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

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* We support the pharmacy's exemption from the rules which govern
manufacturers, while we expect the FDA to enforce standards and principles
relating to labeling, purity, content, etc. We believe that the regulation of the
healing professions is the purview of the States and should remain there as
long as rigid guidelines for methods and materials are maintained by regular
State Inspection.
* We support extended education and training for all pharmacists who
compound and provide specific training in the above requirement methods for
compounding the Wiley Protocol.
The Future of Compounding
While we have a rigorous protocol for the preparations that comprise the Wiley
Protocol that our pharmacists compound and we are confident that our preparations
contain what they say they contain due to rigorous and frequent testing (evidence
attached), should the detractors accuse the profession of custom Compounding to fall
short of quality benchmarks in general or in specific cases, more over sit of the
profession by the States, is long overdue and not an unbearable burden, fiscally. The
conundrum is how to regulate compounding pharmacists and pharmacies.
The logical answer is to look back at history. Pharmacy schools need to once
again assume the responsibility of training compounding pharmacists. Academic
accrediting bodies need to be in charge of credentialing compounding pharmacists.
State Boards of Pharmacy need to be in charge of inspecting and monitoring
compounding pharmacies. In most states, the State Board of Pharmacy is responsible for
licensing sterile compounding; there is no reason why they should not assume to
responsibility of licensing non-sterile compounding as well.
If the Federal Government stopped the practice of compounding, all it would
achieve is leaving millions of patients without resources to alleviate various conditions.
We certainly need the federal government to support Schools of Pharmacy, State Boards
of Pharmacy and accrediting agencies, to ensure that compounding pharmacies are
meeting the required highest of standards.