As you are well aware, cleanrooms are held to a very high cleanliness standard. Some cleanrooms that work with compounding pharmaceuticals are held to additional regulations through USP 797. Recently there have been several news stories in which contamination in these cleanrooms led to the deaths of 58 people and the sickness of many others.
Because of these serious consequences related to mistakes in these cleanrooms, a proposed bill is expected to hit the Senate perhaps before the end of the summer. This charge is being led by Kansas Senator Pat Roberts and is aimed at catching those pharmacies that are not adhering to strict cleanliness standards while giving flexibility to smaller pharmacies to still create specialized prescriptions.
This new bill would give FDA authority over those pharmacies that ship products outside of state lines with, or in advance of, prescriptions. Unfortunately, this could help large compounding pharmacies avoid FDA oversight if their sales are solely within the state. It will be interesting to see the eventual outcome of this bill.
Do you want to read more? Check out this article in the Kansas City Journal.