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Physicians, Patients, Pharmacists Express Disappointment with AMA Resolution
FOR IMMEDIATE RELEASE
December 18, 2006
Contact: Joshua Wenderoff
202-777-3502
jwenderoff@clsdc.com
Physicians, Patients, Pharmacists Express Disappointment with AMA Resolution
CHICAGO A coalition of the nation’s top pharmacist associations expressed disappointment with a recently-passed American Medical Association resolution. Signed by leaders of the American Pharmacists Association, the International Academy of Compounding Pharmacists, the National Association of State Pharmacy Associations, and the National Community Pharmacists Association, the letter stresses that state boards of pharmacy should continue to be the primary regulators of pharmacy practice, just as state medical boards oversee medical practice. In letters and faxes to the AMA, more than 2,200 patients and physicians members of the patients’ and physicians’ rights advocate, Patients and Professionals for Customized Care also expressed concern with the resolution.
The resolution calls for increased federal regulation of compounded hormones. Regarding this point, the letter reads: “State pharmacy boards, the U.S. Pharmacopeia, and the Pharmacy Compounding Accreditation Board all play important roles as regulators and standard-setters for pharmacy compounding. Unfortunately, by failing to acknowledge these organizations, [the AMA’s resolution] suggests that there is no role or, at best, a secondary role for these organizations to play.”
The resolution also was introduced by three organizations that receive significant funding from hormone manufacturer Wyeth, yet failed to disclose those ties to the body within the AMA that passed the resolution. The letter notes: “These organizations should have disclosed this information to the House of Delegates before the vote.” The letter recognizes that the AMA has addressed pharmacy compounding issues more deliberately and appropriately in the past, but asks that it take a similar approach in the future. “Just this June,” the letter explains, “the AMA passed a more measured, compounding-related resolution. … The June resolution was significantly stronger as a result of the AMA’s consultation with the pharmacy profession. The AMA should have taken a similar approach this time.”
In addition to the joint letter, more than 2,200 members of Patients and Professionals for Customized Care including more than 260 physicians expressed disappointment to the AMA. “As a physician in private practice and Colorado Medical Society member for over 25 years, I have literally written thousands of prescriptions for compounded medicines for patients that were unable to take FDA approved pharmaceuticals. Without access to compounded formulations, some of these patients would have died. I do not feel that this resolution accurately represents my interests as a practicing physician and it certainly doesn’t serve the interests of my patients,” wrote Robert Rountree, MD, Adjunct Faculty Member, Institute for Functional Medicine (Gig Harbor, Wash.) from Boulder, Colo.
With more than 18,000 members and growing, Patients and Professionals for Customized Care is the leading grassroots organization dedicated to protecting patients’ and physicians’ access to customized medicine.
The joint letter is available online at www.iacprx.org/AMAletter.
About IACP
The International Academy of Compounding Pharmacists (IACP) is a non-profit association founded in 1991 to protect, promote and advance the compounding pharmacy profession. We represent more than 1,800 pharmacists, physicians, technicians and patients who are committed to the safe practice of pharmacy compounding. We are committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and of patients to take customized medications that meet their unique, individual needs. Visit http://www.iacprx.org/ to learn more about pharmacy compounding.
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IACP Concerned with AMA Resolution Regarding Compounded Hormones
FOR IMMEDIATE RELEASE
November 15, 2006
Contact: Joshua Wenderoff
202-777-3502
jwenderoff@clsdc.com
IACP Concerned with AMA Resolution Regarding Compounded Hormones
MISSOURI CITY, Texas The American Medical Association (AMA) House of Delegates yesterday passed a resolution that departs from the longstanding position that states oversee pharmacy practice and, for the first time, urges the Food and Drug Administration (FDA) to oversee certain compounding practices in connection with the preparation of bioidentical hormones.
The International Academy of Compounding Pharmacists supports efforts to promote patient safety and education for all medicines including compounded, bioidentical hormones. However, the AMA resolution calls for sweeping regulatory changes and the organization’s rush to judgment may have unintended consequences that impede rather than strengthen quality healthcare.
“The introduction of the resolution appears to be an extension of Wyeth’s campaign to restrict patients’ access to bioidentical hormones,” said L.D. King, executive director of IACP. “The organizations behind it the Endocrine Society, the American Association of Clinical Endocrinologists and the American Society for Reproductive Medicine have received at least several hundred thousand dollars in funding from Wyeth. Yet in their dealings with the media, with the government and with organizations like the AMA, these groups continue to fail to disclose their financial relationships with Wyeth, which benefits most directly from FDA intervention in compounding.”
When patients have individual medical needs that one-size-fits-all medications cannot meet, doctors often prescribe compounded medicines. And even though the mainstream medical community recognizes the value of pharmacy compounding, the FDA’s position on compounded medicines is that they are all illegal. As a result, compounding pharmacists generally oppose expanding FDA oversight of their profession.
Millions of Americans rely on “off-label” and compounded medications for their health that are lawful and medically appropriate, even though they are not “FDA-approved.” The AMA has long recognized and protected the right of doctors to use their professional training to prescribe the medicines they feel are best suited for their patients. If the FDA extends its reach into these areas of physician discretion, what begins as restrictions on compounding may well lead to comparable limitations on the availability of medicines for off-label uses.
"The AMA resolution also is troubling because it recommends a new role for the federal government in an area of healthcare pharmacy practice that long has been the province of states,” continued Mr. King. “State medical and pharmacy boards regulate their respective professions. Encroachment on state authority by the FDA, which considers all compounded medicines illegal, threatens patients’ access to compounded medicines prescribed by their doctors. Would the AMA recommend federal oversight of medical practice regulated by states? Would AMA recommend state oversight of the prescription drug approval and labeling processes overseen by the FDA? Surely not. So why does AMA feel it is appropriate to inject the federal government into health practice that always has been regulated by states?”
The resolution ignores the primary roles that state boards of pharmacy, U.S. Pharmacopeia, the Pharmacy Compounding Accreditation Board and pharmacy organizations play in regulating and setting standards for pharmacy compounding.
Of additional concern to IACP, the resolution indiscriminately labels compounding pharmacies as ‘drug manufacturers;’ it refers to unnamed studies of unknown merit; and it calls for potentially unconstitutional restrictions on pharmacists’ commercial free speech rights.
IACP supports and is funding studies of bioidentical hormone replacement therapy. We have developed and are promoting labeling guidelines that explain to patients the unique nature of their compounded medications. IACP also supports adverse event reporting for compounded medicines. What concerns IACP is that FDA does not have nor should it have the authority to do what AMA will ask of it.
In the past, the AMA has considered compounding-related resolutions and listened to all sides of the debate. A resolution that came before the AMA House of Delegates in June of this year, introduced by two members of an AstraZeneca-funded coalition and broadly attacking pharmacy compounding, was referred to the Board of Trustees because the language needed refinement. After months of deliberation that included consultation with the pharmacy profession, the end product called for cooperation between state pharmacy boards, USP and FDA as well as self-regulation.
“The June resolution was significantly stronger as a result of the AMA’s consultation with the pharmacy profession,” concluded Mr. King. “The AMA should have taken a similar approach this time.”
About IACP
The International Academy of Compounding Pharmacists (IACP) is a non-profit association founded in 1991 to protect, promote and advance the compounding pharmacy profession. We represent more than 1,800 pharmacists, physicians, technicians and patients who are committed to the safe practice of pharmacy compounding. We are committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and of patients to take customized medications that meet their unique, individual needs. Visit http://www.iacprx.org/ to learn more about pharmacy compounding.
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In Victory for Patients, Federal Court Rules that Compounded Medicines are Legal
FOR IMMEDIATE RELEASE
August 31, 2006
Contact: Joshua Wenderoff
202-777-3502
jwenderoff@clsdc.com
In Victory for Patients, Federal Court Rules that Compounded Medicines are Legal
Missouri City, Texas - The International Academy of Compounding Pharmacists today applauded the ruling from U.S. District Court Judge Robert Junell that compounding is legal. The Court’s written opinion follows an initial ruling from the bench issued on May 25, 2006.
"The Court’s ruling is a precedent-setting victory for millions of patients, their doctors who prescribe compounded medicines for them and the compounding pharmacists who prepare their medications," said L.D. King, executive director of IACP. "Congress, the U.S. Supreme Court, and each of the 50 state boards of pharmacy that regulate compounding have long recognized the value of pharmacy compounding, yet the FDA has contended for nearly 20 years that compounded medications are illegal. This ruling affirms what the rest of the government and medical establishment have long held - compounding is vital and it is legal."
The case - Medical Center Pharmacy, et al. v. Gonzalez, et al., No. MO-04-CV-130, in the United States District Court for the Western District of Texas, Midland-Odessa Division - was filed in September 2004 by 10 pharmacies against the Food and Drug Administration and addressed a number of issues affecting the practice of pharmacy compounding.
First, the Court ruled that "compounded drugs do not fall under the new drug definitions" and, as a result, are legal. Judge Junell explained: "If compounded drugs were required to undergo the new drug approval process, the result would be that patients needing individually tailored prescriptions would not be able to receive the necessary medication due to the cost and time associated with obtaining approval. ... It is in the best interest of public health to recognize an exemption for compounded drugs that are created based on a prescription written for an individual patient by a licensed practitioner."
Second, the Court ruled that pharmacies are exempt from the requirement to submit to an FDA inspection of their records unless FDA can demonstrate that the pharmacy is not compliant with applicable state laws and does not operate as a retail pharmacy. The Court also ruled that each of the 10 plaintiffs met the requirements for exemption.
Third, the Court ruled that compounding from bulk pharmaceutical ingredients for non-food animals is legal. This is an important issue for animal owners and their veterinarians who prescribe compounded medications to treat a variety of conditions, many of which require medications that are only available by compounding bulk pharmaceutical ingredients. Without them, animals may needlessly suffer or even die. Until now, FDA asserted that prescribing and preparing these treatments was illegal.
The plaintiffs were represented by the Austin, Texas, law firm of Hance, Scarborough, Wright, Woodward & Weisbart.
IACP was not a plaintiff in the case but filed Amicus Curiae briefs supporting them. IACP's March 2005 brief can be downloaded directly from http://www.iacprx.org/midlandamicus and its May 2006 brief from http://www.iacprx.org/midlandamicus2.
About IACP
The International Academy of Compounding Pharmacists (IACP) is a non-profit association founded in 1991 to protect, promote and advance the compounding pharmacy profession. We represent more than 1,800 pharmacists, physicians, technicians and patients who are committed to the safe practice of pharmacy compounding. We are committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and of patients to take customized medications that meet their unique, individual needs. Visit http://www.iacprx.org/ to learn more about pharmacy compounding.
Resources
Midland District Court Order (.pdf)
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IACP Comments on Senator Grassley’s Reported Investigation of Illegal Substitution of Prescription Drugs by Pharmacies
FOR IMMEDIATE RELEASE
July 14, 2006
Contact: Joshua Wenderoff
202-777-3502
jwenderoff@clsdc.com
IACP Comments on Senator Grassley’s Reported Investigation of Illegal Substitution of Prescription Drugs by Pharmacies
MISSOURI CITY, Texas - USA Today reported today that Senator Charles Grassley (R-Iowa) is looking into incidences of illegal substitution of prescription drugs by pharmacies and home health care companies. The following statement on this report is attributed to L.D. King, executive director of the International Academy of Compounding Pharmacists:
“While IACP has not seen the correspondence between Senator Grassley and the FDA, illegal substitution is already improper under state law and is regulated by state boards of pharmacy. We are confident that any instances of illegal substitution are isolated, that pharmacies comply with substitution restrictions, honor the prescriptions written by physicians and other prescribers, and comply with other laws governing pharmacy as they are vital to patient safety.
“Whether pharmacists are dispensing compounded, brand-name or generic medications, IACP supports and encourages state boards of pharmacy to take action against any businesses and individuals not complying with the laws governing pharmacy.
“The relationship between physicians, patients and pharmacists is the cornerstone of our profession, and any violation of this trust strikes at the core of our ethics as pharmacists.
“Compounding is a longstanding and basic component of pharmacy practice. As a profession, we remain committed to improving every aspect of pharmacy compounding via an accreditation program as well as strong state and national standards.”
About IACP
The International Academy of Compounding Pharmacists (IACP) is a non-profit association founded in 1991 to protect, promote and advance the compounding pharmacy profession. We represent more than 1,800 pharmacists, physicians, technicians and patients who are committed to the safe practice of pharmacy compounding. We are committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and of patients to take customized medications that meet their unique, individual needs.
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Return to topJuly 12, 2006 - RS Software Offers Labels for Compounded Medicines that Comply with International Academy of Compounding Pharmacists Uniform Labeling Guidelines
FOR IMMEDIATE RELEASE
July 12, 2006
RS Software Offers Labels for Compounded Medicines that Comply with International Academy of Compounding Pharmacists Uniform Labeling Guidelines
MISSOURI CITY, Texas The International Academy of Compounding Pharmacists (IACP) announced today that Norman, Okla.-based RS Software, a leading pharmacy software provider whose compounding software, Compound Assist, has become a household name in compounding pharmacy, is now offering its customers the ability to use its Script Assist program to produce labels for compounded medications that comply with IACP’s uniform labeling guidelines. IACP released the guidelines earlier this year to assist pharmacists in providing patients with consistent and complete information about compounded medications, which are prepared in pharmacies to meet the unique needs of patients for whom manufactured products are inappropriate.
Pharmacy practice, including the preparation and labeling of custom medications, is regulated by state boards of pharmacy. As such, labeling requirements may vary from state to state. Moreover, the consumer information that is commonly included with manufactured pharmaceuticals is not available for compounded preparations, as these preparations are individually designed for each patient, eliminating the possibility of uniform pamphlets. IACP’s labeling guidelines are intended to address the above issues by providing consistent and complete information about the nature of compounded medications.
Robert M. Standridge, D.Ph., president of RS Software and a compounding pharmacist said, “IACP’s labeling standards are a leap forward for compounding pharmacists and their patients. While patients taking compounded medicines already communicate regularly with their pharmacists and physicians, these labels will reinforce that communication. They further ensure that patients are consistently getting accurate information about their prescription medicine. By offering them as a part of our software, we hope to encourage as many pharmacists as possible to start using these labels. We are already heartened by our customers’ response.”
RS Software offers a number of software programs for pharmacists, and has incorporated IACP’s suggested labels a succinct label that can be affixed to most prescription packages and a longer insert that can be placed into dispensing bags into its Script Assist product. Pharmacists using these programs can now access and print labels that comply with IACP’s uniform labeling guidelines. RS Software is the first company of its kind to take this step.
L.D. King, executive director of IACP added, “We commend RS Software for taking the lead here. Pharmacists work hard to fill prescriptions and, thankfully, they have companies like RS Software to make the administrative tasks a lot easier. By incorporating these new labels into their Script Assist product, RS Software has now made it easier for pharmacists to educate their patients about the positive differences between compounded medicines and manufactured products.”
For compounded medications prepared in response to a prescription for a specific patient, IACP recommends and RS Software now offers a label that reads: “This medicine was specially compounded in our pharmacy for you at the direction of your prescriber.” For office-use compounds, IACP recommends a label reading: “This medicine was compounded in our pharmacy for use by a licensed professional only.”
Scott Berliner, a compounding pharmacist and RS Software customer, said, “It is important that our profession takes responsibility and ensures that patients always know what they are being prescribed. I strive to provide each and every one of my patients with complete and accurate information about their treatment a responsibility I share with their physicians. Printing IACP labels via Script Assist has helped me communicate even more regularly and thoroughly with my patients, and in a way that defines compounded medicines in accurate and positive terms.”
About RS Software
RS Software is a pharmacy software development company founded by pharmacists for pharmacists. RS Software has developed software tools to support retail and compounding pharmacy. These pharmacy software tools include veterinarian pharmacy software enhancements, DME billing, long term care software features, flexible accounts receivable tools, patient counseling tools, a visual label designer, internet automation and Medicare Part D billing, as well as many other dispensing software and compounding software features and enhancements.
About IACP
The International Academy of Compounding Pharmacists (IACP) is a non-profit association founded in 1991 to protect, promote and advance the compounding pharmacy profession. We represent more than 1,800 pharmacists, physicians, technicians and patients who are committed to the safe practice of pharmacy compounding. We are committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and of patients to take customized medications that meet their unique, individual needs.
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MEDIA CONTACTS
IACP
Joshua Wenderoff
jwenderoff@clsdc.com
202-777-3502
RS Software
Phil Blouch
philb@rssoftware.net
405-321-5356
May 26, 2006 - Federal District Court Rules in Landmark Pharmacy Compounding Case: Compounded Preparations are not New, Unapproved Drugs Subject to Food, Drug, and Cosmetic Act
FOR IMMEDIATE RELEASE
May 26, 2006
Contact: Joshua Wenderoff
202-777-3502
jwenderoff@clsdc.com
Federal District Court Rules in Landmark Pharmacy Compounding Case: Compounded Preparations are not New, Unapproved Drugs Subject to Food, Drug, and Cosmetic Act
International Academy of Compounding Pharmacists Applauds Decision
MISSOURI CITY, Texas A federal district court judge in Midland, Texas, yesterday ruled that compounded preparations are not new, unapproved drugs. Two other issues in the case the Food and Drug Administration (FDA)’s broad authority to inspect pharmacies’ records and pharmacies’ ability to compound from bulk active ingredients for non food-producing animals (e.g. pets, horses, zoo animals) are still being considered by the judge. The judge ruled from the bench on the first issue and may issue a written opinion. The case Medical Center Pharmacy, et al. v. Gonzalez was originally filed by nine pharmacies in September 2004.
“This landmark ruling stops the FDA’s encroachment on the authority of state boards of pharmacy in its tracks and it ensures that patients and physicians will continue to have access to compounded medicines on which they rely,” said L.D. King, executive director of the International Academy of Compounding Pharmacists. “For years, FDA told pharmacists that what they were doing compounding medicines to fill doctors’ prescriptions was illegal. This ruling lifts the veil of uncertainty from pharmacy compounding and once again allows pharmacists to serve their patients confidently. That the judge ruled from the bench shows us just how strong the plaintiffs’ case was.”
IACP was not a plaintiff in the case but filed Amicus Curiae briefs supporting them. To view IACP’s Amicus Curiae briefs, visit www.iacprx.org/midlandamicus.
In 1938, Congress passed the Food, Drug, and Cosmetic Act to empower the FDA to require approval of new drugs made by pharmaceutical manufacturers. FDA began arguing in the late 1980’s that Congress intended for that law to apply to compounded preparations in addition to manufactured products. This meant that, according to the FDA, each compounded medicine was a “new, unapproved drug” subject to the same requirements as manufactured products. Because these requirements are inherently impossible for compounding pharmacists to meet, it meant that FDA considered all compounded preparations illegal. The judge ruled that this is not the case.
Millions of Americans have conditions that off-the-shelf, one-size-fits-all pharmaceuticals cannot meet. For them, customized, compounded medicines prescribed by physicians and prepared by licensed, trained pharmacists are the only way to better health. These medications are also critical for treating many non-food producing animals whose medical needs are too unique to be met by mass-produced drugs.
“While the court ruled on the most important issue, the remaining issues in the case are also critical,” continued Mr. King. “Unauthorized FDA inspections create uncertainty and harm pharmacies and the patients they serve. In addition, many veterinarians and pet owners rely on medications compounded from bulk ingredients to treat their pets. If FDA is allowed to decide unilaterally that this act is illegal, these animals will suffer and many will die. We hope the court will rule in favor of plaintiffs on these issues as well.”
About IACP
The International Academy of Compounding Pharmacists (IACP) is a non-profit association founded in 1991 to protect and promote the art and skill of the compounding pharmacy profession. We represent more than 1,800 pharmacists, physicians, technicians and patients who are committed to the safe practice of pharmacy compounding. We are committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and of patients to take customized medications that meet their unique, individual needs.
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May 10, 2006 - PCAB Accepting Applications
FOR IMMEDIATE RELEASE
May 10, 2006
Contact: Ken Baker
PCAB
515-341-1250
kenbaker@pcab.info
http://www.pcab.info/
Gail Street
APhA
202-429-7558
gstreet@aphanet.org
PCAB Accepting Applications
WASHINGTON, DC- The Pharmacy Compounding Accreditation Board (PCAB) is now accepting applications for accreditation from all compounding pharmacies. The initial class of nearly sixty pharmacies has begun the documentation process and the first in-pharmacy surveys are complete. Based on the successful inauguration of the accreditation program, PCAB is now inviting all compounding pharmacies to apply at http://www.pcab.info/. PCAB accreditation is a voluntary program for compounding pharmacies which was founded and continues to be lead by the American College of Apothecaries, the American Pharmacists Association, the International Academy of Compounding Pharmacists, the National Association of Boards of Pharmacy, the National Community Pharmacists Association, the National Alliance of State Pharmacy Associations, the National Home Infusion Association, and the United States Pharmacopeia.
As a part of the accreditation process, PCAB will provide accredited pharmacies with advertising and marketing material designed to provide an advantage in a very competitive field. Ken Baker, PCAB Executive Director, noted several advantages that can be gained by pharmacies that become PCAB Accredited™ compounding pharmacies. “Accreditation will not only provide assurance to patients and prescribers that this pharmacy has been tested against very strict quality and safety standards, but it will also identify it as one of the preeminent compounding pharmacies.”, Baker adds, “A compounding pharmacy now has a way of proving its adherence to high standards, not only patients and physicians, but also to insurance companies and regulators.”
With so many sensationalized stories concerning compounding being highlighted in the news, accreditation provides a positive, quality based message to patients, prescribers and the public. PCAB believes accreditation has other benefits. By answering payors demands for proof from pharmacies that they are following quality standards, PCAB believes that accreditation will lead to an increase in the number of insurance companies willing to write policies for compounding pharmacies. “Accreditation should also help hold the line on insurance premiums for accredited compounders,” says Baker. “Insurers understand that adherence to strict quality standards helps minimize errors and risks which leads to fewer liability claims.”
“Compounding is a critical component of the healthcare industry.” said PCAB Board President John A. Gans, PharmD., “because ultimately, PCAB accreditation is for the patient.” Dr. Gans, who holds the dual role of being APhA Executive Vice President, added that pharmacists must ensure that the process is driven and controlled by the profession. He believes that this will improve pharmacy practices and thereby improve patient care.
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April 4, 2006 - Thousands of Patients to FDA: Don't Let Wyeth Rob Us of Our Hormone Treatments; Responses to Wyeth Citizen Petition Likely to Top 30,000
FOR IMMEDIATE RELEASE
April 4, 2006
Contact: Joshua Wenderoff
202-777-3502
jwenderoff@clsdc.com
Thousands of Patients to FDA: Don’t Let Wyeth Rob Us of Our Hormone Treatments;
Responses to Wyeth Citizen Petition Likely to Top 30,000
SUGAR LAND, Texas More than 27,000 physicians, patients and pharmacists have written the Food and Drug Administration within the last several months to say they oppose Wyeth’s citizen petition to restrict patients’ access to bioidentical hormones. The comment period closes today, 180 days since Wyeth filed its citizen petition, and with an unknown number of comments pending, the total number of comments likely will top 30,000.
“The response to Wyeth’s citizen petition is unprecedented and very telling,” said L.D. King, executive director of the International Academy of Compounding Pharmacists. “On the one hand, Wyeth and a small number of paid allies support restricting patients’ access to bioidentical hormones. On the other hand, you have literally thousands of patients who are justifiably scared that Wyeth’s campaign will rob them of hormone treatments on which they and their physicians rely to treat pain and discomfort. This imbalance should make it easy for FDA to deny Wyeth’s petition.”
“Wyeth has a history of using politics to solve its business problems,” continued Mr. King. “In the 1990s, Wyeth successfully lobbied FDA to keep a generic version of its brand-name product, Premarin, off the market. Fortunately for patients today, Wyeth’s campaign has been exposed for what it is. It’s not about patient health, but Wyeth’s wealth.”
When Wyeth filed its comments on October 6, 2005, it triggered a 180-day comment period that ends today. Before the period ends, FDA must approve or deny (in whole or in part) the petition, or it must provide a tentative response explaining why it could not reach a decision.
IACP filed comments in December and March in response to Wyeth’s filing. In those comments, IACP explained how Wyeth’s petition is based on numerous flawed and misleading statements. The implications of Wyeth’s proposal are far-reaching and would potentially restrict patients’ access not only to compounded hormones but compounded medicines overall. IACP’s comments can be found on its website, http://www.iacprx.org/.
About IACP
The International Academy of Compounding Pharmacists (IACP) is a non-profit association founded in 1991 to protect and promote the art and skill of the compounding pharmacy profession. We represent more than 1,800 pharmacists, physicians, technicians and patients who are committed to the safe practice of pharmacy compounding. We are committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and of patients to take customized medications that meet their unique, individual needs.
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March 20, 2006 - IACP Launches Online Grassroots Campaign to Protect Patient Access to Customized Medicines
March 20, 2006
FOR MORE INFORMATION CONTACT:
Joshua Wenderoff, jwenderoff@clsdc.com
202-777-3502
International Academy of Compounding Pharmacists Launches Online Grassroots Campaign to Protect Patient Access to Customized Medicines
SUGAR LAND, Texas The International Academy of Compounding Pharmacists (IACP) today launched a new web site and online campaign designed to increase the understanding of the valuable role that customized compounded medications play in meeting the unique needs of millions of patients and their physicians or presribers. The site will make it possible for pharmacists, physicians, patients and others to get up-to-date information on compounding, join together with others of like mind and interest, and communicate their views to relevant health legislators and policymakers.
IACP also announced the launch of a companion site, CompoundingFacts.org, to address directly some of the common myths about compounding as a further means of providing the public with complete and accurate information about the profession and services provided to patients.
As part of this campaign, IACP is launching a grassroots organization called Patients and Professionals for Customized Care (P2C2) and companion website, http://www.savemymedicine.org/. The site will allow visitors from patients and physicians to pet owners and veterinarians to sign up for e-newsletters, to write to their elected officials and to find pharmacists who can provide the compounded medicines they need. Already, IACP has used its website to help more than 23,000 patients, physicians and pharmacists file comments with FDA opposing a citizen petition from pharmaceutical giant, Wyeth, that would restrict patients' access to compounded, bioidentical hormone treatments.
“For the first time, P2C2 and http://www.savemymedicine.org/ will give a voice to those who benefit most directly from pharmacy compounding the professionals who prescribe these customized medicines and the patients who rely on them for better health,” said L.D. King, executive director of IACP. “Millions of Americans have triumphed over disease thanks to compounded medicines. No army of pharmaceutical lobbyists can compete with that.”
“In addition,” continued Mr. King, “Wyeth’s attempts to restrict patient access to bioidentical hormones are perfect examples of why we need another site like CompoundingFacts.org. If the misinformation Wyeth is filing with the FDA and spreading publicly isn’t corrected, patients will suffer. To reinforce our point, we have even created an editorial cartoon on the homepage of CompoundingFacts.org to illustrate more colorfully Wyeth’s real objective: to bury its competition.”
IACP has also revamped its original website, http://www.iacprx.org/, to better serve its members. Enhancements include a password-protected section exclusively for IACP members, and sections specifically for journalists and policymakers to learn about pharmacy compounding.
About IACP
The International Academy of Compounding Pharmacists (IACP) is a non-profit association founded in 1991 to protect and promote the art and skill of the compounding pharmacy profession. We represent more than 1,800 pharmacists, physicians, technicians and patients who are committed to the safe practice of pharmacy compounding. We are committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and of patients to take customized medications that meet their unique, individual needs.
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March 14, 2006 - U.S. Supreme Court Bolsters Argument for State Authority Over Compounding; IACP Cites Case in Filing with FDA
FOR IMMEDIATE RELEASE
March 14, 2006
Contact: Joshua Wenderoff
202-777-3502
jwenderoff@clsdc.com
U.S. Supreme Court Decision Bolsters Argument for State Authority Over Compounding; IACP Cites Case in Filing with FDA
SUGAR LAND, Texas A recent U.S. Supreme Court ruling that reaffirmed state jurisdiction in regulating the medical profession has set a legal precedent that undercuts numerous arguments in a Citizen Petition filed with the FDA by pharmaceutical manufacturer, Wyeth. The International Academy of Compounding Pharmacists (IACP) today called on the FDA to consider Gonzalez v. Oregon and to reject Wyeth’s Citizen Petition. IACP represents about 1,800 pharmacists, patients and physicians who recognize that compounded medicines are a vital part of modern, individualized healthcare.
On January 17, 2006, the U.S. Supreme Court ruled in the case of Gonzalez v. Oregon that the Drug Enforcement Administration (DEA)’s interpretation to bar Oregon physicians from assisting suicide was unconstitutional. According to IACP’s supplemental filing, the case undercuts Wyeth’s petition in two ways. First, the majority opinion gives great deference to state regulation. Second, the court also ruled that federal agencies cannot selectively read into statutes to impinge upon areas traditionally regulated by the states. As IACP states in its filing, “Wyeth’s position that compounded preparations are subject to FDA regulation is based not on one full section of law, but on a single word. This argument ignores the unambiguous context of the FDCA [Food Drug and Cosmetic Act], which does not provide for the broad federal regulation of compounding claimed by Wyeth.”
“The main reason FDA should reject Wyeth’s petition is because it would harm patients,” said L.D. King, executive director of IACP. “This Supreme Court ruling, however, provides FDA with additional legal rationale for rejecting Wyeth’s petition by reaffirming the principle of limited federal authority over state-regulated areas.”
On October 6, 2005, Wyeth petitioned the FDA to impose far-reaching restrictions on the practice of compounding bio-identical hormones. Since then, more than 7,000 comments have been filed with the FDA, the vast majority of which are from physicians, patients and pharmacists who oppose Wyeth’s petition.
Wyeth’s petition is based on numerous flawed and misleading statements, including a central point that federal legislation designed to regulate manufacturers also applies to the distinct practice of compounding. The implications of Wyeth’s proposal are far-reaching and would potentially restrict patients’ access not only to compounded hormones but compounded medicines overall. IACP’s comments filed with the FDA on this and other issues can be found on its website, http://www.iacprx.org/. Please click here (.pdf) to view a copy of the comments filed March 14th.
About IACP
The International Academy of Compounding Pharmacists (IACP) is a non-profit association founded in 1991 to protect and promote the art and skill of the compounding pharmacy profession. We represent more than 1,800 pharmacists, physicians, technicians and patients who are committed to the safe practice of pharmacy compounding. We are committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and of patients to take customized medications that meet their unique, individual needs.
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January 17, 2006 - IACP Approves Uniform Labeling Guidelines
January 17, 2006
FOR IMMEDIATE RELEASE
Contact: Joshua Wenderoff
202-777-3502
jwenderoff@clsdc.com
International Academy of Compounding Pharmacists Approves
Uniform Labeling Guidelines
SUGAR LAND, Texas - The International Academy of Compounding Pharmacists, representing more than 1,800 pharmacists, patients and healthcare professionals, today issued national guidelines for the labeling of custom-prepared, compounded medications by its member pharmacists. The guidelines are intended to provide patients receiving compounded medications with the most complete information possible about how to use and care for their prescriptions; to standardize labeling across all 50 states; and to help promote best practices by compounding pharmacists.
The compounding of individually prepared prescriptions is a longstanding pharmacy practice. Physicians prescribe compounded medications either when their patients cannot use off-the-shelf pharmaceuticals because of allergies or other problems, or when these medications are not effective or appropriate for the particular condition. The new labeling guidelines are part of an ongoing effort by IACP and its member pharmacists to improve healthcare. The organization said that the vital triad relationship between physicians, patients and pharmacists works best when patients have full, complete and consistent information about the medications prescribed to treat their particular health conditions.
“This is an important step forward for pharmacy compounding,” said L.D. King, executive director of IACP. “As a profession we are committed to patient awareness, understanding and safety, and we will go beyond state requirements to achieve this.”
Today pharmacy practice, including the preparation of custom medications, is regulated by state boards of pharmacy. As such, the labeling requirements for compounded medications vary from state to state. Moreover, the consumer medicine information that is included with manufactured products is designed specifically for those products and, as a result, is not appropriate for compounded preparations. The new guidelines are intended to address these issues by providing more consistent and complete information about compounded medications.
The IACP guidelines cover medications compounded for human use both medications that are compounded in direct fulfillment of a prescription for a specific patient and those that are compounded for administration by licensed institutions and practitioners, also called “office-use compounds.”
“Pharmacists and physicians both bear responsibility for ensuring that their patients know what medicines they are taking and how to take them,” continued Mr. King. “Proper and consistent labeling of compounded medicines is an important tool that pharmacists can use to provide patients with this essential information.”
For compounds prepared in response to a prescription for a specific patient, IACP recommends affixing a label to the primary container of each compounded medication that reads: “This medicine was specially compounded in our pharmacy for you at the direction of your prescriber.” IACP also recommends that its members include an insert with the compounded prescription to explain why the patient’s physician prescribed a compounded medicine and what information the patient should have received from his or her physician.
For office-use compounds, IACP is recommending the following label: “This medicine was compounded in our pharmacy for use by a licensed professional only.”
In addition, IACP supports state regulations that require additional information on all prescription labels, such as: the patient’s, prescriber’s and pharmacy’s name; the prescription number; and the medication’s name, quantity, strength, storage information, beyond-use date, and directions for use.
Click here to view a copy of the IACP labeling guidelines.
About IACP
The International Academy of Compounding Pharmacists (IACP) is a non-profit association founded in 1991 to protect and promote the art and skill of the compounding pharmacy profession. We represent more than 1,800 pharmacists, physicians, technicians and patients who are committed to the safe practice of pharmacy compounding. We are committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and of patients to take customized medications that meet their unique, individual needs.
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