FDA has another case-study of the drawbacks of its unwieldy and inefficient monograph system governing availability of most OTC drugs in the US. Agency officials are concerned that they could act fairly quickly to limit indications for codeine-containing Rx drugs but labeling for OTCs with the ingredient would remain unchanged.
'Not As Easy' OTC Codeine Label Changes Worry FDA Rx Product Advisors
FDA officials acknowledge at the Pediatric Advisory Committee Sept. 11 that labeling restrictions for opioid-containing Rx antitussives for pediatric cough wouldn't apply to labeling for codeine cough products available under an OTC monograph.