Pharmacy Profession Gravely Concerned by Anti-Patient Compounding Bill

    WASHINGTON, March 7 /PRNewswire-USNewswire/ -- 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 longstanding 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 counterproductive
 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.
 
     For more information, please contact:
 
     American Pharmacists Association
     Gail Street
     202-628-4410
     gstreet@aphanet.org
 
 
 
 
     National Community Pharmacists Association
     Robert Appel
     703-682-8200
     robert.appel@ncpanet.org
 
     International Academy of Compounding Pharmacists
     Joshua Wenderoff
     202-777-3502
     jwenderoff@clsdc.com
 
 

SOURCE Pharmaceutical organizations