Keith Hasson authored an article published by Law360 on March 28, 2017, discussing the ongoing regulatory updates compounding pharmacies must monitor, including changes in the U.S. Food and Drug Administration (FDA) inspection methods and the proposed rule adding new bulk substances that can be used in compounding.
“A change in the methods FDA inspectors follow when inspecting compounding pharmacies could be a precursor to tougher regulatory enforcement actions when the FDA believes a pharmacy is not following the rules,” Hasson said. As of Aug. 1, 2016, investigators have begun to make preliminary assessments during inspections to include deviations from Current Good Manufacturing Practices, and strong punishments like seizing potentially adulterated drugs have been levied under such circumstances.
The other major change in the industry is the potential addition of six bulk drug substances that may be used in compounding. In addition to beginning the bulks list outlined in Section 503A, this finalized rule would also establish criteria to evaluate future bulk drug substances for inclusion on the list. While the FDA has not specified costs and benefits of the proposed rule, the proposal suggests that enacting the rule would lead to better outcomes for pharmaceutical consumers and minimal negative effects for small entities in the industry.
For more information on FDA inspection changes and the 503A bulks list, please read the full article here.