GFI #256
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Our experts help make the ordering process easy with GFI-256 so you can focus on patient care.
What is GFI #256?
Guidance for Industry (GFI) 256 Compounding Animal Drugs from Bulk Drug Substances describes the FDA’s enforcement policy regarding the compounding of animal drugs from bulk drug substances (BDS). This guidance applies to pharmacies and veterinaries preparing compounded medication from a BDS. When a veterinarian needs a compounded medication from a BDS, a medical rationale is necessary when prescribing a patient-specific compounded medication. This rationale must be documented within the prescription if the FDA considers a similar medication commercially available. The GFI 256 changes are here.
What Changes Were Implemented?
When ordered from a compounding pharmacy, compounded drugs made from active pharmaceutical ingredients (APIs) NOT on the FDA “positive list” must be tied to a patient-specific prescription, including a medical rationale for prescribing.
Without a patient-specific prescription, office-stock compounded drugs for emergency use must be compounded from the approved List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals under the circumstances described in GFI #256. The FDA expects the list to expand as the agency reviews additional nominations. Office Stock compounds from the approved list are authorized when necessary to prevent animal suffering or death under the circumstances described in GFI #256.
What Types of Rationale May Be Used When Writing a Prescription?
Pharmaceutical Ingredients (APIs) by or under the direct supervision of:
- Veterinarians, or
- Pharmacists in either State-licensed pharmacies or Federal facilities (i.e., facilities operated by the Federal government)
When requested by your pharmacy to provide information, an example of the following rationale may be provided:
- The commercial product would reduce compliance and/or be ineffective in achieving medical outcomes.
- The commercial product is not available and/or cannot be sourced.
- Utilization of commercially available dosage forms is unachievable or unsafe for the patient.
- Patient and/or population has an intolerance, sensitivity, toxicity, or aversion to commercial products.
- Patient-specific prescriptions are eligible when the veterinarian determines a difference between the compounded and commercial drugs that will produce a clinical difference in the identified patient. (The veterinarian’s medical rationale must be documented upon ordering.)
Where Can I Find a Copy of the Guidance, and Who Regulates These Changes?
- This guidance describes the Food and Drug Administration’s (FDA) enforcement.
- This guidance does not apply to animal drugs compounded for use in investigations of new animal drugs or animal drugs compounded from FDA-approved animal or human drugs, which are considered legal extra-label uses of such drugs.
The contents of this document do not have the force and effect of law and are not meant to bind the public in any way unless expressly incorporated into a contract. This document is intended only to clarify existing requirements under the law to the public.
What Does This Mean For You?
GFI 256 can affect office-use compounding by limiting the products available from compounding pharmacies for office stock. It may encourage practices to prescribe patient-specific compounded medication rather than distribute compounds from office stock.
How Does Boothwyn Pharmacy Deal With These Changes?
Boothwyn Pharmacy is aware of the potential implications of GFI 256. We are working to support the veterinary community by nominating products to the approved List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals. Boothwyn Pharmacy will also work with you on any necessary medical rationales to meet your patient’s medical needs.
When You Prescribe a Compounded Drug For Office Stock, You Should Also:
- Confirm that the BDS is on the approved List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or the list of Bulk Drug Substances Currently Under Review.
- Use the compounded office stock to treat the species of animals under the conditions identified for the BDS on the list.
- Drugs NOT on this approved list must be tied to a patient-specific prescription when compounded.
Note: If you would like the FDA to consider adding other drugs to the list, you can nominate a BDS at any time by following the directions in the Appendix of the GFI #256. Or, see Nominating a Bulk Drug Substance (BDS) to a List: A Quick Reference.