September 11, 2013
In honor of all those who lost their lives 12 years ago on 9/11.
IACP Obtains New Draft of House Bill
Your Academy is preparing immediate comments for House Energy and Commerce staff however we wanted you to see the latest iteration. Please note, this bill is not yet final and has not been formally introduced.
Click here to review the New Draft of House Bill.
Member Alert: Some Insurers Plan to Halt Coverage of Compounded Medications
IACP Members: What your prescribers and patients should know…
- Some health plans intend to discontinue coverage for compounded medication.
- The International Academy of Compounding Pharmacists strongly believes that the question of FDA approval of compounded drugs is not a concern.
- Tricare, Harvard Pilgrim Health Care and Anthem, which runs Blue Cross Blue Shield plans, have all announced an intended change.
- Many insurers for years have routinely paid for scores of drugs that are not FDA approved, including any drugs developed before the federal Food, Drug, and Cosmetic Act of 1938. No full rationale has been stated for why coverage of these medicines is being discontinued at this time.
- There have been multiple challenges to these insurers’ actions, including civil actions in court and actions by state agencies in Massachusetts (in the case of Harvard Pilgrim); and appeals to Congress (Tricare), which resulted in the Plan’s agreement to delay implementation of the policy change for 90 days).
- If patients find that their compounded medicines, previously covered by insurance, are no longer paid or partially paid for, they should be advised to contact their health plans to complain. Until this complicated issue is resolved, prescriptions will have to be purchased out of pocket in many cases.
The landscape of compounding pharmacy, including the policies of the federal Food and Drug Administration (FDA) and of insurers, continue to change in the wake of the tragic injury and loss of life that followed the problems that were uncovered in fall of 2012 at the New England Compounding Center in Framingham, MA (which is no longer in business).
There was no intent in the law that created the FDA in 1938 to place all compounded medicines in use under FDA scrutiny. Click here to read entire story including information on Harvard Pilgrim, Tricare, Anthem and Blue Cross Blue Shield of Michigan.
Congress Back in Session - Legislative Update
Congress arrived back in town officially on Monday morning and already there are conflicting reports on what may or may not happen with S. 959 and its "to be released" House equivalent. Click here for an article discussing the ongoing discussions between the House and Senate staffers of which IACP was a part during the August recess.
IACP will keep you posted on what we learn over the next few days; but, remember, there are only nine working days for Congress in the month of September and with the Syria situation, much of that time will be devoted to that and the looming government budget shortfall. For more on legislation, please click articles below.
Congressional Quarterly Roll Call: A Primer on Compounding Pharmacies and Regulation by Congress, September 9, 2013
Congressional Quarterly Roll Call: Importance of Compounding Pharmacies Not Disputed by Congress, September 9, 2013
Working the Hospital Side of S.959
By IACP Member Linda F. McElhiney, PharmD, RPh, FIACP, FASHP, FACA
After attending IACP's 2013 Compounders on Capitol Hill, I spoke to our VP of Government Affairs at Indiana University Health about the proposed S.959 bill, and sent her the information that was provided to the Congressman. Within a few weeks, we had conference calls with the American Hospital Association (AHA), the Children’s Hospital Association (CHA), and members of the Senate HELP Committee to discuss how S.959 was going to have a negative impact upon hospital compounding practices, such as anticipatory or batch compounding, compounding for hospital subsidiaries, compounds as “new drugs,” notification to the FDA for compounded backorder items, and the FDA “Do Not Compound” list. The discussions were very positive and I think that we are gaining support for changes to the S.959 from the various hospital organizations.
About a month ago, the president of the American Society of Health-system Pharmacists (ASHP) urged the entire membership to fully support the passage of S.959 without revisions and to talk to their Congressman. As a fellow of both ASHP and IACP, I was alarmed that ASHP was fully supporting this proposed bill, so I sent an e-mail to ASHP’s Government Affairs department and listed the problems with S.959 that would have a negative impact on hospital compounding. The “hospital exemption” that ASHP helped to write does not exempt hospitals from following all of the regulations that “traditional compounders” must follow; it only exempts hospitals from registering as “compounding manufacturers." Within a couple of hours after that e-mail was sent, I was on a conference call with ASHP’s Government Affairs department, and they are now seriously reviewing how S.959 will impact hospital compounding practices, too.
Last week, to my surprise, Senator Dan Coats’ (R-Ind) legislative aide came to our compounding laboratory at the hospital to get a better understanding about hospital compounding and the impact that S.959 will have upon health-systems. It was a great visit and helped us to present our point-of-view with all of the show-and-tell visuals, such as our quality assurance program, anticipatory/batch compounding process, and examples of unique compounds that we need to prepare for our patients that could potentially be banned by the FDA. The legislative aide seemed very impressed and assured us that she would reinforce our concerns to the Senate HELP Committee and talk with the other Senate staff members.
Click here to read the rest of the story.
New Tennessee Law Limits Opioid and Benzodiazepine Dispensing
On or after October 1, 2013, "no prescription for any opioids or benzodiazepines may be dispensed by a Tennessee licensed pharmacy (including out-of-state Tennessee licensed pharmacies mailing into Tennessee) in quantities greater than a thirty (30) day supply."
What law is this? Public Chapter 430 (also called the "Addison Sharp Prescription Regulatory Act") enacted by the Tennessee General Assembly during the 2013 session made changes to requirements for prescribing, dispensing, and use of controlled substances in Tennessee. This legislation was brought at the request of the Knoxville Chief of Police in an attempt to curb drug abuse in Tennessee. This new limitation on dispensing was included in the Act to decrease the amount of drugs available at any one time in Tennessee.
What drugs are affected by the law? The law does not specify a list of drugs and no regulatory entity has issued such a list. This means that the pharmacist must use professional judgment. TPA notes that the intent of the law is for the limitation to apply to any drug pharmacologically classified by the FDA as an opioid or benzodiazepine.
Click here for more.
Affordable Care Act (ACA) Deadline to Notify Employees on October 1, 2013
With the implementation of the Affordable Care Act (ACA), there is a new federal requirement that all employers provide an "Exchange" notice to each employee by October 1, 2013.
This notification must be provided to employees regardless of plan enrollment, part-time or full-time status. The employer is not required to provide separate notices to dependents or other individuals who are or may become eligible for coverage under the employer’s plan but who are not employees.
However, employers are required to provide the Exchange notice to both new hires and current employees as follows:
If you wish to be proactive and fill out the Employer Coverage Tool form for future employees, you may access the form on the link above. Once completed, you may copy it and keep those copies on file for use as needed. Additionally, you should retain a copy of your notification, when it was provided to current employees, and adjust any personnel or employee manuals and new hire procedures to incorporate the provision of this information.
HIPAA Has New Rule Changes Effective Sept. 23, 2013
Is your pharmacy ready?
There are several changes to the HIPAA Rules that go into effective September 23rd. Pharmacies need to take action now to avoid repercussions of non-compliance. Every pharmacy should review, revise and/or replace its existing HIPAA Compliance Program.
Who do the Changes Affect?
HIPAA business associates, including a wide range of vendors who contract with pharmacies and access protected health information (PHI). So if you do business with an organization that comes into contact with Personal Health Information from your pharmacy, make sure you have a business associate agreement on file!
What Action is Required?
So, if your pharmacy cannot locate your HIPAA Manual or Procedures, or if these procedures have never been reviewed or revised, they need to be updated now to be compliant. Click here to read entire article.
IACP Member Carol Petersen Named First Chair of APhA's Compounding Special Interest Group
Congratulations to IACP Member Carol Petersen, Women's International in Madison, Wisconsin, for being named the first chair of the American Pharmacists (APhA) Compounding Special Interest Group.
Carol encourages IACP Members to join the committee by logging into pharmacist.com, and choosing, "Get Involved," and then "e-communities." Carol's objective through this forum is to provide more support for pharmacy compounding.
Corporate Partner Spotlight: EMD Millipore Corporation
Ensuring the Highest Level of Microbiological Quality and Patient Safety
Author: Karen Chronholm
Director Regional Marketing
EMD Millipore Corporation
290 Concord Road
Billerica, MA 01821 USA
Phone: +1 978-715-1748
As the regulatory environment for compounding pharmacies continues to evolve, facilities can take immediate steps to strengthen their microbiological testing and environmental monitoring programs. Robust programs that are timely, comprehensive, and effective will minimize risk and help support patient safety and positive outcomes. This article is the first in a series that will outline strategies to increase control in the sterile compounding process, identify contamination faster, and improve the sterility testing of final products.
Testing and microbiological quality measures for sterile, compounded drugs conducted by US and Canadian facilities are addressed by the United States Pharmacopeial Convention’s USP <797>, Pharmaceutical Compounding – Sterile Preparations. This chapter provides guidelines for facilities in which compounded sterile preparations are prepared, stored and dispensed. However, several US states do not have laws providing guidance for sterile compounding, and USP <797> guidelines were written to allow for flexibility, which can be challenging when an organization is trying to define the right approach.
In response to recent well-publicized contamination events, compounding pharmacies and the regulations governing them are coming under intense scrutiny, with regulations likely to evolve in the coming months and years.
Earlier in 2013, FDA officials reported results of their inspection of over 30 compounding pharmacies that mix sterile drugs. Federal inspectors observed “concerning sterility practices, inappropriate conditions for sterile processing and other practices that create risk of contamination”. 1 This report further galvanized the effort to reform the industry.
Click here to read the entire article.
The IACP Contributor List Continues to Grow! Thank you for Donating to your Profession's Future.
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.
Have You Registered To Attend #EduCon2014?
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.
Join your colleagues for destination education at its finest! “The ACA/IACP/ACVP Educational Conference is a must on my calendar. It provides an opportunity to network with old friends, meet new ones, and find out what is happening with our compounding friends from ACA and ACVP. This conference always provides valuable information for my business and helps me to stay current on legislative, political and legal issues which affect compounding now and in the future.” Dale Coker, RPh, FIACP, IACP Board of Directors Vice President, Cherokee Custom Script Pharmacy (Canton, GA).
With superior education and networking opportunities for pharmacists, technicians, marketing representatives, and pharmacy students, the Educational Conference is a must attend event.
Click here to book your hotel room at the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida. Advance discount deadline ends on or before December 3, 2013. For the latest conference news, visit www.EducationalConference.org.
February 5-8, 2014
Harbor Beach Marriott Resort & Spa
Fort Lauderdale, Florida
Thank you to Our Exhibitors and Meeting Sponsors!
We would like to thank the following exhibitors for their commitment to the Educational Conference: Analytical Research Laboratories (ARL); Associates of Cape Cod, Inc.; Attix Pharmaceuticals; Charles River; Compounding Matters; Digi-Trax Corporation; EXAKT Technologies, Inc; Fagron; Freedom Pharmaceuticals, Inc.; Hardy Diagnostics; Humco Compounding; ICA Health, LLC; International Journal of Pharmaceutical Compounding (IJPC); International Medical Industries, Inc.; JMH, Inc; Letco Medical; Live Oak Bank; MEDISCA; PCCA; Pharmacy Compounding Accreditation Board (PCAB); RXTaxPros; Storey Marketing; Tacit Almonds, LLC; Televox; Topi-Click Topical Dosing Applicator.
We would like to thank the following meeting sponsors for their support of the Educational Conference: Attix Pharmaceuticals (Meeting Syllabus Sponsor); B&B Pharmaceuticals, Inc. (Name Badge Holder, Education Session Sponsor); Fagron (Welcome Reception, Education Session Sponsor ); Freedom Pharmaceuticals, Inc. (Meeting Tote Bag, Conference Pen, Education Session Sponsor ); Humco Compounding (ACA/ACVP AND IACP Fellowship Luncheon Sponsor, Meeting E-Brochure Sponsor, Education Session Sponsor ); Letco Medical (Celebration Dessert Reception, ACA Education CEnter & IACP AdvanCE Education Sponsor); MEDISCA (Meeting T-Shirt Sponsor); PCCA (Hotel Room Key, Thursday Mid-Day Break with Exhibitor Experience, Education Session Sponsor ); Tacit Almonds, LLC (Media Sponsor); Topi-Click Topical Dosing Applicator (Friday Lunch with Exhibitor Experience Sponsor).
We would like to thank the following individual and pharmacy meeting sponsors for their support of the Educational Conference: Linda McElhiney, PharmD, RPh, FIACP, FACA, FASHP, Indiana University Health (Indianapolis, Ind.)
To learn more about the exhibitors and meeting sponsors click here.
February 5-8, 2014
Harbor Beach Marriott Resort & Spa
Fort Lauderdale, Florida
Connect and network with fellow colleagues.
IACP Regional Education Meeting in Salt Lake City, Utah; Tulsa, Okla; and Scottsdale, Ariz!
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. We hope you’ll join us for an evening of legislative and regulatory education, Q&A, and networking with your local compounders! For more information, please visit www.iacprx.org/RegionalEducationMeetings.
Title: 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.
Speaker: David G. Miller, RPh, IACP’s Executive Vice President & CEO
CE Credit: 2.0 contact hours (.20 CEUs) of ACPE-approved LIVE LAW continuing education credit; knowledge based
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 is held in conjunction with Freedom’s November CPCSI training and the Freedom Pharmaceuticals 2nd Annual Seminar. More information coming soon!
Scottsdale, Arizona – March 21, 2014
6:30 - 9:00 p.m.
FireSky Resort & Spa, Sun and Moon Meeting Rooms
4925 North Scottsdale Road, Scottsdale, AZ 85251
Save the date! Registration will open shortly.
Discounted registration fees: $20 for IACP Members, $40 for Non-Members, and Free for Pharmacy Students
This program is made possible through an unrestricted educational grant-in-aid from Storey Marketing.
This meeting is held in conjunction with the 2014 Functional Medicine Seminar presented by ZRT and Storey Marketing, to be held March 21-23, 2014 at the FireSky Resort & Spa in Old Town Scottsdale, Ariz. More details 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 Atkinson 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
Welcome to the IACP Career Center!
Your destination for exciting job opportunities and the best resource for qualified candidates within the Industry.
Click here to view the IACP Career Center.
Stay connected to IACP by joining our online communities!