IACP News Roundup - February 16, 2018

To keep you informed on all of IACP  member-driven initiatives  and latest legislative & regulatory updates, IACP has debuted a weekly  News Roundup ! Check out this week's report below, and email us at  [email protected]   with questions.


ABOUT

IACP Testifies at U.S. House of Representatives Energy &Commerce Health Subcommittee Pharmacy Compounding Hearing



The International Academy of Compounding Pharmacists (IACP) testified Tuesday, January 30, 2018, before the U.S. House of Representatives' Energy & Commerce's Health Subcommittee Hearing on pharmacy compounding, "Examining Implementation of the Compounding Quality Act." The Subcommittee on Health is chaired by U.S. Congressman Michael C. Burgess, MD (TX).

IACP Vice President Shawn Hodges, PharmD, served as a witness representing 503A compounding pharmacies at Tuesday's Congressional hearing. Dr. Hodges' written testimony submitted to the Congressional Health Subcommittee can be viewed in its entirety here.

On behalf of the IACP Board of Directors, we thank Shawn Hodges for his willingness and dedication to serve our patients, and our profession, at this hearing!

E&C Health Subcommittee Hearing Video Clips Available

To help you navigate this week's E&C Health Subcommittee Hearing recording - below are specific clips for appearances by IACP Vice President Shawn Hodges, Representative Buddy Carter (GA) and Representative Morgan Griffith (VA). 
Thank you to all for going to bat for patients' continued access to compounded medications!
  • IACP Vice President Shawn Hodges Testimony - please click here.
  • Congressman Buddy Carter (GA) Comments - please click here.
  • Congressman Morgan Griffith (VA) Comments - please click here.
  • Congressman Griffith asks IACP Vice President Shawn Hodges questions on how FDA's MOU could affect patients and their access to compounded medications - please click here.
  • Entire hearing recording can be found here.  


Member Initiatives

IACP Initiatives - A Progress Report Card

IACP Executive Vice President Cynthia Blankenship, Esq.
A Look Forward to What's in Store for 2018 - A Visual Vision!

We've discussed A LOT in the last two EVP articles -  first installment,  second installment.

For me, it's always great to  really visualize the goals I've set for myself. Take a look at our  Visual Vision below to really get a sense of  what and when we want to achieve in 2018. It's a lot; but, we have a phenomenal  IACP Board of Directors, Committees and Staff who are all excited to get this done for YOU, our IACP Members! 

Everything shown in these visuals is supported and further expanded upon in the  2018: What's In Store article below.


Please email  [email protected] if you have any questions,  OR if you'd like to get more involved with IACP!  We'd love your help in achieving these 2018 goals!





IACP Affiliate News


USP Offers IACP Members Special Discount for Spring Session of Safe Compounding & Safe Handling of Hazardous Drugs Week Course!

IACP Members: 
USP is offering you special Early Bird Discount rates for its Live Courses <800>, <797>, <795> - Spring Session to be held March 21-23, 2018:
Safe Compounding & Safe Handling of Hazardous Drugs Week

Please click here  to access more information including Special Codes created just for IACP Members.

Thank you IACP Affiliate, USP, for offering these special member discounts!


USP Debuts New Resource - USP <800> HazRx™ Mobile App. 
The <800> HazRx™ Mobile App is an innovative tool that combines information from three trusted data resources (NIOSH, RxNorm, General Chapter <800>) to help identify hazardous drugs at the point of practice and to inform the healthcare worker on what measures to take to help reduce their risk in accordance with established standards.

As we all move toward safer handling of hazardous drugs in the work place, USP encourages early adoption and implementation of USP General Chapter <800> to protect the public health in all healthcare settings.

Read more here!
   


NEWSROOM

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.




See today's statement from Rachael Brand...in a speech (attached and below)
https://www.justice.gov/opa/speech/associate-attorney-general-brand-delivers-remarks-washington-dc-lawyers-chapter

One of our early challenges was getting a handle on DOJ's regulatory footprint.  DOJ doesn't put out anything like the volume of regulations issued by the EPA or the FDA.  But it does have regulatory agencies including the DEA, which regulates doctors, pharmacies, and hospitals under the Controlled Substances Act; the ATF, which regulates the entire firearms industry; and the Civil Rights Division, which regulates under the ADA and other statutes.

And an agency's regulatory impact is not limited to rules.  Because the notice-and-comment rulemaking process is so slow, agencies sometimes skirt it by issuing "guidance."  Agencies often claim these documents are not binding on the public, but then treat them as though they are.

This is not just inconsistent with the technical requirements of the APA  --  it can result in bad decision-making by agencies.  The point of notice-and-comment rulemaking is to help agencies make informed decisions.  Federal employees sitting in Washington cannot possibly fully understand the potential effects of a proposed regulation on the public, and the notice-and-comment process is designed to solve that problem.  For all these reasons, the Attorney General recently prohibited DOJ from using guidance documents as a substitute for rulemaking.  Although his memorandum cannot bind other federal agencies, we hope they will follow DOJ's lead. 

I recently took this one step further by prohibiting DOJ litigators from using other agencies' guidance documents to establish violations of law in DOJ's affirmative civil enforcement actions. 

Guidance documents cannot impose new legal requirements on the public.  And if they cannot impose new requirements, then we should not treat failure to follow them as a legal violation that subjects a party to a suit by the Justice Department.

Under the memorandum I issued last month, DOJ will no longer use civil enforcement actions to convert agency guidance documents into binding rules.

Guidance documents are not the only way that DOJ's actions can have regulatory effect without rulemaking. 

Member Alerts
IACP in the News




Congressman Buddy Carter and IACP Vice President Shawn Hodges, PharmD Featured in Inside Health Policy Article on E&C Hearing 

Carter Alleges FDA Guidance Improperly Drives Compounding Enforcement

Today's edition of  Inside Health Policy  featured a wrap-up article from Tuesday's
Energy & Commerce Health Subcommittee pharmacy compounding hearing.

From IHP - FDA came under fire from  Rep. Buddy Carter (R-GA) Tuesday (Jan. 30) for what he alleges is the agency's use of guidance documents as the basis for compounding enforcement actions. Carter's concerns were buoyed by a new policy from the Department of Justice which bars use of guidance to create binding standards, or to take enforcement action based solely on noncompliance with guidance -- although there is some debate as to how that policy will impact FDA.

Carter, who has been one of the most outspoken members of Congress against FDA's stance on office use compounding, also took FDA to task for ignoring appropriations language directing it to change course. Gottlieb largely punted on the issue, but in a separate line of questioning indicated that the compounding office is underfunded.

"How are you justifying that you're going to use guidance policy for rulemaking here?" Carter asked Gottlieb during a Energy & Commerce health subcommittee hearing held Tuesday on implementation of the compounding law.'"

IACP Vice President Shawn Hodges, PharmD  also is quoted, "We have some ideas about what we can do to ensure the quality and access but we are looking for a sit down with commissioner. We've requested this year, years prior we've sent letters and we're not getting a response."

Please click here to read this entire  Inside Health Policy  article.




ADVOCACY

Federal Advocacy

IACP Submits Comments for FDA's Review of Existing Center for Drug Evaluation and Research Regulatory and Information Collection Requirements

The International Academy of Compounding Pharmacists (IACP) has submitted comments to the Food & Drug Administration (FDA) for its Docket No.: FDA-2017-N-5101 for "Review of Existing Center for Drug Evaluation and Research Regulatory and Information Collection Requirements."

View IACP's Comments Submitted to FDA:

Please click here to view IACP's complete comments on the Guidance for Industry: Prescription Requirement Under 503A of the Food, Drug and Cosmetic Act.

Please click here to view IACP's complete comments on the Draft Standard Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the States and the Food and Drug Administration.

Comments are due by Monday, February 5, 2018 - You are welcome and encouraged to use IACP's comments in submitting your own.

Please click here for more information including submission instructions.

  • 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 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. Act, Today!
State Advocacy
  • AVAILABLE FROM IACP! 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  weekly 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


  • Grassroots Advocacy - Tell Your Patients and Providers to sign up for the Partnership for Personalized Prescriptions P3 Patient Advocacy Website! Patient 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 535 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? Please email IACP Communications at [email protected].