Rules Would Have Restricted Veterinarians’ Use of Compounded Medications.
In December 2017, the Illinois Department of Financial and Professional Responsibility (IDFPR), which regulates pharmacy practice in Illinois, issued proposed revisions to Illinois’ rules governing compounding pharmacies. Those rules expressly permitted pharmacies to continue the long-standing practice of compounding sterile and nonsterile products for office use by a veterinarian. This was a welcome development since several other states, in recent months, were proposing damaging new rules that attempted to mirror a Federal law—the Drug Security and Quality Act or DQSA—that applied only to compounded medications used in human health.
However, also under the proposed rules, veterinarians would be restricted to dispensing no more than a seven-day supply of compounded medications. The proposed rules also were silent on whether other restrictions that would be imposed on compounding pharmacies that supply compounded medication for human-health use would apply to veterinary compounding. These included a restriction limiting sales of compounded drugs for office use to 5% of the annual dollar sales of prescription drugs by any pharmacy. This, essentially, would punish high-quality compounding pharmacies and the veterinarians who depend on them by arbitrarily setting limits on sales.
Recognizing the risks posed to both veterinary compounding and the practice of veterinary medicine by IDFPR’s proposed rules, Wedgewood Pharmacy formed a coalition with several other compounding pharmacies—Diamondback Drugs, Pet Health Pharmacy, and Veterinary Pharmacies of America—to voice opposition to IDFPR’s proposed rules. The Coalition also joined forces with the Illinois State Veterinary Medical Association (ISVMA) to assist ISVMA with submitting its own comments to IDFPR regarding the negative impacts of the proposed rules. ISVMA’s comments emphasized that the limitations in the proposed regulations on office use would interfere with veterinarians’ medical judgment and could cause great harm to animal patients.
IDFPR issued revised proposed rules in response to comments by ISVMA and others. The proposed rules, however, failed to achieve the veterinary profession’s desired results and, in fact, placed even greater restrictions on their use of veterinary compounding! For example, the revised proposed rules would restrict sterile compounding for office use to those medications purchased from registered federal 503B “outsourcing facilities.” The problem: 503B facilities were created by Federal law to serve human-health compounding needs and, explicitly, not to serve animal-health compounding needs.
The revised rules also clarified that all veterinarians would be cut off from ordering non-sterile compounded medications for office use purchased from a pharmacy once 5% of the annual dollar sales of prescription drugs by a pharmacy were represented by compounded medications. Worse, although IDFPR removed the proposed seven-day supply restriction on office-use dispensing, because of the way the proposed rules were drafted, veterinarians were effectively prohibited from dispensing office-use medication to their patients; they would, instead, be permitted only to administer office-use medication to their patients at their offices.
In opposition to the revised proposed rules, the Coalition and ISVMA launched a two-prong effort to make IDFPR fully aware of the negative impact the changes would have to the practices of pharmacy and veterinary medicine. The Coalition and ISVMA submitted new comments to IDFPR about the revised proposed rules. They emphasized the fact that compounding pharmacies specializing in animal-health medication have been instructed by FDA not to register as 503B outsourcing facilities! As a result, IDFPR would have created a situation in which the only way to comply with Illinois law would be to breach FDA’s edict with respect to animal compounding in a 503B outsourcing facility.
The comments also stressed that if compounding pharmacies were limited to selling 5% of their non-sterile medications for office use, and if veterinarians could not dispense office-use medication to their patients, veterinarians would be prevented from obtaining and dispensing the medications they believe are most appropriate for their patients.
Representatives of the Coalition and ISVMA reached out directly to IDFPR to reinforce the concerns raised by the proposed rule changes. These efforts culminated in a meeting between representatives of the Coalition, ISVMA, and IDFPR in October 2018, during which the Coalition and ISVMA convinced Illinois representatives to re-evaluate their proposed rules and remove the proposed restrictions on veterinary compounding for office use.
Ultimately, as a result of the coalition members’ and ISVMA’s efforts, IDFPR agreed to re-write its rules to ensure that animal patients in Illinois continue to benefit from access to sterile and non-sterile office-use medication.
We are very proud of our efforts in Illinois. We will continue to monitor both Federal and state legislative and regulatory developments and will continue to fight for the rights of veterinarians to prescribe and compounders to supply medications that veterinarians say are most appropriate for their patients.