Pharmacy board files final veterinary clinic regulations

Following several months of discussion and modifications, the Ohio Board of Pharmacy officially filed its final version of regulations for veterinary clinics. The new rules take effect on March 1, 2020.

OVMA was actively engaged in working with the Board of Pharmacy as the proposed regulations made their way through the rule-making process. As a result, several onerous provisions were removed, and a number of less-burdensome aspects of current regulations were incorporated.

To assist practices in understanding and following the new rules, the pharmacy board has issued an inspection guide and will also present at the Midwest Veterinary Conference on Thursday, Feb. 20 (Sessions 156–157). Additionally, OVMA will provide a complete breakdown of the new provisions early next year and be available to local VMAs to present on the new regulations and answer questions.

Want to have an impact on these and other issues that affect how YOU practice? It’s easy! Take 60 seconds to become a member of the OVMA Grassroots Club or make a contribution to VPAC.


FDA warns companies making health claims about CBD products

Last month, the federal Food and Drug Administration issued warning letters to 15 manufacturers of CBD products for making health claims in violation of the Federal Food, Drug, and Cosmetic Act. Since the 2018 passage of the federal Farm Bill—which removed hemp (Cannabis sativa L. containing less than 0.3% THC) from classification as a Schedule I controlled substance—there has been widespread confusion and misrepresentation regarding the permissibility of selling CBD products.

Central to the remaining legal prohibitions is that the law change did not change the FDA’s authority to regulate drugs and food. While possession of CBD products is not a violation of federal law (assuming they contain less than 0.3% THC; currently there is not independent testing to verify the same), making and selling them with stated or implied health claims is a violation of law.

To date, only a single CBD product used to treat two pediatric epilepsy disorders have been approved by the FDA. All others, including those that claim to be either a dietary supplement or a food additive, are not approved. As such, health care prescribers—including veterinarians—should not sell or recommend them at this time. The FDA is reviewing CBD products and may or may not change its position in the future.

For more information, click below to read the entire FDA release, and look for more details on CBD product concerns in the next issue of the Observer and in an upcoming podcast.


Guidance issued on compounding animal drugs from bulk substances

Following feedback from a guidance document issued in May 2015, the FDA has updated its draft guidance on the compounding of animal drugs from bulk substances (CVM GFI #256). While technically the compounding of a drug from bulk substances constitutes a new animal drug subject to FDA approval, the agency states that it does not intend to take enforcement action for violations, providing that:

  • The compounding is done by or under direct supervision of a veterinarian or pharmacist within the parameters of USP 795 or 797;
  • When dispensed by a pharmacist, it is at the prescribing direction of a veterinarian; and
  • Any adverse events are reported, and the product is appropriately labeled.

In addition, patient-specific compounded drugs cannot copy (same or similar pharmaceutical ingredient, route of administration, and/or strength) a marketed and FDA-approved drug. The document also provides a pathway for non-patient-specific, office stock compound medications, such as that allowed for by veterinarians under Ohio Revised Code 4729:7-2-05 (i.e. to treat an emergency situation or where a delay would negatively impact patient outcome).

For food-producing animals, a veterinarian must document a scientifically based withdrawal time, and the compounded drug must be made from bulk substances on the FDA list of “Bulk Drug Substances for Compounding Office Stock Drugs for Use in Non-food Producing Animals or Antidotes for Food Producing Animals.”

While this is only a guidance document and is still subject to comment and revision, it does provide some “official/unofficial” allowance for the continued use of compound medications from bulk substances in veterinary medicine, providing they are not simply a lower-cost alternative to an existing FDA-approved drug.


Department of Labor changes overtime threshold

The United State Department of Labor has changed a component of its overtime rule. Effective Jan. 1, 2020, the minimum pay for exempt salaried employees will be raised from $23,660 annually to $35,568. This means an employee currently paid by salary and considered exempt from overtime because of the “duties test” must make at least $35,568 a year or they must be paid overtime, regardless of whether they would be exempt based on their work responsibilities/duties.


ADDL reports on insect-borne diseases in animals in 2019

The ODA Animal Disease Diagnostic Laboratory reported the following statistics from 2019:

  • Only three cases of West Nile virus in horses were confirmed this year, as compared to 50 in 2018. The cases were reported in Stark, Morrow, and Fulton counties.
  • Four horses—two each from Ashtabula and Portage counties—were infected with eastern equine encephalitis virus in 2019; all four horses died.
  • None of the aforementioned animals were current on vaccinations against the virus with which they were infected.
  • Two horses in Hamilton County died following infection with Neorickettsia risticii, the agent of Potomac horse fever.
  • PCR testing of lymph node tissue confirmed that 12 white-tailed deer were infected with epizootic hemorrhagic disease virus. Eight were wild deer located in Butler, Clermont, Knox, Logan, Morrow, Preble, and Warren counties; and four were from captive deer herds in Butler and Tuscarawas counties.

AVMA develops website of ASF resources

African swine fever (ASF) has been reported in seven of the top 10 pork-producing countries, driving up pork prices worldwide and potentially leading to a global pork shortage. U.S. veterinarians and public health officials are working hard to keep ASF out of the country while preparing to respond in the event it is detected.

As part of that effort, the AVMA has released a new website of resources to assist the veterinary community in understanding ASF, communicating with clients, implementing prevention practices, and more.



Free online CE covers opioid use in veterinary medicine

In response to the human opioid epidemic, a growing number of states are mandating training for opioid prescribers. To address this training need among veterinarians, the University of Illinois College of Veterinary Medicine has developed “Safe Prescription of Opioids in Veterinary Care,” a series of online education on opioid use in veterinary medicine. All three modules follow the FDA’s educational blueprint for mandated opioid training while addressing situations specific to veterinary practice.

The first session in the series is offered free of charge. Click below to read a full course description and to sign up.

MEMBER RESOURCE: Last year, OVMA’s Opioid Diversion Awareness Task Force partnered with VetBloom to develop an on-demand webinar on opioid pharmacology in veterinary medicine, which is available to OVMA members for free. Learn more & view webinar

Share the News!

About the author