FDA Guidance for Industry (GFI) #256 is now in effect
Covetrus® Compounding Pharmacies is here to help.
Covetrus is aware of the implications of GFI #256, and we are committed to staying up to date on all FDA standards and guidelines.
We are continuously working to support the veterinary community by nominating products to the FDA’s “positive list.” We are also monitoring submissions as well as approvals and denials on a daily basis.
Note: Veterinarians may submit comments here to the FDA regarding this guidance and the products nominated to be approved for office stock.
What is GFI #256
Guidance for Industry #256 describes the FDA’s approach to enforcement discretion for compounded drugs from bulk substances. This Guidance may help veterinarians in providing appropriate care for the medical needs of their patients when no FDA approved drug can be used.
What does GFI #256 mean for you?
GFI #256 limits the compounded products available for office stock. The Guidance may encourage practices to prescribe patient-specific compounded medication, including a medical rationale for prescribing, rather than distributing compounds from office stock.
- Office stock compounded drugs for emergency use, without a patient specific prescription, will need to be compounded from the FDA’s “positive list”. List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals.
- Compounded drugs made from active pharmaceutical ingredients (APIs) that are NOT on the FDA “positive list” will need to be tied to a patient-specific prescription.
- When prescribing patient-specific compounds, if there is an FDA approved product available with the same active ingredient, with the same route of administration, then you should document a medical rationale in your records noting why the compounded product will make a clinical difference for the patient. You will then need to provide this rationale to the compounding pharmacist upon ordering. If the veterinarian does not provide medical rationale on the prescription, it will be up to the pharmacy to obtain the rationale for the compounded product.
Medical justifications for prescribing a compounded drug over an FDA-approved drug include, but are not limited to:
- Compounded product increases compliance
- Compounded product offers strength not commercially available
- Compounded product offers flexibility in dosing
- Compounded product avoids ingredients harmful to the patient
- FDA-approved product unavailable
To adapt to these workflow changes more easily, you can sign up for our patient-specific ordering platform to ensure continuity of care for patients and to make patient-specific ordering easier. Personalized, pet-friendly dose forms can be ordered and sent from your prescription management platform directly to your patients, making it convenient for your staff and for pet owners. Medical rationale for prescribing can be easily entered in the “Notes to Pharmacy” section when writing each script.
Please reach out to your local Covetrus® representative or call our pharmacy at 1-877-999-2838 to learn more.
How do we work to meet these FDA standards and guidelines so veterinarians can provide optimal care?
- A DEDICATED TEAM OF 300+ PHARMACY STAFF MEMBERS
Our pharmacists are trained to ensure veterinarians receive quality medications to deliver top notch care in accordance with the new guidelines. - CONTINUOUSLY MONITORED FACILITIES
Our facilities are continuously monitored to ensure the highest quality product possible is delivered to you and your patients in the right form, at the right time. - USP COMPLIANT AND PCAB ACCREDITED 503A PHARMACIES
Our pharmacies are proud to adhere to the highest compounding standards in the nation, delivering quality you can count on. - 503B OUTSOURCING FACILITY (ATLAS PHARMACEUTICALS) FOR OFFICE-USE COMPOUNDS
Covetrus compounds are manufactured under strict FDA regulated cGMP standards, delivering quality you can rely on for your office-use medications. Our pharmacies are backed by a team of quality experts ready to fulfill all of your compounding needs at compounds.covetrus.com.