Have you Received a Cease & Desist Letter from Ther-Rx?
Have you received a letter from Ther-Rx (KV Pharmaceutical's marketing arm for MakenaTM ) regarding hydroxyprogesterone caproate? Click here to view the letter.
IACP Members: Please be advised, this is a blanket "warning letter" which Ther-Rx is using to create confusion. Note that it is really nothing more than an information letter. It does not accuse or suggest you are doing anything specifically at your pharmacy.
If you actually read the statement from the FDA cited in the letter, there is nothing new or unusual here. A pharmacy that is engaged in large-scale production of a commercially available product would indeed be violating section 503(a) of the Food Drug and Cosmetic Act.
What can/should you do? Definitely document on any patient prescription you received from a physician for a compounded 17-P preparation that you have: 1) contacted the prescriber; 2) advised him/her of the commercially available product; 3) if the prescriber determines that in his/her professional judgment, a compounded version is what is needed for appropriate patient therapy. That documentation would be of great help to you in the event that a specific complaint against your practice was made by the manufacturer or if you were to be inspected by the FDA over allegations of producing a "commercially available" preparation.
If you actually read the statement from the FDA cited in the letter, there is nothing new or unusual here. A pharmacy that is engaged in large-scale production of a commercially available product would indeed be violating section 503(a) of the Food Drug and Cosmetic Act.
What can/should you do? Definitely document on any patient prescription you received from a physician for a compounded 17-P preparation that you have: 1) contacted the prescriber; 2) advised him/her of the commercially available product; 3) if the prescriber determines that in his/her professional judgment, a compounded version is what is needed for appropriate patient therapy. That documentation would be of great help to you in the event that a specific complaint against your practice was made by the manufacturer or if you were to be inspected by the FDA over allegations of producing a "commercially available" preparation.
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