Honoring our Veterans!
IACP honors all those who have served on this Veterans Day, November 11th. Thank you for your service.
Confused About the FDA Lists?
In our last newsletter, IACP reported on two guidance documents released by the FDA on October 26, 2015 that outlined how the agency intends to exercise its enforcement discretion for the bulk drug substances permitted under section 503A and 503B of the Food Drug and Cosmetic Act (FDCA).
In those documents, FDA referred to four new "lists" that they would use to guide inspectors and others when determining whether or not a traditional compounder or outsourcing facility is using an acceptable API. The lists themselves are not easily accessible; you have to find an internet link within the guidance documents to then connect to what's been published. IACP has those lists available for you.
Click here for traditional 503A compounders.
Click here for 503B registered outsourcing facilities.
The two lists are different depending on whether you are a traditional compounder or an outsourcing facility.
Are these lists in effect yet? NO!
The guidance documents are still going through their formal 60-day comment period and are only drafts at this point. Stakeholders, including IACP, have until the end of December to submit comments on the concept of the lists, whether this is an appropriate and reasonable approach, and request or recommend any changes to the lists or to the concepts expressed in the guidance. Our Legislative Committee, chaired by IACP Director Erik Tosh, already has begun their review of the document and invites input from any IACP member. You can send your comments to us at email@example.com.
In Case You Missed it: FDA Recap from Last Capitol Connections
New Guidance Documents and New Lists
The Food and Drug Administration (FDA) recently released two interim guidance documents to clarify how it intends to exercise enforcement discretion with both 503A traditional compounders - click here to view - and 503B outsourcing facilities - click here to view.
These guidance documents address the agency’s current position on what APIs can be used in preparing a compound when those bulk ingredients do not meet the Drug Quality and Security Act (DQSA) provisions that require the existence of either a USP monograph or that the API be a component of an FDA approved product.
Please click here to read more.
Loud and Proud: Your Actions Make a Difference!
Stop FDA's Misguided Veterinary Compounding Guidance
A big thank you to the more than 300 members who sent in their action alerts to your congressional representatives asking them to sign a letter to FDA to withdraw its Guidance for Industry #230: Compounding Animal Drugs from Bulk Substances. Your participation resulted in generating 20 congressional co-signers on the effort led by Congressmen Matt Salmon (R-AZ) and Kurt Schrader (D-OR).
The letter points out that the agency does not have statutory authority to interfere with the state-regulated practice of veterinary medicine. More importantly, the Congressmen point out that as written, the guidance attempts to create new regulatory authority without legislation to support that effort.
Please click here to view the final letter featuring 20 co-signers.
The Wall Street Journal Interviews IACP's David Miller on Tricare
IACP Emphasizes Importance of Continued Patient Access to Compounds
IACP's David Miller Executive Vice President/CEO is quoted in this week's The Wall Street Journal, "US Targets Pharmacies Over Soaring Claims to Military Health Program." In a negative article essentially citing all compounding is fraudulent, Miller takes issue with that and emphasizes compounded medicines have considerable value for patients and have increasingly been prescribed for patients who rely upon them.
Excerpted: "David G. Miller, chief executive of the International Academy of Compounding Pharmacists, said fraud is only a small reason for increased use of compounded medicines. A bigger factor, he said, is that doctors have become wary of patients abusing opioid pain pills and, as a result, have turned to alternative, nonaddictive treatments such as compounded pain creams."
What The WSJ didn't include from Miller's interview is his statement below:
"The increase in per claim compound prescription costs to Tricare had been evident to its pharmacy benefit management contractor Express Scripts (ESI) for more than a year. All other prescription drug programs have a computer infrastructure to limit excessive billings yet ESI continued to accept and pay claims without rejecting them or requiring additional information from the pharmacy provider. That's what happens in all prescription benefit plans for branded and generic drugs but, for whatever reason, ESI did not do that for compound prescription claims."
Please click here to read the entire article.
IACP's Prescription Billing Accounting Statement
IACP believes public and private health care payers should aggressively address health care fraud, including taking action against any health care provider that has allegedly broken the law. If a provider has misrepresented what they have dispensed or has not followed law or regulation, they should be held fully accountable.
Click here to read IACP's complete statement.
IACP Provides 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
Hot Button Issues on the PBMs Radar Screen
Please contact IACP with questions at firstname.lastname@example.org.
Closing November 20th: IACP Foundation Board of Directors Call for Nominations
IACP Foundation’s 2015 Call for Nominations and the 2015 Election Cycle for the new March 1, 2016 – February 28, 2018 Board members is now open!
The Bylaws of IACP set forth an open election process with nominations for candidates accepted directly from the community of pharmacists, pharmacy technicians, other healthcare professionals, patients, etc.
Nominations close on November 20, 2015.
Please click here for more information as well as a nomination form.
Corporate Partner Spotlight: Spectrum Pharmacy Products
Serving Compounders since 1971
Spectrum Pharmacy Products provides compounding chemicals, equipment and supply items – with quality and delivery you can count on every time. Easy 24/7 access to over 1,200 monograph chemical items, and the industry’s most comprehensive line of consumables and equipment used daily by Pharmacists is what sets Spectrum apart from other suppliers. But our commitment to both customers and their patients does not end there. Compounding chemicals are tested in-house to strict quality standards for purity and strength. We work with ACPE accredited providers to bring you the education courses you need to stay current with advanced techniques in a rapidly changing regulatory environment. Your Spectrum Pharmacy Products team is also active in many national pharmacy associations and organizations to provide support and ensure that the compounder’s voice is heard.
Please click here to read more!
Thank You PCCA for Contributing $7,500 to IACP's One Fund!
Sincere thanks to IACP's long-time Corporate Partner PCCA for contributing $7,500 to our One Fund campaign. Your contributions both monetary and in kind over the years have helped us to Protect, Promote & Advance Pharmacy Compounding!
A Message from PCCA's President Jim Smith
PCCA supported the formation of IACP 25 years ago and continues to acknowledge the important work IACP does for compounding today. We encourage staff members to serve on IACP boards and committees and we give generously to IACP causes. Collaborative efforts have and will continue to be part of our joint missions to see compounding flourish.
Independent community pharmacies make up PCCA’s membership and those pharmacies dominate the compounding space. We have always recommended that our members join IACP and appropriately they have responded to make up a large part of IACP’s core membership. This common membership is the natural reason our organizations work together. Working together, we amplify our members’ unique mission and voice to make a difference.
On behalf of the entire IACP Board, Membership and Staff - thank you PCCA - for this very generous contribution to IACP. Your support is greatly appreciated.
Help Us Reach $2 Million
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.
One Fund Contributors List
Please click here to view our One Fund Contributors to date!
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 Members in the News
PCCA Names Michael Collins Pharmacist of the Year
Congratulations to IACP Member Michael Collins, RPh, FIACP, Healthway Compounding Pharmacy in Saginaw, Mich., for being named Pharmacist of the Year during PCCA's International held last week! Please click here to read PCCA's press release.
Congrats also to IACP Member Thomas “TJ” Marti, RPh, CareFirst Pharmacy, Broken Arrow, Okla., for being awarded PCCA's George Roentsch Scholarship. More info here!
Accredited Since 2009, The Compounding Center Receives PCAB Reaccreditation
Congratulations to IACP Member Jay Gill, PharmD, The Compounding Center in Leesburg, Va., for receiving PCAB Reaccreditation! Click here to read more.