When Is a Monograph Not a Monograph?
In order to prepare a customized medication with a bulk ingredient, whether you are a 503A traditional compounder or a 503B outsourcing facility, the Active Pharmaceutical Ingredient(s) must meet certain requirements included in the Drug Quality & Security Act. Specifically, the API must have a USP or NF monograph, be a component of an FDA approved drug, and/or be formally included on a list established by the Secretary of Health and Human Services.
Pretty straightforward, right? Well, maybe not.
During the June 17, 2015 meeting of the FDA Pharmacy Compounding Advisory Committee (PCAC) a question was asked about the dietary supplement monographs included in USP. FDA representative Jane Axelrad stated that “we don't consider dietary supplement monographs to be the kind of monograph that they were referencing in the statute as being okay to compound.” In other words, even if pharmacists and physicians and even USP believes that a published monograph is a monograph, the FDA now states that they have a completely different view.
Please click here to read the entire article.
Tricare Update: Mailing Letters, Mailing Prescriptions
Thanks to the calls and e-mails from IACP members, Congressman Buddy Carter (R-GA) along with 30 other House members (at newsletter press time) are submitting letter of inquiry to Tricare asking about the implementation of their restricted reimbursement program by their contracted PBM Express Scripts. Signing onto the letter directed to Assistant Secretary of Defense for Health Affairs Jonathan Woodson were Congressmen Walter Jones, Sam Farr, Tim Ryan, Reid Ribble, Tom McClintock, Blake Farenthold, Pete Olson, Peter Welch, Collin Peterson, David Schweikert, Scott DesJarlais, Ron DeSantis, Alexander Mooney, Peter DeFazio, Austin Scott, Charles Rangel, Paul Gosar, D.D.S., Chris Stewart, Matthew Salmon, Mike Pompeo, Gary Palmer, Diane Black, Sanford Bishop, Jr., Rod Blum, Frank Guinta and Doug Collins. Those individuals serve on important health care and armed forces committees and the support of our members were instrumental in explaining why Tricare beneficiaries must continue to receive needed compounded prescriptions. Please click here to view the letter.
Please note: Congressman Carter has extended the sign-on deadline to this Wednesday, September 16, 2015. Additional congressional offices have expressed interest in supporting. IACP will publish the final letter when available.
But it isn’t just compounding that’s under fire within the Tricare system. In 2014, Tricare and Express Scripts launched a pilot mail-order program to assess whether or not there was cost-savings to the system without adversely impacting patient access. That pilot rolls out to all Tricare beneficiaries except active duty service members on October 1, 2015. Calling it “Home Delivery” instead of what it is – mailed prescriptions – ESI and Tricare are reminding beneficiaries that refills of all brand and generic maintenance medications must now be filled either at a military pharmacy or be sent to ESI’s mail order fulfillment center. Otherwise, the servicemen or their families will be responsible for the full 100% of the cost.
If you provide non-compounded prescription services to Tricare beneficiaries, this change will impact you. Express Scripts has additional details, including a toll-free number for questions, here.
Learn More About the FDA's Veterinary Compounding Guidance
With just a little over two months to go before comments are due on the FDA’s Guidance For Industry (GFI), click here, and the substantial changes the agency is seeking to veterinary compounding oversight, IACP members IACP’s Legislative Committee is actively working on formulating industry comments. You, too, can participate by sending your input to the Committee no later than Wednesday, September 30, 2015 at firstname.lastname@example.org.
IACP has three resources for our members to review to learn more about this GFI.
The first is our analysis of the GFI and its evolution that appears in our Summer issue of Compounding Matters Quarterly. Please click here to view this issue.
The second are two recordings of seminars presented at our 2015 Compounders on Capitol Hill annual meeting that included panel discussions about veterinary compounding, the pending Guidance, and its impact on both veterinarians and pharmacists. Please click here to watch those sessions.
Questions About Compounding Kits
Have you received an e-mail or phone call from a sales person promising significant profits if you buy their compounding “kit”? Perhaps it’s been a message on your LinkedIn or Facebook account.
In May and June, First DataBank announced that because of “unanswered questions regarding the legal marketability of "compounding kit" drugs” they would be removed from the MedKnowledge database effective June 8, 2015. In that announcement, FDB went on to state: “Despite their intended use as finished products, we are aware of no regulatory review process that demonstrates their safety and efficacy. Additionally their self-characterization as bulk ingredients to be used by compounding pharmacies is questionable, since bulk pharmaceutical ingredients are not intended for use by an individual patient. Finally, these products lack FDA-approved labeling and adequate supporting information as to indications, warnings, and precautions and side effects.” In other words, the nation’s primary source of NDC and pricing information used by third-party payers has and continues to remove these products from their databases.
Please click here to read the entire article.
Massachusetts Releases Draft Plan for Out-of-State Pharmacy Permits
The Massachusetts Board of Pharmacy recently announced its draft regulations for non-resident pharmacy permits. Massachusetts is the next-to-last state to require out-of-state pharmacies to obtain permits before shipping prescription drugs to its residents. Following the passage of enabling legislation in 2014, the Board will require:
•A "Drug Store Store Pharmacy" license is required for any non-resident pharmacy to ship or dispense a controlled substance into the state.
• A separate and additional a non-resident sterile compounding pharmacy license is required to ship or dispense any sterile compounded preparations into the state.
• A separate and additional non-resident complex non-sterile compounding pharmacy license is required to ship or dispense any complex non-sterile preparations into the state.
Click here to read more.
Sanders, Cummings Introduce Comprehensive Legislation to Lower Soaring Drug Prices
FDA Releases Draft Guidance on Naming System for Biological Products, Seeks Public Comment
Compounded or Repackaged Drugs Stored in Becton-Dickinson Syringes: FDA Expands Warning
Forbes: Patients Are Tired Of Waiting On The FDA
Exclusive IACP Member Benefit: Compounders Stateside
IACP’s Compounders StateSide is a members-only one-stop resource for state legislative updates and the latest happenings with state Boards of Pharmacy. Need to know the latest happenings in your State? IACP has the information for you! Be sure to visit Compounders Stateside for the latest legislative and regulatory activity in your state. This is vital information for your practice to ensure you're operating within your state guidelines.
Please check this page periodically, as it will continue to be updated weekly as situations continue to evolve with each individual state.
IACP Compounders Stateside provides you with a State Compounding Legislation Tracker, a comprenhensive document with up-to-date compounding activity in your state. And, brand new, IACP Compounders Stateside also now provides Members with a State Regulation Tracker of all the regulations and rules that Boards of Pharmacy are considering that deal with compounding.
IACP Members: Please click here to visit IACP's Compounders Stateside!
IACP President Dale Coker Tells You Why He Supports IACP's One Fund in New Video
Help IACP reach our fundraising goal of $2 million dollars by the end of 2016. This funding allows us to continue our efforts to Fix DQSA and to be ready for the next challenge on the horizon. Through your generosity and support we are shaping the future of compounding.
At Compounders on Capitol Hill this year, IACP President Dale Coker, RPh, FIACP, issued a personal challenge to our membership and Corporate Sponsors to donate to IACP’s One Fund.
Please click here to view IACP President Dale Coker's message!
"IACP has a clear goal to be proactive rather than a reactive organization," says Coker. "To accomplish this, it requires capital. We need to replenish our reserves used in defending compounding in the wake of the NECC crisis of 2012. We need to build our war chest for the next coalition that will need to be formed. There are many issues on the horizon, with the Veterinary Compounding Compliance Policy Guide, third party reimbursement and third party credentialing to name a few. We need funding available to act NOW, not after a crisis sets in.
It’s this simple—IACP is your voice in Washington, in the industry, and on the national stage. They are also the voice of your patients who would otherwise never be heard.
Ensure your interests are represented by donating to IACP today. I make financial support of IACP a routine part of my yearly budget. I’m asking you to do the same. Your donation of $100 a month will help ensure YOUR best interests and bottom line are guarded by IACP representatives in the halls of Congress. Thank you for your support."
IACP Members and Corporate Partners: Please join us in our efforts to Protect, Preserve and Advance Pharmacy Compounding by making a donation to IACP’s One Fund fundraising campaign. Please click here to donate online, or click here to access a One Fund donation form.
Please contact Jennifer Petska, BS, CPhT,IACP Director of Development & Membership, with questions about One Fund.
IACP Provides You with Educational Resources on How to Work with Third Parties
IACP has several self-paced, on-demand CE offerings on how to work with third parties. Check our our expanding library below:
CMS and Reimbursement for Medicaid/Medicare Prescription Drugs
Third Party – Part 1 Private
Don’t Mess with Uncle Sam! How the Stark Law and the False Claims Act Impact Pharmacists
Contracting and Audit Considerations for Compounding Pharmacy
Medicare Part B: Documentation Requirements and 2013 Update
CMS and Reimbursement for Medicaid/Medicare Prescription Drugs
Hot Button Issues on the PBMs Radar Screen
Please contact IACP with any questions at email@example.com.
Registration Opens October 5th for the ACA, IACP, ACVP Educational Conference
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 24-27, 2015, at the Loews Coronado Bay Resort. Perched on its own 15-acre peninsula, Loews Coronado Bay is a private oasis of tranquility with views of the shimmering bay waters and the San Diego skyline.
Please click here for more information!
IACP Foundation News
IACP Foundation Seeking Grant Proposals
The IACP Foundation Research Committee is now seeking proposals for funding consideration. Please click here to read the Grant Request for Proposal, and submission guidelines. Please click here to read more about IACP's Grant Proposal program.
The Application Deadline is November 1, 2015. Grant Awards will be announced on December 15, 2015.
NEW! Announcing the Fall 2015 Student Writing Competition
Essay Theme: "How is the Drug Quality & Security Act Affecting the Future of Compounding?"
The IACP Foundation created its semi-annual Student Writing Competition to recognize outstanding original papers by student pharmacists on a particular topic affecting pharmacy compounding. THREE winners will be selected by a review committee from the papers submitted. The winners of this writing competition will each receive a $500 cash prize. All student pharmacists are encouraged to compete.
The submission deadline is Monday, November 30, 2015. Please Click Here to obtain a Guidelines/Requirements document for essay submission.
IACP Foundation August Newsletter
Please click here to read the August Newsletter!
For more information, please email Jennifer Petska, BS, CPhT, IACP Foundation Administrator and Director of Development.
Tune into IACP Podcasts #18 and #19!
Podcast #18 - The Washington State Court Ruling on the Pharmacist Conscience Clause and The Stocking of Plan B
Podcast #19 - FDA Guidance on 503B Facilities
For more information on IACP's Podcasts and Publications, please contact Scot Maitland-Brownell.
Mark your Calendars - 2016 CCH Exhibitor Prospectus will be Released November 2015!
The 22nd Annual Compounders on Capitol Hill (CCH) will be held June 11-14, 2016 at the Renaissance Washington, in Washington D.C. With more than 400 expected attendees in 2015, Compounders on Capitol Hill brings together the top-level compounding pharmacists and technicians from across the country with the same goal – to protect pharmacy compounding. Don’t miss the only pharmacy compounding event that takes our issues directly to Washington, D.C.’s doorstep.
CCH returns to Downtown Washington, D.C.! Conveniently situated in the Penn Quarter district, this premier location is surrounded by shops, a variety of dining options, the Spy Museum, Chinatown, the National Portrait Gallery, the Smithsonian American Art Museum, and world-famous National Mall monuments.
More details to come!
Save $100 on Freedom’s 4th Annual Seminar and Attend the IACP Regional Education Meeting in Denver, CO - THIS SATURDAY!
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. Listen to David G. Miller, RPh, IACP’s Executive Vice President & CEO 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 are affecting compounders today.
Click here for more information!
Protect Your Pharmacy from a Data Breach
Chad Leedy, Vice President of Retail Compliance
Thursday, September 22, 2015
1:00 – 2:00 p.m. CST (2:00 ET / 11:00 PT / 12:00MT)
In this presentation, pharmacy owners will learn about the growing risk of a credit card or medical data breach, and what they can do to protect themselves against cybercriminals. They will also learn about best practices for complying with both PCI and HIPAA regulations. Overall, this presentation will make pharmacy owners aware of data security issues in the marketplace and how to combat hackers in the medical space.
At the conclusion of this program, the attendee will be able to:
• Describe the risk pharmacy owners face when processing sensitive customer data.
• Discuss the financial and brand impact of a data breach.
• List the best practices/measures to take to avoid a data breach.
• Prepare a crisis management plan in the event of a breach.
Need Additional CE Credit? If you need CE credit, check out IACP AdvanCE's on-demand library, which houses more than 100 programs on various pharmacy topics. Please click here to access the self-paced programs.
Featured Webinar Programs: