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PCAC Meeting Details
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On March 8, 2016, the committee will discuss six bulk drug substances nominated for inclusion on the section 503A bulk drug substances list. FDA will discuss the following nominated bulk drug substances: Quinacrine hydrochloride, boswellia, aloe vera 200:1 freeze dried, D-ribose, chondroitin sulfate, and acetyl-L-carnitine. On March 9, 2016, the committee will discuss two categories of drug products nominated for the list of drug products that present demonstrable difficulties for compounding. These categories of drug products are metered dose inhalers and dry powder inhalers.


Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 1, 2016. Oral presentations from the public will be scheduled between approximately 11 a.m. to 11:15 a.m. and 3:15 p.m. to 3:30 p.m. on March 8, 2016, and between approximately 11:30 a.m. to 12 noon on March 9, 2016.


Cindy Hong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, email:,

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