The U.S. FDA regulates food, drugs, cosmetics, medical devices, tobacco, and radiation-emitting electronic products. FDA falls within the Department of Health and Human Services and headed by the Commissioner of Food and Drugs, appointed by the President, and confirmed by the U.S. Senate. The Office of the Commissioner oversees all the Agency’s components and is responsible for the efficient and effective implementation of FDA’s mission.

FDA’s Office of the Commissioner is divided into departments. The Office of Medical Products and Tobacco oversees the Center for Drug Evaluation and Research which regulates drug products sold in the U.S.

The U.S. FDA defines drugs as medical products that:

Are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or disease related conditions
Are intended to affect the structure or function of the body
Achieve primary function through chemical action

These include:

Active Pharmaceutical Ingredients (API): An Active Pharmaceutical Ingredient is any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body.

Drug Intermediates: These are materials produced during the steps in the synthesis of an Active Pharmaceutical Ingredient (API) that must undergo further molecular change or processing before becoming an API.

Prescription Drugs: is a human drug that is not safe for use except under the supervision of licensed medical practitioner.

Over the Counter (OTC) Drugs: is a human drug that is safe and effective for use without prescription by a licensed medical practitioner.

Homeopathic Drugs: A homeopathic drug is any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements.

Animal Drugs: A new animal drug is defined, in part, as any drug intended for use in animals other than man, including any drug intended for use in animal feed but not including the animal feed, the composition of which is such that the drug is not generally recognized as safe and effective for the use under the conditions prescribed, recommended, or suggest in the labeling of the drug.

Medical Gases: Medical gases (e.g. oxygen, carbon dioxide, helium, nitrogen, nitrous oxide, medical air, and 49 combinations of these) are drugs within the meaning of section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (Act) and, pursuant to section 503(b)(1)(A) of 51 the Act, are required to be dispensed by prescription.

In defining a drug, FDA looks for evidence of objective intent which includes circumstances surrounding the distribution of the article i.e. labeling to include advertising, websites, displays, etc. FDA’s strict requirements for drug companies that are selling to the U.S. are defined in the Food, Drug, and Cosmetic Act (“Act”).

One of the requirements imposed by FDA is Drug Establishment Registration. Owners or operators of all drug establishments, not exempt under section 510(g) of the Act, that engage in the manufacture, preparation, propagation, compounding, or processing of human, veterinary, and biological drugs must register and submit a list of every drug in commercial distribution.

Here’s how facilities and products undergo the FDA Drug Registration:

Veterinary and Human Drug Establishments

Establishments, both domestic and foreign, that manufacture, re-label or repack drug products that are intended to be imported into and made commercially available in the U.S. are required to register with FDA. This will be done through FDA’s Electronic Drug Establishment Registration process. Establishments that have registered electronically appear on FDA’s Drug Firm Annual Registration Status website. The provided information helps FDA keep track of all existing drug establishments whose drug products are sold in the US market.

The Office of Compliance, Immediate Office oversees the Drug Registration and Listing System (DRLS) and the electronic Drug Registration and Listing System (eDRLS), which are both key components of the Food and Drug Administration’s (FDA) ability to monitor drug safety. In 2009, FDA announced that it will no longer accept drug establishment registrations in paper format, requiring them to be submitted electronically.

The Drug Establishment Registration with FDA must be submitted annually. The Food and Drug Administration Safety and Innovation Act (FDASIA) requires drug companies to submit annual establishment registrations during the period from October 1 to December 31 of each calendar year. Firms must also list any drugs not previously listed during this period.

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