Drug Labeling; Sodium Labeling for Over-the-Counter Drugs; Partial Delay of Effective Date

The Food and Drug Administration (FDA) is delaying the effective date of the sodium labeling final rule for over-the-counter (OTC) drug products intended for oral ingestion, except for those products that contain sodium bicarbonate, sodium phosphate, or sodium biphosphate as an active ingredient. The regulation established conditions under which the labeling must include the sodium content and a general warning that persons who are on a sodium- restricted diet should not take the product unless directed by a doctor. This partial delay of the effective date of the sodium labeling final rule is in response to requests that the effective date for the sodium labeling final rule coincide with the effective date for the calcium, magnesium, and potassium labeling final rule. The final rule for calcium, magnesium, and potassium labeling is expected to publish in the Federal Register in the near future and will be effective 12 months after the date of publication. The agency is delaying the effective date of the sodium labeling final rule to correspond with the effective date of that final rule. DATES: The effective date of paragraphs (a) through (h) of Sec. 201.64 added at 61 FR 17806 (April 22, 1996) is delayed until further notice. The revision of paragraph (i) of Sec. 201.64 in this document is effective April 24, 1997.