Bi-weekly Member Newsletter                                             January 26, 2018
Keep up-to-date with the latest legislative and regulatory news. Visit IACP's websiteArchived  Capitol Connections  newsletters here. Send your suggestions and questions to .
Energy & Commerce's Subcommittee on Health to Hold Pharmacy Compounding Hearing on Tuesday, January 30, 2018

The  U.S. House of Representatives' Committee on Energy & Commerce's Subcommittee
on Health  will  hold a hearing  on Tuesday, January 30, 2018, at 11:00 a.m. Eastern Time in 2123 Rayburn House Office Building. The hearing is entitled, "Examining Implementation of the Compounding Quality Act." 

The  International Academy of Compounding Pharmacists (IACP)  has been invited to serve as a witness by the Subcommittee on Health chaired by U.S. Congressman Michael C. Burgess, MD (TX).

IACP Vice President Shawn Hodges, PharmD , will serve as a witness representing 503A compounding pharmacies.  Ple ase  click here  to view Shawn's bio. On behalf of the IACP Board of Directors, we thank Shawn for his willingness and dedication to serve our profession at this hearing.

Click here  to read more, including how to access the hearing webcast.

View the complete hearing witness list   here .
Breaking News - Associate Attorney General Brand Announces End To Use of Civil Enforcement Authority to Enforce Agency Guidance Documents

On Thursday, January 25th, the  Associate Attorney General  issued a memorandum that prohibits the Department of Justice from using civil enforcement authority to "convert agency guidance documents into binding rules."  According to the Memorandum published on the Department of Justice website, Justice Department civil litigators are prohibited from using guidance documents - or noncompliance with guidance documents - to establish violations of law in affirmative civil enforcement actions. Further, in that same news release, DOJ Associate Attorney General Brand stated "Although guidance documents can be helpful in educating the public about already existing law, they do not have the binding force or effect of law and should not be used as a substitute for rulemaking." 

PLEASE NOTE: IACP currently is reviewing this information and determining what impact this has for current FDA Guidance for Industry (GFI) documents. IACP will send you additional updates as they become available.

Please click here to view the Department of Justice's press release.


IACP Inducts New Fellow!

Congratulations to Omar Allibhai, PharmD, RPh , Johnson Compounding and Wellness in Waltham, Mass. 

Omar was inducted as a new IACP Fellow during IACP's Educational Conference held in Ft. Lauderdale, Fla. #EduCon2018.

More info on IACP's Fellowship Program here

In addition to establishing a brand-new  IACP International Committee chaired by IACP Member Marisol Lopez, RPh, MPh, IACP is pleased to bring you the first of an ongoing series of International news & updates. Please see below from the Association of Compounding Pharmacists of Canada.

On behalf of the Board of Directors and the Association, I am pleased and grateful to the IACP for offering us the opportunity to provide this update on issues affecting Compounding Pharmacy from a Canadian perspective. 

At the outset, I want to wish all our readers in the USA a Happy New Year. From our perspective, 2017 can best be described as a watershed moment for Compounding Pharmacy and the Association representing compounding pharmacists throughout Canada. The Board of Directors appointed a new Executive Director this past year and I am honoured to assume the role. As the former CEO of Canada's. largest Pharmacy Association from 2003 to 2007, I was actively inserted into some of the most controversial and complex public policy initiatives in Canada resulting in prescription drug reform across our great nation. Of course, these reforms have had positive and negative impact on the practice of pharmacy in Canada, but most importantly, created awareness about pharmacy in the provision of integrated healthcare. To that end, and armed with that experience, the Association of Compounding Pharmacists of Canada chose assertive management to build on scope of practice reforms that have been imposed on compounding pharmacy in Canada under NAPRA (the national association of regulatory bodies in Canada).

Keep reading here.

IACP Executive Vice President Cynthia Blankenship ESQ. 
Member Initiatives: A Progress Report Card! 

Keep checking  IACP's Executive Vice President (EVP) Cynthia Blankenship's Member Initiatives  to see where we're making progress and what we're checking off the list! 

You asked IACP for several key changes - and we're making them! IACP is in the midst of reviewing & revitalizing ALL of our current programs. 

We want to ensure we're completely in tune with our membership, providing you with what you need. Do you have suggestions or questions? Please email .
Let's Keep the Momentum Going! 
Please Contribute to IACP's One Fund!

IACP Member Alerts
Industry News

Politico - Pulse
  • THE ALEX AZAR ERA BEGINS. NOW WHAT? - The 24th secretary of Health and Human Services was confirmed in a 55-43 vote yesterday, securing enough support thanks to Democrats.
  • The six Democrats who backed him. Sens. Tom Carper, Chris Coons, Joe Donnelly, Heidi Heitkamp, Doug Jones and Joe Manchin.
  • "I think he's incredibly competent," said Heitkamp. "I don't share a lot of his philosophy, but I think he understands - as someone who has been at the administration - the importance of the rule of law and compliance."
  • The Republicans who didn't. Sens. Bob Corker and John McCain were both away from the Senate - Corker's at the financial conference in Davos, Switzerland, and McCain's recuperating in Arizona.
  • Sen. Rand Paul, who has disagreed with Azar over the merits of drug reimportation, was the only Republican present to oppose the nomination.
  • Last week FDA announced the release of its 2018 "Compounding Priorities Plan." FDA also released several guidance documents in the wake of its announcement, such as its final guidance on essentially copies of commercially available drug products for Section 503A and 503B facilities (more on that in another blog post), and guidance on repackaging of biologic products outside of an approved BLA. FDA notes that "Our 2018 compounding policy priorities plan lays out how the agency will implement certain key provisions of DQSA and other provisions of the law relevant to compounders over the course of the coming year. Our policy will be part of a series of draft and final guidance documents, proposed and final rules and a revised draft memorandum of understanding (MOU) between the FDA and the states." 
IACP Weekly Roundup

IACP Weekly Roundup provides a new way to keep you up-to-date on IACP's Member Communications! We know you're busy, so we are making sure you don't miss a beat by rounding up all the IACP news that goes out to members in one location to make it easier for you to never miss any news on compounding!  Check out what news your Academy has been sending. 
Compounding In the News
  • IACP is quoted in a Bloomberg Law article, "FDA Updates its Oversight of Drug Compounding." Please click here to read article.
Please ASK YOUR Providers and Patients also to Support HR 2871! Provide your audiences with this Action Link, today.

Click Here for IACP's Patient Testimonial Handout! 

Federal Advocacy
  • DQSA Coalition - Appropriations Update - IACP Members: the Appropriations deadline is rapidly approaching! We are diligently working with the  DQSA Coalition to ensure language is included in  FY 2018 Appropriations that addresses our continuing concerns on how the  Food & Drug Administration (FDA) has not implemented the  Drug Quality & Security Act (DQSA) according to Congressional intent. We will keep our members updated on this process!  
  • Your Efforts are Making a HUGE Difference! We Now Have 43 HR 2871 Cosponsors! Has Your Representative Signed On? Please send a direct communication to your Member of Congress. HR 2871 will help clarify the Drug Quality & Security Act (DQSA) in a way that will better align the statute with congressional intent and most importantly, better balance public safety and patient access. 
  • Continue to collect patients' stories and let us know if a patient would like to get involved! We need patient stories for our Congressional documents as well as any potential future hearing.  Please let us know if you are willing to be the voice of your patients or whether you know of patients willing to provide quotes or speak on the record!
State Advocacy  
  • Check out IACP's State-by-State Analysis of Office-Use Compounding Regulations! Your Government Affairs team just released a State-by-State Analysis of Office-Use Regulations! We researched State regulations, State notices, State activity, and called State Boards of Pharmacy when regulations conflicted with actions to determine each State's office-use actions. In the instance where a State had recently changed its office-use practices, we called to determine why, and the response was noted when FDA had communicated that State law was pre-empted with Federal law.
You will find two documents - (1) the State-by-State analysis and (2) a complete supplemental document where all State regulations and actions are housed. The State-by-State analysis is a quick reference guide that demonstrates State regulations and current thinking on office-use and all supporting documents to this research can be found in the supplemental document. The DQSA Coalition intends to use this document to see whether model office-use State laws exist, to educate and assist States that are attempting to change office-use practices on the intent of Congress, and to focus on specific states for the State Board of Pharmacy/Board of Medicine Coalition Letter that is coming soon!

IACP provides our members with a we ekly state tracking report - including legislative and regulatory updates! Check out this week's Compounders Stateside report here - you will need to log-in to view this members-only report.
  • USP General Chapter <800> State Adoption Status Chart. NASPA has developed a chart providing each state's current adoption status of USP's General Chapter <800>. Thank you, IACP Affiliate NASPA, for developing this invaluable tool!

Grassroots Advocacy  
  • FDA Launches New Patient Engagement Collaborative, Call for Nominations 
    Due by January 29th  IACP Members: Encourage Your Patients to Get Involved - Make Their Voices Heard on FDA's New Site - Why Access is NEEDED to Compounded Medications!
The Food & Drug Administration (FDA) is launching a Patient Engagement Collaborative and has issued a Call for Nominations. According to the Agency, "FDA is committed to collaborating with patients, caregivers, and advocates, as well as incorporating the various perspectives from these groups into the FDA's regulatory decision-making processes. And we know that patients and other stakeholders agree with the agency's commitment to improving and increasing patient involvement in FDA matters. In fact, members of the patient and stakeholder communities commented in public feedback on Section 1137, Patient Participation in Medical Product Discussions, of the Food and Drug Administration Safety and Innovation Act (FDASIA). Stakeholders recommended that the FDA create an outside group to provide input on patient engagement across the agency. We are pleased to announce that in response to that feedback and to accelerate the FDA's efforts in this area, today the FDA published a request for nominations to join the FDA's Patient Engagement Collaborative (PEC)." Click here for more FDA information.
  • Tell Your Patients and Providers to sign up for the P3 Patient Advocacy WebsitePatient Advocacy efforts make a real difference. That's why we need our IACP members' help to encourage more people to Join P3 and to Share their Stories! So many of our own IACP members have joined the P3 effort. Share this resource with everyone in your communities - your patients, your providers, your staff, your friends and family. 
  • Your Patients and Providers are asking their Representatives to Support HR 2871 with 534 messages sent to the Hill! Encourage your patients and providers to visit P3's Patient Advocacy Website. Advocates can instantly send a direct message to their Congressional Representatives, asking them to cosponsor the bipartisan legislation, HR 2871. Visit P3's Patient Advocacy Website. It's easy to use and will only take a few minutes to send an important HR 2871 message to Congress. 
  • IACP MEMBERS: We NEED your patient stories to feature on the P3 website - how have compounded medications helped your community? Share YOUR Stories! Please ask your patients and providers to also share their stories on the P3 website
Registration NOW OPEN for IACP's 24th Annual Compounders on Capitol Hill!

June 23-26, 2018 
999 Ninth Street NW
Washington, DC 20001

The 24th Annual Compounders on Capitol Hill (CCH) will be held June 23-26, 2018 at the Renaissance Washington DC Downtown Hotel! With more than 400 expected attendees, 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. 

Network! Reconnect with friends and meet new colleagues who share your passion and interest in protecting, promoting and advancing pharmacy compounding!

Register Here! Reserve Your Hotel Room Here!
IACP Compounder Calendar

IACP's Compounder Calendar is your one-stop resource for all things compounding! Compounder Calendar provides a comprehensive listing of compounding events and continuing education programs.

Corporate Partner Spotlight:  Mecart Cleanrooms


The cost of a clean room can range from less than $100 to more than $1,000 pe r square fo ot and although you can find both lower and higher prices more than 90% of projects typ
ically fall between these amounts.

Not satisfied with this answer, we thought so.

If you want a price for your cleanroom project, give David a call or fill in this form. We will go over your design together, and do a preliminary engineering and send you a budgetary proposal.

If you want to know why you won't find a price for your cleanroom project on the web, keep reading.

Letco Med, L.L.C. Launches Company Rebrand to Help Meet the Specific Needs of Today's Compounding Pharmacies

Please click here to read Letco Med's announcement!
IACP Affiliate News 

Safe Compounding & Safe Handling of Hazardous Drug Week - Register by January 31st for Early Bird Discounts!
  • USP Education - Live Courses <800>, <797>, <795> - Spring Session March 21-23, 2018 - Safe Compounding & Safe Handling of Hazardous Drug Week - Register by January 31st for Early Bird Discounts! Please click here for more information. 
Coming soon... in 2018
  • Know your exposure: Awareness campaign
  • HazRx™ Mobile App:  At the point of practice tool to identify HDs and take measures to help decrease risk associated with handling hazardous drugs. 

IACP Foundation News
Principal Investigator: Venkata Kashyap Yellepeddi, Ph.D., Assistant Professor of Pharmaceutical Sciences, College of Pharmacy, Roseman University of Health Sciences
Click here to view the abstract.* 

This abstract was published in  American Journal of Health-System Pharmacy January 2018, 75 (1) e28-e35 The link to the abstract on AJHP is available here

Click here to view IACP Foundation Research.
  • Through the generosity of donors to the IACP Foundation Fund-the-Future campaign, the IACP Foundation provided pharmacy students with an opportunity to attend the IACP Educational Conference held January 24th-27th, 2018 in Fort Lauderdale, FL. Each grant is valued up to $2,500. The IACP Foundation is pleased to announce the winners of the 2018 Educational Conference Fund-the-Future.   
Congratulations to  Christine Borunda (middle) , University of Texas at Austin School of Pharmacy, Austin, TX and  Ralph Galega (right) , University of Texas at Austin School of Pharmacy, Austin, TX! IACP Foundation Administrator Jennifer Petska, BS, CPhT, shown left.

For more information about Fund-the-Future program and the IACP Foundation click  here!
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