What Is FDA’s Drug Registration?

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. buy ketamine liquid online 

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.

Leave a Reply

Your email address will not be published. Required fields are marked *