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CPG Sec. 430.400 Urinary Preparations - Misbranding - Lack of Rx Legend and Claims March 1995

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


We are not prepared to take regulatory action against the following class of products, particularly those which have been on the market for a significant period of time:

Products offered as urinary antiseptics, urinary analgesics, acidifiers, or diuretics; which are botanical mixtures, botanical with sodium biphosphate, ammonium chloride, phenazopyridine hydrochloride, or these chemicals alone or in combination.

Generally, we would prefer not to initiate regulatory action on such products based on misbranding charges (lack of Rx legend or inadequate full disclosure) until our medical position has been clarified.

If the product contains ingredients which may cause the drug to be dangerous to health when used as directed or if its labeling makes direct claims for more serious conditions, we might want to consider action. If you encounter such products which you believe warrant action, submit full labeling and formulation to Division of Drug Labeling Compliance, *HFD-310* for advice before collecting samples for regulatory consideration.

*Material between asterisks is new or revised*

Issued: 10/1/80
Revised: 5/22/87, 3/95

Submit Comments

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If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: None found.

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