Re: limiting YOUR choices (C&P)
JB, from what I understand, and 2 pharmacists I know, it will effect any custom dosed medication, and any custom blended medication.
And you know a bill this size has dozens of hidden secrets in it, they always do.
http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=414436
Safe Drug Compounding Act of 2007
Apr 2, 2007
By: Reid Paul
Drug Topics
L. D. King
Pharmacy industry critics are "gravely concerned" that the Safe Drug Compounding Act of 2007, a draft Senate bill, would sharply curtail the practice of compounding by giving the Food & Drug Administration authority to regulate compounding. A coalition of nine pharmacy organizations drafted a letter to the bill's expected sponsors?Senators Edward Kennedy (D, Mass.), Pat Roberts (R, Kan.), and Richard Burr (R, N.C.)?insisting that the bill "would negatively impact patient access to necessary compounded prescription medications and create onerous, new requirements for prescribers and pharmacists."
In the letter, the American Pharmacists Association, National Community Pharmacists Association, International Academy of Compounding Pharmacists (IACP), American College of Apothecaries, American Society of Consultant Pharmacists, National Alliance of State Pharmacy Associations, Massachusetts Pharmacists Association, North Carolina Association of Pharmacists, and Kansas Pharmacists Association strongly urged the senators "to reconsider introducing this draft legislation." The groups touted the work of the U.S. Pharmacopeia, state boards of pharmacy, and the Pharmacy Compounding Accreditation Board (PCAB) and promised to work with Congress to address concerns about pharmacy compounding.
Larry Sasich
"State boards of pharmacy have done a great job to write compounding standards," asserted L. D. King, executive director of IACP. "The PCAB just started. Our emphasis should be on these institutions, not moving power to the FDA. There's no way that the FDA will be equipped to handle this."
The bill has yet to be introduced, and the likelihood of its passage is unclear. Still some critics worry that the bill may be added as an amendment to upcoming healthcare or other legislation and may pass without a debate. "We have not seen broad support to enable the bill to pass as a stand-alone, but we are concerned about it as an amendment," explained King.
Several provisions of the Safe Drug Compounding Act of 2007 promise to redefine oversight and regulation of the practice of compounding. The act gives power to the FDA to inspect all retail pharmacies that make or dispense compounded medications and to determine whether or not compounded medications are medically necessary or are "essentially copies" of existing FDA-approved medications. In addition, the act would take a number of steps to inhibit the distribution of compounded medications beyond state lines.
Critics of the bill also contend the bill would potentially come between doctors and their patients by forcing doctors to prove that the compounded prescription is medically necessary. "It will put up barriers, preventing patients from receiving medications prescribed by their doctors," insisted King. "We feel that interferes in the doctor-patient relationship."
Compounding critics, on the other hand, were largely pleased with the draft bill and insist that the act would clarify several issues that have been unclear since 1997 when the Supreme Court struck down portions of the FDA Modernization Act (FDAMA) dealing with compounding. "Kennedy's bill goes a long way in correcting the problems and dangers we have with pharmacy compounding," argued Larry Sasich, Pharm.D., consultant for Public Citizen and assistant professor of pharmacy practice at Lake Erie College of Osteopathic Medicine School of Pharmacy in Erie, Pa. "This corrects the deficiencies of the 1997 law and addresses everybody's major concern: patient safety."
Although the bill has not even come to the Senate, pharmacy organizations appear to be girding for a battle. "We have to educate the senators on the health committee about the unintended consequences this bill will have," said King. "There have been some petitions from pharmaceutical companies calling on the FDA to regulate compounding. We know that they have tremendous influence on Capitol Hill. There's no way we can match up with them."
http://www.freerepublic.com/focus/f-news/1825261/posts
WASHINGTON 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.
