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 : EC711
Submitter : Mrs. Kathleen Steinmetz Date & Time: 10/12/2005 06:10:15
Organization : Mrs. Kathleen Steinmetz
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?
no
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?
no
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
no
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?
only if laws were passed--like liquor laws
B. If it could, would it be able to do so as practical matter and, if so, how?
with a law in place stating that a consumer could purchase the OTC with picture proof of identification showing the person was of legal age to purchase the product. A consumer would have to show a photo ID with age on it in order to purchase the product from the pharmacy. I recommend the product be behind the counter to prevent shoplifting and abuse by segments of the population that should not have it.
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--it would be confusing and could lead to misuse of the product. (would you like to see a child molester give the drug to a 12 year old child?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Only if the OTC was actually behind the counter, being obtained by showing photo ID.
GENERAL
GENERAL
Powerful hormones should not be on the shelves of stores where they can shoplifted by kids playing pranks. Imagine the teen party where kids think it's funny to lace their friends's drinks with something they think will make them "faggy". Imagine child molesters giving the drug to young children in order to keep their secret safe. I beg you to keep this powerful drug out of the hands of people with no legitimate use for it and keep it behind the counter if it truly has to be sold at all. At least having it behind the counter will better ensure it is in the hands of those old enough and responsible enough to use it.