Bioidentical Hormones - U.S. Senate Special Committee on Aging

It is self-maintaining financially and it's profits are only used to promote the Wiley
ill
Protocol to doctors and academic institutions and to develop educational materials like
the website.
Our Process for Standardization
In an effort to standardize the compounded preparations of Estrogen and
Progesterone we have asked the pharmacists to do several things in order to minimize the
potential for variation:
* Drug specifications: we use the bulk drugs estradiol and USP progesterone
which are recognized and standardized by the United States Pharmacopoeia.
We compare the USP Standards with the Certificate of Analysis which
accompanies each bulk drug shipment. We want to assure ourselves of that the
Purity and Identification Standards are met.
* Formulation Specifications: We use a detailed formulation so that the
prescription conforms from batch to batch. The formulation is spelled out like
a recipe (formulary) and the quantities are recorded with the lot nu1hmbers,
expiration dates, if any, and manufacturer's or supplier's name.
* Method of preparation is detailed and for our preparations we use specific
equipment for weighing, measuring, and mixing. i.e. an ointment mill
* In order to assist the patients in measuring the correct dose, we use a special
syringe. The objective in using this measuring device is to apply to the skin a
specific amount of cream containing a particular content of hormone. The
calibrations on the syringe allow for the physician's prescription of the Wiley
Protocol to be "individualized" in the spirit of a compounded product to the
variation in endocrine physiology from woman to woman. So with the Wiley
Protocol we have provided "standardization in customization", something no
one has ever done before, except in the case of commercial pharmaceutical
products like the Vivelleg and Ctimeras patches which are offered in a range