Part 56Institutional Review Boards (IRBs)21 CFR Part 58Good Laboratory Practice for Nonclinical Laboratory Studies21 CFR 314.80Postmarketing Reporting of Adverse Drug Experiences21 CFR Part 117Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food21 CFR Part 111Current Good Manufacturing Practice for Dietary Supplements21 CFR Part 226Current Good Manufacturing Practice for Type A Medicated Articles21 CFR Part 225Current Good Manufacturing Practice for Medicated Feeds21 CFR Part 1271Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)21 CFR Part 606Current Good Manufacturing Practice for Blood and Blood Components21 CFR Part 803Medical Device Reporting (MDR)21 CFR Part 1, Subpart LForeign Supplier Verification Programs (FSVP)21 CFR Part 121Mitigation Strategies to Protect Food Against Intentional Adulteration
All 66 in the standards library →