This is a copy of a press release from the International Association of Compounding Pharmacies.  This is a response to the latest FDA action that contradicts Congressional law. 

FDA Asserts New Policy to Restrict Women’s Access to
Bioidentical Hormones
Agency Warns Pharmacies Not to Compound Commonly Prescribed Hormone
Treatments, Use the Term “Bio-identical”
MISSOURI CITY, Texas – In a series of warning letters to compounding pharmacies
across the country, the Food and Drug Administration (FDA) has asserted a policy that
would deny hundreds of thousands of women access to many commonly compounded
bioidentical hormones, substituting its judgment for that of doctors. Wyeth
Pharmaceuticals, the number one manufacturer of synthetic hormone products, petitioned
the FDA to do so in October 2005. More than 70,000 doctors, patients, and pharmacists
filed comments with the FDA opposing Wyeth’s petition, the vast majority of whom
opposed the petition.
“Under this policy, patients will suffer while Wyeth profits,” said L.D. King, executive
director of the International Academy of Compounding Pharmacists (IACP). “Thousands
of doctors are making patient-by-patient decisions that compounded hormones are
medically appropriate, sometimes because Wyeth’s products are found to be ineffective
or produce side effects. This is a decision that should be left to doctors.”
In the letters, the FDA states that it will “halt” compounding of medications containing
estriol, an estrogen produced by the human body. Estriol is one of the most widely
prescribed hormones and is regularly compounded with other bio-identical hormones
pursuant to doctors’ prescriptions for women suffering from symptoms of menopause.
Like many commonly prescribed drugs, estriol has a monograph from the U.S.
Pharmacopeia (USP), but is not a component of an FDA-approved drug. When it passed
the FDA Modernization Act in 1997, Congress clearly indicated that drugs with a USP
monograph could be compounded.
The FDA also stated in its letters that pharmacies may not use the term “bio-identical” to
characterize compounded hormone therapies, even though the chemicals used in such
compounds are chemically identical to what is produced by the human body.

Furthermore, manufacturers of drugs containing the same bio-identical hormones
commonly use the term to characterize their products. The chemical structure of these
drugs is indisputable.
Pharmacy compounding is a long-standing, state-regulated and medically vital practice.
Millions of Americans have unique health needs that off-the-shelf prescription medicines
cannot meet. For them, customized, compounded medications prescribed or ordered by
licensed physicians or veterinarians and mixed safely by trained, licensed compounding
pharmacists are the only way to better health.
About IACP

The International Academy of Compounding Pharmacists (IACP) is a non-profit
association founded in 1991 to protect and promote the art and skill of the compounding
pharmacy profession. We represent more than 2,000 pharmacists, physicians, technicians
and patients who are committed to the safe practice of pharmacy compounding. We are
committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and
of patients to take customized medications that meet their unique, individual needs.

IACP Press Release Link