Hair Loss

Here's what the FDA said about having lithium gluconate compounded... (Hair Regrowth Research & Clinical Trials)

posted by jarjarbinx, 04.01.2012, 11:52

It is not legal for a pharmacy to compound a medication using bulk active ingredients that aren't components of FDA-approved drugs, without an FDA-sanctioned New Drug Application. Lithium gluconate is not a component of an FDA approved drug and therefore it would not be legal for a pharmacy to compound this medication for you. In order for your physician to prescribe you lithium gluconate, they will need to file an Investigational New Drug (IND) application with the FDA. Please note, when a physician would like to submit an IND to obtain an unapproved drug for an individual patient, he or she should first ensure that the manufacturer of the unapproved drug is willing to provide the drug. If the manufacturer agrees to provide the drug, the physician should submit an IND to the appropriate review division.




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Complete thread:

• Here's what the FDA said about having lithium gluconate compounded... - jarjarbinx, 04.01.2012, 11:52 (Hair Regrowth Research & Clinical Trials)
  • Here's what the FDA said about having lithium gluconate compounded... - jarjarbinx, 04.01.2012, 11:54
  • Here's what the FDA said about having lithium gluconate compounded... - jarjarbinx, 04.01.2012, 11:56