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

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Senator SMITH. Thank you, Doctor.
I am going to let Dr. Allen testify, and then I have a question
for the both of you.
STATEMENT OF LOYD ALLEN, EDITOR-IN-CHIEF, INTER-
NATIONAL JOURNAL OF PHARMACEUTICAL COMPOUNDING,
SUGAR LAND, TX
Dr. ALLEN. Thank you, Senator Smith. I appreciate and share
your dedication to improving the health of Americans. I thank you
for the opportunity to speak to you about my profession, pharmacy
compounding, and the role that we play in preparing compounded
hormone treatments.
In the way they are prescribed, prepared and regulated, compounded
hormones are just like all other compounded medicines, so
I will first address pharmacy compounding overall briefly.
Most of the time, when patients need pharmaceutical treatment,
doctors prescribe mass-produced, off-the-shelf drugs. But for some
patients, those drugs are inappropriate. When they are, doctors
may prescribe compounded medications, which are then customcompounded
by licensed and trained compounding pharmacists.
Compounded medicines are most commonly prescribed for a
number of reasons. Sometimes patients are allergic to the inactive
ingredients that are in off-the-shelf products. Other patients require
personalized dosage strengths or delivery forms. Also, many
times pharmaceutical manufacturers discontinue drugs because
they aren't profitable but patients still rely on them and can have
doctors prescribe compounded versions of them.
Hospice care patients; cancer patients, dental patients, especially
pediatric patients, HIV and AIDS patients, ophthalmology patients
all tend to have individual medical needs and, thus, tend to rely
on compounded medicines.
State boards of pharmacy, State medical boards, the Food and
Drug Administration, the Federal Trade Commission, the Drug Enforcement
Agency, and other Federal and State agencies each have
some degree of oversight over pharmacy compounding. The United
States Pharmacopeia and -the Pharmacy Compounding Accreditation
Board all play critical roles. Together, they have constructed
a web of regulations and 'standards that protect patients.
State boards of pharmacy license pharmacists and pharmacies
and enforce laws that cover the processes and equipment pharmacists
use to prepare these medicines, including sterile medicines,
recordkeeping, and labeling, among other aspects of pharmacy
practice.
Since 1820, the United States Pharmacopeia has been the national
standard-setting body for pharmaceuticals and pharmaceutical
ingredients, and recognized by Congress as such. It, too,
has strong enforceable standards for pharmacy compounding of
both sterile and non-sterile medications. States are increasingly
codifying USP standards.
The profession is also taking action. Most notably, the United
States Pharmacopeia, American Pharmacists Association, National
Community Pharmacists Association, National Boards of Pharmacy,
and other associations have launched the Pharmacy
Compounding Accreditation Board.