Labeling of Orally Ingested Over-the-Counter Drug Products Containing Calcium, Magnesium, and Potassium; Extension of Comment Period

Resumo

The Food and Drug Administration (FDA) is extending to September 20, 1996, the comment period on the notice of proposed rulemaking to amend the general labeling provisions for over-the- counter (OTC) drug products intended for oral ingestion to require the content per dosage unit and warning labeling when the product contains certain levels of calcium, magnesium, or potassium. The notice of proposed rulemaking was published in the Federal Register of April 22, 1996 (61 FR 17807). FDA is taking this action in response to a request for extension of the comment period to allow interested persons additional time to comment on the notice of proposed rulemaking. DATES: Written comments by September 20, 1996. Written comments on the agency's economic impact determination by September 20, 1996. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.