by Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services

Federal law does not address compounding from bulk drug substances, also known as active ingredients, for animals like it does for people through Section 503A of the Food, Drug and Cosmetic Act. Due to this distinction, FDA created a framework for what they believe is appropriate when compounding for animals using active ingredients and, if this framework is followed, they will not take enforcement action against the compounder for serving the needs of their animal patients.

FDA describes their framework for animal compounds in Guidance for Industry #256, Compounding For Animals From Bulk Drug Substances. It is imperative that you read the full guidance document and other resources to ensure compliance. To get you started, here are the top five things you need to know about patient-specific animal compounds.

1. FDA expects that manufactured drug products, including animal or human drugs, will be used for animals when they are appropriate for their care. If an FDA-approved, conditionally-approved or indexed drug can be used to treat the animal, then it is supposed to be used.

2. FDA is concerned about compounded copies of manufactured drug products for animals. GFI 256 states that a copy occurs for an animal when the compound has the same active moiety (erythromycin, erythromycin stearate, erythromycin ethylsuccinate are all the same in the eyes of GFI 256) and the same route of administration. This means that a compounded suspension of the same active ingredient in a manufactured tablet could be a copy. If your compound could be considered a copy, then you need a documented reason why the compound was necessary, such as the animal could not be pilled. GFI 256 provides other examples.

3. If you are going to compound any preparation for an animal, FDA expects that you will determine if you can compound that dosage form from a manufactured drug product. If you determine that you cannot compound that medication from a manufactured product, then you need to document the rationale. GFI 256 provides examples.

4. Ingredient quality matters. FDA’s GFI expects you to use a USP- or NF-grade chemical when a monograph exists. Notably, water has a USP monograph. You need to use Purified Water USP or a better grade of water (i.e., sterile water for irrigation, sterile water for injection). Please note that grocery store water products labeled as purified water are not Purified Water USP.

5. GFI 256 also points out that like all drugs, animal drugs cannot be produced under insanitary conditions. It is paramount that you stay vigilant to avoid the types of examples FDA has provided in the Insanitary Guidance Document.

These are our top 5 things for you to know about GFI 256 and patient-specific animal compounds. However, there are many more valuable details and nuances provided through a variety of resources, including: FDA’s own FAQ; a letter from FDA to APC and NCPA that answered their questions; and many others. Links to these resources are listed below. If you’d like a deeper explanation, please see the GFI 256 webinar produced by PCCA in collaboration with Alliance for Pharmacy Compounding. This webinar recording is on sale through June 15, 2023. PCCA members with access to clinical services can contact the Clinical Services team of pharmacists to discuss their questions.

FDA plans to start using the framework in GFI 256 starting April 1, 2023, through a phased-in process. For those who compound for animal patients, now is the time to make decisions regarding how you utilize GFI 256.

Resources

• GFI 256: Compounding Animal Drugs from Bulk Substances

• FDA’s FAQ on GFI 256

• Resources from FDA for GFI 256

• FDA answers questions from APC/NCPA on GFI 256

• FDA Letter: Phased In Inspections on Animal Compounding

• Insanitary Conditions GFI

• FDA Green Book (FDA approved animal drugs)

  • About the Green Book

• Indexed Animal Drugs

  • About Indexed Animal Drugs

• Current Animal Drug Shortages