Prepared by AVMA department of State Legislative and Regulatory Affairs
State Legislative Update: June
Newly adopted laws
As usual, the beginning of summer brings newly signed state laws. This month’s batch of veterinary-related enactments includes:
- Alabama SB 51 requires animal shelters to report on a monthly basis the total number of animals that have entered the facility, their disposition and costs incurred. The reports will be made available to the public.
- Florida HB 1049 provides that the Florida Pharmacy Act does not prohibit a licensed veterinarian to administer a compounded drug to a patient, or dispense a compounded drug to the patient's owner or caretaker.
- Kansas SB 189 creates an institutional license to practice veterinary medicine for a person employed by a school of veterinary medicine.
- Nebraska LB 360 makes several changes to the state’s Commercial Dog and Cat Operator Inspection Act, including unannounced inspections and appointment of special investigators.
- Nevada SB 288 requires every person who prescribes a controlled substance, including veterinarians, to register biennially with the State Board of Pharmacy.
- Nevada SB 261 requires research facilities and product testing facilities engaged in scientific, medical or educational research to offer dogs and cats that are appropriate for adoption to an animal shelter or rescue organization before euthanizing or destroying the dog or cat. Under the new law, those facilities will be limited to conduct research on a dog or cat for only two years.
- New Hampshire SB 31 removes from the definition of a “dispenser,” who must register with the controlled drug prescription program, a veterinarian who dispenses less than a 48-hour supply of a schedule II-IV controlled substance to a patient.
- Oregon SB 614 provides that a peace officer who has probable cause to believe an animal is being subjected to certain criminal offenses may enter a motor vehicle to provide an animal with food, water and emergency medical treatment, and may impound the animal.
- Texas HB 1740 provides that a veterinarian who is employed by a county or municipality and administers or supervises the administration of a rabies vaccine as part of a local control program is not required to establish a veterinarian-client-patient relationship before administering or supervising the administration of that vaccine.
- Washington SB 5501 provides that law enforcement officers are authorized to enter a vehicle or other enclosed space to remove an animal believed to be suffering from exposure to extreme temperatures or lack of water or ventilation.
The Louisiana Board of Pharmacy issued a temporary emergency rule authorizing pharmacies to compound drugs for office use intended for administration by veterinarians for emergency use without the necessity of a patient-specific prescription. Any dispensed compounded product must be generated by a pharmacy after receipt of a patient-specific prescription.
The U.S. Food and Drug Administration (FDA) published its new expectations for the preparation of compounds from bulk active ingredients. The FDA is accepting comments on the draft through August 17, 2015. The preparation of compounds from bulk continues to be outside of the FDA rules, yet the two new publications lay out activities against which FDA generally does not intend to take enforcement action. The AVMA has previously developed policies (see Compounding page) that advocate for the needed allowances for compounding in veterinary medicine. At the same time, the AVMA is reviewing the new draft guidance to determine if these publications are aligned with veterinarians’ needs and AVMA’s policies. The two draft FDA publications are Guidance For Industry #230 and a request for nominations of bulk drugs from which outsourcing facilities can create compounds. The AVMA has requested an extension to comment on the nomination of bulk drugs.
Veterinary Feed Directive
The FDA also issued a final rule for the Veterinary Feed Directive, which will cement veterinary oversight of medically important antibiotics used in feed for food animals, ensuring the protection of animal health and welfare as well as food safety and public health. The AVMA’s early and ongoing collaboration with the FDA helped ensure that the rule is practical and in the best interests of animal health, public health and the veterinary profession. Through the VFD, producers must obtain veterinary approval prior to using medicated feeds containing medically important antibiotics. The VFD final rule states that veterinarians must follow state laws related to the veterinarian-client-patient relationship (VCPR), provided that they apply to the VFD. Otherwise, veterinarians must meet the criteria for the federally defined VCPR to issue an order for a VFD. The AVMA is reviewing the entire contents of the final rule and will be submitting official comments.
FTC issues pet medication report
The Federal Trade Commission (FTC) published a long-awaited report on the pet medication industry. The agency conducted many meetings on the pet medication industry throughout 2012 and held a public workshop in October of that year. Among the findings in the report are that FTC staff believes that improved consumer access to prescriptions would likely enhance competition in the pet medication industry, and that legislative and regulatory efforts to mandate aspects of prescription release have the potential to enhance consumer awareness about the ability to purchase pet medications from non-veterinary retail outlets. However, the report indicates that FTC staff does not have sufficient data to evaluate the overall economic effect of any specific proposal.
The report also finds that exclusive distribution and exclusive dealing practices by pet medication manufacturers could come under increasing competitive pressure in the marketplace and may be difficult to sustain, particularly if prescriptions become even more widely requested by clients and retail pharmacies continue to compete to fill them. The report concludes that a number of issues could benefit from further study, including (1) the pricing of pet medications across different channels of distribution, (2) the rate of errors in pet medication dispensing by retail pharmacists and veterinarians, (3) the need for and impact of automatic prescription release requirements and (4) details regarding the secondary distribution system for pet medications.
The link at the top or bottom of this page will take you to the latest chart of significant pending bills and regulations from around the country.
State Legislative Update: June