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Capitol Connections, March 23, 2015
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March 23, 2015

In This Issue

1. Tricare Summit on Compounding Pharmacy - Changes in Store

 

2. IACP Board Updates Position on Compounding for Lethal Injections

 

3. FDA Reopens Docket on Compounding Documents

 

4. 3 Biggest Compounding Pharmacy Myths Debunked


5. IACP Provides You with the Latest State Updates

 

6. Announcing the Spring 2015 Student Writing Competition!

 

7. USP Announces Revised <800> Chapter Available for Viewing

 

8. Corporate Partner Spotlight: Health Engineering Systems

 

9. CCH Registration is Open!

 

10. Register Today for The Compound Conference 2015!



Capitol Connections is a biweekly newsletter for IACP Members Only.

Please email iacpinfo@iacprx.org with your editorial ideas and suggestions.



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tricare Summit on Compounding Pharmacy – Changes In Store

On Friday, March 20, more than 50 representatives from the compounding and pharmaceutical industry met with officials from Tricare, the federally funded medical program that supports members of the military and their families, to discuss the growing costs of the compounding component of the prescription plan. Since the beginning of 2015, average compounded prescription billed to Tricare was more than $3,300 with more than $240 million in reimbursements paid in February 2015. That compares to $45 million a year ago. At the current rate, Tricare expects to spend more than 2 billion dollars for compounds in 2015 even though the number of prescriptions billed has not substantially increased.

In order to balance the need for cost-containment and the ability of beneficiaries to access compounds, Tricare is implementing a series of controls including prior-authorization, limitations on reimbursement for certain preparations, and an assessment of whether or not to cover certain APIs (active pharmaceutical ingredients).

On or about April 1, 2015, Express Scripts will issue a contract addendum to existing Tricare network providers. That addendum will include a pricing schedule for commonly used compounded ingredients. Network pharmacies will be required to sign and adhere to the pricing scheduled when submitting claims. This strategy is necessary to address the escalating costs of the program.

 

Please click here to read more!



IACP Board Updates Position on Compounding for Lethal Injections

In March of 2013, the Colorado Department of Corrections Director Tom Clements contacted 97 compounding pharmacies in that state with an unusual request: "I am reaching out to compounding pharmacies throughout the state of Colorado in order to comply with state law that the CDOC acquire sodium thiopental or other equally or more effective substance to cause death." That represented the first instance in what would become a more and more frequent question for the Academy and its members – how and should a compounding pharmacist be involved in the preparation of drugs for lethal injection?

The International Academy of Compounding Pharmacists (IACP) Board of Directors established a formal policy, pointing out the well-recognized Pharmacist’s Conscience Clause as a guiding principle and identifying the unilateral decision by pharmaceutical companies to restrict the sales of their products to Departments of Correction. Additionally, the Academy recommended a series of self-assessment questions for a compounding pharmacist to consider when requested to be involved in a capital punishment case when commercially manufactured drugs were intentionally withheld. Those included: verifying the legality of preparing and dispensing a drug that will knowingly cause harm with a state Board of Pharmacy, confirming that professional and business practice insurance covers such compounding, and to assess the potential impact on the individual staff members, and the pharmacy’s security and reputation from potential negative publicity surrounding the controversy of capital punishment.

 

Please click here to read more.


IACP Members: Your Comments are Needed!

FDA Reopens Docket on Compounding Documents

 

The U.S. Food & Drug Administration (FDA) has established a public docket to receive information, recommendations, and comments on matters related to the Agency’s regulation of compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

 

This docket is intended for general comments related to human drug compounding that are not specific to documents or issues that are the subject of other dockets. So, while IACP and compounders can submit comments on the draft guidance documents that are directly related to repackaging, adverse event reporting, and the Memorandum of Understanding there has been no place where physicians, patients, pharmacists and others can voice our concerns about office-use.

If office-use is important to your practice or your prescriber clientele, this public docket is the perfect place to file your comments about how the FDA is ignoring Congressional intent and disregarding state laws and regulations permitting office-use.

FDA Public Docket

 

IACP Members! Click here to access the FDA Public Docket, which includes comment submission instructions.

 

Make your voice heard! Let the FDA know of your concerns on the recent compounding implementation plan.

 

IACP Summary on FDA Four Draft Guidance Documents and MOU


Please click here to view.

 

Watch for additional information through IACP’s Capitol Connections newsletter, our email and FAX Member Alerts, our social media postings via Twitter and FaceBook. Be sure to continue visiting the Breaking News section of our website.


3 Biggest Compounding Pharmacy Myths Debunked

 

IACP's David G. Miller, RPh, EVP/CEO was interviewed for a Pharmacy Times article – "3 Biggest Compounding Pharmacy Myths Debunked." Read it today and share with your patients, prescribers and community!

 

Click here to access the article.

 


IACP Provides You with the Latest State Updates!

 

IACP Members: Check out the latest state news on IACP's Compounders Stateside page. We've also added a new State Legislation Tracker on Pharmacy Provider Status. Click here to view!


Announcing the Spring 2015 Student Writing Competition!

 

The Theme: "Should States Institute a 'Wet Lab' Examination as Part of the Pharmacist Licensing Process?"

The IACP Foundation created its semi-annual Student Writing Competition to recognize outstanding original papers 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 pharmacy students are encouraged to compete.

Entries are due by Monday, April 20, 2015! Click here for more information.
Please email IACP Foundation's Jennifer Petska with any questions!

 


IACP Members: Have You Used the New Compounding Fact Sheet, Yet?

To help our members address questions from their patients, practitioners, media and others in their community, IACP has prepared a new Compounding Fact Sheet for your use.

 

It includes a compounding profession overview, message points in response to the NECC tragedy, current oversight info, and IACP concerns regarding DQSA. Please click here to access.


USP Announces Revised Chapter of the Proposed <800> Available for Viewing

The United States Pharmacopeial Convention (USP) announces that the revised chapter of the proposed <800> is now posted on the USP website. Please click here to review.


The chapter will still be proposed in the Pharmacopeial Forum 41(2) in Mar/April 2015. The comment period for this chapter will end on May 31st, 2015.



FDA Update

FDA Drug Shortage App

FDA Launches Drug Shortage App

What's New on the FDA Drugs Site

Drug Firm Annual Registration Status (updated)
Drug Firm Annual Registration Status Download File (updated)

The FDA Drug Shortage Report


Please click here for the most recent Drug Shortage information.



Compounding/Member News


Please send your news to iacpinfo@iacprx.org!

During its March Business Breakfast Club networking meeting, the Middlesex West Chamber of Commerce featured the new compounding lab at Acton Pharmacy in Acton, Mass. Pictured are Acton Pharmacy employees John Pavlik, Lynne Hearne, Tony Ferullo and IACP Member/Owner Saad Dinno, RPh, FIACP (front).


 

Congratulations to FPR Specialty Pharmacy in Victor, N.Y., for earning its PCAB Accreditation, a service of ACHC.Lisa Martone, Billy Rue, Megan Weir and the fine pharmacy technicians at FPR Specialty Pharmacy are pictured here. Please click here for the pharmacy's press release.

 

 


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:

What beyond use date is IACP proposing to the FDA for biologics? I heard that 14 days was being proposed and was wondering what the rationale behind that Beyond Use Date (BUD) was. Is it 14 days after a sterility test or 14 days without a sterility test?

 

Answer:

 

At this point, IACP is not proposing anything for the guidance document on biologic repackaging. We are still collecting input from our members. We haven't had any discussions regarding BUDs and won't until we've finished obtaining comments.

 

Question:

Also, is the microbial challenge test done once per each product made in order to determine that the container and technique is not adversely affecting the products integrity? I am assuming it does not need to be done for every lot, but just wanted to make sure my interpretation was correct.

 

Answer:

Based upon the draft guidance language we have received from the FDA that a microbial challenge test is done for each product AND for each type of container and not on each lot or batch, changing suppliers of a vial or syringe would necessitate a repeat of the test for container integrity. Similarly changing the API source would require a repeat of the test as well.


Corporate Partner Spotlight: Health Engineering Systems

 

Health Engineering Systems (HES) specializes in the distribution and servicing of Unguator EMP’s and the Unguator Accessory line. The Unguator and its Accessory line are distributed to compounding pharmacies and laboratories throughout the United States and Canada via our Unguator Distribution Partners.

Originated in Germany, the Unguator Electronic Mortar and Pestle, or EMP, offers an advanced mixing technology in a closed system that optimizes the results of your formulation mixes. This state of the art technology has raised the standard for pharmaceutical and laboratory preparations worldwide.


Please click here to read more.

 


CCH Registration is Open!

 

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.

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. Click here to read more!


Save the Date for Rx Mixer!

 

Lots of blue eye shadow, acid washed jeans with popped-up shirt collars, fingerless lace gloves, giant hair bows, and layers of beaded necklaces are totally tubular once again for Rewind: Back to the 80s— the theme for IACP Foundation’s 11th Annual Rx Mixer, a fundraising event to be held in conjunction with IACP’s 21st Annual Compounders on Capitol Hill (CCH), Sunday, June 7, 2015!

Travel back to the place where you uttered slang phrases like “gag me with a spoon,” “like, totally,” “gnarly,” “grody,” “grody to the max,” “rad,” “awesome,” or any combination of these words excessively. If your hairdresser couldn’t stop laughing long enough to actually give you the Flock of Seagulls haircut you wanted. And, if you still know all the dance moves to “Thriller.” You know you belong to the 80s.


Click here for more!


IACP Regional Education Meeting Heading to San Diego, CA and Boston, MA!

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 for more information!


Register Today for the Compound Conference 2015!

The Compound Conference is the only conference annually partnering with a state pharmacy association, bringing together the leaders in the pharmacy compounding profession. At the Compound Conference, attendees have an unprecedented opportunity to meet face-to-face with compounding pharmacists, technicians, and marketing representatives in their home state.

 

Offering a variety of Continuing Education sessions focused on understanding the essentials in building a compounding practice, the 2015 Compound Conference is a joint meeting with the Ohio Pharmacists Association (OPA) and the International Academy of Compounding Pharmacists (IACP).

 

Don’t miss this unique conference bringing together two leading pharmacy associations, August 15, 2015 at the Hilton Columbus at Easton in Columbus, Ohio. Click here for more.


IACP would like to thank all of you who attended and exhibited at the 2015 Educational Conference this past February in Fort Lauderdale, Florida. This meeting was a huge success! With a grand total of 400 attendees consisting of 250 Pharmacists, 27 Technicians, 21 Marketers, 7 Pharmacists Students, and 40 Retirees/Guest. Thank you for your help in creating a successful meeting.

Mark your calendars because we’re going back to the West Coast.

The 2016 Educational Conference will be held at the Loew’s Coronado Bay Resort in San Diego, California!


Need CE ASAP? Check out the IACP AdvanCE On-Demand Library!

If you need CE credit, check out IACP's 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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