Hydroxyprogesterone Caproate (17P)
The March 2011 statement regarding compounding of 17-alpha-hydroxyprogesterone caproate (17P) has been superseded by the June 2012 statement and the related June 2012 Q&A document, in which FDA recommended using an FDA-approved drug product, such as Makena, instead of a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.
In addition, under section 503B, an outsourcing facility may not compound any drug that is essentially a copy of an approved drug. Section 503B defines the term “essentially a copy of an approved drug” to include either: (1) a drug that is identical or nearly identical to an approved drug, unless the approved drug appears on the drug shortage list in effect under section 506E at the time of compounding, distribution, and dispensing; or (2) a drug, a component of which is a bulk drug substance that is a component of an approved drug, unless there is a change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner between the compounded drug and the comparable approved drug.
When FDA identifies a pharmacist that compounds regularly or in inordinate amounts any drug products that are essentially copies of Makena as defined under section 503A, it intends to take action as it deems appropriate. If FDA identifies a registered outsourcing facility that compounds any drug products that are essentially copies of Makena as defined under section 503B, FDA intends to take action as it deems appropriate.
FDA has advised its investigators and other field personnel that imports of hydroxyprogesterone caproate active pharmaceutical ingredient (“API”) must meet the applicable FDCA registration and listing requirements, and any accompanying entry documentation and product labeling should be carefully examined for compliance with drug import requirements.