Compliance
Built for FDA GFI #256.
The Animal Medicinal Drug Use Clarification Act lets you use approved drugs extra label inside a valid VCPR. It does not cover compounding from bulk drug substances. Guidance for Industry #256 describes when FDA uses enforcement discretion for that compounding. The platform is built around it.
01
Valid VCPR
02
Named patient, written Rx
03
State licensed 503A pharmacy
04
USP grade components
05
Dispensed to vet or owner
The patient specific compounding path for dogs, cats, and other nonfood animals
Key safeguards from Guidance #256
What the guidance asks of a compounded prescription.
- Who compounds
- A veterinarian, or a pharmacist in a state licensed pharmacy or federal facility.
- Which rules
- Full compliance with state pharmacy and veterinary law, in the state where the patient lives.
- What goes in
- Bulk substances and ingredients that meet applicable USP and NF standards. Injectables are sterile preparations under USP <797>.
- Why compound
- No medically appropriate approved or indexed option. Document the clinical difference and the need for a bulk source.
- Who it goes to
- Dispensed on a prescription for a specific patient within a valid VCPR, to the prescribing veterinarian or the owner. Never to a distributor, a retailer, or a veterinarian who did not write it.
- Label and report
- Identify the patient, strength, beyond use date, and compounded status. Adverse events and product defects are reported to FDA within 15 business days.
A teaching summary, not legal advice. The pharmacy applies the complete guidance and your state’s requirements. Office stock is a separate question and is not part of this model.
You, the prescriber
- Hold a valid VCPR and examine the patient
- Choose the peptide and the dose, and document why
- Record that no approved option is medically appropriate, and the clinical difference
- Follow your state veterinary board and pharmacy rules
- Recheck, and report adverse events to FDA on Form FDA 1932a
What we do
- Provide screening, dose math, and prescribing workflows
- Enforce a VCPR attestation and a patient-specific rationale on every prescription
- Route every prescription to our licensed 503A compounding partners
- Collect your client's payment and pay our compounding partner for each prescription
- Keep the prescription record: patient, dose, dates, and your rationale
What we never do
- Manufacture or compound drugs, or handle active ingredients
- Act as a prescriber or interfere with veterinary medical judgment
- Fill an order without a veterinarian's prescription
- Pay a veterinarian for the act of prescribing