Main compounding rules filed, likely effective date in early February


Two key rules that will enhance the ability of veterinary practices to maintain limited supplies of non-patient-specific compound medications on hand, as well as where they can be obtained from, have been filed by the Ohio Board of Pharmacy. OVMA has worked extensively in providing background information and perspectives to the Pharmacy Board on these two as well as other pertinent rules up for review.

Filed on Nov. 30, Rule 4729-16-08 of the Ohio Administrative Code will reverse a prohibition on out-of-state veterinary compound pharmacies providing non-patient-specific medications to a veterinarian. Earlier this year, only Ohio compound pharmacies were permitted to provide non-patient-specific medications. After considerable feedback, the rule is being amended specifically to address those concerns raised by veterinary medicine, to wit:

“A non-resident pharmacy may provide licensed veterinarians non-patient specific compounded drugs for animal use, pursuant to rule 4729-16-12. Such compounding for office use shall comply with applicable federal laws and regulations.”

The net result is a change that will reopen options for Ohio veterinarians to obtain non-patient-specific compound medications for urgent use from either in-state or out-of-state compounders.

Also filed on Nov. 30 was the creation of new Ohio Administrative Code Rule 4729-6-12: Animal Compounded Drugs. This rule will allow a veterinary office to obtain and maintain in stock a “limited quantity” of non-patient-specific compound medications, which are needed for emergency situations, unanticipated procedures, treatments in which a time delay would affect patient outcome, and/or for diagnostic purposes. This new rule expands and replaces a current allowance known as the ”72-hour rule,” which is narrower in focus and was often misunderstood.

Both rules have to undergo an administrative code review process before they go into effect, which should be completed in early February 2016.

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