What will be affected? Covetrus stocks several hydrocodone combination products (HCPs), including Tussigon and generics. These products have historically been sold as C3 controlled substances, but that will now be changing.

Are HCPs actually going to be rescheduled? Yes, it is official. The DEA published notice on August 22, 2014 announcing the rescheduling of HCPs. The effective date is October 6, 2014 which is 45 days after the published notice. 21 U.S.C. 811(a) authorizes the DEA to reschedule HCPs.

What does this new rule mean to our customers? This means several things to practicing veterinarians, researchers, shelters, and any other client who may wish to order HCPs. First and foremost, it means that any DEA registrant wishing to order HCPs must have the C2 designation on their DEA Registration, but that is not all that this new rule will affect.  It will be updated as new questions are presented to Covetrus. Much of this information may also be found on the DEA website:   www.deadiversion.usdoj.gov.

Why did the DEA reschedule hydrocodone? The reasons are numerous and much discussion has taken place on this subject. Hydrocodone alone, as a single entity product, has been a C2 drug since 1971. At that time, HCPs were listed as C3 drugs when formulated with specified amounts of other ingredients, like isoquinoline alkaloid of opium or one or more therapeutically active nonnarcotic ingredients (homatropine, acetaminophen). Over the years, HCPs have become the most frequently prescribed opioid in the US with nearly 137 million prescriptions in 2013. Misuse of HCPs may lead to severe psychological or physical dependence and there is a great deal of data available demonstrating the potential for abuse, as well as risk to public health and safety.

Does the DEA registrant need to do anything now? DEA Registrants who wish to continue ordering, stocking, prescribing or dispensing HCPs must have a DEA Registration that includes Schedule 2 Narcotics on October 6. If your Registration is current and includes C2 no further action is necessary.

If the DEA Registration does not include C2, the registrant should immediately submit a request to update the Registration with the DEA. This can be done online: www.deadiversion.usdoj.gov. The registrant must also order new DEA 222 forms through the same website. This can be done immediately after receiving notice the Registration has been update.

NOTE: it normally requires 7-14 business days to receive the 222 forms. DEA 222 order forms are mandatory when ordering Schedule 2 drugs. Please plan accordingly!

Is there an alternative to use of the DEA222 form to order HCPs or any other Schedule 2 Controlled substance? Covetrus offers order fulfillment through Express222, a DEA approved Controlled Substance Ordering System. If you have been issued a DEA digital certificate, you may order HCPs and any other Schedule 2 or 2N controlled substance through Express222. Submission of HCP orders through Express222 will be simple and efficient and will save you the problem of dealing with the hard copy DEA222 forms.  
Is it legal for a veterinary practitioner to stock HCPs if the Registration does not list C2? Effective October 6, all hydrocodone in the veterinary clinic must be associated with a valid DEA registration that includes Schedule 2. In other words, it will no longer be legal to possess without a C2 designation on one’s DEA certificate.

What actions are required of the veterinary practitioner? Because HCPs have always been a controlled substance, they should already be included in your current controlled substance inventory system. As a Schedule 2 controlled substance, all records and documents regarding HCPs must be maintained separately from the Schedule 3-5 controlled substance records.

Is the veterinary practice required to securely store HCPs? DEA regulations (21 CFR 1301.75) state that “controlled substances should be stored in a securely locked, substantially constructed cabinet”. The intent of the law is to ensure controlled substances are adequately safeguarded. The schedule change does not affect this one way or the other, as these substances should already be securely stored.

What are the requirements for prescribing HCPs after October 6? The rules for prescribing a Schedule 2 Controlled substance will apply. While the federal Controlled Substance Act (CS) and DEA regulations do not specify specific limits on quantities that may be prescribed on a single prescription or the duration of treatment intended for a single prescription, some states do impose limits on prescribing Schedule 2 controlled substances. In these cases, the more stringent rules should apply – hence, if the state has additional limitations on the practitioner, those rules should be followed. Covetrus advises customers they should review specific state regulations regarding dispensing and prescribing of Schedule 2 controlled substances. This information can usually be found through the Board of Pharmacy for your particular state.

In terms of issuing prescriptions for Schedule 2 controlled substances, CFR 1306.12(b)(1)(v) states: Although the CSA prohibits refills of prescriptions for schedule 2 controlled substances, a practitioner may issue multiple schedule 2 prescriptions in order to provide up to a 90-day supply of medication in accordance with 21 CFR 1306.12. Furthermore, DEA regulations do not require patients to be seen monthly by their provider. Rather, practitioners must determine on their own -- based on sound medical judgment, and in accordance with established medical standards -- how often to see their patients when prescribing controlled substances. A prescription for a controlled substance must also be issued for a legitimate medical purpose by an individual practitioner acting in the course of his professional practice. 21 CFR 1306.04(a). Upon the effective date of this rule, the quantity prescribed may not exceed a 30 day supply and the prescriptions must be submitted to a pharmacy in writing.

Is the Practitioner required to exchange Schedule 3 labeled HCP products for Schedule 2 labeled product? Effective October 6, all HCPs delivered to the veterinary practice by Covetrus must be labeled as a Schedule 2 controlled substance. Veterinary practices may continue to dispense and utilize Schedule 3 labeled HCP after October 6. There is no legal requirement to return or exchange Schedule 3 HCP products for Schedule 2 labeled HCPs. Furthermore, effective October 6, HCP products will not be returnable to Covetrus regardless of the label. The DEA ruling on this matter, “Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products From Schedule 3 to Schedule 2”, clearly indicates the DEA does not regulate the labeling and packaging downstream of distributors.   My state requires that veterinarians submit reports of controlled substances dispensed through a state prescription drug monitoring program (PMP). Will I be required to include HCP products? Many state PMPs currently require HCP dispensing to be included in the reports. Questions about what is reportable and what is not reportable should be directed to the applicable State Board of Pharmacy.

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