Veterinary Compounding Guidance -- Your Help Needed!
The International Academy of Compounding Pharmacists (IACP) is hard at work in developing comments for our members to the Guidance for Industry #230, FDA's far reaching attempt to regulate veterinary compounding without clear Congressional direction. In addition to adding extensive new requirements for specific language that must appear on a prescription in order for it to be considered "valid" in the eyes of the agency, FDA has gone even further and permitted 503B outsourcing facilities to compound and distribute veterinary medications even though 503Bs were intended to provide sterile compounds for human patients.
Last week, the IACP Board formally requested an extension to the August 17, 2015 deadline for comments due to our concerns about the complexity and breadth of what it would mean to our members should this document move forward. In addition, a coalition of veterinary compounders secured the support of Congressmen Salmon (R-AZ) and Shrader (D-OR) to request a total withdrawal of the Guidance. Please click here to read the letter.
What can you do to help?
Contact your Congressman today and ask his or her office to co-sign this Guidance withdrawal request. Please email IACP with questions!
FDA Announces Guidelines/Fees for 503Bs
The Food & Drug Administration's (FDA) pace of releasing guidance and requirements for implementation of the Drug Quality and Security Act (DQSA) continues this week with the issuance of two specific documents directly related to outsourcing facilities.
On Monday August 3, 2015, the FDA released a revision to its Guidance document that outlines how 503B outsourcing facilities will collect and report adverse event data. This is in direct follow-up to the comments filed by IACP and others to the initial Guidance that was issued in February and which closed in May. Though the agency made several requested changes, there are still concerns that need to be addressed. Interested stakeholders have 30 days (until September 2, 2015) to respond to the proposed final document. For details on the document and the changes made, please click here.
Also announced at the same time was the fees to be paid by outsourcing facilities for the coming year. The permit fees and the inspection fees have both been increased. For qualified small businesses, the fee is now $15,610 and for non-small businesses the fee is $16,465. Reinspection fees are the same amount regardless of whether the 503B facility is a small business or not; that stands at a flat amount of $15,610.
As a reminder, all 503B outsourcing facility fees must be paid no later than December 10, 2015 in order for the materials to be reviewed by the agency and for the facility to remain registered in 2016.
For additional information, please click here.
DQSA Stakeholders Coalition Files Comments with FDA
The Drug Quality & Security Act (DQSA) Stakeholders Coalition led by the International Academy of Compounding Pharmacists submitted comments on Friday, July 31st to the Food & Drug Administration's (FDA) Compounding of Human Drug Products under the Federal Food, Drug and Cosmetic Act Public Docket.
Excerpt - "During the Pharmacy Stakeholders Listening Session held on April 30, 2015, as well as the listening session for physicians, ambulatory surgery centers, and others, FDA proposed several question to the attendees. To provide a comprehensive set of answers, the DQSA Coalition, a group of more than 20 professional organizations representing prescribers, pharmacist, physicians, ambulatory surgery centers, and patients -- has worked diligently to provide data, examples and responses to FDA's questions in order to aid in the implementation of the DQSA. As a Coalition, we understand and support the need to protect public health. However, we also urge FDA to fully consider the preservation of patient access to vital compounded medications."
Please click here to read the full commentary.
Please email IACP with any questions!
IACP Requests FDA Comment Period Extension - Compounding Animal Drugs from Bulk Drug Substances
On July 27th, the International Academy of Compounding Pharmacists (IACP) requested a formal 90-day extension of the comment period for the Food & Drug Administration's (FDA) Guidance for Industry (GFI): Compounding Animal Drugs from Bulk Drug Substances from August 17, 2015 to November 2015.
In a letter sent to the FDA, David G. Miller, RPh, IACP Executive Vice President/CEO says, "IACP is gravely concerned with many issues within this GFI that create distinct conflicts with existing State-regulated pharmacy practice laws and regulations, that authorizes the preparation and distribution of veterinary medications by 503B outsourcing facilities without the necessary enabling statutory authority from Congress, and will have a detrimental impact on the availability of medications for use by veterinarians in the care and treatment of animals within their practices."
Please click here to read the entire IACP letter.
IACP's Summer CAMP is in Session!
For the past six years, IACP's Summer CAMP (“Congressman At My Pharmacy”) campaign has brought legislators face-to-face with members to see first-hand what compounding pharmacy is all about and the impact you have on the business and health of your community.
This year, we want you to know how important it is to sponsor a Summer CAMP event at your pharmacy during the summer Congressional Recess. Timing couldn’t be better in 2015! Providing your Representative and Senator with an opportunity to meet your patients and their constituents increases the likelihood that they will want to spend time learning about compounding, your business, and the effects of the Drug Quality & Security Act.
IACP's Summer CAMP packet contains everything you need to prepare and host a successful event. Follow the step-by-step instructions and do your part to put a face on compounding for federal legislators!
Please click here to view IACP's Summer CAMP packet!
USP Expert Committee for Compounding Appointed for 2015-2020
•Gigi S. Davidson, RPh, DICVP, Chair
•Lisa Ashworth, BS Pharm, RPh
•Gus Bassani, PharmD
•Ruth Ebiasah, PharmD
•Edmund J. Elder, Jr., PhD
•Ryan Forrey, PharmD, MS
•Deborah Houston, PharmD
•Brenda Jensen, MA
•Patricia C. Kienle, MPA
•William A. Mixon, MS
•John Musil, PharmD
•David Newton, PhD
•Alan Parr, PharmD, PhD
•Robert Shrewsbury, PhD
•Connie Rae Sullivan, BS Pharm
•Brenda Yuzdepski, BS Pharm
•Jane Axelrad, JD
•Jonathan Bray, BS
•Ian DeVeau, PhD
•Edisa Gozun, PharmD
•Susie Homire, DVM
•John Metcalfe, PhD
•Erika Pfeiler, PhD
•Sara Rothman, PhD
USP Documentary Standards Staff
•Shawn Becker, MS, BSN
•Rick Schnatz, PharmD
•Jeanne Sun, PharmD
Primary Points of Contact
•Rick Schnatz, PharmD (email@example.com)
•Jeanne Sun, PharmD (firstname.lastname@example.org
Click here to read more about USP's Expert Committees.
Hospira Recalling 21 Million Units of Three Injectables
Hospira is voluntarily recalling a total of over 21 million units of three injectable products through three separate recalls.
The Lake Forest, Ill., drugmaker’s biggest culprit is the nonsteroidal anti-inflammatory drug ketorolac tromethamine injection, with 20.69 million single-dose vials being recalled because the calcium salt is crystalizing. The recall involves 64 lots, 10 of which — totaling more than 3.25 million vials — carry the Novaplus label, according to an FDA enforcement report.
The recall was initiated by Hospira on June 30 and affects product in the U.S., Puerto Rico, Guam, Canada and Singapore.
Please click here to read more.
IACP Board Elections: Call for Nominations
IACP’s 2015 Call for Nominations and the 2015 Election Cycle for the new 2016 Board members is now open! The Bylaws of IACP set forth an open election process with nominations for candidates accepted directly from the membership. Nominations will close on Tuesday, September 8, 2015.
Interested candidates may be nominated or may be self-nominated to the IACP Nominating Committee chaired by IACP Immediate Past President Pat Stephens, PharmD. The IACP Board of Directors receives the Nominating Committee report at its October Board Meeting, approves the slate of candidates, and then all qualified IACP members are able to participate in the election process held each November. This year, there are four Board of Directors’ seats for which candidates are sought as well nominees for the position of IACP Vice President.
Please click here to read more about the nomination process.
Please click here to access the nomination form.
Support Your Future and Your Academy. Contribute to IACP's One Fund.
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.
"IACP has a clear goal to be proactive rather than a reactive organization," says Coker. "To accomplish this, it requires capital. We need to replenish our reserves used in defending compounding in the wake of the NECC crisis of 2012. We need to build our war chest for the next coalition that will need to be formed. There are many issues on the horizon, with the Veterinary Compounding Compliance Policy Guide, third party reimbursement and third party credentialing to name a few. We need funding available to act NOW, not after a crisis sets in.
During CCH, we raised an additional $52,000 and $15,000 in future donations from members for a total of $87,000. To date we are at $413,000 which is about 21 percent of our goal with a quarter of our timeline already gone.
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.
Corporate Partner Topi-CLICK Donates $25,000 to IACP's One Fund Fundraising Campaign!
Corporate Partner Topi-CLICK heard our call and donated $25,000 to One Fund. Their generosity will help us reach our goal of $2 million dollars by the end of 2016.
Thank you, Topi-CLICK, for your ongoing generosity to the Academy. We greatly appreciated your support. On behalf of our Board and Members, thank you.
Please call Jennifer Petska with questions about One Fund.
IACP Member Janet Beard, RPh, co-owner of Harvest Drug in Wichita Falls, Texas, is the 2015 recipient of PCCA's Evelyn Timmons Advocacy Award. "Janet is passionate about providing customized medications to patients who depend on it, and she is a strong advocate for protecting the compounding industry in both her local community and on Capitol Hill," says, Aaron Lopez, PCCA Senior Director of Public Affairs.
Retail Merchandiser Spotlights Rye Beach Pharmacy
IACP Member Ken GiaQuinto, President of Rye Beach Pharmacy in Rye, New York, was recently featured in the publication, Retail Merchandiser for his long-term pharmacy practice and compounded medications.
"In business for more than 65 years, Rye Beach Pharmacy is a full-service, family owned pharmacy that has served its community since 1946. Today, the company is an independent pharmacy that specializes in patient counseling, compounded medications for humans and pets, Bio-identical Hormone Replacement Therapy (BHRT), nutritional supplements, natural health products, custom fitted stockings, homecare aids and customer service."
“We’ve been able to endure thanks to employees that care and go the extra mile, and our customers recognize and appreciate that,” President Ken GiaQuinto says."
Please click here to read the entire article.