2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC878
Submitter : Mrs. Hollie Silberhorn Date & Time: 10/17/2005 10:10:49
Organization : Mrs. Hollie Silberhorn
Category : Individual Consumer
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
See attachment
GENERAL
GENERAL
I do not think it is a good idea to expand the sale of Plan B to the over the counter market. Thanks! Have a great day!
Hollie Silberhorn
1811 Elmtree Drive
St. Peters, MO 63376