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IACP Capitol Connections, November 23, 2015
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November 23, 2015

In This Issue

1. Happy Thanksgiving!


2. USP Formally Approves General Chapter <800>


3. Assessing the Impact – A Compounding Patient Survey


4. IACP Submits Comments to FDA on the Draft Guidance for Compounding Animal Drugs from Bulk Drugs


5. In Case You Missed It: Confused About the FDA Lists?


6. Do You Dispense Prescriptions Into Pennsylvania?


7. IACP Wants You! Call for IACP 2016 Committee Volunteers


8. Corporate Partner Spotlight: PCCA


9. Educational Conference Registration is Now Open


10. Save the Date: Rx Mixer Roundup - Saddling Up for Research and Education!

Capitol Connections is a biweekly newsletter for IACP Members Only.

Please email with your editorial ideas and suggestions.

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Happy Thanksgiving!


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

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 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

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.

Member FAQ


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


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


Corporate Partner News



Congrats to IACP Corporate Partner MEDISCA for receiving their ISO 9001:2008 Certification! More information by clicking here.

ACA IACP ACVP Educational Conference Registration is Now Open!


Register, Today!


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, 2016, at the Loews Coronado Bay Resort located in San Diego, California.

Perched on its own 15-acre peninsula, Loews Coronado Bay Resort is a private oasis of tranquility with views of the shimmering bay waters and the San Diego skyline.


Friday, February 26 Workshops Include:

ACA- Implementation of cGMP Quality Systems for 503B Facilities
Presented By: Ben Frey, MS, ProPharma Group


IACP- Are You Ready? USP <800> Is Almost Here
This program is made possible through an unrestricted educational grant-in-aid from Letco Medical.


Presented By: Mark Dumas, MSPH, Sage Safety Services; Patricia Kienle, RPh, MPA, Cardinal Health; Erik Tosh, RPh, FIACP, Letco Medical


ACVP-Medication Safety for the Veterinary Pharmacist
Presented By: Heather Lindell, PharmD, BS, RPh, DICVP, FSVHP, University of Georgia Veterinary Pharmacy


Please click here for more information and to register!

SUBMISSION DEADLINE is NOVEMBER 30th for IACP Foundation's Semi-annual Student Writing Competition!

Calling All Students!

Participate in 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.

For more information, please email Jennifer Petska, BS, CPhT, IACP Foundation Administrator and Director of Development.

Save the Date: Rx Mixer Roundup - Saddling Up for Research and Education!


The good guys in the white lab coats are riding to Rx Mixer Roundup - Saddling up for Research and Education! Join us as we gather for the IACP Foundation’s 12th Annual Rx Mixer, a fundraising event to be held at the Renaissance Washington DC on Sunday, June 12, 2016.

Event Co-Chairs, Erin Michael, MBA, CPhT and Richard Harwood, CPhT, with their Live Auction, Big Board and Reverse Card Draw Committees, plan to raise more than $205,000 through sponsorships and the auction to benefit the IACP Foundation! Since the first Rx Mixer was held in 2005, supporters of the pharmacy compounding profession generously have contributed more than $1.8 million to IACP's educational and research mission.


For more information about volunteering, donating an auction item, or becoming a sponsor, please email Jennifer Petska, BS, CPhT, IACP Foundation Administrator and Director of Development, or call the IACP office at 281/933-8400. To obtain a sponsorship or donation form, and to learn more about Rx Mixer please click here.

IACP Regional Education Meeting Heading to Houston, TX!


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 Compounding Medicines: New Laws, New Regulations, New Questions an in-depth presentation on federal and state legislative and regulatory issues that are affecting compounders today.


Please click here for more information and to register!

Developing a Sustainable Cleaning, Sanitization and Disinfection Program - Don't Get Left Behind on the New FDA Guidelines

Andrew Harrison

Chief Regulatory Affairs Officer & General Counsel

Regulatory Compliance Associates, Inc.

Tuesday, December 8, 2015

1:00 - 2:00 p.m. CST (2:00 ET/11:00 PT/12:00 MT)


Effective cleaning and sanitization programs are essential to ensure quality for drug compounders. In July of last year, the FDA issued new Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. This guidance addresses cleaning, sanitization, disinfection and sterility for 503Bs. Because the guideline is still in the public comment phase of the regulatory process, now is the time to understand the requirements and ensure compliance for your facility.

At the conclusion of this program, the attendee will be able to:
• List the areas of the facility that need to be cleaned, sanitized, disinfected or sterilized.
• Develop compliant procedures for cleanroom cleaning and disinfecting as well as defined cleaning schedules.
• List the options for disinfecting agents and methods of application.
• Discuss the requirements for validation, documentation, and environmental monitoring.
• Explain how tips and case studies help outsourcing facilities demonstrate sustainable compliance.


Start Planning Now for CCH 2016!


2016 CCH Exhibitor Prospectus Now Available!

Click here to access the Online Commitment form.


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 2016, 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.
  • A bargain hotel group rate at $199 – that’s almost half the price from previous years!
  • Hear from experts during in-depth Continuing Education sessions on legislative and regulatory issues at the state and federal level affecting pharmacy compounding.
  • Expanded exhibit hall puts attendees face-to-face with 50 leading companies that serve compounding pharmacies.
  • Stay for Hill Day! Be an advocate for compounding during in-person Capitol Hill meetings with your state representatives.
  • Socialize and support the IACP Foundation during compounding pharmacy’s biggest party of the year – Rx Mixer on Sunday, June 12, 2015.
  • On Monday, June 13, the COMP PAC Dinner and Fundraiser is an exclusive opportunity to hob-nob with the powerful movers and shakers of Washington, D.C. The COMP PAC will host a very high-profile influencer to talk face-to-face with our attendees about the future of health care.

Network! Reconnect with old friends and meet new colleagues who share your passion and interest in protecting, promoting and advancing pharmacy compounding!

June 11-14, 2016
Renaissance Washington, D.C.
999 Ninth Street NW
Washington, DC 20001

Thank you to Our Exhibitors and Meeting Sponsors!


Accreditation Commission for Health Care (ACHC); AirClean Systems; American College of Apothecary (ACA); Associates of Cape Cod, Inc.; B&B Pharmaceuticals, Inc.; bioMerieux, Inc.; BiosRx, Inc.; Compounders International Analytical Laboratory (CIAL); DoseLogix; EXAKT Technologies, Inc.; Fagron, Inc.; Freedom Pharmaceuticals; Hardy Diagnostics; Health Engineering Systems; Humco Compounding; ICA Health; International Journal of Pharmaceutical Compounding; International Medical Industries, Inc. (IMI); Kunesa LLC; Letco Medical; LP3 Network; MEDISCA; PCCA; RxCoop, LLC; Storey Marketing; Topi-Pump; Torpac Capsules Inc.; Willow Birch Pharma.


We would like to thank the following meeting sponsors for their support of the Educational Conference: DoseLogix (Conference Pen/Notepad); Letco Medical (Hotel Room Keys, Welcome Reception, Education Session); MEDISCA (Name Badge Holder); PCCA (Meeting T-shirt, Meeting Tote Bags, Meeting Syllabus); Topi-Pump (Travel Mugs).

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.

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