Implementation of Revised Topical Dosage Form Definitions

1
Implementation of Revised Topical Dosage Form
Definitions

• Lucinda (Cindy) Buhse, Ph.D.
• Director, Division of Pharmaceutical Analysis

2
Since October 2003 Advisory Committee Meeting

• Peer reviewed journal publication of proposed
  decision tree and definitions
• Updated CDER Standards Manual
• ONDQA and OGD have begun applying new definitions
  as appropriate to NDA and ANDA applications

3
Implementation Plan

• Obtain USP buy in to new definitions
• Recommend that all new drug applications that are
  not referencing an existing product conform to
  the new definitions
• If only innovator product exists, consider a name
  change before multiple generics are on the
  marketplace
• Eliminate use of terms topical emulsion and
  emollient cream

4
Later Consideration

• Products with generics
• New ANDA products that reference an older
  misnamed product
• Over the Counter (OTC) products without NDAs or
  ANDAs

5
Why Later?

• We need to assess how big the issue is to
  prevent
• Disruption in marketplace
• Legal issues

6
Future Goal

• Have all products (prescription and OTC) comply
  with new definitions
• however, timeline is not yet decided.