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Capitol Connections, May 5, 2015
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May 5, 2015

In This Issue

1. Tricare Now Screening Compound Medications as of May 1st


2. IACP Presents Pharmacist Compounding Concerns At FDA Stakeholder Meeting


3.Texas Supreme Court States Office-Use is a Dispensing Activity


4. College of Psychiatric and Neurologic Pharmacists Releases Practical Guidelines on Naloxone Access for Pharmacists


5. IACP Provides You with the Latest State Updates


6. New IACP Corporate Partners


7. ACHC and IACP Announce Partnership


8. Corporate Partner Spotlight: Fagron Academy


9. CCH 2015 Online Registration Closes Friday, May 15th!!


10. Register Today for The Compound Conference 2015!

Capitol Connections is a biweekly newsletter for IACP Members Only.

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Tricare Now Screening Compound Medications as of May 1st


Effective May 1, Tricare pharmacy contractor Express Scripts began screening each ingredient in compound medications to ensure all are approved by the Food and Drug Administration.


From the Military Times - "An allowance in Tricare's prescription drug coverage policy that has drained nearly $1 billion from the Pentagon's health budget since January will vanish Friday when a new policy on compound medications goes into effect.

Under the new process, many patients who use personalized drug formulas still will have access to their medications, said Dr. George Jones, Tricare's pharmacy chief.

But others — including some who ordered prescriptions directly from compounding pharmacies in recent months —may need to work with their pharmacists to ensure their prescriptions comply with the new requirements or receive prior authorization for coverage."

Please click here to read the entire Military Times article.

Military Times Commentary: "Compound Medications Can Benefit Patients"

In an editorial to Military Times, Dr. Randy Lundell, a family physician in Utah, who has served seven years in uniform, including a tour in Iraq, says compound medications, used carefully, can be of great benefit to some patients.

"As a physician and a veteran who works closely with compounding pharmacies on behalf of my patients, I found that the accusations in the April 10 Military Times article, 'Compound Pharmacies Marketing Directly to Tricare Users,' painted an unfair picture of the overall industry.

A few bad actors can do a lot of damage, but I can assure you that these aggressive marketing practices are spearheaded by the minority.

As the head physician for a clinic that focuses a great deal on family, sport, pediatric, and women's health, I have worked with many patients who need compounded bio-identical hormone replacement therapy — whether it be to help them conceive a child, alleviate complications from menopause or to treat symptoms of post-ovarian cancer."

Please click here to read the entire article.


Potential CBS News Story to Run


Late last week, IACP learned that CBS News may be broadcasting a follow-up to its late February coverage of a compounding pharmacy that allegedly billed more than $18,000 for three compounds through questionable marketing alliances. Click here for the February story.


It reportedly goes further than the previous story and from our sources, it identifies a Tricare beneficiary who was contacted by a marketing company, was prescribed an expensive compound, attempted to cancel/refused the prescription, and Tricare was billed. There is supposed to be considerable focus on the prescribing doctor out of California. We do not know at this time whether it is the same pharmacy or a different pharmacy.

The new broadcast was to have broadcasted last Friday; but, appears to have been pre-empted by breaking news. IACP will continue to monitor for the CBS News broadcast, and will issue message points to our members should the story warrant them.


Please be aware that the 2016 National Defense Authorization Act (NDAA) currently is being addressed in Congress. The timing for this CBS News story could have impact on that legislative process. IACP is watching very carefully, and will keep our members apprised of any developments. Please email IACP at with any questions.

IACP Presents Pharmacist Compounding Concerns At FDA Stakeholder Meeting


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


The FDA has been holding a series of listening sessions with groups of interested stakeholders to discuss FDA’s efforts to implement the compounding provisions of the Drug Quality and Security Act (DQSA), signed into law in November, 2013.

IACP's David G. Miller, RPh, Executive Vice President/CEO and Cynthia Blankenship, Esq., Vice President of Government Affairs attended the meeting, and presented the pharmacist compounding community's concerns regarding DQSA's enactment.


IACP's Comments


Please click here to read IACP's Issues and Concerns of the Compounding Pharmacist Community submitted for last week's session with the FDA.

Texas Supreme Court States Office-Use is a Dispensing Activity

In a closely watched case for compounders, the Texas Supreme Court upheld both that pharmacists and compounding are covered under the state's Medical Liability Act as well as confirms that the practice of office-use as provided for within Texas Law are considered "dispensing."

Accordingly, we hold that a pharmacist who compounds a drug for office use pursuant to a practitioner’s lawful order, as authorized by the Pharmacy Act, is “dispensing” the drug whether or not the order identifies the patients to whom the drug will be administered.

Copy of the Ruling

The case is Randol Mill Pharmacy, et. al., v. Miller. Please click here for a copy of the ruling.

This ruling is especially pertinent in light of the ongoing interpretation by the FDA that office-use is not a dispensing activity and is prohibited by the Drug Quality & Security Act.


Please email IACP at with questions.

College of Psychiatric and Neurologic Pharmacists Releases Practical Guidelines on Naloxone Access for Pharmacists

The College of Psychiatric & Neurologic Pharmacists (CPNP) and members of its Substance Abuse Task Force have announced the release of a guideline document intended to educate pharmacists on naloxone use and administration with the goal of providing increased patient access to this life‐saving medication for opioid overdose.

NALOXONE ACCESS: A Practical Guideline for Pharmacists, provides information on the following:

Patient Selection
How Naloxone is Supplied
Prescribing and Dispensing
Acquisition and Reimbursement
Supporting Laws and Regulations
Frequently Asked Questions (FAQs)
Patient Information Sheets for both Intranasal and Intramuscular Administration of Naloxone


Please click here for more information.

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!


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

New IACP Corporate Partners

Welcome new Corporate Partners: Fagron Academy, Regulatory Compliance Associates, Inc., and TherapeuticsMD! Learn more about these Corporate Partners by clicking on their respective logos, below.


IACP's award-winning Corporate Partner program engages corporate leaders in the pharmacy compounding community by connecting them with IACP’s more than 4,000 Members. We encourage all IACP Members to support these corporate partners that are instrumental in our joint effort to protect and grow this vital part of quality health care. If you are interested in becoming a Corporate Partner, click here and email your completed form to IACP's Ashlyn Grant or by fax to (281) 495-0602.

Please visit IACP's Corporate Partners webpage here.


ACHC and IACP Announce Partnership


Accreditation Commission for Health Care (ACHC) has announced a newly formed partnership with the International Academy of Compounding Pharmacists (IACP). The partnership between the two organizations allows IACP to provide its compounding pharmacy members with special pricing for ACHC’s nationally recognized PCAB accreditation and resources.

“IACP plays a significant role in supporting compounding pharmacies and we believe this partnership will enhance the ability for ACHC to offer relevant compliance solutions and educational resources to compounding pharmacies,” said Matt Hughes, ACHC Director of Business Development and Customer Service. "ACHC is eager to begin growing our new partnership with IACP and we look forward to the many future opportunities our organizations have ahead of us.”

“IACP is proud to partner with Accreditation Commission for Health Care,” said, IACP President Dale Coker, RPh, FIACP. “We deeply value the role accreditation plays in the development of a compounding pharmacy. Over the last several years, IACP has appreciated its long-standing relationship with PCAB, which now has become a part of ACHC. We look forward to the continuing advancement of this organization, and its ability to provide IACP Members with a meaningful resource to help achieve their accreditation goals.”

Please click here to view the press release announcement.

LAST CALL: 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


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.



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



We are dealing with a bulk chemical recall. How do we handle, appropriately?


Handling of a recall from a supplier of bulk ingredients should be consistent with the same process that your pharmacy would use in the event of a finished product recall from a manufacturer. Steps include:

•All products in the effective lot(s) should be removed immediately from the dispensing or compounding laboratory.

•All products in the effective lot(s) should be carefully quarantined and sealed to prevent accidental use by pharmacy staff.

•Returns of the recalled lot(s) should be handled in a manner consistent with provided for by the supplier.

•If required, disposal of the recalled lot(s) can be handled following the pharmacy's Standard Operating Procedure (SOPs) for discarding bulk ingredients including issues related to hazardous drugs and controlled substances.

•Communication to any patient who may be in possession of a medication which has been recalled should proceed in accordance with the pharmacy's internal SOPs.

•Individual state Boards of Pharmacy or other regulatory groups at the state level may have regulations specific to the handling of a recall by which the supplier must abide. Confirm with the supplier whether or not they have informed the regulatory agency in the impacted state(s).

•Individual state Boards of Pharmacy may have regulations specific to the handling of a recall by a compounding pharmacy that includes notification to the Board. IACP is reviewing state laws and will provide a summary of those for members in the near future; however, a member pharmacist should always be familiar with and ascertain their individual state Boards' policies and requirements.

Corporate Partner Spotlight: Fagron Academy


Housed in Miami, Fagron Academy is a state of the art teaching facility that features a technologically interactive classroom, a visually stimulating, fully equipped, non-sterile compounding lab, and a 1300 sq. ft., world class, ISO certified clean room. Fagron Academy provides ACPE approved continuing education programs focused on pharmaceutical compounding. Reflecting all current regulatory and USP guidelines, programs are designed to utilize the most up-to-date, cutting-edge compounding techniques with a goal to expand the art and science of this specialized area of practice. Created for pharmacy professionals who have a dedication to compounding and a commitment to being the best, Fagron Academy provides an opportunity for participants to learn important skills and expand their knowledge base while forming lasting relationships with colleagues and industry leaders. In addition to hands-on programs, Fagron Academy also offers ACPE approved, lecture based symposia in various destinations across the United States.

Please click here to learn more about Fagron Academy.


CCH 2015 Online Registration Closes Friday, May 15th!!


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!


CCH e-Brochure Available! Click here to view.

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 Chicago, IL!

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.

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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