IACP submitted comments on Tuesday to the Food & Drug Administration (FDA) regarding the Draft Guidance: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act. Please click here to read more.
On October 3, IACP also filed comments to FDA regarding the Draft Guidance for Industry: Insanitary Conditions at Compounding Facilities. More information here.
Thank you to all IACP Members who submitted comments. The more participation, the better for our patients and our profession.
Last week, the U.S. Food and Drug Administration (FDA) issued a final rule amending FDA’s list of drug products that "may not be compounded under certain sections of the Food, Drug, and Cosmetic Act (FD&C Act) that allow the marketing of unapproved compounded drugs."
Please click here to view the entire Final Rule as well has IACP Executive Vice President John Voliva’s takeaways on this information. Please click here to view the New Negative List contained in the Final Rule.
By John E. Voliva, RPh, IACP Executive Vice President
Last week, IACP sent out a member alert about the FDA’s notice of final rulemaking for the “list of drug products that may not be compounded under certain sections of the Food, Drug, and Cosmetic Act (FD&C Act).” This list has been commonly referred to in the pharmacy industry as the “negative list” or the “do not compound list”. Since we sent the member alert, we have received many questions about what the list means, why domperidone does not appear on the list (and if it is now allowed for compounding) and what the FDA’s next steps are for this list.
Please click here to read John Voliva's entire article. Did you know IACP has a Blog – DConnection. Stay tuned for more insights from John.
The Pharmacy Compounding Advisory Committee (PCAC) will hold its next meeting on Thursday, November 3, 8:30 am to 4:30 pm.
The committee intends to discuss five bulk drug substances nominated for inclusion on the section 503A Bulks List. FDA will discuss the following nominated bulk drug substances: Glycolic acid, trichloroacetic acid, kojic acid, diindolylmethane, and vasoactive intestinal peptide. The chart in this document describes which use(s) FDA reviewed for each of the five bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances will be invited to make a short presentation supporting the nomination. Read more here.
||Here’s an opinion editorial piece appearing in The Hill from one of pharmacy compounding's staunchest supporters - Congressman Buddy Carter (R-GA). Thank you, Congressman Carter, for bringing this critical patient issue to light,"The Man Behind the Curtain in Drug Price Increases." Click here to read.
Happy American Pharmacists Month from Congressman Carter.Click here to view his message.
How Compounding Pharmacies Can Increase Front End Sales
Recently, a global pharmaceutical player decided to close two of its compounding centers in the United States, largely due to reduced profitability as a result of the changed reimbursement system. This defensive move serves as a wake up call for compounding pharmacies to open up additional sources of revenue if they want to prosper despite a trend toward reduced margins and toughercompetition.
Please click here to read more.
Please ensure IACP has your latest contact information – email address, fax number, etc., so we can keep you connected to the latest IACP news and alerts. Email email@example.com or make online edits to your membership profile. Thank you!
Is your membership up for renewal? Renew online, or call our office at 281/933-8400!
PLEASE REMEMBER: IACP Memberships are based on the individual not the pharmacy. Please email IACP Membership Director Jennifer Petska, BS, CPhT if you have any questions, firstname.lastname@example.org.
By now you should have received a letter requesting your help in keeping IACP front and center on Capitol Hill! We’re 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!
Would You be Willing to Contribute to IACP’s One Fund? Please help us maintain the momentum by contributing today. Your support will allow us to represent your pharmacy’s and your patients’ issues on the Hill! Click here to contribute.
New Compounders Stateside Comprehensive Bill and Regulation updates have been posted for you on IACP’s website! Visit here to view.
IACP works to keep its members up-to-date!
Know someone who needs to join IACP - or need to renew your own membership? Contact IACP Director of Membership Jennifer Petska, BS, CPhT - email@example.com today so that you can continue to have access to Member benefits such as Compounders Stateside.
FREE Webinar Invitation from new IACP Corporate Partner Wellness Works! John Preckshot, RPh, CCN, FAARM is presenting a FREE nutritional business coaching webinar on Tuesday, November 29th at 7pm, CST! For more information and to register.
Meet and greet with IACP’s Executive Vice President John Voliva, RPh and IACP Membership Director Jennifer Petska, BS, CPhT at the National Community Pharmacists Association Annual Convention in New Orleans, October 15-19, 2016.
And, don’t miss John Voliva’s presentation on Sunday, October 16that 7:45 am, “Compounding: What’s on the Horizon.” Bright and early; but, totally worth it!
Board of Director Nominations are Open
IACP Foundation's 2017 Call for Board of Directors Nominations and the 2017 Election Cycle for the March 1, 2017 - February 28, 2019 Board Members is now open!
Interested candidates may be nominated or self-nominated to the IACP Foundation Board Nominating Committee. This year, there are two Board of Director positions for which candidates are sought.The deadline to apply is November 18, 2016. For more information and the nomination form CLICK HERE.
Fund-the-Future Travel Grants: 2017 Educational Conference
The American College of Apothecaries (ACA), International Academy of Compounding Pharmacists (IACP) and American College of Veterinary Pharmacists (ACVP) Foundations are offering up to four (4) pharmacy students a travel grant to attend the 2017 Educational Conference, February 21-25, 2016, in San Diego.
Student Pharmacist Travel Stipend Grant Applications are due by November 15, 2016. Winners will be announced in December! For more information and the application CLICK HERE.
Loews Coronado Bay Resort
REGISTRATION IS NOW OPEN!
Click Here to Register for #EduCon2017
Click Here for more conference information!
Thank you for joining us at the 2nd Annual Compound Conference, October 9, 2016! 95 of your fellow colleagues convened in Columbus, Ohio to take part in a one-day comprehensive program of Continuing Education with captivating speakers, an Exhibit Hall featuring 9 leading companies, and many professional networking opportunities!
Thank you to Our Exhibitors and Meeting Sponsors
Associates of Cape Cod, Inc.; FisherBroyles LLP; MEDISCA; NuAire, Inc.; Spectrum Pharmacy Products; Superior Laboratory Services, Inc.
Don’t miss these upcoming LIVE webinars!
2016 OSHA Training – Bloodborne Pathogens
Multiple webinars throughout year, click title for exact dates.
If you need CE credit, check out IACP AdvanCE’s on-demand library. The library houses more than 100 programs with a variety of pharmacy topics. Please click here to access the self-paced programs.