Busy Week for Compounding and FDA
New Guidance Documents and New Lists
On Monday, the Food and Drug Administration (FDA) released two interim guidance documents to clarify how it intends to exercise enforcement discretion with both 503A traditional compounders - click here to view - and 503B outsourcing facilities - click here to view.
These guidance documents address the agency’s current position on what APIs can be used in preparing a compound when those bulk ingredients do not meet the Drug Quality and Security Act (DQSA) provisions that require the existence of either a USP monograph or that the API be a component of an FDA approved product.
Each of these guidance documents establish four lists. For both 503A and 503B, “List 1” shows a series of APIs which were nominated and accepted for review by the FDA’s Pharmacy Compounding Advisory Committee (PCAC). Although those reviews have not been completed, FDA is essentially permitting the use of these drugs in compounding until those reviews are finished and published on a formal list by the Secretary of Health and Human Services.
A second list, “List 2” shows those APIs which were nominated for review but which the agency deems unsafe at the present time. There is only one API on List 2 for 503A compounders – domperidone. No API appears on List 2 for 503B outsourcing facilities.
For both 503A and 503B, FDA has created a “List 3” of nominated drugs for which they did not receive sufficient background or information in order to present them to the PCAC for review.
Please click here to read more.
Take Action: Step Up and Participate in Two Crucial IACP Action Alerts!
Action Alert #1
Stop FDA's Misguided Veterinary Compounding Guidance
At its September meeting, the IACP Board of Directors unanimously voted to support a bipartisan Congressional letter (please click here to view the letter) 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.
Click here to take action, it only takes a minute, and join 135 of your colleagues who already have sent their message to the Hill.
Our objective was to get at least 50 Congressional signatures on this by the end of October! With your help, the following Representatives have joined this effort!
Matt Salmon (R,AZ) - lead Republican
Kurt Schrader (D,OR) - lead Democrat
Patrick McHenry (R,NC)
Mark Pocan (D,WI)
Paul Gosar (R,AZ)
Dan Benishek (R,MI)
Peter DeFazio (D,OR
Ted Yoho (R,FL)
Joe Heck (R,NV)
Donald Norcross (D,NJ)
Krysten Sinema (D,AZ)
Ted Poe (R,TX)
Frank LoBiondo (R,NJ)
Pete Session (R,TX)
Congressmen Salmon and Schrader's offices have extended the deadline for their letter, and the opportunity for IACP members to secure additional co-signers, until next Friday, November 6.
Action Alert #2
Take Action! Ask your U.S. Senators to Support S.1406 Saving Access to Compounded Medications for Special Needs Patients Act.
Ask your Senators to preserve Office Use as Congress Intended in DQSA! To date, more than 525 members have sent their messages to the Hill on this very important issue. Please join us and send your messages. It only takes a minute!
Click here to take Action, Today!
In Case You Missed It: USP <797> Revisions – Impact on Sterile Compounders
After several years in the making, the USP Expert Committee on Compounding released and advanced preview of its proposed revisions to General Chapter <797> Pharmaceutical Compounding/Sterile Preparations at the end of September.
The revisions can be found by clicking here. When they are formally published on November 2, 2015, an open comment period will begin and run through January 31, 2016.
IACP already has reviewed the proposed revisions and its Legislative Committee has begun drafting comments on how these changes will affect sterile compounders in all types of pharmacy practice settings.
“One of our greatest concerns with the revised <797> standard is the elimination of a clinician’s ability to determine a beyond-use-date based upon the medical and scientific literature,” says David Miller, IACP executive vice president.
“Traditionally, USP has acknowledged that science evolves and that pharmacists have the ability to apply new information and incorporate that into their practices. By establishing specific limits on BUDs for sterile drugs using language similar to FDA guidelines, USP is inadvertently restricting professional decision making.”
Click here to read more.
NABP Supports Increasing Compounding Safety With Qualified Person Credentialing Program
With the goal of increasing compounding safety, CriticalPoint, LLC, has launched the Qualified Persons Credentialing Program (QPCP) for pharmacists at entities practicing compounding under sections 503A and 503B of the Drug Quality and Security Act (DQSA), Title I – Compounding Quality Act.
The National Association of Boards of Pharmacy (NABP) strongly believes that these pharmacists should be able to demonstrate knowledge, design sound compounding methodology, and develop effective quality systems in order to supervise such operations.
The Association is partnering with CriticalPoint to inform its member boards of pharmacy about the QPCP and how the program may assist the boards in establishing a formal and standardized system for evaluating, educating, and credentialing qualified persons for both 503A and 503B entities.
Please click here to read more.
IACP in the News
IACP's David G. Miller, RPh, Executive Vice President/CEO was interviewed by MassLive.com's Shira Schoenberg in the article Pharmacists See Patients Struggle as Insurers Limit Coverage for Compounded Drugs.
"Many of the payers started seeing a significant increase in what they were paying to compounded pharmacists, not because the price went up, but because the way we billed it changed," Miller said. "Over the last year, we've seen more third parties say we don't want to fix the system, we'll just stop paying for it."
Please click here to read the entire article which also features comments from IACP Members Ernie Gates and Andrew Stein.
Closing November 20th: IACP Foundation Board of Directors Call for Nominations
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.
Nominations close on November 20, 2015.
Please click here for more information as well as a nomination form.
Corporate Partner Spotlight: International Journal of Pharmaceutical Compounding
The International Journal of Pharmaceutical Compounding (IJPC)®
Our Compounding Knowledge, Your Peace of Mind®
For almost 20 years IJPC and its associated products have provided compounding pharmacists with invaluable resources. Right now you can access articles and issues for immediate download at IJPC.com and formulas that are referenced with beyond-use dates and SOPs available on CompoundingToday.com.
Each issue of IJPC print/digital contains feature articles on relevant compounding topics, 2-4 peer reviewed scientific studies, ten formulations, series on the basics of nonsterile compounding and sterile compounding, quality assurance and much more. http://www.ijpc.com/Subscribe/
CompoundingToday.com is the world’s largest database for pharmaceutical compounding. It contains over 3,000 documented formulas, over 1,000 ‘Named” formulas, 350 cosmetic formulas, and more than 550 Standard Operating Procedures.
You can sign up for a free two-week trial and download some sample formulas at http://compoundingtoday.com/Register/
Please click here to read more.
Thank You to our Generous One Fund Contributors!
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.
Please click here to view our One Fund Contributors to date!
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.
IACP Members in the News
Sienna Compounding Pharmacy Celebrates Grand Opening
Sienna Compounding Pharmacy owned by IACP Member Sulisa Chow, PharmD and Lori Markel, PharmD, opened August 18 at 9029 Hwy. 6, Ste. 190, Missouri City.
The pharmacy offers a wide variety of services to practitioners and patients, including prescription refills. The pharmacy compounds and sells medications for men, women, children and pets. It also sells dermatology prescriptions, vitamins and essential oils as well as offers hormone replacement therapy.
Lucy Malmberg/Wedgewood Pharmacy Receives Award for Excellence
Congratulations to IACP Board Member Lucy Malmberg, RPh, FACA, FACVP, Wedgewood Pharmacy in Swedesboro, NJ, for being presented the Annual Award for Excellence from the New Jersey Business & Industry Association!
Click here to read more.