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Capitol Connections February 21, 2014
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February 21, 2014  

 

LAST CALL: Request for Nominations to FDA's Pharmacy Compounding Advisory Committee

On Monday, January 13th, the FDA published its request for nominations for the Pharmacy Compounding Advisory Committee (as required by the Drug Quality and Security Act). FDA is requesting nominations for 12 voting members, 1 voting consumer representative (consumer organizations will be participating in the selection of this individual), and 2 nonvoting industry representatives. Nominations for voting members are due March 14, 2014. Individuals can also self-nominate for the positions. The FDA included the following criteria for voting members:

"Persons nominated for membership must have adequately diversified research and/or experience appropriate to the work of the Committee in such fields as pharmaceutical compounding, pharmaceutical manufacturing, pharmacy, medicine, and related specialties. These members will include representatives from the National Association of Boards of Pharmacy, the United States Pharmacopoeia, pharmacists with current experience and expertise in compounding, physicians with background and knowledge in compounding, and patient and public health advocacy organizations. The specialized training and experience necessary to qualify the nominee as an expert suitable for appointment is subject to review, but may include experience in medical practice, pharmacy practice, teaching, research, and/or public service relevant to the field of activity of the Committee."

IACP will submit any and all interested members for consideration.

For complete information on the FDA’s steps in implementing the DQSA, please click here. For the announcement requesting nominations to the Pharmacy Compounding Advisory Committee, please click here.

503B Outsourcing Facilities -- Possible Suppliers to Pharmacies? 

IACP has received many questions from members and non-members about whether or not they could purchase compounded sterile medications from an FDA-registered outsourcing facility to then dispense to patients in their practice.  In other words, compounding pharmacies and even regular non-compounding community pharmacies may see an opportunity to expand the scope of their services if they could obtain compounded sterile drugs without doing the compounding themselves.  But can that happen?

Yes!  

Even though 503B facilities are prohibited from distributed medications to purchasers who will then resell them (e.g., a wholesaler), the Drug Quality and Security Act (DQSA) specifically permits the purchase of a 503B facility's preparations for the purpose of administering to a patient or dispensing pursuant to a patient specific prescription.

IACP Member Call to Action: Your Academy is Seeking Information

IACP Members: Do you currently hold a manufacturer/wholesaler/distributor permit through the DEA for controlled substances? IACP is aware of legislation that could positively or negatively impact our membership. IACP's Board currently is assessing its membership's needs to determine the extent to which it will. Your feedback will assist us in making this strategic decision. Please email iacpinfo@iacprx.org with the information by close of business, Tuesday, February 25th.

IACP Submits Nonvoting Industry Representative Nominations to FDA

The International Academy of Compounding Pharmacists (IACP) has formally nominated Patricia Stephens, PharmD, IACP President, and David G. Miller, RPh, IACP Executive Vice President/CEO to serve as nonvoting industry representatives on the FDA's Pharmacy Compounding Advisory Committee, representing the interests of the pharmacy compounding profession. Click here to view the nomination letter for Pat Stephens. Click here to view the nomination letter for David Miller.

Thanks for the Pharmacy Compounding Advisory Board Individual nominations!

Please note that IACP has received 18 Individual nominations for FDA's Pharmacy Compounding Advisory Board. IACP will be submitting the entire nomination list to the FDA. We currently are compiling all of the information, and will publish the list when finalized. Thanks for your interest in serving the pharmacy compounding profession!

NPR Interviews IACP on Compounded Lethal Injections

Compounding for lethal injections continues to be a trending news topic. IACP’s David G. Miller, RPh, Executive Vice President/CEO sat down with NPR last week to provide the compounding perspective, and to explain how ongoing commercial medication drug shortages have created a controversial situation where compounded lethal injections have become the only option for prison systems. Click here to listen to the interview, and to access a printed transcript.  

In Case You Missed It - IACP First to Issue Comments on for FDA's Draft Guidance: Implementation of 503A & 503B

Your Academy was the first to submit comments to the FDA on its Draft Guidance regarding the implementation for both Section 503A and 503B of the Federal Food, Drug and Cosmetic Act.

IACP is ensuring that the voice of our pharmacy compounding members is heard!

IACP Comments to FDA for your Review

Please click here to view IACP's Comments on FDA's Draft Guidance on the Implementation of Section 503A.
Please click here to view IACP's Comments on FDA's Draft Guidance on the Implementation of Section 503B.
Please click here for IACP's Comparison Chart of 503A and 503B - The Drug Quality and Security Act of 2013.

Complete List of Stakeholder Comments to the FDA

Please click here for a List of All Comments Submitted to the FDA.

IACP is Making Sure the FDA Plays by the Rules Congress Established

IACP also sent a letter to FDA Commissioner Margaret A. Hamburg, MD, expressing our specific concerns regarding what we believe is the premature nature of FDA's communication to stakeholders and State Boards, promoting conducting business with only 503B registered facilities.

"IACP continues to support increased communications between the States and FDA. However, we have strong reservations with FDA sending a letter to State stakeholders encouraging conducting business only with facilities registered as outsourcing facilities when FDA has not yet finalized guidance, restrictions, and quality standards for these 503B outsourcing facilities."

Click here to read letter to FDA Commissioner Hamburg. Please email IACP with any questions at iacpinfo@iacprx.org.  

Next Generation Pharmacist Nominations Now Open

Nominations are now open for the 2014 Next-Generation(TM) awards. Co-founded by Parata and Pharmacy Times, this national awards program honors pharmacists, technicians, students and industry advocates who are defining the future of pharmacy. Since 2010, more than 100 pharmacy leaders have been named finalists or winners. Click here for more information! For program updates and information, please visit: www.nextgenerationpharmacist.com.

WesternU College of Pharmacy Hosting Contemporary Compounding Intensive Certification Course

The Western University of Health Sciences College of Pharmacy in Pomona, Calif., is offering a Contemporary Compounding intensive CE certificate course (1.7 CEUs or 17 Contact Hours), April 11-13, 2014. Deadline to register is April 4, 2014. For more information, click here!  

Corporate Partner Spotlight: MedInvent, LLC

The NasoNeb® Nasal Nebulizer from MedInvent, LLC

Establish a NasoNeb Sinus Program and provide new treatment options to the multitude of sinus sufferers while creating a new revenue line for your compounding pharmacy.

The NasoNeb® Nasal Nebulizer delivers a high concentration of medication, with broad intranasal drug deposition and high intranasal drug retention. NasoNeb-delivered therapy is supported by peer-reviewed clinical data, including positive outcomes in a randomized, double-blinded, placebo-controlled study.

Broad intranasal deposition: The NasoNeb Nasal Nebulizer has been clinically-shown to deliver a high concentration of medication to all areas of the nasal and paranasal sinus cavities in pre- and post-operative patients*.

Click here to read the entire article.

The Third Annual ACA, IACP, ACVP Educational Conference was One for the Record Books!  

Thank you to all who attended the ACA, IACP, ACVP Educational Conference February 5-8, 2014 at the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida. The three-day conference drew347 attendeesfrom38states;seven from Canada andonefrom Puerto Rico including85 First-timers. We thank you all for playing an active role in advancing your profession.

Offering 31.5 contact hours (3.15 CEUs) allowing attendees to acquire up to 14 contact hours (1.4 CEUs), the Educational Conference provided many meaningful hours of networking opportunities both during the meeting and on the oceanfront property of the Harbor Beach Marriott Resort & Spa. The program consisted of targeted sessions for pharmacists, technicians, marketing representatives, and open to pharmacy students on pharmacy law, the fundamental steps to successfully work with your local media; practice-based, compounding, and veterinary clinical and compounding, and much more.

A BIG thank you to our exhibitors and sponsors!Thanks to you the Educational Conference is possible.To review the complete 2014 meeting report,click here.

Spot you and your colleagues at the Educational Conference!

Please check out the Educational Conference photos posted onFlickrbyclicking here.

Save the date!  The ACA, IACP, ACVP Educational Conference returns to Fort Lauderdale, Florida from
February 25-28, 2015 at the Harbor Beach Marriott Resort & Spa.  Stay tuned for more details. 

Heading:  ACA, IACP, ACVP Educational Conference Graphic Toolkit Now Available!

Here's an opportunity to let your patient and prescriber communities know that you will be attending the Educational Conference in 2015! Promote the Conference on your pharmacy or company website, Facebook page and even in print! Attendees, Corporate Partners, and Exhibiting Companies are all encouraged to promote their support by using the Graphic Toolkit. The Educational Conference Graphic Toolkit includes a logo/web banner, Facebook Cover Image, "I'm Attending" e-mail signature as well as ¼-page and ½-page print ads.

 

 


 

Thank you to our Meeting Sponsors and Exhibitors!

A BIG thank you to our exhibitors and meeting sponsors: AirClean Systems; Analytical Research Laboratories (ARL); Associates of Cape Cod, Inc; Attix Pharmaceuticals; B&B Pharmaceuticals, Inc; Blesstia Pharmaceutical; Charles River; Compounding Matters Academy; Digi-Trax Corporation; EXAKT Technologies, Inc; Fagron; Feras Capital, LLC; Freedom Pharmaceuticals, Inc; Hardy Diagnostics; Humco Compounding; ICA Health, LLC; International Journal of Pharmaceutical Compounding (IJPC); International Medical Industries, Inc; KUNESA LLC; Letco Medical; Live Oak Bank; MEDISCA; PCCA; Pharmacy Compounding Accreditation Board (PCAB); RX TaxPros; Storey Marketing; Tacit Almonds, LLC; Take Charge Pharmacist Obesity Education System; Televox; Topi-Click Topical Dosing Applicator.  

We would like to thank the following individual and pharmacy meeting sponsors for their support of the Educational Conference: Bronze Sponsors: Robert Anniharico, RPh, The Compounding Facility (Staten Island, NY); Eddie Glover, PharmD, US Compounding (Conway, AR); Charles Leiter, PharmD, Leiter’s Compounding Pharmacy (San Jose, CA); Scott Popyk, RPh, MBA, FIACP, Health Dimensions (Farmington Hills, Michigan); William Stuart, RPh, Hartley Medical Center Pharmacy (Long Beach, CA); Contributor Sponsors: Jay Ashworth, BS Pharm, RPh, GE Nuclear, (Dallas, TX); Lisa Ashworth, BS Pharm, RPh, Children’s Medical Center of Dallas, (Dallas, TX); David Carter, PharmD, Riggs Drugs, Inc. (Chetopa, KS); Saad Dinno, RPh, FIACP, Acton Pharmacy Inc. (Acton, MA); Justin Dipisa, RPh, FACA, Century Pharmacy, LLC (Paramus, NJ);  Johannes Heine, MBA, KUNESA LLC (Coral Gables, FL); Lucy Malmberg, RPh, CEO, Wedgewood Village Pharmacy, Inc. (Swedesboro, NJ); Arthur Margolis, RPh, America’s Compounding Center (Newton, MA); Linda McElhiney, PharmD, RPh, FIACP, FACA, FASHP, Indiana University Health (Indianapolis, IN); Martin B. Mintz, RPh, Northern Pharmacy & Medical Equipment (Baltimore, MD); Becca Mitchell, PharmD, FIACP, US Compounding (Conway, AR); Suzanne Rosenberg, PharmD, Community Compounding Pharmacy (Portland, OR); Andy Ruiz, PharmD, MSc, Stonegate Pharmacy (Austin, TX). 

To learn more about the exhibitors and meeting sponsors, click here

To see photos from the meeting, check out the Educational Conference Facebook Page here.   

Thank you to all for making the Educational Conference a huge success! Stay tuned for details on the 2015 meeting.   

Compounders on Capitol Hill is Only Three Months Away

The 20th Annual Compounders on Capitol Hill (CCH) will be held May 17-20, 2014 at the Crystal Gateway Marriott in Arlington, Virginia. With an expected 400 total attendees in 2014, CCH 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.

Share with your community that you’re attending CCH. NEW
- Click here for a press release attendees can distribute to your local media, post to pharmacy website, and share among your social media pages!

What you can expect in 2014:

  • We have a sold out exhibit hall awaiting you!  Meet face-to-face with 40 leading companies that   serve compounding pharmacies.
  • Hear from experts during in-depth Continuing Education sessions on legislative and regulatory issues at the state and federal level affecting pharmacy compounding.
  • A bargain hotel group rate at $159 – that’s half the price from previous years!
  • Join us on the Hill!  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 – 10th Annual Rx Mixer Presents The Roaring Twenties: The Compounding Age on Sunday, May 18, 2014.  To learn more about the Rx Mixer, click here.
  • On Monday, May 19, 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 the Honorable Jerry Moran, United States Senate (R-KS) (Tentative Speaker) as the keynote speaker for the COMP PAC Dinner.
  • Network! Reconnect with old friends and meet new colleagues who share your passion and interest in protecting, promoting and advancing pharmacy compounding!

Start planning now! Reserve your hotel room on or before Monday, April 21, 2014 to receive the IACP group rate. To learn more about CCH, visit www.iacprx.org/cch.

 

 

 

 

20th Annual Compounders on Capitol Hill
May 17-20, 2014
Crystal Gateway Marriott
Arlington, Virginia
www.iacprx.org/cch  

Thank you to Our Exhibitors and Meeting Sponsors!
We would like to thank the following exhibitors for their commitment to Compounders on Capitol Hill: AirClean Systems; American College of Apothecaries (ACA); Analytical Research Laboratories (ARL); Associates Of Cape Cod, Inc.; ATS Labs; Attix Pharmaceuticals; B&B Pharmaceuticals, Inc.; Blesstia Pharmaceutical; Campbell University- Pharmaceutical Education and Research Center; Compounders International Analytical Laboratory (CIAL); Diversified Pharmaceutical Ingredients, LLC (DPI);  DYNALABS; Eagle Analytical Services; EXAKT Technologies, Inc.; Fagron; Feras Capital, LLC; Freedom Pharmaceuticals, Inc.; Frier Levitt LLC; Fuji Health Science, Inc.; Health Engineering Systems (HES); Humco Compounding; International Journal of Pharmaceutical Compounding (IJPC); International Medical Industries, Inc; KUNESA LLC; Letco Medical; Live Oak Bank; Medi-Dose, Inc./EPS, Inc.; MEDISCA; National Community Pharmacists Association (NCPA); Pharmacy Compounding Accreditation Board (PCAB); PCCA; Pure Encapsulations; RXinsider; RX TaxPros; RxCoop, LLC; Storey Marketing; TeleManager Technologies; Wellness Works; ZRT Laboratory.   

We would like to thank the following meeting sponsors for their support of Compounders on Capitol Hill: Attix Pharmaceuticals (First Timer Program); B&B Pharmaceuticals, Inc. (Meeting Tote Bag); Fagron (Meeting Syllabus); Freedom Pharmaceuticals, Inc. (Meeting Brochure, Commemorative Travel Mugs); Humco Compounding (Education Session/Door Drop Bag Insert); International Medical Industries, Inc (Door Drop Bag Insert); Letco Medical (Welcome Reception Honoring IACP Fellows, Education Session, CCH Lapel Pin); MEDISCA (Meeting T-shirt); Microtest Laboratories, Inc. (Educational Sessions(2); PCCA (Exhibitor and Monday Continental Breakfast & Lunch Sponsor, Hotel Room Keys, Name Badge Holder, Education Sessions (2); Topi-CLICK Topical Dosing Applicator (Conference Notepad/Pen Combo). 

We would like to thank the following individual and pharmacy meeting sponsors for their support of Compounders on Capitol Hill:  Judicial Sponsor: Eddie Glover, PD, US Compounding, Conway, AR; Contributor Sponsors: Eyad Alsabbagh, Dr, Biomed Specialty Pharmacy, West Chester, OH; Linda McElhiney, PharmD, RPh, FIACP, FACA, FASHP, Indiana University Health, Indianapolis, IN.

To learn more about the exhibitors and meeting sponsors, click here

IACP Regional Education Meeting Headed to Scottsdale, Arizona! 

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.  We hope you’ll join us for an evening of compounding pharmacy law education, Q&A, and networking with your local compounders! For more information, please visit www.iacprx.org/RegionalEducationMeetings.

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 affect you and your practice. Attendees will receive 2.0 contact hours (.20 CEUs) of ACPE-approved LIVE LAW continuing education credit.  

“This was an excellent CE and the speaker was amazing. His knowledge on the subject matter was on spot!!!" - Attendee at Foley, Ala. Regional Education Meeting

“I would highly recommend it for all! It’s important to keep learning and doing our best in compounding! It was great to get together with fellow compounders and others. It was a big step in the right direction!” - Dean Jolley, RPh, Jolley's Compounding Pharmacy, Attendee at Salt Lake City, Utah Regional Education Meeting

Scottsdale, Arizona – March 21, 2014
6:30 - 9:00 p.m.
FireSky Resort & Spa, Sun and Moon Meeting Rooms
4925 North Scottsdale Road, Scottsdale, AZ 85251
Click Here to View the Event Flyer for More Details!

Joint Registration with the 2014 Functional Medicine Conference: This meeting is held in conjunction with the 2014 Functional Medicine Conference presented by ZRT Lab and Storey Marketing, to be held March 21-23, 2014 at the FireSky Resort & Spa in Old Town Scottsdale, AZ. A discounted package rate with Friday’s Marketing Update and/or the 2014 Functional Medicine Conference is available. Please visit www.functionalmedconference.com for more information and to register for the discounted package rates.

Registration for the IACP Regional Education Meeting in Scottsdale Only: $20 for IACP Members, $40 for Non-Members, and Free for Pharmacy Students

 


This program is made possible through an unrestricted educational grant-in-aid from Storey Marketing. 

Would You Like to Sponsor or Host an IACP Regional Education Meeting in Your City?

If you would like IACP to plan a Regional Education Meeting in your city, please email Michelle Greene Atkinson or call 281.933.8400. For more information on sponsorship, please click here. For more information on hosting, please click here.

IACP Calendar

IACP is your one-stop resource for all things compounding! CompounderCalendar provides a comprehensive listing of compounding events and continuing education programs. Click here to view IACP’s Upcoming Events.

IACP Career Center

Welcome to the IACP Career Center! Your destination for exciting job opportunities and the best resource for qualified candidates within the Industry. Click here to view the IACP Career Center.

Stay connected to IACP by joining our online communities!

 

 

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