IACP wishes you and your family a very Happy Thanksgiving! What is IACP thankful for? We are thankful for our Members, Corporate Partners and Affiliates!
IACP will be closed on Thursday and Friday, reopening at 8 am on Monday.
USP Formally Approves General Chapter <800>
On Friday, November 20, 2015, the United States Pharmacopeial Convention (USP) announced that their Compounding Expert Committee had formally approved new General Chapter, <800> Hazardous Drugs—Handling in Healthcare Settings. The purpose of this General Chapter is to provide standards to protect personnel, patients and the environment when handling hazardous drugs (HDs). The chapter applies to all healthcare personnel and all entities which handle HDs. Building on existing standards and guidelines, General Chapter <800> provides a comprehensive approach for handling HDs in healthcare settings with the ultimate goal of preventing and/or limiting potential exposures to HDs.
Please click here to view USP's official announcement.
The revised General Chapter <800> will be published on February 1, 2016 in the First Supplement to USP 39–NF 34. Additionally, the Expert Committee approved a delayed official implementation date of July 1, 2018 to allow entities more than two years to implement the chapter.
"IACP had requested many changes in the original published General Chapter earlier this year and we are very pleased to see that the Expert Committee took our concerns seriously. Although the final chapter represents a significant improvement, there are still challenges that remain as pharmacies and health care professionals adapt to the new requirements," said IACP Executive Vice President David Miller. "We are especially glad that USP recognized the potential financial ramifications and the changes that compounding pharmacy practices will need to implement and provided two years for preparation."
Assessing the Impact – A Patient Impact Survey
IACP is collaborating with PCCA and other compounding supportive pharmacy groups in a new national survey of patients who have been adversely affected by Tricare and Express Scripts. As reported here in your IACP newsletter, Express Scripts continues to roll-out an ever expanding set of restrictions on what types of APIs and what classes of compounds will be covered under the Tricare plan.
As we continue to raise these issues in front of Congress, one of the biggest questions we hear form Representatives and Senators is “how does this affect my constituents?” To help answer that question, PCCA has created a survey to which you can direct your Tricare patients and IACP encourages all of its members who provide care to Tricare beneficiaries to help spread the word.
Please click here to access an e-mail that can be copied and pasted into an e-mail from your pharmacy to your individual patients. The link to the survey, located at a separate and independent site for data aggregation, becomes “active” once you enter it into your e-mail.
Our goal is to have as many individual patient stories and examples available when Congress returns from its series of holiday recesses so we can prevent any further erosion of this critical benefit for Tricare beneficiaries and their families. Tricare and ESI continue to claim that they have received no complaints from beneficiaries over the reduction of compound coverage. And we need to combat that with specific examples!
Please participate in this profession-wide effort!
IACP Submits Comments to FDA on the Draft Guidance for Compounding Animal Drugs from Bulk Drugs
On November 16th, the International Academy of Compounding Pharmacists (IACP) submitted formal comments to the Food & Drug Administration (FDA) regarding the Draft Guidance for Compounding Animal Drugs from Bulk Substances (GFI #230).
IACP's Comments to FDA
Please click here to view the entire comments submitted to FDA regarding the GFI #230. To date, there have been 24 sets of comments sent to the FDA.
Why is GFI 230 a problem for compounders? “As proposed, the FDA’s Center for Veterinary Medicine (CVM) is attempting to circumvent the legislative process and, instead, create an entirely new approach to compounding,” says IACP Executive Vice President David Miller. “It’s not just that which concerns our membership and our Board, it’s that if left unopposed, these new policies could set a precedent to justify the FDA’s further efforts to regulate human compounding.”
Please click here to read more.
In Case You Missed It: 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 firstname.lastname@example.org.
Do You Dispense Prescriptions Into Pennsylvania?
Pennsylvania has formally enacted legislation requiring non-resident pharmacies to be licensed within their state. Beginning in December, out-of-state pharmacies should begin completing and filing their requests for a pharmacy permit with the Pennsylvania Board of Pharmacy.
Please click here to access the form.
IACP Wants You! Call for IACP 2016 Committee Volunteers
IACP invites members to volunteer to serve on a committee in 2016! Committee members provide an invaluable service to the Academy and its members by contributing to initiatives and projects that are essential to the continued advancement of pharmacy compounding.
By serving on a committee you are given the opportunity to network, contribute to your profession, assist IACP Board of Directors and staff and expand your leadership skills.
Click here to view IACP committees. Please email email@example.com for more information or to volunteer.
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.
Corporate Partner Spotlight: PCCA
PCCA Launches New, Exclusive Base – XemaTop™ (PCCA #30-4891)
Designed for Formulations Targeting Patients with Eczema, Psoriasis and Xerosis
More than 24.8 million Americans live with moderate to severe eczema1 and psoriasis.2
Using the power and synergy of natural boswellic acid, avenanthramides from oats, phosphatidylglycerol and elegant film formers, XemaTop delivers and improves the action of common active pharmaceutical ingredients (APIs) used in formulations for patients with eczema, psoriasis and xerosis.
XemaTop nourishes and replenishes the lamellar bilayers of the skin and helps restore health into the skin’s barrier to reduce the appearance of redness and irritation.
Please click here to read more!
Thank You for Contributing to IACP's One Fund!
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.
Every week, IACP members contact our offices for questions about practice, business, legislation and other issues. In every issue of Capitol Connections, we'll highlight a question we've been asked that affects many of our members. If you have a question you'd like answered, please send to email@example.com.
Question: We were looking to find the list of medications that are Grandfathered in for use in compounding. Is this available from the IACP website?
Answer: No drugs were "grandfathered" in for compounding. Currently, any bulk ingredient/API may be used in compounding if it has a USP monograph or is part of a current or previously FDA approved prescription drug product or, if none of those two criteria are met, then the FDA's Pharmacy Compounding Advisory Committee (PCAC) has to review and approve the addition of the API onto a "list."
Please click here for more information.
IACP Welcomes Corporate Partner: Quality Compounding Certification Program
The IACP Corporate Partner program engages corporate leaders in the pharmacy compounding community by connecting them with IACP’s more than 4,000 members who are focused upon the specialty practice of pharmacy compounding. We encourage all IACP members to support IACP's 75 Corporate Partners who are instrumental in our joint effort to protect and grow this vital part of quality healthcare.
To learn more about QCCP, please visit www.qccp.org.
Corporate Partner News
Congrats to IACP Corporate Partner MEDISCA for receiving their ISO 9001:2008 Certification! More information by clicking here.