There has been controversy related to what is legal according to FDA regulations for compounding pharmacists and physicians. This has been seen in thebioidentical hormone arenalately. Many of the shaky ground issues are in regard to unsubstantiated claims and marketing drugs for non FDA-approved uses. In the case of an improperly compounded botulinum toxin,the results were fatal.Some organizations have popped up as compounding advocates, but many may have no specific credentials or authority.
Asimilar issue came up with Jan Marini's eyelash product, as it was a drug marketed for a non-approved purpose.Others try to skirt this issue by marketing a product for a non FDA-approved use but have individual physicians buy directly from a compounding pharmacy. This can be a slippery slope. How this story develops will influence how many physicians practice in the future.