May 29, 2014
400 Attendees Convene in Washington, D.C. for the 20th Annual Compounders on Capitol Hill
The United Voice of Compounders Is Heard!
A special thanks to all the IACP members who participated either in person at Compounders on Capitol Hill,
held, May 17-20, 2014 in Washington, D.C., or via our Virtual Hill Day
-- your efforts made a HUGE impact. And a fast one as well. One of our
key messages to Senators and Congressmen was that the U.S. Food and Drug Administration (FDA's) interpretation of the 2013 Drug Quality & Security Act (DQSA)
appears to ignore Congressional intent. Despite repeated invitations
from IACP to speak with our CCH conference attendees, everyone at the
FDA was "unavailable" to attend and talk to those most impacted by the
agency's activities... and that was noticed by Congress.
U.S. Senator Lamar Alexander (R-Tenn.) announced that, at his request, the Senate Appropriations Committee
is directing the FDA to meet with doctors, patients, and pharmacists to
discuss their concerns about implementation of the compounding
legislation passed into law in November 2013.
“The purpose of the compounding law is to end confusion and improve
communication so we can help prevent another tragic meningitis outbreak.
If FDA isn’t sitting down with doctors, patients and pharmacists and
communicating how it is implementing the law, then I will stay on FDA
until it does.” – Lamar Alexander
Click here to read the U.S. Senate HELP Press Release.
IACP and its legislative team have worked tirelessly for the past
several months emphasizing that FDA should be implementing DQSA
according to congressional intent. This issue was the primary basis of
our CCH 2014 Asks. Click here to review these Asks.
As covered in a Pink Sheet (subscription required)
article from this week, there currently is an unenviable dilemma for
pharmacists: whether to follow FDA regulations or those of their state.
"The International Academy of Compounding Pharmacists argues that FDA is
not following the congressional intent of the Drug Quality and Security
Act (DQSA), which was that office use regulation should be left to the
states. Academy executive VP and CEO David Miller said
the group wants FDA and/or Congress to clarify the office use issue as
well as write other necessary regulations so pharmacists can operate
“'It is much more cloudy, muddy, messed up, uncertain, unclear, than we
had, even from the compounding professionals’ standpoint, originally
anticipated,' Miller said May 19 during a media briefing. Guidance may
be coming, but it is unclear how the agency would address the office use
Congressman Marino Introduces HR 4709 as a Complete Substitute for What was HR 4069
In order to generate bipartisan support, Congressman Thomas Marino (R, PA-10), has introduced HR 4709 as a complete substitute for what was HR 4069 (both are entitled the Ensuring Patient Access to Effective Drug Enforcement Act). HR 4069 essentially "disappears" now and 4709 is the primary legislation. Click here to read more.
IACP Nominations Open for 2014 Elections
IACP officially opened the nomination process for the 2014 election at last week’s Compounders on Capitol Hill annual convention. The Bylaws of IACP set forth an open election process with nominations accepted directly from membership.
An IACP member may nominate him/herself or another IACP member by July 15, 2014
by submitting their name, the position for which their nomination is
being submitted, and the individual’s biosketch or resume to Wade
Siefert, RPh, Chairman of the IACP Nominations Committee at
firstname.lastname@example.org. The Nominations Committee will review all nominees’
qualifications and submit a formal slate to the IACP Board of Directors
for its approval at the Board’s fall 2014 meeting. The approved slate
will then be sent forward to the membership for an open election in
November. Elected Board members will take office on January 1, 2015. Click here to read more.
USP Proposed General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings
The United States Pharmacopeia (USP) currently is seeking public review and comment on its proposed Chapter <800> Hazardous Drugs - Handling in Healthcare Settings. Click here to download this chapter with line numbers
All stakeholders are encouraged to submit comments with corresponding line numbers to CompoundingSL@usp.org. Comments are due by July 31, 2014.
IACP is preparing its comments to the USP, and will share with IACP members as soon as available. Please click here to view why it's important to submit comments. Please email IACP with questions at email@example.com.
FDA Offers Drug & Device Regulations Conference
The FDA is offering an opportunity to interact with Agency experts to
learn about drug & device regulations. The conference is free of
charge, and will be held June 16-17, 2014, at the Hyatt Regency near the
San Francisco Airport.
Click here for more information.
FDA Releases Nominee Names for Nonvoting Industry Representative
As part of the Drug Quality & Security Act, the FDA is required to form a Pharmacy Compounding Advisory Committee.
Although the members of the Committee -- of which 24 individuals were
nominated by IACP -- have not yet been named, the agency did release the
names of the nominees for the non-voting industry representative on
Wednesday, May 28, 2014. The practitioner community is now responsible
with selecting one individual from this list and submit that name to the
FDA by July 28, 2014. IACP will be working with the
nominating organizations to set a discussion date to come to an
agreement on the single representative.
Click here for the list of non-voting industry representative nominees to date.
Click here for FDA's instruction memo for the process of selecting one from the list.
Corporate Partner Spotlight: Fuji Health Science, Inc.
Fuji Health Science, Inc., offers F-MeltR, a ready-to-use ODT/chewable base. The Tablets that Melt in the Mouth.
- Innovative Excipient Matrix for Orally Disintegrating Tablets (ODTs):
- Ready to Use
- Directly compressible via tablet press
- Tablets disintegrate in the mouth without water
- Excellent mouth feel
Click here for more information!
IACP Starts Strategic Plan for the Future of Compounding
Under the leadership of President-elect Dale Coker,
IACP will begin a multi-month strategic planning initiative beginning
this coming summer. In addition to representatives from the current
Board of Directors, your Academy is looking for interested volunteers to
participate in helping shape the future of the organization and develop
key objectives for the compounding practitioner community. "Having
members of the organization help in this process, including those who've
never been on a Committee or even attended an IACP program, will assure
that our planning is multi-dimensional and brings in perspectives that
our Board may not have," said Coker.
Any current IACP member may submit their name and contact information to firstname.lastname@example.org for consideration by June 15, 2014.
IACP's Executive Committee and Board will select from the submitted
names at their upcoming Board teleconference on June 19 and the selected
individuals will be contacted.
IACP Welcomes New Corporate Partner
The IACP Corporate Partner program engages corporate leaders in the
pharmacy compounding community by connecting them with IACP’s more than
3,600 pharmacists, technicians, students, and members of the compounding
community who focus upon the specialty practice of pharmacy
compounding. 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. Thank you for your continued
support of pharmacy compounding!
New Rules Regarding Reporting of CEUs to the CPE Monitor Data Base
Effective May 1, 2014 all
ACPE-accredited providers have 60 days after the CPE activity
participation date to upload the participant credit into CPE Monitor.
The provider must upload the participant information 60 days from the
date the participant completed the CPE activity. This applies to all CPE activities: live, internet-based, and home-study articles.
Please click here for more information!
will open August of 2014. Save the date! The ACA, IACP, ACVP
Educational Conference returns to Fort Lauderdale in 2015
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.
Click here for more details!
Reserve your hotel room now and receive the advance discount!
Start planning now! Book your hotel room at the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida. The deadline to receive the hotel group rate is on or before 6:00 p.m. (EST) on Friday, January 23, 2015.
IACP Regional Education Meeting Heading to Newark, NJ; Atlanta, GA; and Dallas, TX
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!
"Constructive Delivery” Under the Controlled Substances Act Webinar – June 26
Registration is open for June’s live webinar titled "Constructive Delivery” Under the Controlled Substances Act presented by R. David Pore, MA, JD, Senior Legislative and Policy Advisor, Arnold and Porter, LLP on Thursday, June 26, 2014 from 1:00 – 2:00 p.m. CST (2:00 ET / 11:00 PT / 12:00 MT).
This session will give attendees the knowledge necessary to make
informed decisions about appropriate registration under the Controlled
Substances Act (CSA) and how to maintain compliance with the CSA.
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.
Did You Miss the May Live IACP AdvanCE Webinar?
he May 1st IACP AdvanCE webinar Being a Successful Compounding Advocate: Tips for Working with Your Legislators presented by IACP’s Vice President of Government Affairs Cynthia E. Blankenship, Esq. and IACP’s Executive Vice President & CEO David G. Miller, RPh has been uploaded to the self-paced webinar library for your access 24/7. Please click here to view IACP AdvanCE’s self-paced online webinars that are available today.
Save the Date!
For more information about the 2014 IACP AdvanCE live webinars, please click here.
- “Constructive Delivery” and the Controlled Substances Act
- Building a Compounding Practice: Lessons Learned
- Media, Growth, and Quality Improvement
- Current Good Manufacturing Practices – A Compounding Pharmacy Perspective
- Essentials of Non-Sterile Compounding
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:
- Endotoxin Testing
- Environmental Monitoring
- Standards of Practice
- FDA Inspections
- DEA Inspections
- USP 797, 795 and 1163
- Cease and Desist Letters
- Stark Law & the False Claims Act
- Marketing and Sales
- Legislative & Drug Updates
- CMS and Reimbursement
- Media and Public Relations
- Patient Safety Organizations
FDA DOCUMENTS AVAILABLE: Intergovernmental Working Meeting on Pharmacy Compounding
FDA Documents from the Intergovernmental Working Meeting on Pharmacy Compounding, held March 20-21, 2014, are available. Please click here to read.
IACP Member Meets with U.S. Senator Ed Markey
IACP Member Saad Dinno, RPh, FIACP, FACA,
the co-owner of Acton Pharmacy, Acton, Mass., discussed issues facing
his industry during a conference this week in Washington, D.C.
Dinno met with U.S. Sen. Ed Markey, D-Mass., and
attended conferences held by the National Community Pharmacists
Association and the International Academy of Compounding Pharmacists. Click here to read more.
Corporate Partner Press Release
Humco Compounding, a division of Humco Holding Group, Inc., announces the addition of Robert L. (Bob) Light RPh
as Senior Director, Compounding Professional Services. Prior to joining
Humco Compounding, Light was, since 2003, manager of the Compounding
Resource Center for Walgreen Corporation, Tempe, Ariz. Please click here to read the Humco press release.
Congratulations to the following IACP Members for becoming Pharmacy Compounding Accreditation Board (PCAB) accredited!
BioMed Health Solutions, LLC, Southfield, Mich.; Mazen Baisa, PharmD; Initial Accreditation for Non-Sterile Compounding
Chancy Drugs Valdosta; Valdosta, Ga.; Alyssa Pate, PharmD; Initial Accreditation for Non-Sterile Compounding
O'Brien Pharmacy; Mission, Kan.; Eric Everett, RPh; Re-Accreditation for Sterile & Non-Sterile Compounding
Puja Enterprise, Inc. DBA: The Medicine Shoppe; Tampa, Fla.; Rasesh Patel, RPh;
Initial Accreditation for Non-Sterile Compounding
Triangle Compounding Pharmacy Inc.; Cary, N.C.; Danny Barnes, PharmD; Re-Accreditation for Sterile & Non-Sterile Compounding
Westchase Compounding Pharmacy; Tampa, Fla., Silas Raymond, PharmD; Initial Accreditation for Sterile & Non-Sterile Compounding
IACP is your one-stop resource for all things compounding! Compounder Calendar 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.