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U.S. FDA Drug Establishment Registration and Listing Requirements

Owners or operators of all drug establishments, not exempt under section 510(g) of the Food, Drug, and Cosmetic Act (Act), that engage in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register and submit a list of every drug in commercial distribution.

Manufacturing or processing means the manufacture, preparation, propagation, compounding, or processing of a drug or drugs as used in section 510 of the Act and is the making by chemical, physical, biological, or other procedures of any articles that meet the definition of drugs in section 201(g) of the Act. The term includes manipulation, sampling, testing, or control procedures applied to the final product or to any part of the process.

The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).

Registrar Corp helps businesses comply with U.S. FDA Drug registration and listing requirements. For U.S. FDA Drug assistance, simply click the U.S. FDA Drug category applicable to your drug products.


Active Pharmaceutical Ingredient (API) Registration   API Examples
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An Active Pharmaceutical Ingredient is any substance or mixture of substances indended to be used in the manufacture of a drug (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 affec the structure or function of the body. For assistance with U.S. FDA Active Pharmaceutical Ingredient registration and listing requirements, simply click the Active Pharmaceutical Ingredient Certificate shown on the left.
  
Drug Intermediates Establishment Registration
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Drug Intermediates 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. For assistance with U.S. FDA Drug Intermediate registration and listing requirements, simply click the Drug Intermediate Certificate shown on the left.

Prescription Drug Establishment Registration
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A Prescription Drug is a human drug that is not safe for use except under the supervision of licensed medical practitioner. For assistance with U.S. FDA Prescription Drug registration and listing requirements, simply click the Prescription Drug Certificate shown on the left.
  
Over the Counter Drug (OTC) Establishment Registration
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An Over-the-Counter Drug is a human drug that is safe and effective for use without prescription by a licensed medical practitioner. For assistance with U.S. FDA Over-the-Counter Drug registration and listing requirements, simply click the Over-the-Counter Drug Certificate shown on the left.
  
Homeopathic Drug Establishment Registration  Homeopathic Examples
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Homeopathic Drugs are 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. For assistance with U.S. FDA Homeopathic Drug registration and listing requirements, simply click the Homeopathic Drug Certificate shown on the left.
  
Animal Drugs Establishment Registration
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Animal drugs are 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 suggested in the labeling of the drug. For assistance with U.S. FDA Animal Drug registration and listing requirements, simply click the Animal Drug Certificate shown on the left.
  
Medical Gases Establishment Registration
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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 Act. For assistance with U.S. FDA Medical Gas registration and listing requirements, simply click the Medical Gas Certificate shown on the left.
  




 
U.S. FDA Regulations:

U.S. FDA Regulation: 21 C.F.R. Part 207




















































Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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