I don't think the FDA will do it that way. First, they will pull it from the market until compounding labs can prove proper QA and possibly even FDA inspection, similar to all other approved drugs.
Your statement suggest, the FDA is going to say, well okay you were caught giving substandard drugs possibly even dangerous drugs to women and babies, so just do a better job and we will take your word for it that you will comply with FDA standards, even though you haven't for the last 30 years.
I look for it to get pulled from the market and if brought back, it will be regulated to death. What these compounding pharmacies have been doing isn't just neglegence but a medical travesty. How many babies have been lost due to poor quality.
Most important, if the FDA does let it back on the market with new regulations, what do you think KV is going to do. That's right, start another investigation comparing 17P to Makena and 17P will fail again, because 2000 different labs all buying API from different manufactures and mixing 17p from different locations and different technicians will not produce it as good as Baxter.
KV no longer looks bad because of their high price, the FDA and compounding labs do for letting a cheap, adulterated product not only into this country from China, but for actually allowing it to be injected into our women. There is only one way for the FDA to come out and save face with the American people and that is to pull 17P from the market.
Personally I cannot wait until the ambulance chasing lawyers start pulling FDA personel, doctors and hospitals into courtrooms to defend their reasoning for allowing 17P to stay on the market and be prescribed with the evidence that has been found.
17P is dead as we know it.