FDA Adds 6 Substances To Bulks List, Responds To Rulemaking Criticism

By Beth Wang / February 15, 2019 at 2:17 PM
FDA on Friday (Feb. 15) finalized a compounding rule that, for the first time, places six bulk drug substances on the list of bulk substances that can be used by compounders not registered as outsourcing facilities -- also known as the 503A bulks list. The rule also identifies four bulk drug substances that are not allowed. The final rule goes into effect March 21. In its final rule, FDA also responds to stakeholders who alleged the agency was violating the...


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