Prepared by AVMA State Affairs
Only a handful of states are still in session. The California Legislature recently adjourned, and Governor Edmund G. Brown Jr. is reviewing a number of bills approved by both houses. Next month, we will report on the measures he signs that impact veterinary medicine.
AVMA submits comments on FDA compounding draft
The AVMA submitted a letter to the U.S. Food and Drug Administration (FDA) on August 14 regarding the agency’s GFI #230, draft guidance on compounding. The letter highlights the fact that compounding is a necessary practice for veterinarians, as there are a limited number of FDA-approved drug products for the many species and conditions they treat. Currently, the FDA contends that compounding from bulk drug substances (i.e., active pharmaceutical ingredients) for animals remains illegal. That said, the FDA recognizes the medical need for compounding from bulk ingredients – instead of using the FDA-approved drug product – within certain areas of veterinary practice and under very specific circumstances. The FDA has extended the comment period until November 16.
In its letter, the AVMA asked the FDA for clarification on how it will enforce GFI #230, in light of the great variance in state rules regulating compounding in veterinary practice. Some explicitly allow veterinarians to obtain preparations compounded for office use, and administer and dispense from the compounded preparations maintained in their office. The AVMA also asked the FDA how it plans to evaluate whether the compounding of animal drugs is done in accordance with the conditions outlined in the guidance, and whether the FDA will rely on state boards of pharmacy and boards of veterinary medicine to enforce the provisions of GFI #230.
Highlights of the AVMA letter are available here on the AVMA@Work blog.
The AVMA has also compiled summaries of state laws and regulations addressing the administration or dispensing of compounded drugs in a veterinarian’s office or clinic. The summaries are updated on an ongoing basis as needed.
Pharmacy board association adopts veterinary reference provision
The National Association of Boards of Pharmacy (NABP) reports that it has recently amended its Model State Pharmacy Act (Model Act) to require pharmacies that engage in veterinary drug dispensing to have ready access to at least one current reference in veterinary drugs, such as Plumb’s Veterinary Drug Handbook. The change was made in response to a NABP resolution that calls for pharmacists dispensing medications for veterinary patients to possess the competence and have access to the resources necessary to appropriately dispense and provide patient care. The NABP also adopted a resolution to encourage the development and availability of veterinary pharmacology education at schools and colleges of pharmacy in collaboration with schools of veterinary medicine. The NABP Model Act is intended to provide state boards of pharmacy with model language that may be used for developing state laws or board rules for the purpose of protecting public health.
All states allow e-prescribing for controlled substances
Recently, Vermont became the final state to allow e-prescribing for all controlled substances, including Schedule II painkillers such as oxycodone, hydrocodone and morphine. The elimination of this barrier is expected to boost electronic prescribing, as advocates of the technology say the practice has been held back by state laws that require hard-copy scripts for controlled substances. They claim that extending e-prescribing to controlled substances also will help combat opioid abuse, as it will become more difficult to forge prescriptions. However, practitioners must ensure that their e-prescribing software meets U.S. Drug Enforcement Administration (DEA) standards, which is another reason why controlled substances represent a small percentage of prescriptions that are electronically transmitted to pharmacies. Veterinarians can determine whether their practice software is certified for e-prescribing controlled substances by contacting the vendor and asking for documentation that the software is compliant with DEA requirements. Prescribers may need to complete a few security-related steps such as verifying their identities and setting up secure access for staff.