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 : EC733
Submitter : Mrs. Nicole Peck Date & Time: 10/13/2005 08:10:28
Organization : Mrs. Nicole Peck
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?
I do not support simultaneously marketing a prescription drug and OTC drug.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
Again, I do not support this process.
GENERAL
GENERAL
The bottom line is that my family does not support marketing any kind of emergency contraception to anyone without a prescription! We must protect our children and they must obtain their parent's approval and physician prescription.