CPG Sec. 430.400 Urinary Preparations - Misbranding - Lack of Rx Legend and Claims March 1995
- Docket Number:
- None found
- Issued by:
Guidance Issuing OfficeCenter 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*
Revised: 5/22/87, 3/95
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
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.