Compounding Committee Meets to Discuss Drugs Approved for Compounding
FDA’s Pharmacy Compounding Advisory Committee will meet in February to discuss the list of bulk drug substances that may or may not be compounded.
FDA announced on Jan. 23, 2015 that their Pharmacy Compounding Advisory Committee will meet on Feb. 23-24 to discuss the revised lists of drug substances that may not be compounded under the exemptions stated in sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. In July, FDA proposed adding 25 drug products to this list because the drug products have been withdrawn or removed from the market after the drug products or components of such drug products were found to be unsafe or not effective. The meeting will include a discussion of comments FDA received to FDA’s proposed rule on the matter in July 2014.
The committee will also discuss six drug substances that were nominated to be included on the list of bulk drug substances approved for compounding. FDA solicited nominations for the list on Dec. 4, 2013 and July 2, 2014.
Source: FDA.gov
Guidance on Quality Culture Standards
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