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A Critical Update on the FDA’s GFI #256: Compounding Animal Drugs from Bulk Drug Substances

A new draft guidance from the FDA that would shape the way compounded medicines are produced and prescribed for animals hit the stage back in 2019. The guidance was finalized this year after much feedback and many revisions, marking the most prominent change in the history of veterinary compounding. In my earlier article regarding GFI #256, I dive into the details of the new policies and how these changes will impact the way compounded veterinary medicines are prescribed, formulated and priced moving forward. Since the release of the final guidance, compounding pharmacies across the nation have been scrambling to adjust operations and logistics in preparation for the policy enforcement that was to begin October 1, 2022. However, on September 9, 2022, the Alliance for Pharmacy Compounding (APC) and several other organizations who advocate for pharmacy compounding received a letter from the FDA declaring that the “FDA does not intend to shift their resources toward routine inspectional activities until April 2023,” giving compounding pharmacies an additional six months to comply with the rules described in GFI #256.

The FDA’s letter goes on to highlight the process of submitting a bulk drug substance to the “List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals.” This evolving list is the cornerstone of GFI #256, as it is comprised of all of the compounding formulations that are approved to be made with a bulk powdered drug substance. Over the past year, veterinarians, compounding pharmacies and other stakeholders have nominated over 100 different formulas to be included on this list. As it stands today, there are currently 11 approved drug/formula combinations that can be made from bulk drug substances and 137 drug/formula combinations that are currently under review on the FDA’s “Bulk Drug Substances Currently Under Review” list. Most notable is the fact that the amount of drug/formula combinations on the FDA’s unapproved list, “Bulk Drug Substances Reviewed and Not Listed,” has decreased compared to several months ago and currently contains only five drug/formula combinations. This decrease might suggest that the FDA has slightly softened its view on banning the use of bulk drug substances in animal compounding.

One critical question that remains unclear is how much flexibility or interpretation compounders can exercise when referencing the lists mentioned above. For example, Gabapentin oral suspension was recently moved to the “approved” list, which references “50mg/mL” as the strength/concentration. Does this mean that compounders may only make that particular strength from bulk substances, or may they also make 100mg/mL, 75mg/mL, etc.? Conversely, the “unapproved” list also references a strength/concentration value. Does this mean compounders are prohibited from making that strength only, or are they prohibited from making all strengths of that particular product from bulk substances? Surely, time will tell.

It’s imperative for compounding pharmacies to closely monitor which formulas the FDA moves from the “under review” list to either the “approved” or “unapproved” lists, as they are consistently developing. These lists will serve as the main reference points for determining which veterinary formulas compounders can make from bulk substances and which ones they will be forced to make from commercially available products. Stay tuned, as we will have an update on GFI #256 in the coming months.

About the Author

Luke Eilers is the COO of Northwest Compounders, one of the most respected compounding pharmacies in the Pacific Northwest, known for providing excellent customer service, exceptional product consistency and reliability, and expedient fulfillment. Having worked in the industry for 17 years, starting as a pharmacy technician and working his way up, Eilers has supported the organization’s growth from a couple employees to now more than 60. He is responsible for strategic planning, operations, personnel management, HR functions, client relations, regulatory affairs, and marketing.

Eilers earned a Bachelor of Science from Oregon State University in Corvallis, Oregon, and a Doctor of Pharmacy from Pacific University in Hillsboro, Oregon. He also holds a Certificate in Veterinary Pharmacy, and a Certificate in Basic Compounding and Certificate in Aseptic Compounding from the Professional Compounding Centers of America. Eilers is an affiliate faculty member and pharmacy preceptor for Oregon State University College of Pharmacy and Pacific University School of Pharmacy.

William Kenward, CPhT

project manager

Team member since 2015

Chris Gralian, CPhT

Quality Control Lead

Team member since 2019

Rose Hood, CPhT

Quality Control Lead

Team member since 2016

Matthew Peterson, CPhT

Quality Control Lead

Team member since 2016

Helen Dubintsov, CPhT

Quality Control Lead

Team member since 2016

Shannon Kimball, PharmD

Compounding Pharmacist

Doctor of Pharmacy, Pacific University 2022

B.S. Biohealth Science, Oregon State University 2019

Team member since 2018

Mark Liu, PharmD

Compounding Pharmacist

Doctor of Pharmacy, Oregon State University 2005

BA Biology, Reed College 1998

12 years of retail experience

Team member since January 2017

Jill Snyder, RPh

Compounding Pharmacist

B.S. Pharm. 1994 Oregon State University

5 years of retail pharmacy experience

17 years of long-term care experience

Certificate in Veterinary Pharmacy, 2016

Team member since May 2016

Scott Williams, RPh

Compounding Pharmacist

B.S. Pharm. 1992 Oregon State University

24 years of experience in Retail Pharmacy

Team member since November 2015

Certificates in CPR, Diabetes Management, Immunization, Cholesterol Management and Medication Therapy Management

Bob Templin, RPh

Director of Training

B.S. Pharm. 1976 Oregon State University

Certificate in Veterinary Pharmacy, 2019

Over 37 years of pharmacy experience

Over 33 years as a Pharmacy Manager

Team member since February 2013

Megan Gustafson, PharmD

Director of Training

Doctor of Pharmacy, Oregon State University 2021

B.S. Bio-Health Sciences, Oregon State University 2017

Team member since 2016

Sam Llona, PharmD

Director of Sterile Operations

Doctor of Pharmacy, Creighton University 2019

B.S. Biology, Santa Clara University

Certificate in Aseptic Compounding, PCCA 2014

Certificate in Human Compounding, PCCA, 2016

Certificate in Veterinary Compounding, PCCA, 2017

Team member since September 2019

Vivian Pham, PharmD

Senior Operations Manager,
Director of Accounting

Doctor of Pharmacy, Oregon State University 2016

Has worked as a technician, bookkeeper, pharmacy intern and now pharmacist for Northwest Compounders

Team member since May 2008

Jessie Vo, PharmD

Pharmacy Manager,
Director of Quality Assurance

Doctor of Pharmacy, Pacific University 2011

Preceptor for Pacific University SOP, Oregon State SOP

Team member since January 2006

Luke Eilers, PharmD

Chief Executive Officer

Doctor of Pharmacy, Pacific University 2014

B.S. General Science, Oregon State University 2011

Certificate in Veterinary Pharmacy, 2018

Certificate in Basic Compounding, PCCA 2014

Certificate in Aseptic Compounding, PCCA 2014

Preceptor for Pacific University SOP, Oregon State SOP

Team member since October 2005

Tom Eilers, RPh

Founder, Chairman

B.S. Pharm. 1976 Oregon State University

Founder, Northwest Compounders 2005

Member, International Academy of Compounding Pharmacists

Member, PCCA (Professional Compounding Centers of America)

Certificate in Basic Compounding Techniques, PCCA, 2001

Certificate in Aseptic Compounding, PCCA 2005

Preceptor for Pacific University SOP, Oregon State SOP, Washington State SOP

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