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Capitol Connections, April 24, 2015
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​April 24, 2015

 

In This Issue

1. COM PAC to Host Congressman Morgan Griffith at April 28 Reception

 

2. California Board of Pharmacy Withdraws Sterile Compounding Regulations

 

3. Bill Introduced Last Week in Massachusetts Legislature Would Permit Office Compounding in the State

 

4. FY2016 Small Business Reduction for Outsourcing Facility Fee: Deadline for Requests is April 30th

 

5. IACP Leadership Participating in FDA's April 30th Compounding Stakeholder Meeting

 

6. IACP Provides You with the Latest State Updates!

 

7. Comment Period Ends on May 31st for USP's Revised Chapter of the Proposed <800>

 

8. Corporate Partner Spotlight: EAS Consulting Group, LLC

 

9. Register for CCH, Today!

 

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.


 


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

COMP PAC to Host Congressman Morgan Griffith at April 28th Reception


 

 

On April 28th, following an IACP-led Fix DQSA Stakeholder meeting, Congressman Morgan Griffith (R-VA) will be the special guest at a COMP PAC reception.


"Congressman Griffith has been an ongoing supporter of pharmacy compounding, says COMP PAC Chair Michael Blaire, RPh, as well as a proponent of ensuring that the Drug Quality & Security Act (DQSA) is enacted as intended by Congress, specifically in regards to patient access and compounding for office use.


Please join me in contributing to this cause."


Please click here to RSVP and/or to contribute.

 


 

California Board of Pharmacy Withdraws Sterile Compounding Regulations


On April 21, 2015, the California Board of Pharmacy (BOP) voted to withdraw its proposed regulations related to sterile compounding.


The BOP took this action after receiving numerous written comments from the California Pharmacists Association (CPhA) and other stakeholders on the proposed regulations and regulation-setting process.

The BOP will use the most recently revised version of the proposed regulations as a starting point for a new rulemaking package, which the BOP will release in the coming months.


As the BOP moves forward with new proposed regulations, CPhA says it will continue to advocate for regulations that are consistent with USP Chapter <797> and establish meaningful requirements to allow pharmacists to safely produce sterile compounded preparations.


 

Bill Introduced Last Week in Massachusetts Legislature Would Permit Office Compounding in the State

 

Bill S.1173 189th (Current), introduced last week in the Massachusetts legislature, is an Act to authorize the dispensing of compounded prescriptions for office and institutional settings without patient- specific prescription.

Please click here to read more.

 


 

FY2016 Small Business Reduction for Outsourcing Facility Fee: Deadline for Requests is April 30th

 

Facilities that elect to register with FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) must pay an annual establishment fee.


The annual establishment fee is paid at the time of registration and is equal to the sum of $15,000, multiplied by the inflation adjustment factor, plus the small business adjustment factor for the fiscal year in which the fee is due.


The deadline for requesting a small business reduction for the FY2016 outsourcing facility annual establishment fee is April 30, 2015. If you do not request the reduction by that date, you will not qualify for the fee reduction.


Click here for more information.


 

IACP Leadership Participating in FDA's April 30th Compounding Stakeholder Meeting

 

 

 

The Food & Drug Administration (FDA) has invited IACP to participate in a Pharmacy Compounding stakeholder meeting on April 30, 2015 at the White Oak Campus in Silver Spring, Md.

 

In their invitation, FDA states, "As you may recall, we held a series of listening sessions with groups of interested stakeholders last year to discuss FDA’s efforts to implement the compounding provisions of the Drug Quality and Security Act, signed into law in November, 2013.

 

We met with pharmacy and industry organizations, medical organizations, consumer groups, hospital organizations, insurers, animal drug organizations, and radiopharmaceutical organizations."

The FDA says it will hold at least six sessions this year: pharmacy and industry organizations; medical organizations; consumer and patient advocacy groups; hospital organizations and insurers; outsourcing facilities registered under section 503B; and radiopharmaceutical organizations."

Please note: The FDA will not be webcasting the sessions. Each organization will be provided the opportunity to make a statement of five minutes or less, depending upon how many people will be participating in each session.

 

IACP will provide an update in an upcoming Capitol Connections member newsletter.

 

Please click here to view information about FDA meetings at the White Oak Campus. IACP will provide updates regarding this meeting in an upcoming newsletter.



 

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!

 

Click here for a comprehensive document with up-to-date compounding activity in your state. IACP is tracking 48 state bills. Four bills were introduced last week.

 

2015 State Board of Pharmacy Meeting Schedule - please click here to view.

 

 


 

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.


 

Comment Period Ends on May 31st for USP's Revised Chapter of the Proposed <800>


 

 

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

FDAVoice Blog Post, April 6, 2015


FDA to Industry: Let’s Increase the Availability of Safe, Effective Animal Drugs

 

FDA Drug Shortage App

 

FDA Launches Drug Shortage App

 

Confirm Registration Status of a Bulk Supplier on the FDA Website

 

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!

 

 

Diamondback Drugs is pleased to announce the recent appointment of CEO and Founder Michael Blaire to the Arizona State Board of Pharmacy.

 

Appointed by the Governor of Arizona on Monday, March 23, Blaire took up his new role on the board as one of five pharmacists (with 1 technician and 2 members of the public rounding out the group), and began meetings just two days later.

 

Please click here to read more!

 

MEDISCA NETWORK announces its latest compounding training activity: Preparing for a State Board of Pharmacy Compounding Practice Inspection Program.

 

Please click here for more!


 

 

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:

Can I compound domperidone for gastroporesis? For lactation induction?

Answer:

FDCA section 503(a) specifically provides for compounders to prepare medications which are either components of approved drugs or which have a USP monograph or are on a list promulgated by the Secretary.

Domperidone is a drug product that has never been approved by the FDA for marketing or use within the United States for humans. While available outside the U.S. for the treatment of gastroporesis, it does not have approval for treatment of lactation induction.

 

A study is underway at the University of Texas for that specific use. Domperidone is approved in the U.S. for the treatment of lactation induction in mares; drugs approved for veterinary use cannot be used for the treatment of humans.

Domperidone does not have a USP monograph.

Several state Boards of Pharmacy have specifically instructed licensees that the compounding of domperidone is not permitted in their state.

 

Such decisions apply to both in-state as well as non-resident pharmacy permit holders.

The FDA has in place an IND (Investigational New Drug) review and approval process for any prescriber that believes domperidone is necessary for the treatment of their patients.

 

The process is available on the FDA's website here.

Only one pharmacy, Dougherty's Pharmacy in Dallas, Texas, is authorized to compound and fill domperidone IND prescriptions.



 

 

Corporate Partner Spotlight: EAS Consulting Group, LLC

 

 

WHAT TO DO WHEN THE FDA KNOCKS AT YOUR COMPOUNDING PHARMACY DOOR!

 

James Evans, Senior Consultant, EAS Consulting Group, LLC.

First, don’t panic! Have a Plan. The Plan should be written, maintained in a binder and located for easy access by responsible personnel. The Plan should be used for training all affected personnel and include the following:

 

Please click here to read more!


 

 

Register for CCH, Today!

 

 

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!


 

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.


 

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.

Featured Webinar Programs:



 

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