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 : EC925
Submitter : Dr. Stefanie Falz Date & Time: 10/27/2005 08:10:52
Organization : Dr. Stefanie Falz
Category : Health Professional
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?
there are many OTC versions of drugs that are available by prescription as, well. It does not appear a new ruling is required.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
no.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
yes
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
none
GENERAL
GENERAL
OTC availability of emergency contraceptives has been shown to be safe and effective in preventing unwanted pregnancies. It does not interfere with established pregnancy. Providing EC over-the-counter will help lower the abortion rate in this country.