Changes are Coming with FDA Guidance for Industry (GFI) 256. We are prepared, so you can be too!
What is GFI 256?
Guidance for Industry 256 describes the FDA’s approach to situations where veterinarians need
access to drugs compounded from bulk drug substances (BDS) to provide appropriate care for the
medical needs of their patients when no FDA-approved drug can be used.
Projected GFI 256 implementation date is now 4/1/2023.
Compounded drugs made from active pharmaceutical ingredients (APIs) NOT on the FDA “positive list” will need to be tied to a patient-specific prescription, including a medical rationale for prescribing, when ordered from a compounding pharmacy.
Office Stock compounds from the approved list are authorized when urgently necessary to prevent animal suffering or death under the circumstances described in GFI #256.
Patient-specific prescriptions are eligible when the veterinarian determines that there is a difference between the compounded drug and the commercial drug that will produce a clinical difference in the identified patient. The medical rationale from the veterinarian will need to be documented 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. This only pertains to products that are essentially a copy of a commercially available product, which is defined as the same drug, dose, and route of administration.
Examples from the FDA of acceptable and not acceptable medical rationale for prescribing can be found on pages 10-11
of the GFI 256 guidance document.
What does this mean for you?
GFI 256 has the potential to affect office use compounding, limiting the products available for office stock from compounding pharmacies. It may encourage practices to prescribe patient-specific compounded medication rather than distribute compounds from office stock.
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.
You can prepare for these changes by signing up for our patient-specific ordering platform to ensure continuity of care for patients and make patient-specific ordering easy. 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 your pet owners.
Please reach out to your local Covetrus representative or call our pharmacy at 877-518-4589 to learn more.
What is Covetrus® doing to prepare for implementation?
Covetrus is committed to staying up to date on all FDA standards and guidelines.
How do we work to meet these standards so clinics can provide the best care?
A dedicated team of 300+ pharmacy staff members
Our pharmacists are trained and working to make sure clinics 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 your customers, 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 facility (Atlas) for Office Use Compounds
Covetrus compounds are manufactured under strict FDA regulated cGMP standards, delivering quality your clinics can trust for their office-use medications. Our pharmacies are backed by a team of quality experts ready to fulfill all their compounding needs at compounds.covetrus.com.
Compounding Best Practices Outlined in GFI 256:
Prescribing Patient-Specific Compounds:
Under the guidance, when you prescribe or administer a drug compounded from BDS you should:
Have a valid veterinary-client-patient relationship (VCPR).
Consider other FDA-approved options first.
Write a prescription that identifies the patient or group of patients at same location.
Determine if you are prescribing a copy. If there is an approved product with the same active ingredient, that can be given via the same route of administration, you should document a medical rationale in your records noting why the compounded copy will make a clinical difference for the patient.
Provide the pharmacist compounding the drug with the rationale for making a copy, either by writing it on the prescription or verbally when the pharmacist contacts you to obtain it.
The statement of the rationale can be brief; see GFI #256 for examples. Note: If the compounded drug is not essentially a copy of an approved product, the guidance does not ask you to provide a rationale.
Report adverse events and product defects associated with the compounded drug to the compounder and to FDA on Form FDA 1932a.
Obtaining Office Stock
Obtaining Office Stock: For some conditions treatment is urgently needed, and the time needed to compound a drug in
response to an individual patient prescription may result in animal suffering or death. Under GFI #256, FDA reviews
BDS nominated for use in compounding drugs as office stock for these circumstances and lists them on the List of
Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood- Producing Animals. When you prescribe a
compounded drug for office stock, you should also: