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  News from the Maryland Veterinary Medical Association                                                    Winter 2012

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Review of Veterinary Pharmacy Laws and Regulations

by David Handel, DVM

Our day-to-day practice is governed by many laws and regulations. While some of these regulations are quite easy to follow because we are confronted with them on a daily basis, others may require more review, as we do not need to know them on a regular basis. The State Board of Veterinary Medical Examiners (SBVME) routinely sees cases related to lack of knowledge of the Code of Maryland Regulations (COMAR). As a result of this, a review of veterinary pharmacy laws and regulations is in order, which includes requirements on prescribing, dispensing, and disposing of controlled substances relative to a veterinary pharmacy.

Part of our jobs as veterinarians is to dispense medication to patients under our care. Unlike human doctors, we often do this on the premises instead of sending our clients to a pharmacy to pick up a prescription. While it is perfectly acceptable to dispense medications to a patient under our care, it is not acceptable to dispense medication to an animal not in our care; that is, a patient who we have not personally examined. COMAR 15.14.01.12-1 reminds us that a veterinarian-client-patient relationship must exist to legally prescribe or dispense medication. We may not fill a prescription and, therefore, act as a pharmacy for a patient seen at another veterinary hospital if we do not have a valid relationship with that patient. What this all boils down to is, if a client comes into our office with a prescription from another veterinarian, we may not legally fill that prescription. This is a concept that all staff members—not just veterinarians—should understand. However, if you choose to send one of your staff members to a neighboring veterinary hospital, you may borrow or buy medication from that hospital, and then dispense it to your own patient. This regulation does not apply to controlled substances.

COMAR 15.14.01.12 reminds veterinarians that, in order to prescribe and/or dispense a controlled substance, the veterinarian must hold a current federal and state DEA license. Veterinarians must have both registrations to be compliant with the law. Even if a veterinarian is legally and properly prescribing and dispensing controlled substances, the veterinarian’s responsibility runs deeper. All Schedule II drugs must remain under lock and key at all times. It is the veterinarian’s responsibility, as the individual in possession of the DEA registration, to ensure that drugs are properly stored. If more than one veterinarian is to have access to Schedule II drugs, a protocol should be devised for assuring that each time a drug is prescribed, it is recorded as required by the DEA. Further information about recordkeeping by veterinarians regarding controlled drugs can be found here. The DEA's practitioner manual outlines prescribing, dispensing, and keeping records of controlled substances, and it is an excellent resource for veterinarians.

As stated in the SBVME’s regulations, veterinarians are responsible for ensuring that Schedule III-V drugs are locked up when they are not in use. So, if you remove several bottles of controlled substances for use in a procedure, and you are in the area where they are out and being used, you are complying with the regulations. If you are finished with the procedure and leave the room with the same drugs on the counter, however, you are in violation of the regulations. You must return the drugs to their locked cabinet when you have finished with them. This is an easy regulation to overlook, but violation of it may result in a fine.

A final note about COMAR 15.14.01.12 is that a veterinarian must “maintain records of all Schedule II prescriptions for a period of 5 years, and maintain records of all Schedule III—V prescriptions for a period of 2 years.” An inventory of all controlled substances must be done in accordance with the DEA’s requirements. Any controlled substances that require disposal, whether due to out-dating, recall, or for some other reason, must be disposed of in accordance with DEA guidelines. The DEA states on its website, and in the practitioner manual, the following:

A practitioner may dispose of out-of-date, damaged, or otherwise unusable or unwanted controlled substances, including samples, by transferring them to a registrant who is authorized to receive such materials. These registrants are referred to as "Reverse Distributors." The practitioner should contact the local DEA field office (See Appendix E) for a list of authorized Reverse Distributors. Schedule I and II controlled substances should be transferred via the DEA Form 222, while Schedule III–V compounds may be transferred via invoice. The practitioner should maintain copies of the records documenting the transfer and disposal of controlled substances for a period of two years.

Please also remember that it is illegal for a licensed veterinarian to use expired medications of any kind. COMAR 15.14.01.12-3 reminds us that we must store any expired medication(s) separate and apart from our working stock of medications. This will help ensure that errors are not made, and that expired medications will not be prescribed accidentally.

While state and federal laws concerning veterinary pharmacy procedures can be confusing and sometimes onerous, it is our responsibility as licensed veterinarians to follow each and every one of them. If a question arises regarding how to handle a certain drug, prescription, or law, resources are available to assist you. The SBVME is available to help practitioners understand what is required of them in the State of Maryland. Additionally, the “Questions and Answers” page on the DEA's website has answers to the most common questions related to controlled substances. A local DEA office may also provide guidance on federal law requirements.
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Important Links from this article

More information about recordkeeping by veterinarians regarding controlled drugs

Answers to the Most Common Questions Related to Controlled Substances

 

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