United States of America. The Food and Drug Administration has amended the final monograph for over-the-counter (OTC) nasal decongestant drug products to add the ingredient l-desoxyephedrine (levmetamfetamine) and to classify this ingredient as generally recognized as safe and effective for OTC use for the relief of nasal congestion caused by acute or chronic rhinitis. The agency is also removing the name “l-desoxyephedrine” from the list of nonmonograph active ingredients.
Reference: Federal Register 63(146): 40647-50 (1998).