Originally published in the May/June 2018 issue of the OVMA Observer.

By Jack Advent, CAE
OVMA Executive Director

In recent months, some of you may have experienced or heard about Ohio Board of Pharmacy inspections in veterinary facilities. The Board does have the authority under law to inspect the care, storage and security of dangerous drugs (i.e. prescription medications) of terminal distributor of drugs (TDDD) licensees. These inspections are typically unannounced.

In the inspection, you will receive a written report, and you will have 30 days to respond to any deficiencies they find. You can read more about their inspection authority in Ohio Administrative Code regulation 4729:5–3–03.

It should also be pointed out that not everything inspectors are citing is in fact a violation for a veterinary facility; therefore, you may certainly challenge their findings where you believe they are in error.

One common mistake inspectors make is to tell clinics they must secure animal vaccines and treat them as a prescription drug. Animal vaccines are regulated by the USDA—not the FDA—as they are not a federally classified as drugs and do not have to be secured as such.

A second common mistake is telling clinics that they must keep non-controlled prescription drugs secured from veterinary clinic staff who are not veterinarians or technicians. Animal aides, which are any veterinary staff who are not either, are permitted to be around and in some cases administer non-controlled prescription drugs.

These and other errors by inspectors have been shared with Board of Pharmacy.

Common areas of lawful concern that have been found during some inspections include:

• Written verification of accuracy by a prescriber on personally furnished/administered prescription drugs after they are taken from inventory.
• Who has knowledge of and access to the controlled drug area key. This should be limited to veterinarians and technicians—the only two groups permitted to handle controlled drugs. In some practices, the location of the key is common knowledge among all staff and/or in an unsupervised area.
• For injectable drugs, there needs to be a log or label as to the date when the seal is broken and the drug first used. If there is not manufacturer guidance as to how long the drug maintains its efficacy in an unadulterated state, then the shelf life of that injectable drug is considered 30 days.
• For refrigerated drugs, practices must maintain a log reflecting a staff person’s verification of the temperature inside the refrigerator, each day the clinic is open. This is a human pharmacy requirement, and we have been in conversations with the Board of Pharmacy about modifying this requirement in a veterinary facility.