Compounding Under Attack: Pharmacy Profession Gravely Concerned by Anti-Patient Compounding Bill

Senators Edward Kennedy (D-Mass.), Pat Roberts (R-Kan.) and Richard Burr (R-N.C.) have devised a plan to limit your Healthcare Freedom.
Please take action now to preserve your rights and citizens residing in MA, NC, KS may want to contact these senators and express your displeasure with their actions.

Pharmacy Profession Gravely Concerned by Anti-Patient Compounding Bill

WASHINGTON [Compounding Pharmacy News, June 2007], - A coalition of nine pharmacy organizations representing more than 60,000 pharmacists today expressed grave concerns over proposed legislation that would restrict patients' access to vital compounded prescription medications and create onerous, new requirements for both prescribers and pharmacists. The American Pharmacists Association, the National Community Pharmacists Association, the International Academy of Compounding Pharmacists, the American College of Apothecaries, the American Society of Consultant Pharmacists, the National Alliance of State Pharmacy Associations, the Massachusetts Pharmacists Association, the North Carolina Association of Pharmacists, and the Kansas Pharmacists Association expressed their concerns in a joint letter to expected sponsors of the Safe Drug Compounding Act of 2007, Senators Edward Kennedy (D-Mass.), Pat Roberts (R-Kan.) and Richard Burr (R-N.C.).

The draft legislation "would not have the intended effect on patient health you desire," the organizations noted in the letter. "Instead, the proposal would negatively impact patient access to necessary compounded prescription medications and create onerous, new requirements for prescribers and pharmacists. We strongly urge you to reconsider introducing this draft legislation."

"This proposed legislation would disrupt long-standing and well accepted medical and pharmacy practices," the organizations continued, "and it would set precedents for the disruption of non-compounding practices, such as the prescription of medications for off-label use. Most importantly, it would negatively impact patient care by placing undue and counter-productive restrictions on licensed prescribers and pharmacists, while doing nothing to stop the rogue compounding practices that exist."

The organizations also noted in the letter: "The profession has taken great strides over the last decade to improve pharmacy compounding practice. U.S. Pharmacopeia standards and State Board of Pharmacy regulations are increasingly rigorous. Furthermore, the establishment of the Pharmacy Compounding Accreditation Board which is co-managed by the undersigned as well as the U.S. Pharmacopeia has started accrediting compounding pharmacies that meet high standards of practice. We would encourage Congress to work with these institutions to address any concerns with pharmacy compounding."

The organizations outlined several concerns in the letter, noting that the proposed legislation would:

Insert the FDA into the physician-patient relationship by giving the Agency the authority to determine broadly when compounded medications are needed; Create new requirements for physicians to document when compounded medications are needed, duplicating the underlying purpose of a prescription, pursuant to which a product is compounded. Allowing FDA to regulate compounded medications in this way is one short step away from requiring doctors to document medical need for prescribing medications for off-label use and restricting the practice altogether; Prohibit well-established compounding practices authorized by stringent state pharmacy laws and regulations. For example, this bill would restrict the ability of prescribers to prescribe and administer compounded medications for office use, a critical function explicitly allowed by many State Boards of Pharmacy that enables prescribers to prescribe and administer certain compounded medicines that patients cannot administer themselves, such as injectables; Broadly eliminate the availability of many critical, commonly compounded sterile preparations, particularly those commonly prescribed by physicians in hospitals; Call for FDA to establish federal requirements for sterile compounding that duplicate and supersede those already established by the U.S. Pharmacopeia while also requiring these medications to carry a label reading: "This drug was not prepared using FDA's manufacturing standards for sterile drugs;" Severely restrict interstate distribution of compounded medications, a move that will endanger many patients served by pharmacies practicing near state borders, "snowbird" patients whose hometown pharmacies continue to serve them during winter months, and patients living in rural communities who may be hundreds of miles away from the nearest compounding pharmacy; Dilute the FDA's already strained resources. Compounding pharmacies are already regulated by their State Board of Pharmacy.

FDA's resources should remain focused on addressing the overwhelming backlog of manufactured drugs pending approval and strict oversight of the source ingredients that both pharmacies and manufacturers use; Give wider authority over compounded medications to a federal agency, the FDA, thereby removing the current authority of State Boards of Pharmacy. Just as State Boards of Medicine regulate medical practice, State Boards of Pharmacy regulate pharmacy and their regulatory authority should be preserved. The FDA, while acknowledging the need for legitimate pharmacy compounding and expressing strong interest in taking over the regulation of this aspect of pharmacy practice, is not the appropriate regulatory agency to oversee this practice. FDA's recent record on this front is not strong, as evidenced by the fact that FDA has yet to revise poorly written compliance policy guides despite three and four year-old requests of more than one hundred Members of Congress to do so; Prematurely establish a new regulatory structure before these issues are resolved in an ongoing federal case, Medical Center Pharmacy v. Gonzalez. In August 2006, a Federal District judge ruled in this case that compounded drugs for humans are not new, unapproved drugs subject to the Federal Food, Drug and Cosmetic Act and that pharmacies in compliance with all state regulations are exempt from FDA inspections.

This decision is currently under appeal; and Create onerous regulations that do little to improve patient safety while significantly impeding the ability of community pharmacies to continue to provide these services for their patients and prescriber community.

This law, if passed, would invalidate any court's decision that compounded medications are not subject to FDA's jurisdiction. It is essential that this proposal is defeated. Our understanding is that Senator Kennedy is planning to attach this to the Prescription Drug User Fee Act (PDUFA) that must be re-authorized by September 2007.

We need your help to stop this proposal from gaining more traction with members of the senate or access to your compounded medications will be limited severely impacted:

Take action now!