As previously described, FDA has updated its Draft Guidance for Industry, #120, regarding the Veterinary Feed Directive Regulation.
The intersection of federal and state law impacted by this regulation is interesting.
Specifically, what is the impact to a veterinarian when the Veterinarian-Client-Patient relationship as defined by the relevant state law (governing that veterinarian’s license) conflicts with or is otherwise different from FDA’s definition?
FDA has revised its guidance regarding this issue, quoted here. See #120, at page 12.
In those States that require a VCPR that includes the key elements of the Federally-defined VCPR in order for a veterinarian to issue a VFD, the veterinarian issuing the VFD must be operating within the context of a VCPR as that term is defined by the State. In all other cases, the veterinarian must be operating within the context of a valid VCPR as defined by FDA in 21 CFR 530.3(i). (21 CFR 558.6(b)(1)(ii)). FDA considers States with VCPR definitions that at least address the concepts that the veterinarian (1) engage with the client to assume responsibility for making clinical judgments about patient health, (2) have sufficient knowledge of the patient by virtue of patient examination and/or visits to the facility where patient is managed, and (3) provide for any necessary follow-up evaluation or care to include the key elements of the Federally-defined VCPR as set forth in 21 CFR 530.3(i).
In States where the veterinary practice requirements do not require that a VFD be issued within the context of a State-defined VCPR that includes the key elements of a valid VCPR as defined in Federal regulations at 21 CFR 530.3(i), FDA is requiring that the VFD be issued within the context of a Federally-defined valid VCPR as defined at 21 CFR § 530.3(i). (21 CFR 558.6(b)(1)(ii)).
FDA has worked with State regulatory authorities to verify whether their State has VCPR requirements in place that apply to the issuance of a VFD and include the key elements of the Federally-defined VCPR. FDA has compiled a list of states that require a VCPR that includes the key elements of the Federally-defined VCPR in order for a veterinarian to issue a VFD. This list is available online and the list will be updated periodically as FDA receives and verifies information from States if they change their VCPR definition or its applicability.
Veterinarians can review whether FDA believes a state-defined VCPR is consistent with its definition by visiting the FDA’s website FDA titled “Does the State or Federal VCPR Definition Apply to a Lawful VFD in my State?”
The FDA webpage, last updated on 03/04/2019, lists the following states in which FDA has determined that the federal definition of VCPR, not the state definition, controls: Alabama, Alaska, Arkansas, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Kansas, Maryland, Massachusetts, Michigan, Montana, New Jersey, New York, Pennsylvania, Rhode Island, South Dakota, Vermont, Washington, and Wisconsin.
In those states, if a veterinarian who prescribes medication pursuant the VFD, does not fulfill the requirements of a VCPR as defined by FDA, s/he may be found to be in violation of these federal regulations, even if complying with the state-defined VCPR. An outstanding question is whether and to what extent that state’s veterinary medical board may take punitive action against the veterinarian based on the alleged federal violation. And if so, how that would impact that licensee’s veterinary licenses in sister states, if licensed in more than one state.
Veterinarians may be required to affirmatively disclose federal charges and/or findings, depending on the nature of such violations, whether civil or criminal. For example in New Jersey, initial and renewal applicants must answer the following questions.
- Have you ever been summoned; arrested; taken into custody; indicted; tried; charged with; admitted into pre-trial intervention (P.T.I.); or pled guilty to any violation of law, ordinance, felony, misdemeanor or disorderly persons offense, in New Jersey, any other state, the District of Columbia or in any other jurisdiction? (Parking or speeding violations need not be disclosed, but motor vehicle violations such as driving while impaired or intoxicated must be.)
- Have you ever been convicted of any crime or offense under any circumstances? This includes, but is not limited to, a plea of guilty, non vult, nolo contendere, no contest, or a finding of guilt by a judge or jury.
- Have you ever been disciplined or denied a license or certificate to practice veterinary medicine or any other professional license in New Jersey, any other state, the District of Columbia or in any other jurisdiction?
- Have you ever had a professional license or certificate of any type suspended, revoked or surrendered in New Jersey, any other state, the District of Columbia or in any other jurisdiction?
- Has any action (including the assessment of fines or other penalties) ever been taken against your professional practice by any agency or certification board in New Jersey, any other state, the District of Columbia or in any other jurisdiction?
- Have you ever been named as a defendant in any litigation related to the practice of veterinary medicine or other professional practice in New Jersey, any other state, the District of Columbia or in any other jurisdiction?
- Are you aware of any investigation pending against a professional license or certificate issued to you by any professional board in New Jersey, any other state, the District of Columbia or in any other jurisdiction?
- Are there any criminal charges now pending against you in New Jersey, any other state, the District of Columbia or in any other jurisdiction?
Because of these possible impacts to their licenses, veterinarians should make every effort to comply with the governing law when prescribing medications via the VFD.