OTC ANTIBIOTICS FOR HUMAN USE ARE EXEMPT FROM BATCH CERTIFICATION
Executive Summary
OTC ANTIBIOTICS FOR HUMAN USE ARE EXEMPT FROM BATCH CERTIFICATION if they are generally recognized as safe and effective and not misbranded. FDA amended the antibiotic drug regulations to exempt OTC antibiotics in July and the rule became effective Aug. 14. In a July 15 Federal Register notice announcing the final rule, FDA explained that current regulations exempt antibiotic drugs for human use from batch certification only if they are approved under an antibiotic application or an abbreviated antibiotic application. "FDA did not intend to exclude OTC antibiotic drugs that are generally recognized as safe and effective from the exemption from batch certification," the notice states. Therefore, the agency said it proposed in July 1985 to amend the antibiotic drug regulations to exempt from batch certification OTC antibiotics that meet the conditions for GRAS/E status and conditions in an applicable final OTC antibiotic drug monograph. FDA noted that it did not receive any comments or requests for an informal conference in response to the proposal.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth