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October 19, 2004 - IACP Files Amicus Brief on Behalf of Compounding Pharmacy
October 19, 2004
FOR IMMEDIATE RELEASE
Contact: Patricia Paget
IACP
281-933-8400
IACP Files Amicus Brief on Behalf of Compounding Pharmacy
HOUSTON , TX - The International Academy of Compounding Pharmacists (IACP), a non-profit organization that advocates on behalf of pharmacists who prepare customized medications, filed an Amicus Curiae brief in a district case on behalf of a Kentucky pharmacy that is charged with unlawfully compounding medications for animals.
IACP’s amicus brief refutes the FDA seizure of BET pharmaceuticals as it was based on “the erroneous argument that the compounding of veterinary drugs from bulk active ingredients is illegal because they result in unapproved new drugs which must go through the FDA approval process” and goes on to state that the court should “reject that argument and grant the Motion to Dismiss.”
The brief provides important points in an effort to refute FDA’s claim against BET that compounded drugs are subject to new animal drug applications (NADA). IACP demonstrates that:
- Compounding is legal. The Food and Drug Cosmetic Act (FDCA) of 1938 did not ban compounding. Congress intended, through enactment of sections in FDCA, to control human and veterinary drug manufacturers, not pharmacists or physicians who compound medications to treat unique patient needs.
- The United States Pharmacopeia (USP) and National Formulary (NF) both recognized the practice of compounding and have long included instructions for compounding as part of their compendial standards.
- Colleges of Pharmacy continue to teach compounding to pharmacy students.
- Kentucky law expressly authorizes and regulates pharmacy compounding, both for animals and humans, This is true for every other state.
- Compounding for animals fills a critical need. Compounding drugs for non-food animals is necessary because there are often no approved animal drugs in the necessary dose or dosage form to treat the condition.
“It is essential that the FDA recognize compounded medications are a vital component of the healthcare industry,” said IACP President Eric Vidrine. “In declaring that compounded medications are subject to the NADA process, FDA is effectively stating they are illegal.”
Friend of the court briefs provide valuable information about legal arguments, or how a case might affect people other than the parties to the case. For a copy of IACP’s brief, click here.
About IACP:
The International Academy of Compounding Pharmacists (IACP) is an international, non-profit association established in 1991 to protect, promote and advance the art and science of compounding custom medications. IACP provides support to more than 1,800 members through programs and services including reimbursement/third-party advocacy, government representation, regulatory analysis, public relations support, referral services, literature searches, and a fellowship program. For more information, visit http://www.iacprx.org/.
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September 9, 2004 - FDA Announces Revision of Animal Compounding Guidance
September 9, 2004
FOR IMMEDIATE RELEASE
Contact: Patricia Paget
IACP
281-933-8400
FDA ANNOUNCES REVISION OF ANIMAL COMPOUNDING GUIDANCE
Pharmacists' Advocacy Group Pleased With Outcome of Grassroots Efforts
WASHINGTON, DC - On September 1st, FDA's Center for Veterinary Medicine (CVM) publicly announced that it will revise its Compliance Policy Guide (CPG) on animal drug compounding. The guidance, which currently bans pharmacists and veterinarians from preparing custom medications from pure pharmaceutical ingredients for companion animals, is expected to be revised and re-released by the Fall of 2004.
After months of hard work involving Congressional grassroots efforts, the International Academy of Compounding Pharmacists (IACP), an advocacy group for pharmacists who prepare customized medications, is pleased to see its efforts bring about such change.
"FDA's CVM has progressed in its responsiveness to the concerns of the compounding profession since we first met with them in September 2003," said IACP Executive Director L.D. King. "At that time, CVM largely wrote off compounding pharmacists' concerns with the CPG. However, due to the persistence of compounding pharmacists, their veterinarians, and patients, CVM has obviously recognized that the CPG needs to be changed."
IACP worked with premier organizations such as the American Pharmacists Association (APhA), the National Community Pharmacists Association (NCPA), the Small Business Administration (SBA) and the American Veterinary Medical Association (AVMA) to bring attention to the flawed provisions of this CPG. IACP's membership, totaling 1,800, also worked extensively with members of Congress to encourage FDA to revise the guidance, ultimately garnering public support from more than 80 Congressmen and Senators.
"We are now waiting anxiously to see what the revised CPG will look like," said King. "We hope our efforts result in a policy that will allow animals to receive the best medication therapy as prescribed by their veterinarian. There is a desperate need for FDA to issue a new draft for public comment soon, as delays in clarification will lead to increased confusion among vets and pharmacists regarding how they can treat their animal patients."
About IACP
The International Academy of Compounding Pharmacists (IACP) is an international, non-profit association established in 1991 to protect, promote, and advance the art and science of pharmacy compounding. IACP provides support to more than 1,800 members through programs and services including third-party advocacy, government representation, regulatory analysis, public relations support, referral services, literature searches, and a fellowship program. For more information, visit http://www.iacprx.org/.
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July 4, 2004 - X12 Pharmacy Advisory Panel Renamed PSTAC
July 4, 2004
FOR IMMEDIATE RELEASE
Contact: Patricia Paget
IACP
281-933-8400
X12 Pharmacy Advisory Panel Renamed Pharmacist Services Technical Advisory Coalition
Alexandria, VA- The X12 Pharmacy Advisory Panel, formed in 2002 to advocate and improve the coding infrastructure necessary to support pharmacists billing for their professional services, has been renamed the Pharmacist Services Technical Advisory Coalition (the Coalition).
During the past two years, the Coalition’s activities have included developing a master inventory of billing codes for pharmacists’ professional services, building consensus on new codes, and supporting an industry standard to expedite a HIPAA-compliant electronic data exchange (EDI) health encounter/claims processing and payment environment for pharmacists professional services.
The Coalition was formed in April 2002 following the February 2002 release of the HIPAA-compliant X12N 837 Health Care Claim: Pharmacy Professional Services Companion Guide an EDI subset of the ASC X12N 837 Health Care Claim Implementation Guide: Professional. The guide relates to Form CMS-1500 formatted health care claims submitted by pharmacies and pharmacists for payment of professional pharmacist services.
The pharmacy associations making up the Coalition are: the American College of Clinical Pharmacy (ACCP), the American Pharmacists Association (APhA), the American Society of Consultant Pharmacists (ASCP), the American Society of Health-System Pharmacists (ASHP), the International Academy of Compounding Pharmacists (IACP), the National Association of Chain Drug Stores (NACDS), and the National Community Pharmacists Association (NCPA). IACP is the newest member of the Coalition.
Said IACP Executive Director L.D. King, “IACP is excited to be taking part in this effort to ensure pharmacists have access to the infrastructure and billing codes to bill and receive payment for the crucial health care services they provide.”
In addition to the activities listed above, the Coalition has been active representing pharmacy’s interests on the American Medical Association’s Health Care Professionals Advisory Committee. The Health Care Professionals Advisory Committee represents non-physician health professionals in the AMA’s Current Procedural Terminology (CPT) Editorial Panel process. It is responsible for maintaining the CPT code set that is used by all health professionals to document and/or bill for professional services, procedures, and tests.
The Pharmacist Services Technical Advisory Coalition was founded in 2002 to improve the coding infrastructure necessary to support billing for pharmacists’ professional services. The Coalition works to provide the national leadership necessary to position and secure pharmacy’s place in the electronic data interchange (EDI) health encounter/claims processing and payment environment concerning all health care providers’ professional services.
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June 22, 2004 - Pharmacists Return from Advocating on Capitol Hill
June 22, 2004
FOR IMMEDIATE RELEASE
Contact: Patricia Paget
IACP
281-933-8400
PHARMACISTS RETURN FROM ADVOCATING ON
CAPITOL HILL
WASHINGTON , D.C. - On June 6, 7 and 8, over 230 attendees representing 42 states gathered in the nation’s capital to participate in Compounders on Capitol Hill, a legislative conference sponsored by the International Academy of Compounding Pharmacists (IACP). The pharmacists met to discuss pharmacy issues, in particular, a recent Food and Drug Administration guidance that bans pharmacists and veterinarians from preparing custom medications from bulk drugs for companion animals.
“Due to our members’ efforts on the Hill this year, 47 Congressmen and 18 Senators signed on to sponsor the rescission of this fundamentally flawed guidance,” said IACP Executive Director L.D. King. “We must let Congress know that our pet population will needlessly suffer if the present policy is adopted and I’m confident we made an impact as a direct result of our annual visit to Washington , D.C. ”
Compounding pharmacists have spoken on behalf of pharmacy compounding, tackling medical related issues since 1995 when they first started meeting in D.C. to educate legislators about the necessity of individualized medications
“During the last ten years, we’ve taken the most innovative and professional pharmacists to meet with members of Congress to advocate the importance of customized therapies,” said King. “Members of Congress who recognize the necessity of compounding pharmacy work with us to ensure the safest and most effective medications are available and affordable for their constituents, and as this year’s concern would suggest, their constituents’ pets.”
Although the focus of the meeting was to reach members of Congress with pharmacy compounding’s message on medication availability for pets, pharmacists also participated in an open forum to collectively discuss the future of the practice with other stakeholders in the profession. Participants in these discussions and educational sessions included top officials from the Small Business Administration, as well as stakeholders in the Pharmacy Compounding Accreditation Board, which was established this year in cooperation with eight leading pharmacy related professional and regulatory associations in an effort to improve the quality and raise awareness of compounding.
About IACP
The International Academy of Compounding Pharmacists (IACP) is an international, non-profit association established in 1991 to protect, promote and advance the art and science of pharmacy compounding. IACP provides support to more than 1,800 members through programs and services including third-party advocacy, government representation, regulatory analysis, public relations support, referral services, literature searches, and a fellowship program. For more information, visit http://www.iacprx.org/.
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*Photos available upon request.
May 14, 2004 - PCAB Appoints Standards Task Force
May 14, 2004
FOR IMMEDIATE RELEASE
PHARMACY COMPOUNDING ACCREDITATION BOARD APPOINTS STANDARDS TASK FORCE
WASHINGTON , D.C. On May 3, 2004 , Pharmacy Compounding Accreditation Board (PCAB) stakeholder organizations announced the appointment of the PCAB Standards Task Force. The work of this task force will be to set standards for a voluntary site accreditation process for compounding pharmacies.
The task force includes one appointee from each PCAB Governing Board organization, as well as four at-large positions. The PCAB Governing Board has appointed the following individuals:
Jerrod Roberts, Chair (Oklahoma City, OK)
Loyd Allen, Jr. (Edmond, OK)
Patsy Angelle (Baton Rouge, LA)
Dan Fucarino (Tampa, FL)
William Johns, Sr. (Memphis, TN)
Ken Latta (Durham, NC)
Paul Lofholm (Larkspur, CA)
John Musil (Scottsdale, AZ)
Kenneth Speidel (Ravenna, OH)
Larry Trissel (Houston, TX)
Tony Welder (Bismarck, ND )
The PCAB is a coalition of leading pharmacy-related professional and regulatory organizations. The PCAB’s announcement of the creation of a voluntary accreditation program for pharmacy compounding the preparation of customized medications for individual patients -- was made earlier this year.
“Appointment of the Standards Task Force is a significant step toward our being able to offer the voluntary accreditation sought by compounding pharmacies,” said Don Coody, Chairman of the Board of the American College of Apothecaries. “The Pharmacy Compounding Accreditation Board has received expressions of interest from compounding pharmacists who are eager to enter an accreditation process for their pharmacies,” said Bruce Roberts, Executive Vice President of the National Community Pharmacists Association. The PCAB anticipates that the first compounding pharmacies will be accredited in late 2004.
The Pharmacy Compounding Accreditation Board (PCAB) was established to provide standards to benchmark quality compounding practices and to raise awareness of compounding. The governing board, entrusted to execute a nationwide accreditation program, consists of the following organizations: 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 Council of State Pharmacy Association Executives, the National Home Infusion Association, and the United States Pharmacopeia. Stakeholder organizations invited to provide input include the American Association of Colleges of Pharmacy, the American Society of Consultant Pharmacists, the American Society of Health-System Pharmacists, and the National Association of Chain Drug Stores.
CONTACT:
| Dana Easton ACA 901-383-8119 dana@acainfo.org |
Michael Stewart APhA 202-429-7558 mstewart@aphanet.org |
Patricia Paget IACP 281-933-8400 patricia@iacprx.org |
| Karen Oster NABP 847-698-6227 koster@nabp.net |
Deleisa Johnson NCPA 703-838-2686 deleisa.johnson@ncpanet.org |
Lorrie Kline Kaplan NHIA 703-838-2658 lorrie.kaplan@nhianet.org |
| Becky Snead NCSPAE 804-285-4145 becky@ncspae.org |
Sherri Borden USP 301-816-8268 slb@usp.org |
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April 15, 2004 - Pharmacy Groups Create Compounding Accreditation Board
April 15, 2004
FOR IMMEDIATE RELEASE
PHARMACY GROUPS CREATE COMPOUNDING ACCREDITATION BOARD
Leading Organizations Pioneer Effort to Improve Patient Care
WASHINGTON , DC - A coalition of leading pharmacy related professional and regulatory organizations announced the creation of a voluntary accreditation program for pharmacy compounding, the preparation of customized medications for individual patients. The announcement was made at APhA2004, the annual meeting of the American Pharmacists Association.
This coalition, the Pharmacy Compounding Accreditation Board (PCAB), was established to help improve the quality and raise awareness of compounding. The governing board, entrusted to execute a nationwide accreditation program, is expected to consist of the following organizations: 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 Council of State Pharmacy Association Executives, the National Home Infusion Association, and the United States Pharmacopeia. Stakeholder organizations invited to provide input include the American Association of Colleges of Pharmacy, the American Society of Consultant Pharmacists, the American Society of Health-System Pharmacists, and the National Association of Chain Drug Stores.
“We are excited to work with this diverse group of leading pharmacy organizations to make compounding accreditation a reality and look forward to the further development and education of best practices and standards,” said IACP Executive Director L.D. King.
As an initial focus, the program will accredit pharmacy sites engaged in compounding at a designated level of complexity. The process, initially focusing on sterile compounding in the community practice setting, will bring increased quality assurance for pharmacy compounding.
“Compounding is a critical component of the healthcare industry. As pharmacists, we must ensure that the process, driven and controlled by the profession, improves our practices and thereby improves patient care,” said APhA Executive Vice President John A. Gans, PharmD.
The program is expected to be developed within the following months with the first pharmacy site accredited by the end of the year.
CONTACT:
| Dana Easton ACA 901-383-8119 dana@acainfo.org |
Michael Stewart APhA 202-429-7558 mstewart@aphanet.org |
Patricia Paget IACP 281-933-8400 patricia@iacprx.org |
| Karen Oster NABP 847-698-6227 koster@nabp.net |
Deleisa Johnson NCPA 703-838-2686 deleisa.johnson@ncpanet.org |
Lorrie Kline Kaplan NHIA 703-838-2658 lorrie.kaplan@nhianet.org |
| Becky Snead NCSPAE 804-285-4145 becky@ncspae.org |
Sherri Borden USP 301-816-8268 slb@usp.org |
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