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

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Dr. WARTOFSKY. In the case of the Endocrine Society, I mentioned
our professional organization of endocrinologists, the specialty
of medicine that deals with hormone therapies. Our members
brought to our attention that they were getting questions from
their women patients about these bioidentical hormones. They were
lacking information., They were concerned about the claims that
were being made about these bioidentical hormones-custom-compounded
hormones.
Although Dr., Allen is correct that pharmacists should not prescribe
anything without a prescription written by a physician, our
information is that there are large pharmacy chains that sell these
products on the Web; that one can get these mail-order; that they,
in fact, will provide the names of physicians who will write prescriptions
for these compounds.
We believe these physicians are acting without a basis in science,
as you alluded to, that they are perhaps on the fringe of medicine
and do not represent our mainstream endocrinologists.
Senator SMITH. These pharmacies-we call it "forum shopping"
in the law-do they doctor-shop to find physicians who
Dr. WARTOFSKY. I am sure that is the case, yes.
Our concern about the need for a Federal regulation is because
the degree of regulation by the States is highly varied. From State
to State, there is no consistency.
The National Association of State Boards of Pharmacy has issued
guidelines for compounding which, as of recently, were adopted and
codified by less than a quarter of the States in the U.S. So these'
guidelines are not uniformi .
We have heard this morning how difficult it is for the FDA, given
everything that is on their plate, to do the kind of enforcement and
regulation that Dr. Allen indicates that they^ do do, because this is
not happening. It just is not feasible, given the broad practice of
the dispensing of these bioidentical hormones.
So we believe there should be some greater oversight at the Federal
level with more formal guidelines for regulation under which
the State boards of pharmacy would operate; that there would be
consistency throughout the country; and importantly, that there
would be more teeth put into the regulations with enforcement.
Senator SMITH. Dr. Allen, obviously, if these products are being
sold on the Web and somebody in Oregon can get- it from a doctor
in Arkansas on a Web site, that is clearly an interstate commerce
issue. That is where the Federal Government comes into play. So
I wonder how you reach a conclusion that the States ought to do
it. Dr. ALLEN. Well, basically the individual States recognize professions-medicine,
pharmacy, nursing, et cetera-in their State professional
acts. In addition to that, they establish certain laws governing
that profession and State boards to regulate those and enforce
those.
The State boards, then, enact regulations to govern the practice
of pharmacy. So the practice of pharmacy and medicine is something
that should be regulated at a State level.
Now, from the pharmacy standpoint, if a pharmacy sends a compounded
preparation into another State, they are required to be
registered with the State board of pharmacy in that State.