Cosmic Peptides research library

Unapproved new drug

A drug that is not generally recognised as safe and effective for its labeled uses and has no approved application, which may not be sold in interstate commerce.

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Section 201(p) of the Federal Food, Drug, and Cosmetic Act defines a new drug as one not generally recognised, among qualified experts, as safe and effective for the uses in its labeling. Section 505(a) prohibits introducing a new drug into interstate commerce without an approved application, and section 301(d) makes doing so a prohibited act.

An approval covers a specific product from a specific applicant. A substance that is the active ingredient of an approved medicine is still an unapproved new drug when sold by anyone else for use in people.

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For in vitro laboratory research only. Not for human or veterinary use. This library describes chemistry, analytical methods and published laboratory research; it gives no guidance on use in people or animals.