FDA Advisory Committee Votes Against Compounding Of Coated Modified Release Drugs
Executive Summary
FDA’s Pharmacy Compounding Advisory Committee votes to place coated modified release drugs on the “difficult-to-compound” list, thus barring these drugs from being compounded in the foreseeable future. The committee agreed with FDA’s recommendations that the complex formulation and the difficulty in manufacturing them precludes them from being compounded at the current time.
You may also be interested in...
FDA panel: Don't compound Vioxx, Bextra, oxy-ER
A decade after Merck yanked Vioxx and Pfizer withdrew Bextra from the market because of cardiovascular concerns associated with the anti-inflammatory drugs, an FDA panel of outside experts on 23 February said those drugs' active ingredients – rofecoxib and valdecoxib, respectively – should not be compounded by US pharmacists.
Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”
EU GMP Annex I Is A Top Priority For EMA While Industry Has Lingering Concerns
Questions about contamination control strategy raised as European Medicines Agency makes EU GMP Annex I revision a top priority in its 2021 work plan.