The March 2011 statement regarding compounding of 17-alpha-hydroxyprogesterone caproate (17P) has been superseded by the June 2012 statement and the related June 2012 Q&A document, in which FDA recommended using an FDA-approved drug product, such as Makena, instead of a compounded drug except when there is a specific medical need (e.g., an allergy) that cannot be met by the approved drug. FDA is not aware of any scientifically reliable evidence demonstrating that compounding 17P without a preservative or in an oil base different than the one used in Makena produces a significant difference for an identifiable group of patients (aside from the rare patient who is known to be allergic to either the preservative or the oil base).
Under section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA), a pharmacist may not compound regularly or in inordinate amounts any drug products that are essentially copies of Makena. A compounded drug product is not essentially a copy of Makena if the compounded drug product includes a change from Makena that was made for an identified individual patient, and a prescribing practitioner determines that the change produces a significant difference for that patient between the compounded drug product and the commercially available drug product. Moreover, a drug compounded under section 503A must be compounded for an identified individual patient and distributed after the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient.