The FDA’s GFI #256 Implementation Date is Approaching, Here is What You Need to Know

Over the past several months, Northwest Compounders has received dozens of questions from veterinary practitioners about how the enforcement of GFI #256 on April 1, 2023, might impact the availability of compounded medications for in-clinic use. We have been closely monitoring the development of GFI #256 since its announcement last year and would like to provide all of our partners with an up-to-date overview of what this means for the veterinary industry.

With already one delay to the enforcement date, originally slated for October 1, 2022, industry professionals have been preparing to make all necessary adjustments as the new enforcement period quickly approaches. Beginning April 1, 2023, FDA inspectors will use the guidelines in GFI #256 to inspect compounding pharmacies. Compounding pharmacies are motivated to comply with FDA guidelines to avoid the negative consequences of non-conformity. FDA inspections occur infrequently and at random, so it’s best to be fully prepared to satisfy GFI #256 requirements on an ongoing basis.

The verbiage of GFI #256 is complex, but overall the guidance document aims to change three aspects of veterinary compounding:

  • How clinic-use medications are made
  • How prescriptions for compounded veterinary products are documented
  • How compounded products are labeled

The first aspect, “how clinic-use medications are made,” has raised the most concern in the veterinary community. The guidelines provide very specific language that limits compounders to using a commercial product as the source ingredient when making clinic-use compounded products. This differs from the current practice of pharmaceutical compounding, where compounders prefer to use bulk powdered pharmaceutical ingredients, which oftentimes promotes better formulation compatibility with the absence of unwanted excipients at a reasonable price point.

The most challenging aspect of these new guidelines is that not all compounded products can be made from commercial products. The FDA has acknowledged that this statement is true. In instances where compounded products can’t be made from commercial products, the FDA has deemed it appropriate and necessary for compounders to continue compounding from bulk powdered drug substances. In order to identify all of the compounded products that cannot be made from commercial products, the FDA asked stakeholders to submit formula candidates to the FDA for review. The FDA received over 220 formula candidates for review. Once reviewed by the FDA, the formula candidate lands on one of two lists: the “List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals” or the “Bulk Drug Substances Reviewed and Not Listed” list. Simply stated, the first list can be thought of as the “approved” list that contains all of the formulas that compounders can continue to provide to clinics in the same manner as they do now. The second list can be thought of as the “denied” list that contains all of the formulas that compounders need to stop producing or continue producing as long as they make the product using a commercial product as the source for the active ingredient.

As of February 6, 2023, the following formula candidates have been approved and added to the first list:

Bulk Drug SubstanceDosage FormStrength/Concentration
Amlodipine besylateOral Solution1.25 mg/mL
Amlodipine besylateOral Suspension1.25 mg/mL
Amlodipine besylateCapsule0.625 mg
Amlodipine besylateTablet0.625 mg
Amlodipine besylateMini-Tab0.625 mg
Apomorphine HCLInjection Solution2.5 mg/mL
CisaprideTablets or capsules2.5 mg and 5 mg
CisaprideOral Suspension5-10 mg/mL
CyclosporineOphthalmic Ointment1-2%
GabapentinOral Suspension50 mg/mL
GuaifenesinPower for reconstitution, for Inj50 gm
IdoxuridineOphthalmic oint or solution0.10%
Itraconazole with DMSOOphthalmic oint or solution1%-30%
MetronidazoleOral Suspension80 mg/mL
Miconazole NitrateOphthalmic oint or solution1-2%
MirtazapineTablet1 mg-3.75 mg
MirtazapineCapsule0.5 mg-3.75 mg
Potassium BromideOral Solution250 mg/mL
RifampinOral Suspension100 mg/mL
TacrolimusOphthalmic Drops0.01%-0.03%

As of February 6, 2023, the following formula candidates have been denied and added to the second list:
Bulk Drug SubstanceDosage FormStrength/Concentration
Amlodipine besylateOral SolutionAny concentration other than 1.25 mg/mL
Amlodipine besylateOral SuspensionAny concentration other than 1.25 mg/mL
Amlodipine besylateCapsuleAny strength other than 0.625 mg
Amlodipine besylateTabletAny strength other than 0.625 mg
Amlodipine besylateTransdermal GelAny concentration
Amlodipine besylateOral PasteAny concentration
Amlodipine besylateSoft Chewable TreatAny strength
Apomorphine HCLSubconjunctival solution3.125-6.25 mg/mL
Apomorphine HCLSubconjunctival tablets6.25 mg
ChloramphenicolOphthalmic Solution1%
CorticotropinInjectable40 & 80 units/mL
DexamethasoneOral Powder10 mg/packet
DipyroneInjection Solution250 and 500 mg/mL
EnrofloxacinOral Paste and Suspension100 to 200 mg/mL
FluoxetineCapsules, tablet, soft chew treat, suspension, paste, transdermal gelAll strengths and concentrations
Isoflupredone acetateSuspension for injection2 mg/mL
Maropitant citrateCapsules2-120 mg
Maropitant citrateOral Paste20-40 mg/mL
Maropitant citrateOral Suspension1.8-60 mg/mL
Maropitant citrateSoft Chew Treat2-60 mg
Maropitant citrateTabletAug-32
Maropitant citrateTransdermal Gel25-300 mg/mL
Maropitant citrateNasal Solution0.10%

There are currently 181 candidate formulas that have not yet been reviewed by the FDA. It is our understanding that the FDA does not intend to penalize compounders for continuing to provide clinics with clinic-use medications that have been nominated but not yet reviewed.

Key Takeaways

  • Enforcement of GFI #256 begins April 1, 2023.
  • If a formula appears on the “approved” list, compounders will maintain their ability to provide it to a clinic in the same manner as they are currently doing.
  • If a formula appears on the “denied” list, compounders may elect to stop providing that item for clinic-use or can continue to provide the item as long as the product is made using a commercial product as the source of the active ingredient.
    • Using a commercial product as the source of the active ingredient will likely cause an increase in price and a change in consistency compared to a clinic-use product that is made from a bulk-powdered pharmaceutical ingredient.
  • There are currently 181 formulas waiting to be reviewed. It is our understanding that compounders may continue to provide these medications to clinics in the same fashion as they are currently doing until the FDA has designated them to one of the two lists.
  • A compounder’s ability to make compounded products for patient-specific use will not be impacted by the guidelines set forth in GFI #256.
  • Northwest Compounders will give our clinic partners as much advanced notice as possible anytime a relevant product will be affected by these new guidelines.
  • Beginning April 1, 2023, compounders will be required to ask veterinary prescribers for a “compounding justification” from the prescriber. If a justification for compounding is not provided, the compounder will prompt the prescriber (or the prescriber’s agent) to provide a justification for compounding. This justification must be documented on the prescription hard copy.
    • To expedite this process, Northwest Compounders has created a fillable prescription form that is available on our website under the “Prescriber Resources” tab.
  • Beginning April 1, 2023, new labeling requirements will require compounders to include warning statements and other verbiage on prescription labels.

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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