The FDA recently finalized regulatory guidance for compounded animal medications from bulk drug substances for use in non-food-producing animals, impacting the way compounded drugs can be used, documented, ordered, and prescribed. This new guidance, Guidance for Industry #256 (GFI 256), affects both office stock in veterinary practices and individual animal-patient prescriptions. The release of this new federal guidance is important and adherence is critical, but the explanations can be complex.
Let’s start with the basics. What’s the gist of GFI 256?
GFI 256 addresses two areas of compounded medication use, both dealing with compounding from bulk drug substances. Bulk drug substances are the raw active ingredients most compounded medications are made from. The two areas addressed by GFI 256 include:
- Office stock (aka “office use”): To obtain a drug for office stock from a 503A compounding pharmacy, the active ingredient, strength, dosage form, and species it is to be used in MUST be on the list provided by the FDA on their website found (here). In addition, the same information and the indication for the drug must be provided to the pharmacy with each order.
For example, Apomorphine 2.5mg/ml injection for use in dogs is on the list but no other strength can be compounded for office stock from a 503A compounding pharmacy.
- Individual patient prescriptions: This is not as restrictive but does put a documentation burden on veterinarians and pharmacists if the drug is a copy of an FDA-approved or indexed drug. If the drug is a copy, veterinarians MUST document what clinical difference is produced in the patient with the compounded product that is not produced with the FDA-approved or indexed product.
What is a drug copy?
A drug is a copy according to the guidance when it has the same active moiety and route of administration as an FDA-approved or indexed product. Pharmacists must document why an FDA-approved or indexed product is not being used to compound the medication. Dosage form availability could potentially be impacted by this portion of the guidance.
Why was GFI #256 released?
The FDA has long taken the position that the safest way to compound a drug is to start with an FDA-approved product because it is a known product following cGMP manufacturing standards.
Reminder: cGMP Drugs = commercially manufactured and 503B medications.
The FDA is more concerned with the compounding of office stock medications because a mistake in large batches of drugs for widespread distribution can cause problems with many patients. For patient-specific prescriptions, the FDA wants veterinarians and pharmacies to use FDA-approved or indexed products whenever suitable, which is why documentation is required when those approved or indexed products are not being used.
So, what changes does your practice have to make? And how are your prescribing or inventory management methods going to be impacted? Below, our team takes a closer look at the top four points you and your veterinary staff need to know—and how to solve some of the challenges these changes present.
Continue reading for the Top 4 GFI 256 Guidelines Veterinary Practices Need to Understand
For additional information on GFI #256, visit Epicur Pharma’s resource page.
This is a paid sponsored content article from Epicur Pharma.
