A company called Biostratum has applied to sell a form of pyridoxine as a drug - if approved, they will be allowed to make specific claims and indicate it for specific diseases (in this case, some forms of kidney disease). It also means that insurance companies will have to pay for it when it is prescribed.
The fact that something is approved as a 'drug' does not mean it will be banned in other products or forms. Saline solution (salt water) is regulated as a drug when it intended for use in an intravenous drip. Not a problem, I want the IV bags to be manufactured with pure salt, pure water, at a controlled concentration, and free of bacteria and viruses. That highly specific regulation of saline doesn't outlaw buying and selling salt and various brine solutions for other uses.
Here is some of the FDA regulatory info for one brand of contact lens solution (sterile saline):
Quote:
FDA Medical Specialty Code OP - Opthalmic
FDA Product Code LYL
FDA Classification Name ACCESSORIES, SOLUTION, ULTRASONIC CLEANERS FOR LENSES
FDA Device Classification Code Standards
FDA Regulation Number 886.5928
FDA Common Generic Name CONTACT LENSE SALINE SOLUTION
FDA Proprietary Device Name BLAIREX STERILE SALINE SOLUTION
FDA Owner / Operator Number 1825549
FDA Owner / Operator Name BLAIREX LABORATORIES, INC.
FDA Establishment Registration Number 1825549
FDA Registered Establishment Name BLAIREX LABORATORIES, INC.
FDA Operation Code(s) MS - Specification Developer
FDA Listing Date 02-21-01
FDA Listing Status Code Active