Posted by Deborah14 on November 1, 2000, at 18:41:35
In reply to Re: Selegeline Patch - Update? » Deborah14, posted by chdurie2 on November 1, 2000, at 12:25:57
> > > > Caroline
Under the Pharmacy Preservation Act of 1977, the compounding of a gel IS legal if the pharmacist is:
1) Not making it in bulk e.g.manufacturing it in mass quantities.
2) The "active drug" within the gel is FDA approved, or does not fall under the jurisdication of the FDA e.g. an herbal remedy.
3) Is not in competition with a manufacturer who formulates the same product the same way for the same use. e.g. a compounding pharmacist cannot make a selegeline capsule in direct competition with Somerset Pharmaceutical.
4) Is prescribed by a physcian for a specified person and is formulated by a licensed pharmacist.
Under the Pharmacy Preservation Act of 1977, it is ILLEGAL for a licensed pharmacist to use the following delivery systems for compounds:
1) Transdermal patches
2) Inhalers
3) A compound that is used to treat a open wound or area subject to contamination since the FDA does not have direct oversight or regulatory authority over compounding pharmacists' facilities. This authority is given to the states. The FDA is concerned about product contamination and lack of quality control (compounding pharmaceutical under non-sterile conditions)
From my research, it appears that the FDA is unhappy with the law and has repeatedly attempted to get Congress to delay implementation of it.As per the selegeline gel, my p-doc, who is pretty conservative, is all for me trying it. I am the one who is reluctant. What I was really confused about was the diametrically opposed positions concerning the selegeline gels efficacy explained by Mike at Family Pharmacy and Steve at College Pharmacy.
At this point, my pdoc is going to speak with the psychopharm "guru" and then speak with Mike at Family if he feels it is worth going ahead with a trial of the gel.
I can't believe that my insurance company would approve payment of the gel through the Long Island pharmacy you mentioned. It would mean that I would only pay my usual copay and they would get hit with the difference. Why would they do it if they can keep me on the generic brand?
poster:Deborah14
thread:46818
URL: http://www.dr-bob.org/babble/20001022/msgs/47952.html