Members-only Site   |   Print Page   |   Contact Us   |   Sign In   |   Register
IACP Capitol Connections, January 12, 2017
Share |

 




 

 

January 12, 2017

 

In This Issue

READ

 

Today's Table of Contents

 

 SUPPORT

 

 

 CONNECT

 





CONTACT

 

 Capitol Connections is a biweekly newsletter for IACP Members Only.

 

 Have a story idea? Please email iacpinfo@iacprx.org with your editorial ideas and suggestions!

 

Find Capitol Connections Newsletter Archives here.


IN THIS ISSUE

 

Happy National Pharmacist Day

 

 FDA Releases Draft and Final Repackaging Related Guidances

 

 FDA Releases Additional Guidances and Regulatory Information at the End of 2016

 

 Congressman Carter Appointed to the Energy and Commerce Committee

 

 BPS Conducting Sterile Compounding Survey

 

 IACP Insurance & Reimbursement Committee Update

 

 Corporate Partner Spotlight: BIOSRX

 

 OneFund: Help Keep Compounding Front & Center in 2017

 

 Exclusive to Members: Compounders Stateside Updates

 

 IACP Member: Q&A

 

 IACP Fellowship’s Spring Deadline is May 5th!

 

 Educational Conference Registration Advanced Discount Ends February 1st!

 

 Save the Date for the 13th Annual Rx Mixer!

 

 Compounders on Capitol Hill Registration Now Open!

 

 Upcoming AdvanCE Live Webinars

 

 Need CE, ASAP?

 

 

 

 

 


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Wishing our IACP Members a Happy National Pharmacist Day. You make a difference for your patients EACH and EVERY day!


FDA Releases Draft and Final Repackaging Related Guidances

The U.S. Food & Drug Administration (FDA) officially will release tomorrow a Draft Guidance - Revised Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (pertains to drugs like bevacizumab) and a Final Guidance: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.

IACP currently is reviewing these guidances and plans to comment on the Draft Guidance for Mixing Diluting or Repackaging Biological Products. The Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities is final – we advise pharmacies to download and review as soon as possible.

Please also be aware FDA yesterday released: FDA’S Human Drug Compounding Progress Report: Three Years After the Enactment of the Drug Quality and Security Act. IACP is reviewing and considering a potential response.

Please email iacpinfo@iacprx.org if you have questions.


FDA Releases Additional Guidances and Regulatory Information at the End of 2016

In December, FDA published a handful of additional guidances and one new proposed rule for the compounding industry. On December 15, FDA published what will be their first proposed rule for the List of Bulk Drug Substances that can be used to Compound Drug Products. This initial rule proposes to add the following substances to the “positive list”: Brilliant Blue G, Cantharidin (topical use only), DPCP (topical use only), N-Acetyl-D-Glucosamine (topical use only), Squaric Acid (topical use only), and Thymol Iodide (topical use only). It also proposes to NOT add the following substances: 5-HTP, piracetam, silver protein mild, and tranilast. Note that this a proposed rule and open for comments. Comments are due on March 16th, 2017 and IACP will have additional information on this proposed rule in the future. For more information about “the lists” and how they work, please see our blog post from last fall.

Also, FDA finalized the Guidance Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act dealing both with the issue of office use and anticipatory compounding. We will have more in-depth analysis on this guidance in the coming weeks, but please make sure to download and read the guidance, as it is now final. For office use compounding, the agency’s stance has not changed – the FDA still holds that providing compounds for office administration via non-patient specific prescriptions or drug orders is not allowed under 503A and that stance is now final. For the anticipatory compounding part of the guidance, there are some additional items to scrutinize within this document; but, it is best to start familiarizing yourself with FDA’s thinking on this issue. It can be found on pages 8 and 9 of the guidance.

FDA also published two draft guidances dealing with nuclear pharmacy: Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities and Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear PharmaciesComments are due by February 27th. IACP is working closely with our APHA colleagues on these guidances.

 

Finally, FDA finalized a guidance for Outsourcing Facilities - Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.

 

If you have any comments or questions about any of these documents, please e-mail us at iacpinfo@iacprx.org.

 


U.S. Congressman Buddy Carter Appointed to the Energy and Commerce Committee; Congressman Michael Burgess Named Health Subcommittee Chair

IACP is pleased to announce Congressman Buddy Carter (R-GA), a longtime champion of pharmacy compounding, has been appointed to serve on the Energy and Commerce CommitteePlease click here for a press release from Congressman Carter’s office.

In addition,Congressman Michael C. Burgess, M.D. (R-TX) was named by House Energy and Commerce Chairman Greg Walden as the Chairman of the Subcommittee on Health for the 115th CongressPlease click here to read a press release from Congressman Burgess’ office.


BPS Conducting Sterile Compounding Survey

Sterile Compounders: The Board of Pharmacy Specialties (BPS) is conducting a survey to consider sterile compounding as a pharmacist specialty. The survey can be completed in 5-10 minutes.

 

All survey results must be received by Tuesday, January 31, 2017, at 11:30 pm ET.

 

To access the survey form, please click here.


IACP Insurance & Reimbursement Committee Update

The IACP Insurance Reimbursement Committee has been notified that new provider manuals have been sent to participating pharmacies in the Express Scripts Network in late December. It is important as a network provider that you carefully review the new manual for any changes which may affect your pharmacy practices.


Corporate Partner Spotlight: BIOSRX

 

The Cappucine™Computerized Dispensing and Filling System marks the start of a new era in compounding where volume-digitalization is coupled with automation. Cappucine™ supersedes how stock formulations have been traditionally transferred from large EMP Unguator® (Gako, Inc.) jars into smaller dispensing devices that patients take home. With Cappucine™, TICKER® Transdermal Dispensers, pumps, and jars are able to be filled with just the push of a button. The transfer is fast, exact, and simple.

 

Please click here for more information.

 


Help Keep Compounding Front & Center in 2017!

 

IACP is making real progress through our DQSA Coalition as well as your efforts in educating your respective congressional representatives. We have a lot more before us in the New Year! Keeping IACP and pharmacy compounding top of mind on Capitol Hill is an ongoing challenge and a considerable investment. There’s an old saying in D.C. – “if you don’t have a seat at the table, you’re on the menu.”

On average, IACP spends $1,000 a day just in lobbying and regulatory surveillance. And, when you consider the legislative/regulatory environment of the last several years – this investment has become even more critical and costly. Click here to view a few of our milestones.

Would You be Willing to Contribute to IACP’s One Fund? Please help us maintain the momentum by contributing today. Your support will allow us to represent your pharmacy’s and your patients’ issues on the Hill! Click here to contribute.

 


Exclusive to Members:Compounders StatesideUpdates

New Compounders Stateside Comprehensive Bill and Regulation updates have been posted for you on IACP’s website! Visit here to view.

IACP works to keep its members up-to-date! Know someone who needs to join IACP - or need to renew your own membership? Contact IACP Director of Membership Jennifer Petska, BS, CPhT-jennifer@iacprx.orgtoday so that you can continue to have access to Member benefits such as Compounders Stateside.


IACP Member Q&A

Question: I own a 503A compounding pharmacy. We ship more than 5% of our products outside of Texas where we are located. I'm trying to determine whether Texas has signed an MOU with the FDA regarding this issue. To my understanding, if Texas has not signed an MOU, the FDA can then classify us as an un-registered outsourcing facility. Likely, Texas has NOT signed an MOU. In that case, can you give me any guidance as to how to get this issue before my legislators to get it signed.

 

Please click here for the answer.

 


IACP Fellowship’s Spring Deadline is May 5th!

IACP's Fellowship Program offers pharmacists the opportunity to be recognized by their colleagues and to be distinguished in their communities as specialists in the art and skill of pharmacy compounding.

 

Established in 1997, the Fellowship Program distinguishes pharmacists who are exemplary in their professionalism and commitment to the practice of pharmacy compounding. Each applicant’s credentials are assessed against rigorous criteria that include contributions to published literature, continuing education, presentations, leadership, professional and civic service as well as professional awards. The criteria are designed to maintain a balance between subject areas and to ensure that the IACP Fellows are diverse in their practices and community activities. Click here for more information on the Fellowship Program.

 

2017 Spring Deadline: May 5, 2017. For more information, please email IACP's Jennifer L. Petska, BS, CPhT at Jennifer@iacprx.org.


 

Registration Advanced Discount Ends February 1st!

 

 

Advanced Hotel Discount Ends January 23, 2017

 

 

Click Here for more conference information!


Educational Conference Exhibit Booths Available!

 Click here to access the Exhibitor Booth Registration

We would like to thank the following exhibitors for their commitment to the Educational Conference: Accreditation Commission for Health Care (ACHC); AirClean Systems; Air-Tite Products Co., Inc.; ARL Bio Pharm, Inc.; Associates of Cape Cod; Bill Pro Rx; Bios Rx, Inc.; Charles River; DoseLogix; Fagron; Hardy Diagnostics; Health Engineering Systems; Humco; ICA Health; IJPC; ISO-MeD, Inc.; Letco Medical; LP3 Network; MEDISCA; PCCA; Pharmacists Mutual Companies; Pharmacy Law Counsel; Revolution Advisors; Spectrum Pharmacy Products; Storey Marketing; Total Pharmacy Supply; Wellness Works.

 

 We would like to thank the following meeting sponsors for their support of the Educational Conference: DoseLogix (Conference Pen); Letco Medical (Closing Dessert Reception); MEDISCA(One Education Session) PCCA (Meeting Syllabus, Name Badge Holder).


Save the Date for the 13th Annual Rx Mixer!

 

Join us as we gather for the IACP Foundation’s 13th Annual Rx Mixer, a fundraising event to be held at the Washington Marriott Wardman Park, Washington D.C. on Sunday, June 11, 2017.

 

 Registration and donations are now open! Please click here for more information!



 

Register Today!

 

 

Registration advance discount pricing ends on or before March 3rd

Reserve your hotel room on or before Thursday, May 18, 2017 to receive the IACP group rate.

 

Exhibit Booths Available!

 

Reserve your booth TODAY

 

Over the course of three days, vendors will have 7 HOURS dedicated solely to EXHIBITION TIME. This is the BEST place take advantage of face-to-face networking with the top compounding pharmacists in the profession. These pharmacists and technicians are committed to meeting the unique needs of patients through customized medication solutions. Exhibitors receive complimentary listings in all conference program materials plus the meeting website, onsite signage and the meeting e-newsletter.

We would like to thank the following exhibitors for their commitment to the 23rd Annual Compounders on Capitol HillAirClean Systems; ARL Bio Pharma, Inc.; Associates of Cape Cod, Inc.; Attix Pharmaceuticals; Compounder's International Analytical Laboratory (CIAL); DoseLogix/Topi-CLICK; Eagle Analytical Services; Exakt Technologies, Inc.; Hardy Diagnostics; Health Engineering Systems (HES); Humco; International Journal of Pharmaceutical Compounding (IJPC); International Medical Industries, Inc.; Kunesa LLC, Letco Medical; LP3 Network; MEDISCA; Ortho Molecular Products; PCCA; Q.I. Medical, Inc.; RXinsider; Storey Marketing; Topi-Pump; Total Pharmacy Supply; Triova Pharmaceuticals, LLC; Willow Birch Pharma; World Wide Medical Distributors.

 

We would like to thank the following meeting sponsors for their support of the 23rd Annual Compounders on Capitol HillDoseLogix (Conference Notepad/Pen Combo); MEDISCA (One Education Session); PCCA (Meeting Tote Bag, Meeting Syllabus, Mobile Meeting App, Name Badge Holder, Hotel Room Keys, Network Lounge/ Charging Station, Welcome Reception, One Education Session); Topi-Pump (Conference Travel Mugs).

 

Don’t miss these upcoming LIVE webinars!

 

2017 OSHA Training – Bloodborne Pathogens


Need CE, ASAP?

If you need CE credit, check out IACP AdvanCE’s on-demand library. The library houses more than 100 programs with a variety of pharmacy topics. Please click here to access the self-paced programs.


If you wish to stop receiving email from us, you can simply remove yourself by
visiting: iacpinfo@iacprx.org.

(C) 2017. All Rights Reserved. IACP.



 

Association Management Software Powered by YourMembership  ::  Legal