Your Patients’ Compounds
are at Risk.
You MUST Take Action
Today!
Comment period ends in October.
Let your concerns be heard.
To learn more and examples, CLICK HERE
NEW FDA Draft Guidance
The FDA says it intends to consider a compounded drug product to be “essentially a
copy of a commercially available drug” if:
The Compounded drug has the same active pharmaceutical ingredient(s) (API) as the commercially available drug.
The API(s) have the same, similar or an easily substitutable dosage strength of the commercially available drug.
Can be used by the same Route of administration as prescribed for the compounded drug, unless a prescriber determines that that there is a change, made for an identified individual patient, which produces for that patient a significant difference from the commercially available drug.
This will potentially adversely affect all prescribers’ of compounded thyroids, progesterone, testosterone, and any compound you in your professional judgement feel is most appropriately custom compounded for your patient for a specific reason.
To learn more and examples,CLICK HERE
There is a 90 day comment period that ends in October.
Let your concerns be heard!
This pending action has the potential to dramatically decrease your prescription options for your patients.
Act now. It only takes a few minutes.
Together, we can make a difference!
