January 30, 2009
On behalf of the nearly 2,000 pharmacists represented by the International Academy of Compounding Pharmacists, thank you for your recent programs about bioidentical hormone replacement therapy and for bringing this important issue to the forefront of the health care conversation. We applaud the work of your producers and the research that was evident throughout the two programs.
We want to clarify several issues raised by Dr. Lauren Streicher.
First, Dr. Streicher drew a false distinction between “FDA-approved pharmacies and non- FDA-approved pharmacies,” and insinuated that compounding pharmacies are not approved by the FDA. In fact, there is no such thing as an FDA-approved pharmacy. All pharmacies are registered, inspected and regulated by state boards of pharmacy—including compounding pharmacies.
There are national standards of practice in the United States Pharmacopia as well as local state regulations for pharmacy compounding. Further, there is a national accreditation program, the Pharmacy Compounding Accreditation Board (www.pcab.org) that evaluates and gives recognition to those pharmacies that meet the highest standards of quality assurance.
Dr. Streicher also said, “They (compounding pharmacists) have no obligation to support their claims. They can say what they want… The truth is, you can get the exact same product in an FDA-approved pharmacy from true experts.”
Actually, the truth is pharmacies cannot say whatever they want. They cannot give false or misleading information without facing potential enforcement action by FDA, FTC and the state board of pharmacy. Further, it is true that most bioidentical hormones are now manufactured by FDA-registered manufacturers and dispensed by state board registered pharmacies. These meet the needs of some patients. For other patients, they are prescribed compounded doses and dosage forms that must be compounded by a specialty pharmacy. There are standards by which pharmacies abide to ensure the quality of their medications.
We encourage patients to ask their compounding pharmacist about the procedures they follow to ensure the quality of the preparation. One simple question to ask is if the pharmacy sends out samples to an outside testing lab to ensure preparations are of appropriate strength and purity.
Dr. Streicher also misstated that all synthetic hormones were plant-derivatives. This is not the case. For example, some of the most widely prescribed synthetic hormones are conjugated estrogens derived from horse urine. These are not biological equivalents as are estradiol or estriol. Equally misleading was Dr. Streicher’s suggestion that bioidentical hormones are generally obtained directly from compounding pharmacies. Bioidentical estrogens, whether compounded or manufactured, may only be dispensed to a patient pursuant to a valid prescription from a licensed prescriber (physician, nurse practitioner,
etc). Dispensing these medications without a valid prescription is a violation of both federal and state law.
Finally, you should be aware that there has been a campaign by Wyeth and others to try to restrict access to estriol, a key component in many compounded BHRT therapies. We encourage patients and prescribers to engage in our collective effort to protect access to these important therapies. For more information, see www.savemybhrt.org.
Again thank you for your efforts to highlight this critical issue in women’s health, and we appreciate the opportunity to set the record straight. If we can be of assistance in any way as a resource on the value of compounding pharmacies in today’s health care, please do not hesitate to give us a call at (281) 933-8400.
Executive Director / EVP