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 : EC653
Submitter : Ms. MARY ANN AUGUSTINE Date & Time: 10/12/2005 06:10:19
Organization : HOLY LOVE MINISTRIES
Category : Federal Government
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?
NO, NOT FOR THIS OVER THE COUNTER ABORTION PILL. THIS IS OUT RIGHT MURDER. REMOVE IT FROM THE MARKET PERIOD!
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?
THE ACTIVE INGREDIENT CAUSES A DEATH OF A HUMAN BEING. STATE THAT.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
YES, THERE IS.
C. If so, would a rulemaking on this issue help dispet that confusion?
NO.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
NO.
B. If it could, would it be able to do so as practical matter and, if so, how?
NO, NOT THIS DRUG.
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?
NO.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
ALWAYS INAPPROPRIATE.
GENERAL
GENERAL
THIS ABORTIFICANT PILL GOES AGAINST OUR US CONSTITUTION. EVERY PERSON HAS A RIGHT TO LIFE, LIBERTY AND THE PURSUIT OF HAPPINESS.