Take Action! Stop FDA’s Misguided Vet Guidance
At its September meeting, the IACP Board of Directors unanimously voted to support a bipartisan Congressional letter, please click here to view, demanding that the FDA withdraw its Guidance for Industry #230: Compounding Animal Drugs from Bulk Substances.
Led by Congressmen Matt Salmon (R-AZ) and Kurt Schrader (D-OR), the letter points out that the agency does not have statutory authority to interfere with the state-regulated practice of veterinary medicine.
More importantly, the Congressmen point out that as written, the guidance attempts to create new regulatory authority without legislation to support that effort.
How to Take Action!
Please click here to read the entire article.
Also learn how you can have your respective congressional contacts sign onto Congressmen Salmon and Schrader's letter to the FDA.
FDA Inspections Accelerate
In the past week, more than a dozen IACP members reported that FDA representatives are inspecting their pharmacy practice. While these practices are engaged in sterile compounding, the FDA also is inspecting all non-sterile compounding activities as well.
Even though a pharmacy may be in full compliance with its state pharmacy practice act, the agency continues to interpret the compounding of any medication for office-use as a violation of section 503A of the federal Food Drug and Cosmetic Act.
Please click here to read more, including information on IACP's October 6th webinar, FDA Inspections for Compounders: The Impact of DQSA.
Revisions to USP <797> Announced
On Friday, September 25, the United States Pharmacopeial Convention (USP) released an advance copy of its proposed revisions to General Chapter <797> - Pharmaceutical Compounding – Sterile Preparations.
The Compounding Expert Committee has been reviewing this chapter since 2010 with an eye towards clarifying and incorporating input from the compounding community. This will represent the first time in seven years that USP has announced an update to <797>.
Please click here to read more, including when comments to the USP are due.
GAO Report on Veterinary Compounding Released
One of the requirements included within the Drug Quality & Security Act of 2013 was for the Government Accountability Office (GAO) to conduct analysis of animal compounding with specific focus on the extent to which that practice occurs, FDA's approach to regulating compounded animal drugs, and the benefits and risks of drug compounding for animals.
The report was released yesterday and is entitled: DRUG COMPOUNDING FOR ANIMALS: FDA Could Improve Oversight with Better Information and Guidance (GAO 15-671). IACP staff were interviewed at length last summer on pharmacists' services, issues and concerns with veterinary compounding and our input was included in the GAO report.
Please click here to read more, as well as access the full GAO report.
IACP Foundation Board of Directors Call for Nominations is Now Open
IACP Foundation’s 2015 Call for Nominations and the 2015 Election Cycle for the new March 1, 2016 – February 28, 2018 Board members is now open! The Bylaws of IACP set forth an open election process with nominations for candidates accepted directly from the community of pharmacists, pharmacy technicians, other healthcare professionals, patients, etc.
Please click here for more information as well as a nomination form.
IACP in the News
Bloomberg BNA Q&A: IACP CEO David Miller
P&T Community: Two Draft FDA Guidance Documents Stir Controversy
Pharmacy Times: Pharmacists Commend Lawmaker's Opposition to Tricare Cuts
Fox News: What Every Patient Should Know Before Giving Their Child Prescription Meds
APhA News: Key Changes to Part D for 2016
DVM 360: FDA Warns Pet Owners, Veterinarians of NSAID Toxicity from Use of Topical Flurbiprofen
Stars and Stripes: Military Update|DOD Resists Hill Push to Roll Back Compound Drug Rules
Roll Call: Congress Speaks - Tricare's Sweeping Action Hurts Veterans|Commentary
RAPS: Final Rule Allows FDA to Destroy Some Drugs Denied Entry into US
MEDISCA Contributes $50,000 to IACP's One Fund!
In a press release last Friday, MEDISCA announced that it is contributing $50,000 to IACP's One Fund Campaign.
"The practice of pharmacy compounding is one that has transformed considerably over the years. Through the efforts of the International Academy of Compounding Pharmacists (IACP), the industry has benefited from a number of innovative programs and research initiatives, with the ultimate goal focused on the continuous advancement of patient care.
MEDISCA recognizes the importance of the IACP and recently has made a donation of $50,000 to the well-established organization."
Please click here to read MEDISCA's entire press announcement.
On behalf of the entire IACP Board, Membership and Staff - thank you MEDISCA - for this very generous contribution to IACP. Your support is greatly appreciated.
Help IACP reach our fundraising goal of $2 million dollars by the end of 2016. This funding allows us to continue our efforts to Fix DQSA and to be ready for the next challenge on the horizon. Through your generosity and support we are shaping the future of compounding.
At Compounders on Capitol Hill this year, IACP President Dale Coker, RPh, FIACP, issued a personal challenge to our membership and Corporate Sponsors to donate to IACP’s One Fund.
Please click here to view IACP President Dale Coker's video message!
IACP Members and Corporate Partners: Please join us in our efforts to Protect, Preserve and Advance Pharmacy Compounding by making a donation to IACP’s One Fund fundraising campaign.
Please click here to donate online, or click here to access a One Fund donation form.
Please contact Jennifer Petska, BS, CPhT,IACP Director of Development & Membership, with questions about One Fund.
Corporate Partner Spotlight: International Filter Products
International Filter Products Engineers and products have been serving the needs of the Pharmaceutical, Biotechnology, and Medical communities for over 30 years with world class technical support and products.
We are a stocking distributor making it possible to ship your products needs within 24 hours. Our technical staff consistently provides technical support and products that are well suited and cost effective for each user’s individual needs.
Our inventory includes filter, medical tubing, Bio-Bags, filter capsules, and filter disc capsules. We offer eight capsule configurations with seven media selections, and multiple inlet/outlet options.
Please click here to read more!
IACP Members in the News
Congressman Scott DesJarlais Visits Medical Center Compounding Pharmacy
Pharmacist Donny Ahlberg, DPh, Medical Center Compounding Pharmacy in Cleveland, Tenn., discusses the Drug Quality & Security Act and office use with a supportive U.S. Congressman Scott DesJarlais (R-Tenn) during a recent visit at the pharmacy. Congressman DesJarlais also signed onto the Congressman Carter letter to Tricare.
Vic's Family Pharmacy Moves to New Home
Vic's Family Pharmacy owned by Victor Allen, RPh has moved to a new facility in Nampa, Idaho. Please click here to read the news story.
Diamondback Drugs, National Veterinary Compounding Pharmacy, Launches New Website
Michael Blaire, RPh and his staff at Diamondback Drugs in Scottsdale, Ariz., have launched a new interactive website. Please click here for more information.
Fusion Specialty Pharmacy Increases Custom Compounding
"Compounded medications are on the rise," states Koby Taylor, PharmD, Pharmacist for Fusion Specialty Pharmacy in Santa Clara, Utah"By providing compounding services, we can provide customized medications to meet the prescription needs of all of our customers." Please click here to read more!