September 19, 2014
IACP Successful in Introducing Senate Bill 2825 - Ensuring Safe Access to Prescription Medication Act of 2014
Working with U.S. Senators John Cornyn (R-TX) and Sherrod Brown (D-OH), the International Academy of Compounding Pharmacists (IACP) successfully has introduced legislation that would allow a pharmacist to deliver a controlled substance to a practitioner.
S. 2825 ‘‘Ensuring Safe Access to Prescription Medication Act of 2014’’ is designed to "amend the Controlled Substances Act to treat as dispensing the delivery of a controlled substance by a pharmacy to a practitioner, pursuant to a patient-specific prescription of the practitioner, under certain circumstances."
"This has been a long-term goal of the Academy," said IACP President Pat Stephens, PharmD. "When we established our 2014 legislative agenda in February, resolving the constructive transfer issue once and for all was one of the top three directives we gave our Washington offices. Even while we keep our focus on monitoring the implementation of the Drug Quality & Security Act, IACP continues its work on other critical issues affecting our members."
Please click here to read the entire bill.
How IACP Members Can Help!
Please contact your Senators and ask them to sign onto S. 2825. In doing so, they will be ensuring that patients have continued and safe access to the medications they need. IACP is working with the House to generate a companion bill for S. 2825 and that is expected to be filed in the next few days.
Please email IACP at firstname.lastname@example.org with any questions or input. We will continue to update our members on this legislation.
FDA Says "No Office Use" to Congress
Letters to FDA Regarding the Implementation of the DQSA
With FDA not providing any guidance as to “office use” or repackaging, Representatives Morgan Griffith (R-VA), Gene Green (D-TX), Diana DeGette (D-CO), and Gus Bilirakis (R-FL) sent letters to FDA reiterating Congressional intent to leave these issues to be governed by State law and asking for FDA’s plan of future action against pharmacies that compound for office use or repackage. IACP was successful in helping the Representatives collect almost 50 bipartisan signatures.
Just this week, FDA answered Congress in the form of a response to the Congressional letter and responses to Questions for the Record that were submitted by Congressman Griffith and Bilirakis during a House Energy and Commerce Committee hearing. Responding to the Congressional letter, FDA stated that contrary to Congressional intent, FDA will be using its “discretion” to prohibit all 503A pharmacies from compounding for office use. Regarding repackaging, FDA stated that it is reviewing its policies to determine whether FDA will allow repackaging and will communicate the results of its review to all interested stakeholders as soon as it is able to do so.”
When pressed in the Questions for the Record on what authority FDA has toward pharmacies providing office use where the State law allows such action, FDA failed to answer the question of State vs. Federal authority and stated that “FDA is examining its compounding enforcement policies….” and “anticipate communicating further with the public as the examination progresses.”
IACP will be working with compounding pharmacy champions in the House and Senate and all stakeholder on next steps to address FDA’s failure to comply with Congressional intent with a legislative initiative. We will keep our Members apprised of developments.
IACP and Others Urge Medicare to Keep CME Exemption Payments Program
Industry stakeholders, including the American Medical Association, International Academy of Compounding Pharmacists (IACP) and the Medical Group Management Association, urge the Centers for Medicare & Medicaid Services to retain a reporting exemption for payments made to physicians attending or participating in continuing medical education events under the Open Payments program, according to comment letters on a CMS proposed rule (CMS-1612-P).
Click here to read the letter. Click here for more.
Access the Latest State Updates with IACP's Compounders Stateside
State Compounding Legislation Tracker
Click here for a comprehensive document with up-to-date compounding activity in your state. Document contains all 79 of the compounding bills that were in process this year.
NEW Click here for "IACP Enacted and Pending State Legislation Affecting Compounding 09012014," contains only those bills that were actually enacted (17) and a separate section at the bottom containing the list of bills that are still "pending" upon resumption of the state's legislature after their recess (22 of those). This is a brand-new IACP report for members to advise "what has changed."
IACP’s Compounders StateSide is a one-stop resource for state legislative and regulatory updates and the latest happenings with state Boards of Pharmacy. Click here for complete Compounders Stateside information.
Every week, IACP members contact our offices for questions about practice, business, legislation and other issues. If you have a question you'd like answered, send it to email@example.com!
This week's question comes from an IACP member regarding the proposed USP Chapter <800>.
Question: When is USP <800> going to be enforceable?
Answer: Not until....
1) USP completes the review of all the submitted comments (deadline was 31 July).
2) The Expert Committee reconvenes and makes changes.
3) The revised standard is put out for additional public comment and review.
4) Repeat steps 1 and 2.
5) The final standard is published.
6) There is a 6 month implementation date.
7) Just this week, NIOSH issued an updated list of hazardous drugs that may warrant additional comments to USP as well.
Best guess... January 2016 at the very earliest. Click here for more information.
Corporate Partner Spotlight: Bestech GMP Contracting
Bestech GMP Contracting provides comprehensive Quality Assurance and Technical Consulting Services in line with FDA’s current Good Manufacturing Practices (cGMP’s). Our end goal is assurance that the client manufacturing and support environment is compliant with the cGMP regulations (21 CFR Parts 210 & 211). Focus is on the FDA Quality Six-Systems Approach to Pharmaceutical cGMP’s: 1) Quality System 2) Production System 3) Packaging and Labeling 4) Materials System 5) Facilities and Equipment and 6) Laboratory Controls. We assess compliance across these elements and correct identified gaps based on risk management principals. Our close involvement enables transformation of quality and manufacturing practices into compliant and self-sustaining systems and processes.
Click here to read more!
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.
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.
Why should you attend the Educational Conference 2015?
ACA Executive Vice President Edward J. Hesterlee, PharmD invites you to come to Fort Lauderdale, FL and join us for the ACA, IACP, ACVP Educational Conference 2015 in February. Don’t miss this one-of-a-kind, 3-in-1 conference that brings the pharmacy profession together in paradise. For more Educational Conference videos, visit our YouTube page at http://bit.ly/VSUFvX. #EduCon2015
Advance discount deadline ends on or before December 15, 2014. For the latest conference news, visit, www.EducationalConference.org.
Click here for more details!
Two New Pharmacy Student Activities at the 2015 Educational Conference
Participate in the Educational Conference Spring 2015 Student Writing Competition
Essay Topic: Discuss the importance of being involved in a professional association as you’re starting your career.
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.
Click here to download the Spring 2015 Student Writing Competition Flyer.
Essay Topic: Why networking with professional colleagues helps identify career paths for pharmacy students.
Through the generosity of donors to Fund-the-Future at the annual Rx Mixer in 2014, the IACP Foundation will be offering five pharmacy students a scholarship to attend the Educational Conference February 25-28, 2015, in Fort Lauderdale, Florida. All pharmacy students are encouraged to compete.
Click here to download the IACP Foundation Fund-the-Future Scholarship Application.
Meet the 2015 Exhibitors
The Educational Conference Exhibitor Experience has expanded to 29 exhibiting companies. Discover how you can work with them before you arrive. To learn more about the meeting Exhibitors and Sponsors and how their services can help you effectively manage and grow your business, click here. Make sure to stop by their booth when visiting the Exhibit Hall.
On behalf of ACA, IACP, and ACVP, we would like to thank the International Journal of Pharmaceutical Compounding (IJPC) for their support of the Educational Conference as the sponsor of Three Education Sessions. #EduCon2015