March 2, 2015
To the Editor,
Pharmacy Times’ coverage of a study about women’s knowledge of compounded hormone therapy (More Patient Education Needed on Compounded Hormone Therapy, February 20) left out several facts and key points that are important to understanding the broader story.
First, it is important to note that the study the article referenced was funded by a manufacturer of hormone medications, a direct competitor of compounding pharmacies. We believe full disclosure and transparency around the organization that is funding a study is important when considering both the study and its findings.
Second, compounded medications are derived from either manufactured products, which are FDA approved, or from bulk chemicals, which are produced at FDA-approved facilities. In the former case, the compounded medication is FDA approved. In the latter, the ingredients have been prepared under FDA supervision, even though the compounding process falls outside of FDA approval.
Third, traditional compounding pharmacies are licensed by state boards of pharmacy. They are subject to unannounced inspections and must follow rigorous United States Pharmacopeia (USP) standards that govern compounding. While we all know state oversight was lax in the 2012 meningitis outbreak that resulted from medications produced by New England Compounding Center (NECC), in the two-plus years since that event, legislators and state regulators have worked to significantly tighten oversight and regulation of compounding pharmacies across the nation. Legislators in Massachusetts, where NECC was located, say the state now has one of the toughest compounding laws in the nation.
A compounding pharmacy operated under stringent state regulation that is preparing either FDA-approved medications or medications from FDA-approved ingredients offers women a safe, high quality product. Whether consumers know what federal agency might regulate the entity that prepared their medication seems far less relevant.
David G. Miller, R.Ph
EVP & CEO
International Academy of Compounding Pharmacists