Statement From The American Pharmacists Association Regarding FDA's Action Against Compounded Menopause Hormone Therapy Drugs

Main Category: Menopause
Also Included In: Pharmacy / Pharmacist
Article Date: 15 Jan 2008 - 2:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Following is a statement by John A. Gans, PharmD., Executive Vice President and CEO of the American Pharmacists Association (APhA), in response to warning letters sent to seven pharmacy operations by the U.S. Food and Drug Administration (FDA). The letters state "bio-identical hormone replacement therapy," (BHRT) products, are unsupported by medical evidence and are considered by the Agency false and misleading, and that the use of estriol in these products violates the FDA's compounding compliance policy guide.

"APhA does not support misleading marketing claims of any pharmacy products. Patient safety is our utmost concern. However, APhA believes that limiting compounded medications to those that include bulk drug ingredients of FDA-approved drug products, greatly limits patient access to medications that address their unique needs. While this FDA warning focuses solely on the compounding of menopause hormone replacement therapy drugs, APhA believes that other compounded medications may be at risk for future FDA scrutiny.

"The practice of compounding is an important and long-standing component of pharmacy practice. While early practice of pharmacy required the compounding of virtually all medications, the advent of pharmaceutical companies created less of a demand for pharmacist compounded products. However, the need for compounding has certainly not disappeared. Today, compounding allows pharmacists to use their extensive medication knowledge and expertise to produce individualized medication formulations that meet an patient's needs and improve health outcomes.

"The 1997 Food and Drug Administration Modernization Act (FDAMA) provided a number of regulations on food, drugs, devices and biological products. FDAMA listed three sources of bulk drug ingredients that could be used in compounding: drug substances that are components of FDA-approved drugs, drug substances that comply with the standards of an applicable U.S. Pharmacopoeia or National Formulary monograph, and/or drug substances that appear on a list developed by the FDA. However, in a set of guidelines that the FDA released five years later, the Agency asserted that compounded drugs should only use active ingredients that are components of FDA-approved drugs, essentially reducing the number of potential sources for bulk drug products from three to one. The Agency is using this interpretation to oppose the use of estriol in BHRTs, stating it is not an FDA-approved drug. APhA does not agree with limiting pharmacy compounding to only FDA-approved drug components. The Agency guidelines fail to address the use of drugs that have been on the market since before the development of the FDA process in 1938. While not technically considered FDA-approved, acetaminophen, aspirin, phenobarbital and chloral hydrate are commonly compounded for specific patient needs based upon a physician order.

"Finally, APhA believes that the FDA has been empowered by Congress to regulate the manufacturing of pharmaceuticals; however the regulation of pharmacy practice - and of compounding for specific patient needs pursuant to a legitimate prescription order - should remain with state boards of pharmacy. Additionally, the Pharmacy Compounding Accreditation Board provides standards for compounding pharmacies to follow that ensure integrity and quality of compounded medications.

"In all cases, APhA encourages patients to talk with their physicians and pharmacists to determine their best treatment option including appropriately compounded medications."

The American Pharmacists Association, founded in 1852 as the American Pharmaceutical Association, represents more than 60,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians, and others interested in advancing the profession. APhA, dedicated to helping all pharmacists improve medication use and advance patient care, is the first-established and largest association of pharmacists in the United States.

American Pharmacists Association