Three major areas to be aware of
1. Most manufacturers of limited distribution drugs such as cayston, aubagio, ampyra etc arrange special deals with national specialty pharmacies prior to approval and sales of the drug. There are a lot of politics involved wrt things such as volume, rebates, special billing procedures, reporting and rems compliance etc. If you are not a big player with staff dedicated to these issues and negotiating power, you may be facing a steep climb.
2. If the manufacturer is willing to consider a bid by you , you need to have a nurse and or pharmacist staff to do monthly monitoring and counseling calls, registration in applicable REMs , have clinical lab monitoring ie you'll sometimes need legit access to actual patient lab results and have arrangements with specialty prescribers.
3. Some drugs are restricted @ time of fda approval, by the fda, to only certain pharmacies. Bottom line is: you can't distribute these drugs no matter who you are without petitioning the fda.
Just went through this process at my last institution (large tertiary academic center). We gave up even though we met most of the clinical requirements. . There was just too much bureacratic bs to make it worthwhile.
If you are really dedicated, start by calling the manufacturer. They (the phone tecnician or medical affairs office) can arrange a call between you and the sales execs and clinical execs to inform you of the details and requirements. Most of them won't even take you seriously though unless you can buy bulk
