HCCE PERMIT INFORMATION UPDATE
By Edwin A. Bayó, Esq., FVMA Legal Counsel The FVMA over the past several months has been working diligently to make sure their members are adequately informed and provided guidance on who needs or does not need a health care clinic establishment (HCCE) permit. The FVMA has been engaging with the Division of Drugs, Devices and Cosmetics (DDC) of the Department of Business and Professional Regulation (DBPR) to provide better guidance and more specific clarifications regarding HCCE permits when it comes to veterinarians and veterinary clinics. The DBPR recently provided us with specific guidance to provide FVMA members, along with veterinarians across the state of Florida, regarding HCCE permits. Existing law states that individual practitioners (licensed veterinarians) may order prescription drugs with their veterinarian license and pay for prescription drugs in their own name without an HCCE permit. This is set forth in section 499.01(2)(r), Fla. Stat., which provides that an HCCE permit is only required when a business “at one general physical location” provides health care or veterinary services. However, when the veterinarian purchases (or pays) for drugs in his/her corporate capacity then the corporation (business) may be deemed to be the purchaser and thus need the HCCE permit. After considerable discussion, the DDC has agreed that it will exercise enforcement discretion in some situations. Solo practitioners who are practicing as a professional association or a professional limited liability corporation may purchase prescription drugs with their veterinary license and pay for the prescription drugs with their professional association or professional limited liability corporation funds. This is perhaps the biggest compromise we were able to achieve. In the case of individual practitioners, they can purchase drugs and pay with a corporate check. We were able to convince the DDC that individual practitioners who have their own corporation to run the practice do not have to obtain the HCCE permit. Mobile veterinary clinics cannot obtain an HCCE permit unless they have a permanent location that is not a personal residence. An HCCE permit cannot be issued to a residence. If the mobile veterinary clinic is a business entity, it may pay for the prescription drug with business entity funds as long as the wholesale distributor confirms with the purchaser that the prescription drugs are being ordered by a Florida licensed veterinarian and that the veterinarian is operating a mobile veterinary clinic or has a solely mobile practice. This is existing law and was a problem because DDC rules state that you cannot have an HCCE permit at a residence. Those veterinarians with mobile practices need to send a letter to their wholesalers stating that they only operate as a mobile clinic/practice.
18 | FVMA ADVOCATE
A veterinarian operating as a “house call” veterinarian through a general business entity may order prescription drugs as long as the wholesale distributor confirms the veterinarian is a Florida licensed veterinarian and confirms the veterinarian is only operating as a “house call” veterinarian. The house call veterinarian may pay for the prescription drugs with business entity funds. This is existing law and, like mobile clinics, was a problem because DDC rules state that you cannot have an HCCE permit at a residence. Those veterinarians with “house call” practices need to send a letter to their wholesalers stating that they only operate as a “house call”/practice. Veterinarians who operate in a group practice that have a physical permanent location where they provide veterinary services must obtain an HCCE permit for that location. However, the DDC will exercise enforcement discretion regarding the requirements in Rule Chapter 61N-1, F.A.C. so long as the veterinary establishment has satisfactory inspections under Rule 61G18-15.005, F.A.C. and all drugs are stored in accordance with the manufacturer’s requirements. This is the most reasonable interpretation of existing law. We have clarified/agreed that the DDC will not enforce the 61N-1 requirements dealing with security, temperature monitoring, record keeping, policies and procedures, etc. so long as the clinics have satisfactory Board of Veterinary Medicine inspections and they are storing drugs according to manufacturer’s requirements (i.e. refrigerated or “store in a cool dry place”). Regardless of whether they have a mobile practice or a permanent location, veterinarians may receive delivery of veterinary prescription drugs at any locations where they need veterinary prescription drugs in order to provide services. As to agricultural, equine (e.g. a stable or racetrack), farm or similar veterinarian services where the veterinarian practices at various locations, the wholesale distributor who receives an order for veterinary prescription drugs from a Florida licensed veterinarian may have the veterinary prescription drugs shipped to the farm or other temporary practice location in care of the veterinarian and the farm, stable or racetrack. The veterinarian must have a current Florida license. The veterinarian must advise the wholesale distributor in writing that the farm is a valid practice address in which he/she treats animals. The wholesale distributor must maintain a copy of the veterinarian’s letter in the wholesale distributor’s business records and produce the letter when requested by the DDC. The veterinarian must make payment for the veterinary prescription drugs. This discretion will not apply to human-labeled drugs or controlled substances. In other words, human-labeled drugs or controlled substances may not be drop shipped to a farm, stable or racetrack. This last one is an excellent clarification. Veterinarians can have veterinary drugs drop-shipped to the stable/farm/racetrack so long as they are veterinary drugs (not human labeled or controlled substances).