August 9, 2013
IACP Update on S. 959
Revision to S. 959 Secured by IACP: Expressly permits anticipatory compounding for office use
As a result of our continued discussions with the Senate HELP Committee, IACP has succeeded in securing language which clarifies that anticipatory compounding will be permitted within S. 959 as part of the bill’s overall revision of Section 503A of the Federal Drug and Cosmetic Act (FFDCA).
As Section 503A (a)(2)(A) reads now, compounds drug can only be prepared "by a licensed pharmacist or licensed physician in limited quantities before the receipt of a valid prescription order for such individual patient." Although never enforced, that language does essentially prohibit anticipatory compounding for preparations that are subsequently dispensed or sold to health practitioners for office-use.
Although earlier versions of S. 959 had different language for anticipatory compounding – one of which made it even more stringent and associated with an individual patient – IACP and the Senate HELP Committee have found common ground with new wording. While S. 959 retains most of the original language of 503A, it now includes an entirely new provision that would - for the very first time - acknowledge and permit anticipatory compounding for office use. Specifically, with respect to a "traditional compounder," the bill provides that "in lieu of the prescription for an identified individual patient... the pharmacy receives a practitioner order." [Page 16, lines 1 - 5].
While that’s a “win” for compounders, there are still so many unworkable provisions within S. 959 that push the scope of federal authority over traditional pharmacy compounding practice well beyond that necessary to prevent a future NECC tragedy. For example, new requirements for office-use prescriptions mean burdensome recordkeeping provisions for pharmacies including a 10% monthly limit, a 14 day “window” in which the pharmacist must obtain the names of specific patients to whom the medication was administered by the ordering office or practitioner, and a 14-day cap on beyond use dating.
Please continue to visit IACP's S. 959 Updates section on our website/homepage for continuing news updates from IACP's D.C. legislative team.
NEW: Click here for today's IACP Fax Facts for another update from IACP's legislative team.
NEW: Click here for the latest IACP State Legislation Tracker.
IACP CAMP! What You Can Do to Help Ensure a Positive Outcome on S. 959
The IACP 2013 Summer CAMP (Congressman at My Pharmacy) packet is now available. Click here to access IACP CAMP! It also can be found in the Members-only site - click on Member Resources.
Your IACP CAMP packet includes everything you need to prepare and host a successful congressional visit at your pharmacy. It includes:
- Instructions for setting up a pharmacy tour with a member of Congress
- Sample invitation FAX/e-mail to the Senator or Representative's scheduler
- Sample schedule for the legislator and a sample schedule for your pharmacy team
- Talking points on pending federal legislation with background explanations to educate yourself and your staff
- "Day Before" and "Day Of" event instructions
- A sample thank you letter for follow-up
- Information on inviting a local media outlet to showcase your visit (pending approval by the legislator)
- Evaluation form to share your experience with IACP
Please email IACP at firstname.lastname@example.org with questions!
Change.org Petition Targets IACP Regarding Issue of Compounding for Legal Injections
IACP Members: Please be aware that a change.org petition was initiated this past week (source of petition unknown) calling for IACP to address the ethics of providing drugs for executions by compounders. Click here to view the petition.
IACP does not take a stance on the use and/or purpose of any medication. That is the responsibility best managed by the individual pharmacist. We support the profession-wide acknowledgement of the rights of the individual pharmacist to engage in informed decision-making based up the professional judgement of the pharmacist, and the prescribing physician.
Please email IACP should you have any questions at email@example.com.
Domperidone and Boards of Pharmacy: Further Scrutiny?
In a July issue of their electronic newsletter, the National Association of Boards of Pharmacy published an article entitled "Domperidone Not FDA Approved, Should Not be Marketed in the US, FDA Stresses." Click here for the NABP article.
The article references the June 2004 FDA warning to compounding pharmacies and suppliers that it is illegal to compound domperidone because the product has never been reviewed or approved for marketing within the US. It also includes information about the access to compounded domperidone for GI motility disorders through the agency's Expanded Access to Investigational Drugs program - click here to view.
The FDA requires that domperidone only be obtained from certain specific suppliers and authorization must be approved by them in advance prior to the importation, shipment or administration of the drug. According to the agency, the only authorized supplier of domperidone is Dougherty's Pharmacy in Dallas, Texas.
For compounders, this information is not new. What is concerning about the NABP article is the following statement: "Boards observing that an entity may be obtaining or compounding domperidone under circumstances not in compliance with FDA regulations are encouraged by the agency to report any concerns." IACP members who currently provide compounded domperidone to patients and prescribers should be aware that Board inspectors may be following this federal policy during inspections and should contact their Boards to determine whether or not the state has a different interpretation or position than that of the FDA.
For additional information on the FDA position, pharmacists may direct any questions to the FDA Division of Drug Information by sending an e-mail to firstname.lastname@example.org or by calling (855) 543-3784.
Harvard Pilgrim Update: Judge Denies Preliminary Injunction Filed by New England Pharmacies
The preliminary injunction filed by three pharmacies in New England against Harvard Pilgrim, alleging that a change in their reimbursement/coverage of compounded medications was damaging to beneficiaries, has been denied by the judge. Click here for a copy of the decision, provided by IACP's counsel.
Click here for a Boston Globe editorial, "More Nuanced Rules Needed at Harvard Pilgrim," August 6, 2013.
IACP Members: Please note that IACP prepared an amicus brief for this case which was excluded by the judge. We are holding it for now as this case may continue to proceed and, unfortunately, we may need it for other cases against third-party plans seeking to reduce or eliminate coverage of compounded medications.
Unhappy Patients Voice Displeasure on Harvard Pilgrim's Facebook Page
While the Harvard Pilgrim situation continues to swirl, the company's Facebook page is the target of many unhappy customers who are not pleased that their compounded meds will no longer be covered. Click here to visit Harvard Pilgrim's Facebook site. The company states: Many of you have questions and comments about our recent decision to discontinue coverage of compound medications. Our goal is to provide our members and providers with access to a wide variety of safe and effective medications. If you and your physician feel a compound medication is medically necessary, your physician may submit to our review process on your behalf. Harvard Pilgrim will review your request within one business day. We encourage you to contact our Member Services team with any questions via our secure message portal here http://bit.ly/1cbqlTf or by calling 1-888-333-4742.
For those IACP members with patients being affected by this situation, be sure to send them to Harvard Pilgrim's message portals noted above to voice their opinions. IACP will continue to keep you apprised of this situation. Please email email@example.com with any questions.
My Health. My Compounds - P2C2 Campaign Designed to Educate Patients and Practitioners About Legislation - Preserving Access to Compounds
IACP's Patients and Professionals for Customized Care (P2C2) advocacy group now encompasses more than 164,000 patients and practitioners who have enlisted to protect and preserve pharmacy compounding! IACP is working to increase this support base to 200,000 members in 2013 to make our voices even stronger! P2C2 brings together people who know first-hand that compounded medicines are a critical part of modern, individualized health care and provides them the necessary tools to ensure that access to personalized medication solutions remains possible.
As part of this effort, IACP designed a new grassroots campaign - My Health. My Compounds - to help our members communicate to your respective patients and practitioners about the immense value of compounding, and the importance of protecting their access to personalized medications. We urge you to feature this artwork on your websites, newsletters, social networking sites, email signatures, printed pieces,etc., as well as share with your patient/practitioner audiences.
Ask your patients and practitioners to add their voices to the S. 959 advocacy site, making their respective representatives aware of the concerns about the draft pharmacy compounding bill.
ENCOURAGE YOUR PATIENTS TO TAKE ACTION: Click here to tell Washington how important your customized meds are!
My Health My Compounds Artwork For Member and Patient Use!
Please use this artwork on your websites, newsletters, social networking sites, and as your email signature!
My Health. My Compounds. Email Signature Artwork
My Health. My Compounds, Website Banner 390x240 px
My Health. My Compounds. Website Banner 500x333 px
My Health. My Compounds. Facebook Cover Artwork
Pharmacy Compounding Postcard - General
Compounding for Bio-identical Hormone Patients Postcard
Compounding for Veterinary Patients Postcard
Compounding for Pediatric Patients Postcard
Compounding for Geriatric Patients Postcard
Corporate Partner Spotlight: Letco Medical
Since 1993 Letco Medical has been committed to providing compounding pharmacies complete customer satisfaction by offering the highest quality products, customer service, technical support and the fastest delivery time s in the industry. Letco is your partner in compounding. We have an extensive line of chemicals, supplies, equipment, capsules, solutions and bases to support compounding pharmacies. Letco Medical was also the first in our ndustry to offer CSOS ordering for your convenience.
Through a consistent, straightforward formula — high quality products, value-driven service and a commitment to customer success — Letco has helped generations of compounding and specialty pharmacies thrive. In addition to pharmaceutical ingredients, excipients, supplies and equipment, we deliver the insight and responsiveness that customers need to grow and streamline their business.
We pride ourselves on knowing that satisfaction of a job well done is derived through a combination of hard work, perseverance and a thoughtful approach to do our best for our customers and our company. We communicate honestly and openly to continue to build long lasting, trustworthy relationships with our customers and employees. We thank you for trusting us as partners in your compounding pharmacy.
Let us put our expertise to work for you. Quality compounding starts here.
Please Donate to IACP!
IACP is working to Protect, Promote & Advance Pharmacy Compounding. Please help IACP continue our ongoing legislative, regulatory and press efforts on issues including: S. 959, reimbursement, and preserving patients and practitioners' access to pharmacy compounds. With your help, IACP can continue to play an active role in protecting our profession.
Please click the Donate button above to access an IACP donation form. One-time sums, or monthly contributions are both available for your consideration. We greatly appreciate anything you can do to help support our efforts, and for being an IACP Member!
We Thank the IACP Members and Corporate Partners Contributing to the Academy!
Click here to view the entire list.
IACP Welcomes New Corporate Partner!
The IACP Corporate Partner program engages corporate leaders in the pharmacy compounding community by connecting them with IACP’s more than 2,700 pharmacists, technicians, students, and members of the compounding community. We encourage all IACP members to support these corporate partners that are instrumental in our joint effort to protect and grow this vital part of quality health care. Thank you for your continued support of pharmacy compounding!
The Educational Conference Goes to Fort Lauderdale, Florida, February 5-8, 2014.
Registration Is Now Open!
Don’t miss this one-of-a-kind, 3-in-1 conference that brings the pharmacy profession together in paradise. The American College of Apothecaries (ACA), the International Academy of Compounding Pharmacists (IACP) and the American College of Veterinary Pharmacists (ACVP) are joining forces again to bring you an extraordinary Educational Conference, February 5-8, 2014 at the ocean front property, the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida.
What you can expect in 2014:
- Benefit from multiple education tracks; practice-based, compounding, and veterinary clinical and compounding.
- Learn the fundamental steps to successfully work with your local media.
- Develop a Social Media campaign about your pharmacy and its role in the community.
- Leverage the latest tools and resources to implement a quality improvement plan in your pharmacy.
- Hear what your peers are doing in the This Works for Me! sessions.
- Tips for hiring and retaining good employees for a successful pharmacy.
- What’s New in Veterinary Pharmacy, and much more!
- Visit with companies showcasing services that can improve your business.
Click here to read more!
Austin, TX and Houston, TX Regional Education Meeting Recaps!
The IACP Regional Education Meeting in Austin, Texas on Tuesday, August 6, 2013 hosted 30 pharmacists, technicians, and pharmacy students! The Houston, Texas IACP Regional Education Meeting on Thursday, August 8, 2013 hosted 20 pharmacists, technicians, and pharmacy students!
At both meetings attendees listed to IACP’s Executive Vice President & CEO David G. Miller, RPh as he presented a two-hour dynamic presentation titled, Pharmacy Compounding Law and Regulations: Staying Current in a Changing World.
A big thank you to Peoples Rx Pharmacy for hosting the IACP Regional Education Meeting in Austin!
Where is IACP’s David G. Miller Headed to Next?
The IACP Regional Education Meeting brings 2.0 contact hours (.20 CEUs) of live pharmacy law continuing education credit to pharmacists and technicians all across the United States. At this seminar, you will hear from IACP's Executive Vice President & CEO David G. Miller, RPh as he presents Pharmacy Compounding Law and Regulations: Staying Current in a Changing World, an in-depth presentation on federal and state legislative and regulatory issues that affect you and your practice.
The seminar is designed for any pharmacist, technician or pharmacy student currently involved in or interested in building their understanding about compounding pharmacy. Whether you’re a veteran compounder or just thinking about implementing this critical health service for your community, we hope you’ll join us for an evening of education and fellowship. For more information, please visit www.iacprx.org/RegionalEducationMeetings.
At the conclusion of this seminar, the pharmacist and technician attendee will be able to:
- Explain how compounders are regulated and enforced by the State Boards of Pharmacy, Food and Drug Administration (FDA), and Drug Enforcement Administration (DEA).
- List four different regulatory initiatives and two court cases that have defined FDA’s oversight to compounders.
- State what authority the FDA has when inspecting compounding pharmacies.
- Define “bulk ingredients” and the difference between “FDA-approved” products.
- Define “office use” and describe how compounding for office use differs from wholesaling.
- Describe key components of federal proposed legislation that may change the balance of existing federal and state authorities
Salt Lake City, Utah – September 26, 2013
6:30 - 7:30 p.m. Check-in period with pizza & refreshments
7:30 - 9:30 p.m. Educational Session
9:30 - 10:00 p.m. Q&A with David Miller and Department of Professional Licensing’s Compounding Task Force: Kavish Choudary, Christopher Cox, Kort Delost, Missy Duke, Trip Hoffman, Christine Jacobsen, Dean Jolley, Adam Jones, Wayne Jones, Dallas Moore, Jim Ruble, Evan Vickers, Angela Whitney, and Victoria Zippi
Roseman University of Health Sciences, P2 Classroom, 1st Floor
10920 S. River Front Parkway, South Jordan, UT 84095
Click here to view the event flyer for more details!
Tulsa, Oklahoma – November 9, 2013
5:00 - 7:30 p.m.
Hyatt Regency Tulsa, Diplomat Room, 2nd Floor
100 East 2nd Street, Tulsa, OK 74103
Click Here to View the Event Flyer for More Details!
This meeting will correspond with Freedom’s November CPCSI training and the Freedom Pharmaceuticals 2nd Annual Seminar. More information coming soon.
Would You Like to Sponsor or Host an IACP Regional Education Meeting in Your City?
If you would like IACP to plan a Regional Education Meeting in your city, please email Michelle Greene or call 281.933.8400. For more information on sponsorship, please click here. For more information on hosting, please click here.
IACP is your one-stop resource for all things compounding! CompounderCalendar provides a comprehensive listing of compounding events and continuing education programs.
Click here to view IACP’s Upcoming Events.
IACP Career Center
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