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News & Press: Breaking News

FDA Makes Recommendation to PCAC on Additions to Bulk Drugs

Tuesday, October 20, 2015   (0 Comments)
Posted by: Dagmar Anderson
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Next week, on October 27 and 28, the FDA Pharmacy Compounding Advisory Committee (PCAC) is reviewing ten active pharmaceutical ingredients (APIs) to be included on the list of approved bulk drugs that traditional compounders can use in preparing prescriptions. As required within 503A, a bulk ingredient must  have an applicable USP monograph, be a component of an FDA approved drug, or be added to an official list authorized by the Secretary of Health and Human Services. The ten drugs to be reviewed were nominated by stakeholders including IACP in 2014 in response to formal requests issued by the agency.

Prior to the meeting, the FDA has released documents for the PCAC that show their recommendations on each of the nominated drugs. These recommendations are:

•   Methylsulfonylmethane - FDA does not recommend addition to the approved bulk ingredient list
•   Curcumin - FDA does not recommend addition to the approved bulk ingredient list
•   Germanium Sesquioxide - FDA doesn't recommend addition to the approved bulk ingredient list
•   Rubidium Chloride - FDA does not recommend addition to the approved bulk ingredient list
•   Deoxy-D-Glucose - FDA does not recommend addition to the approved bulk ingredient list
•   Alanyl–L-Glutamine - FDA does not recommend addition to the approved bulk ingredient list
•   Glycyrrhizin - FDA does not recommend addition to the approved bulk ingredient list
•   Glutaraldehyde - FDA does recommend addition to the approved bulk ingredient bulk list for topical use only
•   Domperidone - FDA does not recommend addition to the approved bulk ingredient list

The Committee is not obligated to accept and has, in the past, disagreed with those FDA recommendations.  IACP  will be on-site during the meeting next week and will update our members on the decisions made by the PCAC



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