01-13-2012 11:13 AM
In regard to USP 797: I have a compounding pharmacy willing to make leucovorin in lyophilized power. My question is how are they sterilizing the product and what type of documentation should I request to ensure they are compliant with USP 797?
01-16-2012 10:17 AM
You need to ask the pharmacy how they are preparing this lyophilized drug and how they are sterilizing it. Where is this pharmacy getting the leucovorin powder from? Is their source a FDA registered manufacturer with certificate of analysis? How do you know it is a quality API (active pharmaceutical ingredient)? How do you know that they can make this drug in a lyophilized format and is it therapeutically active? Does your state board of pharmacy permit this compounding pharmacy to "manufacture" this type of medication? What qualifications does the pharmacy/pharmacists have to make this lypophilized powder? What training have they received that they can show you that they know how to properly use the lyophilizer and other critical equipment? Is this pharmacy accredited or certified by a third-party entity? Have you visited this pharmacy? As you can see from my questions, I have lots of trepidation on this matter.
01-16-2012 08:47 PM
I came across a document from the FDA about this issue that is worth reading... http://www.fda.gov/downloads/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/