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PCAC Votes Unanimously to Place Transdermal Delivery Systems on Demonstrably Difficult List

Thursday, November 3, 2016   (0 Comments)
Posted by: Dagmar Anderson
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PCAC Final Vote of the Day: The Pharmacy Compounding Advisory Committee voted unanimously to place transdermal delivery systems on the demonstrably difficult list.

Reminder: The discussion of transdermal delivery systems was relegated to “drug products that employ matrix or reservoir type transdermal or topical delivery systems, which are designed to deliver active ingredient through the skin either systemically or locally.” “For the purposes of this review, FDA does not consider transdermal delivery systems to be liquid or semisolids, such as gels, creams, lotions, foams, ointments or sprays, that are intended for use without a matrix or reservoir type transdermal or topical delivery systems.” The committee stayed true to this statement and only transdermal delivery systems using reservoir or matrix types systems were voted to be placed on the demonstrably difficult list.

PLEASE NOTE: These votes are NOT final. FDA must release final guidance for this to be FINAL. These are the Committee’s votes on FDA’s recommendations.

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