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

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I'd advocate for either Accreditation by the Pharmacy Compounding
Accreditation Board [PCAB] or equivalent or provide more moneys to the States so that
they can hire and train many, many more Compounding Inspectors. A hefty increase in
the Licensure Fees for Compounding as was affected for Sterile Compounding would
also create a healthy revenue stream to State coffers for recruitfijent and training of a
legion of stringent regular inspectors. As far as models of National, not Federal,
regulatory bodies are available for template: the National Association of Insurance
Commissioners (NAIC) acts as a forum for the creation of laws and regulations for the
insurance industry, with each state's Insurance Commissioners reporting to them.
This model also assumes the registering body would be responsible for the ethics
of the profession, but in the UK there has been a move to separate the two roles. Other
nations use representation and regulation at the national level such as, the Royal
Pharmaceutical Society of Great Britain (RPSGB), the Pharmacy Guild of Australia and
we do have our own American Pharmacists Association (APhA) which is a weakly
structured organization. A pilot project among interested States could be a good way to
start restructuring and remodeling the regulation of compounding pharmacy to Good
Compounding Practices (GCP) at a national level.
On the other hand, we have an Accreditation Body who could provide the basis
for inspecting to Good Compounding Practices (GCP) as I have mentioned above. For
those women relying on the Wiley Protocol for hormone replacement therapy, a
compounding pharmacist is essential. I would ask for your support in the potential re-
regulation of compounding pharmacy at the States level to achieve Good Compounding
Practice (GCP).
While the amount of prescriptions which are compounded is relatively small,
compared to the economic Goliath of the big pharmaceutical companies, for those people
who need the service, there is no manufacturer who can or would do it. The pharmacist
plays a vital role in meeting those specific patient needs, if the patient is to be offered a
pharmacologic solution.
Furthermore, as I said, compounding is essential in the hospital environment
where intravenous prescriptions are compounded daily. In the Los Angeles Times, April
9, 2007, Times Staff Writer, Melissa Healy eloquently investigated three new promising