Drugs

The statutory definition of a “drug” emphasizes the fact that it is a substance is “intended” for certain purposes related to disease in man or animals.  For instance, articles that are intended to cure, treat, or prevent a disease and do so by chemical action in the body are “drugs” under the statutes enforced by FDA.  Similarly, if an article is intended to have some effect on the body’s structure or function, it could be a “drug”; but it could also be a food or a dietary supplement.  The “disease” portion of the drug definition is that portion that most clearly separates “drugs” from other non-medical products.

In order for a substance to be a legal drug, its active ingredient must be as listed in the U.S. Pharmacoepia, the Homeopathic Pharmacoepia of the United States, or the National Formulary.  These compendia specify the definition, requirements, and specification of the ingredients. Medicinal ingredients and products must have the strength, quality, and purity stipulated in the product labels or advertising (for instance websites that market the product will likely be regulated by FDA as “labeling” and by the FTC as “advertising”). 

Any foreign company which intends to manufacture, prepare, propagate, compound, or process a legal drug that will be sold in the U.S. must comply with all FDA regulations regarding pre-approvals, compliance with published monographs, labeling requirements (both general and specific), manufacturing controls that ensure the product is safe and effective, and registration and listing requirements.  Consultants and attorneys at FDAImports.com have extensive experience dealing with FDA at all levels.  Call on us to walk you through the necessary steps, ensure compliance, and help you be proactive in avoiding problems.

Registration and Listing
Good Manufacturing Practices
Homeopathic Pharmacopeia U.S. / U. S. Pharmacopeia