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

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The FDA also regulates aspects of compounding, including the
suppliers of the ingredients that pharmacists use to compound.
FDA also has authority to inspect any pharmacy's facility, equipment
and ingredients. Federal laws also prohibit the making of unsubstantiated
claims of safety and efficacy.
A fundamental question is, what is the difference between compounded
and manufactured medicines?
First, compounded medications are always prepared pursuant to
a doctor's prescription. Second, compounded medicines are retail
only, sold directly to the patient.
Third, they are not copies of commercially available drugs. They
are significantly different, as determined by the prescriber, whereas
manufactured medicines are produced well in advance of any
prescription and distributed at wholesale.
So how does this relate to hormone therapy? As I said, like compounded
medications overall, by definition compounded hormones
are always prescribed by doctors, prepared pursuant to those prescriptions,
and dispensed directly to patients at retail.
Compounded hormones meet the needs of patients that are otherwise
unmet by manufactured hormone products. For many patients,
these products are effective, but for some, they are not. That
may be because the manufactured drugs simply don't relieve the
symptoms of menopause. It may also be because doctors determine
that their patients need a lower dose than what is available commercially.
The Women's Health Initiative recommended that
women in search of relief from menopause symptoms take the lowest
effective dose.
Doctors may find that some patients respond better to different
delivery forms or drug combinations. Also, some drugs are made
with peanut oil, and patients allergic to peanut oil may need the
active ingredient to be compounded without it.
Each and every time, though, that doctors prescribe compounded
hormones, they do it because they determine that their patients
have needs for medications that are significantly different from
what is manufactured.
Compounded hormones, like compounded medicines overall, are
regulated by State boards of pharmacy. The U.S. Pharmacopeia
and Pharmacy Compounding Accreditation Board set standards for
their preparation. FDA regulates the suppliers of the ingredients
that pharmacists use to compound these medicines. the FDA and
the Federal Trade Commission regulate the marketing practices of
pharmacies.
In conclusion, millions of women have been prescribed manufactured
hormone products. Many of them have found relief from the
torturous symptoms of menopause. Some have not and, instead,
have been prescribed compounded hormones by their physicians,
and they have found relief.
I would respectfully urge the members of this committee, and
Congress overall, to consider the impact of any new policies that
they would have on them.
Thank you.
[The prepared statement of Dr. Allen follows:]