BOARD OF PHARMACY RULE CHANGE
As you are probably aware, veterinarians are now required to sign a written agreement with your compounding pharmacy stating you will only administer “for office-use” compounded medications in house and will not dispense it to a patient or any other person or entity. This came about in a rule change by the Board of Pharmacy during their February 2025 meeting and went into effect on April 9, 2025. Board of Pharmacy Rule 64B16.27.700 “Veterinary office use compounding” states In section (d) (1):
“(d) The pharmacy and the practitioner enter into a written agreement. The agreement shall specifically provide:
“That the compounded drug may only be administered to the patient and may not be dispensed to the patient or sold to any other person or entity,”
STATUTORY AUTHORITY TO DISPENSE COMPOUNDED MEDICATION
In 2015, due to the diversity of the species we treat, the Florida Veterinary Medical Association (FVMA) secured an exemption to allow Florida veterinarians to dispense compounded medications. Section 465.0276 (Dispensing Practitioner) of Florida statutes was amended, and the following was inserted:
“(5) This chapter and the rules adopted thereunder do not prohibit a veterinarian licensed under chapter 474 from administering a compounded drug to a patient, as defined in s. 474.202, or dispensing a compounded drug to the patient’s owner or caretaker. This subsection does not affect the regulation of the practice of pharmacy as set forth in this chapter.”
This statute clearly gives veterinarians the right to dispense compounded medications and contradicts the rule from the Board of Pharmacy even stating that rules adopted thereunder do not prohibit a veterinarian from dispensing compounded medications.
FDA SEES NEED FOR DISPENSING OF COMPOUNDED MEDICATIONS
The U.S. Food and Drug Administration (FDA) also acknowledges the need for veterinarians to dispense medications compounded from bulk substances obtained from a compounding pharmacy. In GFI #256 they have issued an enforcement discretion policy allowing such dispensing by stating that:
(pg. 12-13). “The veterinarian who stocks the drug dispenses or transfers it only to the owner or caretaker of the animal patient or to another veterinarian in the same practice. The enforcement discretion policy in this guidance does not apply to compounded drugs that are transferred to a third party such as a distributor, retailer or veterinarian at another physical location.”
WHAT THE FAEP IS DOING?
The FAEP Committee has determined that the recent change to Board of Pharmacy Rule 64B16-27.700 could significantly impact equine practitioners. As such, they are working with the FVMA in seeking counsel to approach the board to protect its members.
WHAT THE FVMA HAS BEEN DOING
Over the past four months, the FVMA has:
- Sent all members an email notifying them that this change was coming.
- Contacted several of the large national compounding pharmacies seeking their intent to enforce these written agreements (responses – no they don’t but you still have to sign them).
- Sought legal interpretation concerning a veterinarian’s potential to be sued for “breach of contract” (response – possible but unlikely).
- Spoken with the Board of Veterinary Medicine about disciplinary action against a veterinarian for dispensing compounded meds after signing this written agreement (response – not a violation of Florida’s practice act, thus no action for violating agreement).
- Reached out directly to the attorney for the Board of Pharmacy requesting clarification of this rule (no response thus far).
FVMA’S NEXT ACTION
As you can see from the above, we have received no definitive guidance that we can pass on to you, our members. Thus, the FVMA Board of Directors is in the process of hiring legal representation (a national organization recommended by the AVMA) to pursue legal action against the Florida Board of Pharmacy to get clarification and resolution of this matter.
Unfortunately, this will take time.
WHAT TO DO CURRENTLY
In the meantime, if you need to get compounded medication for office use, you will have to enter into (sign) these written agreements.
Individual prescriptions to a compounding pharmacy for a client/patient are not affected. The FVMA cannot give you any further guidance at this time as to dispensing compounded medication other than to say, you have the legal statutory authority to dispense compounded medications.
We are hopeful of having a more definitive answer soon.