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IACP Press Release Archive - 2001
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April 13, 2001 - FDA Asks Ninth Circuit for a Rehearing on Compounding Legislation
April 13, 2001
FOR IMMEDIATE RELEASE
Contact: Susanne Williams
International Academy of Compounding Pharmacists
281-933-8400
FDA Asks Ninth Circuit for a Rehearing on Compounding Legislation
In a surprising move, the FDA filed for a rehearing of the Western States Medical Center case. FDA argues that the Appellate Court decision dramatically limits Congress's authority to regulate interstate distribution of potentially harmful drugs, and substantially undermines the ability of FDA to protect the public health and to preserve the integrity of the approval process for new drugs. FDA asks that the entire Ninth Circuit rehear the case to allow the advertising restrictions to remain.
The court does not issue its mandate to implement the decision until a time for appeal expires. Because FDA is appealing this case, it is likely that the court will not issue a mandate until a decision on the rehearing is made. Until such time, the compounding section is still in effect. The advertising section remains rescinded as a result of the District Court decision.
The Ninth Circuit Court of Appeals ruled on February 6, 2001 that the advertising restrictions in the compounding section of the Food and Drug Administration Modernization Act (FDAMA) were in violation of the first amendment rights to free speech. The court further held that the advertising restrictions could not be rescinded separately and the entire compounding section was thus found to be unconstitutional and unenforceable by the court. March 22, 2001 , the FDA filed for a rehearing en banc. FDA is asking that the entire ninth circuit rehear the case. The FDA has the burden to convince the Circuit to rehear the case. The group of pharmacists does not have a chance to state its opposition unless the court specifically asks for information. L.D. King, executive director of IACP, believes that FDA’s chances for a rehearing are slim.
IACP will continue to foster the development of standards of practice for compounding through the state boards of pharmacy, the United States Pharmacopoeia, National Association of Boards of Pharmacy, state and national pharmacy associations, and its own committee responsible for evaluating and developing standards for compounding pharmacy. However, in light of the FDA appeal, the compounding section of FDAMA, is still in effect and enforceable by regulators.
Compounding pharmacy is the science and art of preparing prescribed personalized medication to meet the unique medical needs of patients. IACP is a nonprofit association representing nearly 1600 community compounding pharmacists globally. For more information about IACP, please visit the organization’s website at http://www.iacprx.org/.
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February 9, 2001 - Section 353a, Compounding Law Rescinded
February 9, 2001
FOR IMMEDIATE RELEASE
Contact: Susanne Williams
International Academy of Compounding Pharmacists
281-933-8400
Section 353a, Compounding Law Rescinded
On Tuesday, February 6, 2001 , the 9th Circuit Court of Appeals ruled that the compounding section of the Food and Drug Modernization Act (FDAMA), 21 U.S.C.S. 353a and c is unconstitutional and unenforceable. The law and initiatives to implement this provision of the law are now invalid including the federal/state memorandum of understanding, the FDA Pharmacy Compounding Advisory Committee, the list of chemicals that cannot be used in compounding and the recently published FDA “Concept Paper”.
“This certainly leaves us in a federal regulatory gray area,” said L.D. King, executive director of the International Academy of Compounding Pharmacists. “There is great uncertainty about how pharmacy compounding will be regulated in the future. Historically, IACP has held that compounding pharmacy is primarily regulated by the states. In the absence of federal law, we will look to the states for regulatory guidance.”
This decision was handed down as the result of the Western States Medical Center vs. Shalala lawsuit that challenged the constitutionality of the advertising subsection of the compounding law. The lawsuit, filed by several compounding pharmacists, shortly after FDAMA was signed by President Clinton in 1997, claimed that the advertising restrictions in the compounding section were in violation of the first amendment and therefore unconstitutional. A federal district court found in favor of the compounding pharmacists and declared the advertising section unconstitutional.
FDA appealed the case to the 9th Circuit Court of Appeals claiming that compounding is harmful to the public health and that advertising would only increase the potential harm to the public. The FDA asked the court to preserve the advertising subsection but requested that if it found the advertising section unconstitutional, the entire compounding section should be rescinded.
Although the 9th Circuit upheld the district court decision, they determined that Congress would not have passed the compounding section without the advertising restrictions and therefore agreed with the FDA that the advertising section could not be severed.
King believes the appellate court’s opinion, in part strengthens a decade of IACP’s assertions about compounding’s role in medicine and pharmacy. The court stated that the FDA failed to prove that they have a substantial interest in preventing widespread compounding. They also state that FDA failed to support the opinion that increased distribution of compounded drugs is dangerous because of the health risks associated with large numbers of patients taking such drugs. The decision states that most evidence runs to the contrary noting that compounding is legal under state law and that most states require pharmacists to know how to compound. In essence, the court found that FDA failed to prove that compounding is unsafe and should be limited.
“This court essentially said compounding is legal, necessary and there is no evidence to support FDA’s claim that the practice is harmful or unsafe,” said King. “These specific findings about the very fundamental practice of the profession are significant.”
King advises compounding pharmacists, that until they know the true implications of the decision, they should, as always, continue to practice in compliance with their state laws and also within the Triad relationship (Patient-Physician-Pharmacist), which is the legal basis of compounding practice.
“Congress passed compounding law because they saw the importance of compounding in the lives of their constituents and they wanted to preserve this practice,” said Ray Moreno, R.Ph., FIACP, president of IACP and a compounding pharmacist at Universal Arts Pharmacy in Hialeah, FL. “We are hopeful, in light of the courts positive comments concerning compounding, that there will be no restrictions that would now seek to hinder the practice and deny patients vital therapies.”
Compounding pharmacy is the science and art of preparing prescribed personalized medication to meet the unique medical needs of patients. IACP is a nonprofit association representing nearly 1600 community compounding pharmacists globally. For more information about IACP, please visit the organization’s website at http://www.iacprx.org/.
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February 9, 2001 - IACP Refers and Profiles Members on Its Website
FOR IMMEDIATE RELEASE
February 9, 2001
Contact: Susanne Williams
International Academy of Compounding Pharmacists
800-927-4227
IACP Refers and Profiles Members On Its Website
Houston - The International Academy of Compounding Pharmacists (IACP) has expanded its referral service to the Internet. Through a global positioning system locator, patients and physicians can now locate local compounding pharmacists, view directional maps to the pharmacies in their areas and review personal and professional information about the pharmacists and their staff all on IACP’s website. This service complements IACP’s already existing toll-free referral service that gives callers locations and phone numbers of compounding practitioners in their area.
“Not only is this a way for patients and physicians to locate compounding practitioners, but it is also a voluntary initiative to provide full disclosure of pharmacists’ information to those who are wanting to do business over the Internet,” said IACP Executive Director, L.D. King. “Those looking for a pharmacist can obtain important information about the pharmacist before they call or send a prescription.”
IACP first started its referral service several years ago because patients and physicians were frustrated trying to find pharmacists who would fill compounded prescriptions. IACP began promoting its toll-free referral service and the number of calls has increased to as many as 100 calls a day.
“Because more than 72 million people have access to the Internet, the organization decided to expand its service online and make the product more dynamic,” said King.
The toll-free service offers a zip code mapping program, which is able to locate two or three compounding pharmacists in the caller’s area. This telephone service provides callers with an address and phone number. The online service goes further by allowing the customer to choose a radius of up to 50 miles and then provides as many compounding pharmacists that exist in the chosen radius. Customers immediately view the pharmacist’s address, phone number, and have access to a map to help them locate the pharmacy. In addition they have access to complete profiles of pharmacists who participate in the profile service.
Profiles of pharmacists include information about their education, years in practice, continuing education, professional awards, professional affiliations, specialties, staff, mission statement, and store features. Photos also are featured of the pharmacist, pharmacy and/or pharmacy staff.
“IACP members now have a ‘mini website’ to feature information about them, their services and their staff,” said King. “For small business owners, this is a great value.”
There is a set-up fee and annual cost to IACP members who want to participate in the website profile service.
For those looking for a compounding pharmacist, there are now two options, IACP’s toll-free number, 800-927-4227, and IACP’s website.
Compounding pharmacy is the science and art of preparing prescribed personalized medication to meet the unique medical needs of patients. IACP is a nonprofit association representing nearly 1600 community compounding pharmacists globally. For more information about IACP, please visit the organization’s website at http://www.iacprx.org/.
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February 9, 2001 - IACP Names New Executive Director
FOR IMMEDIATE RELEASE
February 9, 2001
Contact: Susanne Williams
International Academy of Compounding Pharmacists
800-927-4227
IACP Names New Executive Director
Houston - The International Academy of Compounding Pharmacists (IACP) has named L.D. King as its new Executive Director.
King graduated Summa Cum Laude from the Honors College at the University of Houston School of Business, where he also completed his master’s degree in business administration. Upon graduation the faculty at the University of Houston awarded King the College of Business Alumni Association Outstanding Graduate Student . He also received the Dean’s Award for Academic Excellence.
Previously King has held positions with the United States Government Equal Employment Opportunity Commission, Null Lairson, P.C., and the International Journal of Pharmaceutical Compounding.
“IACP is a dynamic organization and I’m proud to be working to represent the most innovative and progressive pharmacists in the world,” said King.
Although IACP is a young organization formed in 1991 to protect and promote pharmacists’ rights to compound, the organization has made significant changes for the profession, King said.
“In this last decade IACP has become the voice of the community compounding practitioner,” said King. “IACP has representatives in APhA’s House of Delegates; we are a member organization of the United States Pharmacopeia, and have a strong presence on Capitol Hill.”
King is representing IACP at time of regulatory uncertainty, with the rescinding of the compounding legislation, however, King believes that with uncertainty comes opportunity. “Our goal will be to continue our collaborative work with regulatory agencies, legislatures and the profession of pharmacy to ensure Congress’ intent in passing legislation in 1997 is not lost to secure the continued availability of compounded medications,” said King.
One such collaborative effort for IACP includes working with a coalition of national pharmacy organizations and wholesalers who are pushing for the passage of H.R. 68, a bill to remove pedigree requirements for wholesalers from FDA regulations implementing the Prescription Drug Marketing Act.
“Seeking relief from pedigree requirements for active pharmaceutical ingredients supplied to compounding pharmacists fits with our mission statement because this restriction will ultimately hinder patient’s abilities to receive compounded medications prescribed by their physicians,” said King. “IACP is all about ensuring continued availability of compounded medications.”
In addition to continuing its traditional role in legislative and regulatory affairs, King plans for IACP to also increase awareness of the benefits of compounding pharmacy to patients and physicians.
“We have just recently launched a global positioning system pharmacy locator service on our website,” said King. “This service complements our toll-free referral service for patients and physicians who are looking for compounding pharmacists in their areas.” Currently IACP gets approximately 150 referral calls and 250 hits on its referral website weekly.
“IACP has some great programs and benefits for members and I think from here we take the existing programs and improve them and add to them,” said King. “We are growing and improving our drug information leaflets and our literature search and distribution service to our membership. In addition, we are studying ways we can collect and report adverse drug effects and we are exploring opportunities to promote quality standards for compounding pharmacists,” said King.
Since July 1999, King has served IACP as its Associate Director. He now replaces Shelly Capps, who was the interim Director during the last year.
Compounding pharmacy is the science and art of preparing prescribed personalized medication to meet the unique medical needs of patients. IACP is a nonprofit association representing nearly 1600 community compounding pharmacists globally. For more information about IACP, please visit the organization’s website at http://www.iacprx.org/.
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