In the fall of 2014, a bill was passed that became Public Act 280. This law was written for human medicine, but called into question the practice of compounding within veterinary medicine. More specifically, the practice of compounding in-house as well as keeping a large quantity of compounded medication on-hand for use on a per patient basis or in case of emergency was no longer allowed.
The rules on compounding within this new law had been in dispute because although they did not specifically exempt licensed veterinarians, the State of Michigan did not originally intend to include them and reportedly did not enforce the new rules. To this end, the MVMA has been working with LARA and the State of Michigan to provide further clarification with the goal that exemption language would be developed.
Recently LARA clarified this issue with an FAQ on their website:
No. In 2014, the drug compounding statutes in the Michigan Public Health Code, Pharmacy Practice and Drug Control section, were revised. These changes were made in response to the deadly fungal meningitis outbreak in 2012 which was caused by an out of state pharmaceutical company. The new laws were enacted to strengthen the accountability and accreditation requirements for pharmacies, manufacturers and wholesale distributors that deal with compounded pharmaceuticals for humans. These changes do not apply to veterinarians or drugs compounded and manufactured for use on animals.
The MVMA will continue to work with LARA and the State of Michigan to educate compounding pharmacies on the true intention of the rules change to ensure veterinarians can continue to practice in such a way that protects both their patients and their license. We will update our members as more information on this issue becomes available.
We are currently reviewing the information above with LARA and will update when additional details are available.
I have a client who travels a lot and wants me to give her a two-month supply of a controlled substance. Am I allowed to do this?
Yes, you can give a client a two-month supply, but please only do so only for a client with whom you have an established veterinarian/client relationship and keep detailed records of the transaction.
If we are out of a controlled substance but need it to treat one of our patients, can we get it from a neighboring veterinary clinic?
Yes, you can get the drug you need from a neighboring clinic. However, if you are transferring a schedule 2, you would need to fill out the DEA 222 form. If you are transferring schedule 3-5, you will need to create an invoice for your records. Not having a clearly defined paper trail is simply inviting trouble, should something go wrong and the DEA investigates.
Do I still need to submit my annual controlled substance inventory to the State?
No. Per MCL 333.7321 (2) “Beginning May 1, 1989, and annually thereafter, each person licensed under this article to manufacture, distribute, prescribe, or dispense controlled substances shall inventory all schedule 2 to 5 controlled substances possessed by the person at the time of the inventory. A person described in this subsection may conduct the annual inventory required under this subsection not more than 30 days before May 1, but shall conduct the inventory not later than 60 days after May 1. A person described in this subsection shall retain the inventory required under this subsection for not less than 2 years after the date of the inventory's creation and shall make the inventory available for inspection by the department at the request of the department.”
Schedule 2 drugs should be listed separately from all other drugs and exact counts should be made. For substances listed in schedules 3, 4 and 5, the count or measure may be estimated, but if the container holds more than 1,000 dosage units (pills, etc.), then an accurate count is required. Federal law also requires a biennual inventory be taken and kept on the premises.
Please note the inventory required by the State of Michigan is different from the inventory required by the DEA. After the initial inventory is taken, the DEA requires a new inventory of all stocks of controlled substances on hand to be done at least every two years. The biennial inventory may be taken on any date, which is within two years of the previous biennial inventory date. It requires the same information as the initial inventory of all controlled substances on hand and is maintained at the registrant’s location for two years and is not sent to the DEA.
How do I report dispensed controlled substances to the State of Michigan?
Board of Pharmacy Administrative Rule 338.3162b states all pharmacies, dispensing practitioners and veterinarians who dispense controlled substances in Schedules 2-5 are required to electronically report this prescription data to the Michigan Automated Prescription System (MAPS).
In an effort to provide more accurate and current prescription information to health professionals, the current reporting schedule has been changed from the 1st and 15th of every month to a daily reporting requirement starting July 1, 2014. More information can be found on the LARA website.
You may report your data to the State using one of the two following ways:
In addition to requesting MAPS reports, MAPS Online provides pharmacies and dispensing practitioners the option to submit prescription data via the Data Entry link within the MAPS Online portal. Submitting prescription data through MAPS Online offers tracking mechanisms to the user, to ensure data has been downloaded successfully and to view any prescription record errors, 24 hours after the upload. Registration to MAPS Online is required to request MAPS reports and to submit prescription data.
What data needs to be submitted through MAPS?
When entering prescription data into MAPS for controlled substances dispensed for animals, please keep in mind the following tips:
The NDC Guidelines reviews the different formats of NDC codes and how to apply different formats for data reported to MAPS.
Are there exemptions to the controlled substance reporting process?
Reporting exemptions include controlled substances administered to patients, samples of controlled substances provided to a patient, and controlled substances that are dispensed by a physician at a medical institution for a maximum of 48 hours. If a dispenser or practitioner does not have online capabilities, prescription data may be recorded on a CD in the ASAP 4.1 format and mailed to MAPS for submission into the MAPS database.A waiver may be requested by those dispensers or practitioners who do not have the appropriate software to record prescription data, which will enable dispensers to submit their prescription data in paper form. Upon approval of the waiver application, a MAPS Claim Form is required to be completed for each controlled substances dispensed and then mailed to MAPS for submission into the database. Contact MAPS directly at 517/241-0166 or BPL-MAPS@michigan.gov for more information.
I have several veterinarians at my practice. Can a veterinarian without a controlled substance license use controlled substances obtained by someone else in the practice with a license?
A veterinarian with a Michigan Controlled Substance License and DEA Registration may delegate the administration of a controlled substance to another veterinarian who does not possess a Michigan Controlled Substance license. It’s important that veterinarians realize that this delegated function falls under the Public Health Code Section 333.16215 (I) which states that "a license shall not delegate a task or function that requires the level of education, skill, and judgment required of a licensee.” To comply with the law, the licensed veterinarian must make the determination that a controlled substance is required and must prescribe the substance before the unlicensed veterinarian administers the substance. This means that the unlicensed veterinarian is working under the same constraints as a veterinary technician when controlled substances are involved (such as with euthanasia).
While an associate would save the cost of the DEA registration fee, we ask our members to carefully consider these factors: