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Capitol Connections Archive [January 13, 2014] [1.13.14]
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FDA Re-Establishes Compounding Advisory Committee 

FDA Recommends Sterile Compounding Drug Purchasers Work with Registered Outsourcing Facilities 

IACP Needs Your Input!

FDA Releases Draft Guidance Documents (CPGs) for Comment

IACP Launches $2 Million Campaign to Fund Vital Legislative, Public Relations & Advocacy Efforts

Corporate Partner Spotlight: RX TaxPros

Be Prepared When you Arrive at the Educational Conference!  Download the First Timer’s Guide Now!

Register to Attend IACP’s 20th Annual Compounders on Capitol Hill!

 

Events & Education

Endotoxin Testing and Environmental Monitoring Webinar – January 22 

Register today for an upcoming live webinar titled, Endotoxin Testing and Environmental Monitoring for Your Pharmacy, presented by William A. Stuart, RPh, President/Principal, Hartley Medical Center Pharmacy, Inc. on Wednesday, January 22, 2014 from 1:00 – 2:00 p.m. CST (2:00 ET / 11:00 PT / 12:00 MT).

In this one hour webinar, attendees will learn about new technologies for endotoxin testing, how to implement USP <797> and <1116> requirements for environmental monitoring into their pharmacy setting, and how to create an environmental monitoring plan.

As the demand for compounded medications has increased and in light of recent tragic events, the pharmaceutical sterile compounding profession requires a greater understanding of quality assurance testing. This presentation will educate individuals about sterile compounding principles of bacterial endotoxin testing and environmental monitoring. Attendees will gain technological knowledge about how to implement the highest quality compound preparations for their patients.

 

 

This program is made possible through an unrestricted educational grant-in-aid from Associates of Cape Cod, Inc.

Visit www.iacprx.org/IACPAdvanCE for more information. If you are unable to attend the live webinar, this program will be converted to the self-paced library 24-48 hours after it is recorded.

Save the Date!

Please save the date for the following 2014 IACP AdvanCE live webinars from 1:00 – 2:00 p.m. CST (2:00 ET / 11:00 PT / 12:00 MT):

Click here to review the full schedule of live webinars!

Check out the IACP AdvanCE Self-Paced Library 24/7!

If you were unable to attend our live webinars, they have been added to the IACP AdvanCE self-paced online program line-up so that you can review at your convenience 24/7. Please click here to access the self-paced programs. 

The IACP AdvanCE self-paced library features previous live programs, the United States Pharmacopeia (USP) requirements, recorded sessions from Compounders on Capitol Hill 2012 and 2013, recorded sessions from the ACA, IACP, ACVP Educational Conference 2013, and a wide-range of sessions from the Texas Pharmacy Association, Ohio Pharmacists Association, Arizona Pharmacy Association, and the American College of Apothecaries online libraries.

Webinar topics include:

  • FDA Inspections
  • DEA Inspections
  • USP 797, 795 and 1163
  • Cease and Desist Letters
  • Stark Law and the False Claims Act
  • Marketing and Sales
  • Legislative & Drug Updates
  • CMS and Reimbursement
  • Third-Party 
  • Media and Public Relations
  • Patient Safety Organizations

January 13, 2014

FDA Re-Establishes Compounding Advisory Committee

The Drug Quality and Security Act requires the FDA to reconvene the Pharmacy Compounding Advisory Committee, a group previously established in 1997 by the enactment of FDAMA but essentially disbanded by the FDA in 2005. The Committee will have responsibilities for reviewing submissions for inclusion of APIs on various permitted lists as well as making recommendations for medications which should not be compounded.

The Committee will be composed of a core of 12 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of pharmaceutical compounding, pharmaceutical manufacturing, pharmacy, medicine, and related specialties. Membership also includes representatives from the National Association of Boards of Pharmacy and the United States Pharmacopoeia, and representatives of patient and public health advocacy organizations. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee will serve as special Government employees.

IACP will be submitting nominations to this Committee in accordance with the series of instructions published in the Federal Register. If you would like to have the Academy submit your name, please submit your complete resume or CV to us along with a specific statement that you would like to serve on this Committee to
iacpinfo@iacprx.org no later than Friday, 24 January 2014.

FDA Recommends Sterile Compounding Drug Purchasers Work with Registered Outsourcing Facilities

Yesterday, FDA Commissioner Margaret Hamburg sent letters recommending "purchasers to consider requiring compounders from which they purchase compounded sterile drugs to meet the medical needs of patients that cannot be met by FDA-approved products to register with the Food and Drug Administration (FDA) as outsourcing facilities." Dr. Hamburg also sent letters to State Governors, State Boards of Pharmacies, and State Boards of Health asking them to consider how they could encourage compounding pharmacies located outside of their States that ship compounded sterile drugs into their States to register with FDA as outsourcing facilities under Section 503B of the Federal, Food Drug and Cosmetic Act.

FDA also published on its web site a list of firms currently registered as Human Drug Compounding Outsourcing Facilities, as well as additional information about the firms and what it means to be a registered outsourcing facility. FDA will update the list of firms registered as outsourcing facilities weekly.
Click here to view FDA's Outsourcing Facility information. 

Currently, the following are listed on FDA's website as registered outsourcing facilities: 

Allergy Laboratories, Inc.; Banner Health; Cantrell Drug Company; Kings Park Slope, Inc.; KRS Global Biotechnology, Inc.; Marlborough Hospital; Medi-Fare Drug & Home Health Center, Inc.; PharMedium Services, LLC; Region Care, Inc.; SCA Pharmaceuticals; and, US Compounding, Inc.  

IACP will continue to bring you updates on the Outsourcing Facility Registration process.

IACP Issues Letter to the Editor to Ocala Star-Banner

IACP's David G. Miller, RPh, EVP/CEO, wrote a Letter to the Editor last week to Florida’s Ocala Star-Banner regarding their recent series of articles written about compounding, much of it negative.

In his letter, Miller emphasizes, "Consistency is key. States must adopt uniform standards that will ensure patient safety, and chief among those is USP 797, the standard for sterile compounding. USP 797, and USP 795 for nonsterile compounding, keep patients safe and should be recognized as the standard by every state in the union.

Our organization long has fought for greater consistency in state standards. Those standards need to be applied not only to compounding pharmacies but to all other settings in which customized medications are prepared, including hospitals, physician offices and surgical centers."

IACP is continuing to work to set the record straight about pharmacy compounding, and its necessity for patients. Click here to read the original Ocala Star-Banner article series, and click here  to read IACP's complete response printed in the Ocala Star-Banner. 

Member Action Item: IACP Needs Your Input-List of Drugs with APIs

As covered in our Town Hall teleconference and in the story below, several regulations and requests for input were issued by the FDA on December 4. One of the most critical is the agency's request for a list of drugs for which APIs (Active Pharmaceutical Ingredients) are necessary for compounding preparations. As provided for within 503(a), a pharmacist or physician may compound medications for individual patients using an API only if that drug has a USP monograph, is a component of an FDA approved drug, or appears on a list of APIs reviewed and approved by the FDA's Pharmacy Compounding Advisory Committee and accepted by the Secretary of Health and Human Services.

IACP is assembling a list of APIs used regularly in compounding for which no USP monograph exists or is part of an FDA approved drug to submit on behalf of our members. We need your assistance in identifying as many of these as possible. 

Please submit the following information for each API you use that falls into this category to us at iacpinfo@iacprx.org no later than January 15, 2014:

  • Name of the API including the chemical name and common name
  • Chemical grade, strength, quality and purity of the API
  • Form of the API (powder, liquid, etc.)
  • Whether a monograph in an ex-US pharmacopeia exists such as the British Pharmacopeia
  • Common compounded dosage forms, strengths and route of administration for which the API is used
  • Clinical data, studies, papers, references, etc. on how the compounded version of the API is used
  • Stability data for the compounded preparations

The Academy will compile a formal dossier on each of these medicines you help identify for submission to the agency in time for its March 4, 2014 comment deadline.  

Member Action Item: Comments for FDA's Draft Guidance Documents (CPGs) Due by February 4th!

The US Food and Drug Administration (FDA) last month released its draft guidance documents (CPGs) for the new 503(b) and 503(a) sections of the Drug Quality and Security Act. 

Click here to review 503(b) section (Discusses how registration will be handled)

Click here to review 503(a) section (Please note page 5 and start at line 155) 

Both of these documents are open for comment and input to the FDA by February 4, 2014. IACP currently is reviewing and will be compiling our formal submission to the FDA.

ACTION ITEM: IACP strongly encourages all members to review these documents and submit comments on how these drafts may affect your business and your practice. Additionally, you should circulate these to physicians and other prescribers with whom you work so that they are informed of the pending changes as well. The electronic address for submitting comments to the FDA is including in each of the 503(b) and 503(a) documents.

Please email IACP with any questions or CPG input at iacpinfo@iacprx.org

CMS Proposes Requiring Expansion of Part D MTM Benefits

Centers for Medicare & Medicaid Services (CMS) has proposed requiring an expansion of Medicare Part D medication therapy management (MTM) benefits to a larger pool of beneficiaries. CMS has long encouraged Part D sponsors to cover MTM for more beneficiaries, but has not proposed requiring expanding Part D coverage until now.

The 678-page proposed rule—for contract year 2015 policy and technical changes to the Medicare Advantage and Part D prescription drug benefit programs—have been published in the Federal Registeron. Comments are due March 7.

NECC Agrees to Preliminary Settlement

New England Compounding Center (NECC), the pharmacy at the center of a fungal meningitis outbreak last year, has agreed to a preliminary settlement that would create a $100 million fund for victims.

The fund also will be used to pay off creditors of the bankrupt NECC, attorneys in the case said. A judge will have to approve the plan before it goes into effect. Read more here.

IACP Seeking Volunteer for District V Board Seat

IACP recently held its 2014 Board of Directors Elections. Click here to view IACP's 2014 Board of Directors.

IACP is still seeking volunteers to serve the open board of directors seat in District V (Louisiana, Texas, Oklahoma, New Mexico). Please send your input to IACP at iacpinfo@iacprx.org. Your commitment and dedication to the Academy is much appreciated.  

IACP Launches $2 Million Campaign to Fund Vital Legislative, Public Relations & Advocacy Efforts

IACP has developed a Preserve your Patients’ Access Fund to raise continued support for critical legislative, public affairs and advocacy activity to help preserve our profession and your patients’ access to the customized medication they depend upon. Our two-year goal is to raise $2 million by January 31, 2015 and we are almost halfway there since our campaign launched in July.

We need your financial contributions to protect our beloved pharmacy compounding profession. This is not a short-term situation that will likely see us crossing any goal lines soon. We need your help to maintain and continue what will be a long-term effort.

Please donate to the only association that is solely dedicated to the profession of pharmacy compounding today with a contribution to IACP’s Preserve your Patients’ Access Fund. Help IACP continue to Protect, Promote & Advance Pharmacy Compounding.

Click here to read more about IACP's efforts.

Please click here for a donation form to make your commitment to your profession, patients and association. 

Corporate Partner Spotlight: RX TaxPros

Don’t compound your taxes!  
 
You are unique in your field, and we are specialists in tax-savings.  In our years of serving compounding pharmacies many of our clients have realized significant savings from tax deductions specifically related to compounding.  Based on industry data, less than 1% of eligible pharmacies are taking advantage of this discrete tax deduction.  

RX TaxPros is offering to review tax returns on a first come first serve basis, at no cost, to determine whether or not you have taken advantage of the savings.  RX TaxPros is the premier tax & accounting firm for compounding pharmacies across the U.S., and is a proud IACP Corporate Partner.

Now is the time to act.  The IRS limits how long you have to amend previously filed tax returns so don’t let the savings pass you by!  

Visit rxtaxpros.com or call 855-877-9807 for more information.

Be Prepared When you Arrive at the Educational Conference!  Download the First Timer’s Guide Now! 

Connect and network with fellow colleagues.

Follow us!   

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 5-8, 2014 at the ocean front property, the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida. The Educational Conference offers superior education and networking opportunities for pharmacists, technicians, marketing representatives, and pharmacy students.

We look forward to seeing many of you at the ACA, IACP, ACVP Educational Conference February 5-8, 2014 in Fort Lauderdale, Florida at the Harbor Beach Marriott Resort & Spa. We know attending a conference for the first time can be overwhelming. To help you prepare for the Educational Conference, we’ve put together a comprehensive guide.


Download here the First Timer’s Guide to the Educational Conference sponsored by Take Charge Pharmacist Obesity Education System. The Flipbook technology for the First Timer’s Guide was generously provided by RXinsider.

Have you reserved your hotel room for the Educational Conference?

Reserve your hotel room by contacting Susan Decker, Director of Conferences by phone at (434) 989-5938 or susandecker123@yahoo.com.

Registration is now closed. If you would like to attend, complete the registration form here. For the latest conference news, visit www.EducationalConference.org  

Educational Conference
February 5-8, 2014
Harbor Beach Marriott Resort & Spa
Fort Lauderdale, Florida

Thank you to Our Exhibitors and Meeting Sponsors!

We would like to thank the following exhibitors for their commitment to the Educational Conference: Analytical Research Laboratories (ARL); Associates of Cape Cod, Inc; Attix Pharmaceuticals; Charles River; Compounding Matters Academy; Digi-Trax Corporation; EXAKT Technologies, Inc; Fagron; 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; Pharmacy Compounding Accreditation Board (PCAB); PCCA; RX TaxPros; Storey Marketing; Tacit Almonds, LLC; Televox; Topi-Click Topical Dosing Applicator.

We would like to thank the following meeting sponsors for their support of the Educational Conference: AirClean Systems (Friday Continental Breakfast with Exhibitor Experience); Attix Pharmaceuticals (Meeting Syllabus Sponsor); B&B Pharmaceuticals, Inc (Name Badge Holder, Education Session Sponsor); Blesstia Pharmaceutical (Saturday Continental Breakfast with Exhibitor Experience); Fagron (Welcome Reception, Education Session Sponsor); Feras Capital, LLC (Thursday Continental Breakfast with Exhibitor Experience); Freedom Pharmaceuticals, Inc (Meeting Tote Bag, Conference Pen, Education Session Sponsor); Humco Compounding (Meeting e-brochure, Fellowship Luncheon, Education Session Sponsor); Letco Medical (Celebration Dessert Reception, ACA/ACVP & IACP AdvanCE Education Sponsor); MEDISCA (Meeting T-Shirt Sponsor); PCCA (Hotel Room Key, Thursday Mid-Day Break with Exhibitor Experience, Education Session Sponsor); Tacit Almonds, LLC (Media Sponsor); Take Charge Pharmacist Obesity Education (First Timer Program); Topi-Click Topical Dosing Applicators (Friday Lunch with Exhibitor Experience Sponsor).

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); Charles Leiter, PharmD, Leiter's Compounding Pharmacy (San Jose, CA); Eddie Glover, PharmD, US Compounding (Conway, AR); 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, 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); Becca Mitchell, PharmD, FIACP, US Compounding (Conway, AR); Andy Ruiz, PharmD, MSc, Stonegate Pharmacy (Austin, TX).

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

Register to Attend IACP’s 20th Annual Compounders on Capitol Hill!

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.

What you can expect in 2014:

  • 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); B&B Pharmaceuticals, Inc.; Blesstia Pharmaceutical; Campbell University- Pharmaceutical Education and Research Center; 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; MEDISCA; Medi-Dose, Inc./ EPS, Inc.; PCCA; Pharmacy Compounding Accreditation Board (PCAB); Pure Encapsulations; RX TaxPros; RxCoop, LLC; RXinsider; Storey Marketing; Wellness Works; ZRT Laboratory.

We would like to thank the following meeting sponsors for their support of Compounders on Capitol Hill: 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); 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.   

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.  

“One of the best CEU programs I have attended in the last 5 years." - Attendee at Foley, Ala. Regional Education Meeting

"David's experience in dealing with Congress and State Boards of Pharmacies made this session very informative and helpful in understanding the impact of past and future legislative actions." - Attendee at Austin, Texas 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!

 

 

In this Section

USP to Host Two Compounding Courses in March

PCAB Accreditations

Pharmacy in the News

 
USP to Host Two Compounding Courses in March

The U.S. Pharmacopeial Convention (USP) will host two compounding courses at their Rockville, Maryland facility in March. Click here for information on the <795> Non-Sterile Preparations course. Click here for the <797> Sterile Preparations course.

For more information or to register, please visit www.usp.org/meetings-courses/courses or email PharmEd@usp.org.

PCAB Accreditations

Congratulations to the following IACP members for achieving PCAB Accreditation:

Anderson Compounding Pharmacy
Bristol, TN
Mark Flanary, PharmD
Initial Accreditation for Sterile & Non-Sterile Compounding

River Crossing Pharmacy
New Port Richey, FL
Michael Mobley, PharmD, RPh
Initial Accreditation for Non-Sterile Compounding

Pharmacy in the News

Click here for the latest pharmacy headlines.

 

 

 

 

 

 

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