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CPG Sec. 450.400 Labeling and Distribution of OTC Drugs in Vending Machines May 1987

Docket Number:
None found
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research


There is no provision under the Federal Food, Drug, and Cosmetic Act which prohibits the sale of over-the-counter drug <> preparations in vending machines or in places other than drug stores. However, the article so vended must be in a full compliance with all the applicable sections of the Act.

The Act requires that certain mandatory labeling information must appear prominently, with such conspicuousness (as compared with other words, statements, designs or devices in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. This means that the prospective purchaser must have an opportunity to read and take such information into consideration in reaching a decision whether or not to make the purchase. The vending machine should therefore bear a complete copy of the required labeling for the article being offered for sale or the article should be displayed in such a manner that the mandatory labeling can be viewed by the prospective purchaser.

<> Indicates material has been deleted

Issued: 10/1/80
Revised: 5/22/87

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