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Capitol Connections, October 22, 2014
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October 22, 2014

In This Issue


1. IACP's Fix DQSA Initiative Update

2.IACP Members: Help Elect a Pharmacist to the U.S. House of Representatives

3. Update: GAO Releases Study: TriCare Coverage & Reimbursement of Compounds

4.PCCA Names Saad Dinno Pharmacist of the Year

5. In Case You Missed it: USA Today Story Focuses on Pharmacy Compounding Recalls as the Two-year NECC Tragedy Anniversary Approaches

6. Corporate Partner Spotlight: ZRT Laboratory

7. 2015 Educational Conference Registration Now Open

 

8. IACP Welcomes Corporate Partner: ICA Health



Capitol Connections is a biweekly newsletter for IACP Members Only.

Please email iacpinfo@iacprx.org with your editorial ideas and suggestions
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Connect with IACP Foundation on Facebook!


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

IACP's Fix DQSA Initiative Update!


IACP’s plan to bring together pharmacy and medicine for collaborative and focused effort to correct the many problems within the Drug Quality & Security Act (DQSA) is progressing rapidly.

“There are a series of steps to offer technical corrections to this unworkable and cumbersome law already underway,” said IACP President Pat Stephens. “Our Academy already has a meeting of key stakeholders scheduled for Monday, October 27 in Washington, DC where pharmacy and medicine will develop their strategy for changing DQSA.”

 

Please click here to read more.


IACP Members: Help Elect a Pharmacist to the U.S. House of Representatives

State Senator Buddy Carter, a Georgia community pharmacist prevailed in a runoff election in July to become the Republican nominee in Georgia's 1st Congressional District. Carter has become the heavy favorite to be elected to the U.S. House of Representatives in the November election to succeed Rep. Jack Kingston (R-GA).

IACP Members can contribute as individuals to Buddy directly OR their companies/pharmacies can donate as a corporation to the "super" PAC. Please click here for more information.

If he wins in November, Buddy would become the first pharmacist to serve in the U.S. House of Representatives since the retirement of former Rep. Marion Berry (D-AR) in 2011.



GAO Releases Study: TriCare Coverage & Reimbursement of Compounds

 

The Government Accountability Office (GAO) released its study on TriCare coverage and reimbursement of compounded prescriptions, recently. The GAO recommendation? Though compounded drugs represent a small share of TRICARE’s overall drug costs, its costs for these drugs have risen significantly in recent years. Moreover, because most of these drugs contain bulk drug substances generally not approved by FDA, TRICARE’s practice of paying for them is inconsistent with its regulations and results in added costs for the program.

 

Please click here to read more.

 

UPDATE:

 

Concern about the GAO's recommendation to change TriCare's current benefit on compounded medications is spreading through the armed services.

Please click here to read an article from the Air Force Times.

 


PCCA Names Saad Dinno Pharmacist of the Year


 

IACP Member Saad Dinno, RPh, FIACP, FACA, co-owner of Acton Pharmacy, in Acton, Mass., West Concord Pharmacy, in Concord, Mass., and Keyes Drugs in Newton, Mass., as its Dr. M. George Webber 2014 Compounding Pharmacist of the Year.

 

The award, which is given annually to an independent pharmacist who has demonstrated service excellence to patients, healthcare providers and pharmacy colleagues, was presented to Dinno on October 10, 2014 by PCCA President Jim Smith and CEO David Sparks during the company's International Seminar held in Houston, Texas.

 

Click here to read more.


PCCA Presents George Roentsch Scholarship to Charlene Vernak

IACP Member Charlene Vernak, RPh
, of Vernak Farms Pharmacy in Skaneateles, New York, recently was awarded the George Roentsch Scholarship by the Professional Compounding Centers of America (PCCA).

 

Vernak received the award in Houston during PCCA's International Seminar, held October 8-10, 2014. The scholarship is awarded annually to an independent pharmacist and PCCA member who embodies the innovative and sharing nature of George Roentsch, a well-known pharmacist in the compounding community. Click here for more.


In Case You Missed it: USA Today Story Focuses on Pharmacy Compounding Recalls as the Two-year NECC Tragedy Anniversary Approaches

A USA Today story, "Safety, Sanitation Problems Prompt Scores of Drug Recalls" was published, recently. The article notes the two-year anniversary of the NECC tragedy, the ensuing increase in FDA inspections and recalls, as well as the confusion created as FDA employs cGMP manufacturing standards in these inspections that were never intended for compounding pharmacies.

The International Academy of Compounding Pharmacists (IACP)'s David G. Miller, RPh, Executive Vice President/CEO was extensively interviewed and quoted for the article.

"The FDA was caught by Congress and others for being asleep at the switch in the NECC tragedy. … So (the agency) said, 'OK, we're going to go in and inspect (compounders) as if they're a manufacturer,' " says David Miller, CEO of the International Academy of Compounding Pharmacists. "It's like going to the baseball diamond with your buddies, and the other team shows up wearing helmets, padding and carrying a football."

Please click here to read the USA Today story in its entirety.

Please click here to read the IACP Member Alert including Message Points on this USA Today story.


IACP Member Q&A

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 iacpinfo@iacprx.org.

 

Question: Does IACP have a list of States which require direct to patient shipping of Compounded Preparations. We compound certain preps which are for patient administration only. Where do we go for this information?

 

Answer:State laws do not require direct patient delivery or shipment of a compounded preparation. In general, a patient may designate another person to act as his/her agent to pick-up or accept a prescription on their behalf (e.g., a family member, a friend, a neighbor, the physician, a taxi driver, etc.)

Federal laws and regulations are different. For any medication -- manufactured or compounded -- that contains a controlled substance, only the patient or the patient's agent may pick-up or accept delivery of a prescription. The patient's agent may NOT be the DEA registrant prescriber, an employee/colleague of the registrant prescriber, or anyone affiliated with the registrant prescriber (e.g., a spouse).



Corporate Partner Spotlight: ZRT Laboratory

 

ZRT is a CLIA certified diagnostic laboratory that is the recognized innovator of saliva, dried blood spot and dried urine testing methodologies. Its mission is to support healthcare professionals in health management through accurate, convenient and innovative lab testing.

Operating for over sixteen years, ZRT utilizes the most advanced technologies to help healthcare providers and patients detect hormonal imbalances, cancer risk, element exposure, and much more.

Accuracy is the number one priority in ZRT Laboratory testing. ZRT’s comprehensive Quality Assurance Program includes regulatory compliance, management of information, result monitoring and auditing, internal and external proficiency testing, employee education, and equipment maintenance. ZRT is also engaged in ongoing collaborative clinical research with investigators around the world, including the CDC, NIH and prominent universities.

 

Click here to read more!



2015 Educational Conference Registration Now Open

Connect and network with fellow colleagues. #EduCon2015

 

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 25-28, 2015, at the ocean front property, the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida.

 

On Thursday, February 26, 2015 the Educational Conference program kicks off with the Exhibitor Experience and Continental Breakfast followed by General Sessions accredited for both pharmacists and technicians. Earn up to 13.0 contact hours (1.3 CEUs) of continuing education credit including 5.0 contact hours (.5 CEUs) of LIVE Pharmacy Law. The program will feature dynamic speakers in thought-provoking sessions on hot topics including veterinary compounding oversight, specialty pharmacy, third party reimbursement, a review of the Drug Quality and Security Act, the advantages and disadvantages of the new drugs in the New Drug Update, Approved vs Unapproved Veterinary Drugs-Dispelling the Myths, and much more.

Thursday, February 26 General Sessions Include:

  • Veterinary Compounding Boot Camp: A Future Look at Veterinary Compounding Oversight, presented by Gigi Davidson, BSPharm, FSVHP, DICVP, NC State College of Veterinary Medicine; Ashley Shelton Morgan, DVM, American Veterinary Medical Association; Jane G. Owens, DVM, PhD, Dipl ACVP, Director-Food Animal Refinement, Elanco Animal Health
  • If It Sounds Too Good To Be True…How to Navigate Business Opportunities While Protecting Your Pharmacy, presented by Jonathan E. Levitt, Esq., Frier & Levitt, LLC; John E. Morrone, Esq., Frier & Levitt, LLC; Jesse C. Dresser, Esq., Frier & Levitt, LLC
  • Payor & Governmental Trends: An Update to Stay Ahead of the Curve, presented by Jonathan E. Levitt, Esq., Frier & Levitt, LLC; John E. Morrone, Esq., Frier & Levitt, LLC; Jesse C. Dresser, Esq., Frier & Levitt, LLC
Click here for more details!


Announcing the Educational Conference Spring 2015 Student Writing Competition

Do you have a pharmacy intern? The ACA, IACP, ACVP Educational Conference announces the Spring 2015 Student Writing Competition to recognize original papers on a particular topic affecting the future of independent pharmacy. Two winners will be selected by a review committee from the papers submitted. Thanks to the generosity of donors of both the ACA Foundation and IACP Foundation, the winners of this writing competition will each receive a scholarship to attend the Educational Conference February 25-28, 2015 in Fort Lauderdale, Florida. All pharmacy students are encouraged to compete.

 

To download the Spring 2015 Student Writing Competition Flyer Scholarship Application, please visit www.educationalconference.org/students.html.


Save the Date for CCH 2015!

 

The 21st Annual Compounders on Capitol Hill (CCH) will be held June 6-9, 2015 at the Renaissance Washington, in Washington D.C. With more than 400 expected attendees in 2015, 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.

 

Hear what attendees are saying about CCH!

 

"Compounders on Capitol Hill (CCH) keeps us up-to-date on legal issues and enables us to show our representatives how vital compounding is to the healthcare industry!"

 

Bradley McCloskey, PharmD, University Compounding, Troy, Mich.

 

Click here to read more.


Compounding Pharmacies and the USP <71> Sterility Tests – IACP’s November Webinar

The compendial Sterility Test has a simple premise - test CSP for the presence of viable microorganisms. However, recent regulatory action has highlighted the difficulties in performing the test compliantly. This one-hour webinar will examine the now internationally-harmonized test in terms of its scope as a regulatory requirement and a scientific test method. The discussion will focus on the compendial Sterility Tests (and their Method Suitability requirements) and provide background needed to understand why a harmonized, if admittedly arbitrary, test is so widely required. The discussion will be summarized with a checklist of considerations to review when considering the outsourcing of this important test.


Click here for more information and to register.


IACP Welcomes Corporate Partner: ICA Health

 

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 these corporate partners who are instrumental in our joint effort to protect and grow this vital part of quality healthcare.

 

To learn more about ICA Health, please visit www.icahealth.com.


Register Today for the Upcoming Washington, D.C. Regional Education Meeting!

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 Pharmacy Compounding Law and Regulations: Staying Current in a Changing World, an in-depth presentation on federal and state legislative and regulatory issues that are affecting compounders today.

 

Click here to read more!

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