The FDA has accepted nominations to its "Difficult to Compound"
(DDC) list, which is supposed to identify drugs that cannot safely be
compounded because of their complexity. Included on this list are certain kinds
of safe, bioidentical hormones such as progesterone (including progesterone
with estradiol) and estriol.
This is extremely disconcerting. Compounding pharmacists say these
bioidentical hormones are not difficult to compound and are not dangerous. A
review of the clinical literature concluded that bioidentical hormones are
associated with lower risks, including the risk of breast cancer and
cardiovascular disease, and are more effective than synthetic or animal-derived
Compounded hormones are used by millions of women to manage menopause or
fertility changes. Pharmacies can make hormone medications that are tailored to
a patient's individual needs, as determined by a doctor. Compounded
bioidentical hormones have been used safely for decades; there is no reason for
the FDA or its Pharmacy Compounding Advisory Committee (PCAC) to eliminate consumer access to these medications--particularly
estriol, for which there is no commercially available drug.
Write to Congress and the FDA, telling them to protect patient access to compounded bioidentical hormones.
Please protect bioidentical hormones
Dear [Decision Maker],
Sincerely,[Your Name] [Your Address] [City, State ZIP][Your Email]