If I am interesting in making a cream that contains 1% hydrocortisone,
an "over-the-counter" strenngth medicine (similar to the current
over-the-counter product named 'CortAid 10') what
type of regulatory authorization do I need to get to sell it at retail
stores? I have heard of something called an "FDA monograph" for
over-the-counter medications.
Is there an applicaion process to the FDA to meet the "monograph"
requirements so I can sell it at retail outlets, or is the a
service/company that will submit/apply my product to the FDA for me so
I can sell it in retail outlets?
Thanks,
Dr. C |
Request for Question Clarification by
pafalafa-ga
on
12 Jan 2005 12:04 PST
Dr. C.,
You have asked about what is quite possibly one of the most complex
regulatory processes ever devised by the federal government. However,
there are some FDA "EZ" alternatives for certain categories of drugs.
For the purposes of researching your question, I am assuming that
hydrocortisone is the only active pharmaceutical ingredient in your
formulation. Please let me know if the situation is otherwise.
Also, if your formulation is substantially different than existing OTC
hydrocortisone creams in any way other than a cosmetic sense, please
let me know that as well.
For instance, if the only real difference is the addition of a
particular aroma, I wouldn't call that substantially different. But
if the difference is a totally new base cream to carry the
hydrocortisone, that would may well be considered a substantial
difference.
Thanks.
pafalafa-ga
|
Clarification of Question by
crutchfield-ga
on
12 Jan 2005 18:51 PST
It is essentially the same as any 1% hydrocortisone ointment available
over-the-counter. No additonal active ingredients. Essentailly 1%
hydrocortisone in petrolatum (vasoline). Maybe mild lemon fragrance,
but this is not essential and may not be used.
Thanks!!!!
|
Request for Question Clarification by
pafalafa-ga
on
13 Jan 2005 15:41 PST
Dr. C.,
I had hoped to be able to post a timely answer to your question, but
I'm afraid I'll be leaving town for a week and wasn't able to complete
my research in time. Perhaps another researcher will be able to
provide an answer for you, but if not, I will certainly pick it back
up when I'm back at my desk.
In a nutshell, though:
--hydrocortisone for the application you've described IS covered by an
FDA monograph, which essentially means it is pre-approved, and you do
not have to go through an application process.
--however, you DO need to follow existing guidelines as far as labeling, etc
--As a first step, you should definitely contact the FDA small
business assistance office in your area:
http://www.fda.gov/ora/fed_state/Small_Business/regional.htm
They can begin walking you through the process and point you to all
relevant guidelines. In fact, once you touch base with them, you may
find you have everything you need.
Let us know how things go after you contact FDA, and best of luck to
you in your efforts...
pafalafa-ga
|
Clarification of Question by
crutchfield-ga
on
14 Jan 2005 12:14 PST
thanks, I will start there. I found your info helpful. Please get in
touch with me when you return and I can re submit and I'd like to pay
you for your efforts, let me know how to do so.
thanks,
DR. C
|
Request for Question Clarification by
pafalafa-ga
on
26 Jan 2005 05:14 PST
Hello Dr. C,
Well, I'm back from vacation (very cold, lots of fun) and ready to get
back to work.
Have you been in touch with the FDA? I'd like to know how things are
working out, and most importantly, what sort of additional information
I can provide for you.
Let me know if you have a complete answer at this point, or if not,
what else I can do for you.
All the best,
pafalafa-ga
|
Clarification of Question by
crutchfield-ga
on
30 Jan 2005 20:03 PST
Welcome back. I have not contacted them, but I will thi week and let you know.
Thanks for your help and you will hear from me soon.
Thanks,
Dr. C
|
Request for Question Clarification by
pafalafa-ga
on
31 Jan 2005 02:18 PST
Dr. C.,
Nice to hear back from you. I look forward to learning what the FDA
contacts have to say.
paf
|
Clarification of Question by
crutchfield-ga
on
05 Feb 2005 12:04 PST
i would like to pay you 35.00 for your help.
how do i do so?
Thanks
Dr. C
|
