Bi-weekly Member Newsletter                                                June 5, 2017

Keep up-to-date with the latest legislative and regulatory news. Click here for archived Capitol Connections newsletters. Send your suggestions and questions to iacpinfo@iacprx.org.
Congressmen Chris Stewart and Buddy Carter Lead Letter to Urge FDA to Preserve Patient Access to Compounded Medications   
                                            

IACP Members ! Congratulations and a  BIG THANK YOU for all of your efforts in enlisting your House Members to sign the bipartisan letter to the   Food & Drug Administration (FDA) regarding office-use. 

The letter went to FDA with  65 House Signatures!

Click here to view the full text of the letter. 

Thank you,  Congressmen Chris Stewart (R-UT) and Buddy Carter (R-GA) and the 63 other House signers , for leading the way in preserving patient access to pharmacy compounded medications!

Click here to view Congressman Buddy Carter's press release announcement regarding this letter to FDA effort!

Be sure to attend Congressman Carter's keynote address at Compounders on Capitol Hill, Sunday, June 11th at 8:00 am!

Use passphrase CCH2017

FDA Hosts Listening Session, Today

FDA will hold an invitation-only pharmacy stakeholder listening session, today, June 5, 2017.

The Agency will hold at least seven sessions this year with: pharmacy organizations; hospital organizations; medical and insurer organizations; allergy organizations; radiopharmaceutical organizations; consumer and industry organizations; and outsourcing facilities registered under section 503B. These sessions will not be webcast.

IACP has submitted comments for the record for today's session. Click here to view.

California State Board of Pharmacy Holds Meeting on Pharmacy Compounding

The  California State Board of Pharmacy held an  Enforcement and Compounding Committee Meeting on Friday, June 2nd. IACP attended the meeting and submitted comments.

Click here  for the meeting materials (IACP's comments are on page 3. IACP's Letter to the Board is in Attachment 2.)

We recommend all IACP Members and especially those in California stay engaged in discussion with Board to ensure patient access to compounded meds is not interrupted. 

IACP Comments to California State Board of Pharmacy

IACP supported  California Pharmacists Association (CPHA) comments to the State Board, especially those related to Beyond-Use Dating (BUD) language corrections. The Enforcement and Compounding Committee acknowledged the need to make changes to the BUD regulations, and will recommend such to the full Board. IACP recommends our members continue efforts to ensure any subsequent ch anges make sense.

IACP's comments can be found on page 3 of the meeting materials linked above. The IACP letter can be found in Attachment 2 of the meeting materials.

IACP Letter Excerpt:  IACP has reviewed the current California regulations and has heard from pharmacists as well as patients that specific provisions of the regulations are causing significant constraints in patients being able to access care resulting in decreasing patient access to vital compounded medications. Additionally, IACP had the opportunity to review the recommendations being submitted by the California Pharmacists Association (CPhA) and would like to take this opportunity to express full support for the CPhA's proposed modifications to Sections 1735 and 1751 of the California Code of Regulations. 
Washington State Pharmacy Commission Issues Message to Sterile Compounding Licensees

The Washington State Pharmacy Commission announces one of the Primary and Secondary Engineering Control Certification companies has discontinued doing business in Washington State. This has temporarily placed a hardship on some licensees attempting to obtain re-certification in a timely manner.  Click here to read more.
IACP Works with Media to Raise Awareness of Pharmacy Compounding and Legislative Issues

IACP regularly works with a variety of media outlets to raise the awareness of pharmacy compounding, and the current issues facing our profession. Here are two examples of our recent efforts. 

IACP in the News

Click here to read an  Inside Health Policy article published May 24th, "As FDA Ignores Pressure from Appropriators on DQSA...Lawmakers Push FDA to Withdraw Guidance on Compounding, Issue Rule Allowing Practice."


Click here to read a  Drug Topics article published May 25th, "Could Compounding Pharmacists Solve the Sodium Bicarbonate Shortage?"

IACP President Baylor Rice, RPh, FIACP, explains to Drug Topics that compounding pharmacists could help in the current sodium bicarbonate shortage if they were allowed to provide office-use compounding. 

IACP Invites Media to CCH

IACP will again host a Media Roundtable during  Compounders on Capitol Hill, inviting Washington, D.C.-based media to meet with IACP leaders to discuss issues including:   
  • Congressional Omnibus bill signed into law, HR244, providing funding through September 30, 2017, and including language that addresses the Memorandum of Understanding, office-use, and pharmacy inspections.
  • Continued challenges with the FDA's implementation of the federal Drug Quality and Security Act (DQSA), specifically office-use compounding.
  • The role and challenges to date for compounding stakeholders on the FDA's Pharmacy Compounding Advisory Committee (PCAC).
If you have media ideas, or need assistance in generating press in your community, please email Dagmar Anderson, IACP Communications, VP at Dagmar@iacprx.org.
NIOSH Extends Deadline for Draft Testing Protocol

On September 15, 2016 the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), published a notice in the Federal Register announcing a public meeting and request for public comment on a draft testing protocol,  A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs.

Written comments were to be received by December 7, 2016. NIOSH initially extended the public comment period to June 7, 2017 [81 FR 88687]. NIOSH is extending the public comment period for a second time to August 30, 2017, stating the longer timeframe will allow companies to test the protocol with the proposed challenge agents. Read more here.
JOIN US! IACP is having a Membership Drive!

Joining IACP just got a whole lot better! We're offering a 25% discount on NEW memberships for June, July and August. 

Membership Discount Available for the following membership levels:

  • Staff Compounding Pharmacist
  • Non-Compounding Pharmacist/Retired/Full-Time Faculty
  • Technician
  • Friends of Compounding
Use code: CCH25 -   www.iacprx.org/membership

Please note: Pharmacy Owners and Corporate Partners not eligible for discount.
State Updates

Here's the latest. No new compounding bills. Three new proposed compounding rules. Eight Boards of Pharmacy meeting next week; two with compounding on agendas (Florida, Oregon). 

Keep Up with Your State Legislative and Regulatory News

Exclusive Member Benefit: New  Compounders Stateside Comprehensive Legislative and Regulation updates have been posted for you on IACP's website!  Click here to view.
IACP Launches Advocacy Site - Partnership for Personalized Prescriptions (P3)!

IACP has launched new advocacy program & website for Partnership for Personalized Prescriptions (P3)! Be sure to visit www.p3rx.org and JOIN P3. Invite your patients, physicians and local community to join as well. 

Together - Let's Educate, Advocate, Protect & Advance Patients' Access to Customized Medications.


Like P3 on Facebook and Twitter! Share our P3 Posts with your Audiences! 


Help Keep Compounding Front & Center!

IACP is making real progress through our DQSA Coalition as well as your efforts in educating your respective congressional representatives. We have a lot more before us!  Please help us maintain the momentum by contributing today . Your support will allow us to represent your pharmacy's and your patients' issues!
Corporate Partner Spotlight: Willow Birch Pharma


Willow Birch Pharma is a leading FDA-Registered/VAWD Accredited supplier of Active Pharmaceutical Ingredients (API's) to Compounding Pharmacies nationwide. In addition to our regular line of API's for the human and veterinary pharmacy compounding industry, Willow Birch Pharma is proud to offer our new line of Injectable/Ophthalmic Grade API's.
With the increased FDA scrutiny on compounding pharmacies in recent years, we have made it our mission to search out the best API's from cGMP certified manufacturers that are actually inspected & approved by the FDA and also have an active Drug Master File (DMF) filed with the FDA. With this, our compounding clients can rest assured that they are getting the highest standard API's from Willow Birch Pharma.

Examples of some of the API's now available in Injectable/Ophthalmic Grade are:
Epinephrine, Glycopyrrolate, Magnesium Sulfate, Neostigmine Methylsulfate, Norepinephrine Bitartrate, Rocuronium Bromide, Ropivacaine Hydrochloride, Succinylcholine Chloride, Vecuronium Bromide.

Please ask us about your API requirements for your 503A or 503B facility. We will do our best to provide you with the premium individualized support you deserve.
Need CE, ASAP?

If you need CE credit, check out IACP AdvanCE's on-demand library. The library houses more than 100 programs on a variety of pharmacy topics. Please click here to access the self-paced programs.

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