I want to find the legal steps required to take an existing generic
over-the-counter drug and relabel/rebrand it.  For example, what legal
requirments would need to be met if I wanted to re-package an existing
formulation of aspirin and market it specifically for ear-aches?  What
if I wanted to new make a new formulation/combination of two agents?

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Request for Question Clarification by pinkfreud-ga on 17 May 2003 18:17 PDT

Laws vary greatly from nation to nation. Which country's laws should
we consider when researching your question?

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Clarification of Question by sjjrxprn-ga on 17 May 2003 19:37 PDT

USA, regulations consistent with the Food & Drug Administration (FDA www.fda.gov).

Hello -

IMPORTANT NOTE: This answer is not finished until you're satisfied
with it.  If you choose to rate this answer, I ask that you do so
*after* asking for any necessary clarification/information.  Thanks
for your understanding.


For a drug that you don't plan on altering the chemical make-up of,
the function you plan on repackaging the drug for [for instance,
ear-aches] will have to be consistent with the drug's "monograph," or
approved standards for the drug's usage/indications.

You'll want to visit this page to request copies of monographs:
http://www.fda.gov/ohrms/dockets/GRAS/grasindx.htm

The FDA has published monographs/rules for a number of OTC drug
categories. These monographs, which are published in the Federal
Register, state requirements for categories of non-prescription drugs,
such as what ingredients may be used and for what intended use.

Also, see The CDER Handbook
http://www.fda.gov/cder/handbook/index.htm

Your first step would be to contact the company responsible for
manufacturing the drug that you want to repackage.  Many drugs are
under patent or trademark, and you have to get explicit permission to
use them.
You would have to work on a contractual basis with that company for
express permission to use their product(s).

Your next step is to insure that the drug meets all federal standards
for labeling, repackaging, and registering under these [codes of]
federal regulations:

21 CFR 201 [labelling]
GMP part 211 [repackaging]
CFR 207 [registering, drug listing company]

You can find out more about these at this site:
http://www.fda.gov/cder/

You'll then have to register the drug with the FDA:
Drug Registration and Listing Instructions
http://www.fda.gov/cder/drls/introduc.htm


Here is a specific contact at the FDA.  I encourage you to contact
Barry at the number below, who should be able to give you more direct
assistance.

301-827-3454 [Barry]
also
301-827-8930 [Over the Counter drug department]


jbf777-ga
GA Researcher

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Clarification of Answer by jbf777-ga on 20 May 2003 13:52 PDT

With regard to making a "new formulation," you're essentially starting
from scratch.  It's the same as registering an entirely new drug with
the FDA.