Boothwyn Pharmacy is committed to staying current on all FDA standards and guidelines.

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 to be commercially available. The GFI 256 changes are here.

What changes are coming?

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, when ordered from a compounding pharmacy.

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 example of the following rationale may be provided:

1. The commercial product would reduce compliance and/or be ineffective in achieving medical outcomes.
2. The commercial product is not available and/or unable to source.
3. Utilization of commercially available dosage forms is unachievable or unsafe for the patient.
4. Patient and/or population has an intolerance, sensitivity, toxicity, or aversion to commercial products.
5. 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 medical rationale from the veterinarian will need to be documented upon ordering.)

Where can I find a copy of the guidance, and who regulates these changes?

1. This guidance describes the Food and Drug Administration’s (FDA) enforcements.
2. 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 specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law.

https://www.fda.gov/media/132567/download

What does this mean for you?

GFI 256 can 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.

What is Boothwyn Pharmacy doing to prepare for implementation?

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 on any necessary medical rationales to ensure your patient’s medical needs are being met.

List of Bulk Drug Substances for Compounding Drugs for Use in Food-Producing Animals or Free-Ranging Wildlife Species

Bulk Drug Substances Currently Under Review

Bulk Drug Substances Reviewed and Not Listed

What makes Boothwyn Pharmacy different?

• We work closely with the prescriber to ensure you are getting preparations that fit your patient’s needs.
• USP Compliant
• PCAB accredited

Obtaining Office Stock

For some conditions, treatment is urgently needed, and the time required to compound a drug in response to an individual patient’s 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:

• 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 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.

Helpful Links on GFI #256:

CVM GFI #256 – Compounding Animal Drugs from Bulk Drug Substances

GFI #256 – Compounding Animal Drugs from Bulk Drug Substances

FDA Q&A: GFI #256 – Compounding Animal Drugs from Bulk Drug Substances