This is an old Washington Post article about Makena, but says a lot about what the FDA thinks:
In an interview with The Washington Post on Friday, an FDA official said that, if requested, the agency could approve a lower-priced generic version of the drug for another use that doctors could prescribe 'off label.'
In addition, the official said the agency would not prevent compounding pharmacies from continuing to provide 17P unless patient safety is thought to be at risk.
'We have our hands full pursuing our enforcement priorities,' said the official, who spoke on the condition of anonymity because of the sensitive nature of the issue. 'And it’s not illegal for a physician to write a prescription for a compounded drug or for a patient to take a compounded drug. We certainly are concerned about access of patients to medication.;