Curious About Veterinary Pharmacy Compounding—Who Really has Regulatory Oversight

Veterinary Pharmacy Compounding and Regulatory Oversight

The news about pharmacy compounding has mainly focused on humans. Just recently, the 60 Minutes television program interviewed FDA Commissioner Margaret Hamburg about pharmacy compounding.  Pharmacy compounding usually involves a small quantity of custom made prescriptions. However, this has changed over the years to what some term large scale production. Unfortunately, this matter come to the forefront as a result of the deaths associated with compounded products produced by the New England Pharmacy Compounding Center. I agree with Dr. Hamburg that clear guidance is necessary as well as federal regulatory oversight.  To that end, Congressional action remains paramount. Federal regulatory oversight with clear guidance for the industry is necessary for human as well as veterinary use. The same rules that apply to compounded products for humans should apply to animals, both food producing and nonfood producing and those rules should be federal oversight. This will provide uniformity and provide the industry with a uniform standard.

Veterinary Use of Pharmacy Compounding Products  

However, what about animals and the use of compounded pharmacy products? Do the same rules apply? If so, which rules—federal or state? As indicated on the recent 60 Minutes television program, pharmacy compounding has ballooned from a  “Mom and Pop” process into a billion dollar industry.  Does the regulation of pharmacy compounding even apply to food producing animals? States are the prime regulator of pharmacy compounding yet should there be federal regulatory oversight? 

Congress Needs to Step to the Plate

The landscape has changed in the pharmacy compounding arena from that of compounding for an individual patient to that of large scale production. This is analogous to the changed landscape of health care and the practice of medicine.  The images of “Norman Rockwell’s Going to the Doctor” are no longer. These issues remain in flux with regulation primarily under state jurisdiction until Congress enacts legislation to provide clear guidance to both the United States Food and Drug Administration and industry.

Pharmacy Compounded Products in the Veterinary Arena—Interesting Case Yet No Guidance

Taking this issue one step further—should federal regulatory oversight of pharmacy compounded products for non-food producing animals apply?  The answer is unclear at this point. Interesting, this issue was addressed back in 2011 in the case of United States v. Franck’s Lab. Inc. No. 5:10–cv–147–Oc–32TBS (Sept. 12, 2011), a case which concerned pharmacy compounding for non-food producing animals.  Several polo horses died as a result of use of compounded products. FDA instituted a legal action for an injunction against Franck’s Lab. Inc. and deemed the activity manufacturing and hence being subject to FDA oversight.  In Franck’s Lab., the district court wrote an extensive opinion about the application of federal oversight to pharmacy compounding pertaining to non-food producing animals. The district court judge denied the injunctive relief sought by FDA and ruled that FDA had no authority to regulate in this arena mainly because this type of regulation was historically regulated under state not federal authority. Predictably, the FDA appealed. Subsequently, Wells Pharmacy Network, LLC acquired Franck’s and Franck’s no longer engages in such compounding. A Joint Motion by the government and by Wells Pharmacy Network, LLC to Vacate the District Court’s Judgment and Dismiss the Complaint by the federal government and Appeal by the government as Moot was granted on October 18, 2012.  However, fast forward to 2013 and the answers as to food- producing and  non-food producing animals are still murky.

The What and Why of Pharmacy Compounding

Pills

What is Pharmacy Compounding?

Pharmacy compounding usually involves a small quantity of custom made prescriptions. However, this has changed over the years to what some term large scale production. By way of illustration, in the later part of 2012, the United States Food and Drug Administration (FDA) was forced to confront the issue of pharmacy compounding on a large scale. This was due to several deaths associated with compounded drug products linked to fungal meningitis that involved the New England Compounding Center (NECC). FDA Commissioner Margaret Hamburg testified before Congress and specifically recommended that Congress enact legislation to provide authority FDA with enforcement authority. The NECC distributed contaminated pain injections that caused serious adverse events including approximately 32 deaths.

Why did this happen?

Well back in 2002, an FDA inspection revealed a contamination issue with the same steroid; however, FDA had to defer to Massachusetts state authorities. Traditionally, with pharmacy compounding, state pharmacy boards maintain regulatory oversight. Further, as mentioned, traditionally compounding pharmacies fill special orders from physicians for an individual patient. Yet, over the years, this has changed dramatically from a small to large-scale operation and NECC is an illustration of where thousands of doses of drugs were shipped to several states.

What are the FDA Solutions?

Commissioner Hamburg proposed a two-tier system in which traditional compounding pharmacies continue to be regulated at the state level, and larger pharmacies would be subject to FDA oversight. According to Dr. Hamburg, these non-traditional pharmacies that operate on large-scale compounding would have to register with the FDA as well as undergo regular inspections. Further, these large-scale compounding pharmacies would be obligated to meet the more rigorous manufacturing standards required of pharmaceutical companies.
Previously, FDA attempts to regulate large scale operations have been stymied; however, that should change. For example, Ameridose LLC, managed by the same parties who managed NECC, voluntarily recalled all of its unexpired products in 2012 due to FDA sterility assurance concerns. The recall was conducted for preventive measures not because of reports of adverse events such as infections.

As background, when the United States Supreme Court decision of Thompson v. Western States, was decided back in 2002, FDA then clarified that the agency would continue to use enforcement action against those who compounded drugs that are actually attempts to illegally manufacture drugs. FDA released a Compliance Policy Guide (CPG) section 460.200 [Pharmacy Compounding] issued by FDA on May 29, 2002, following the Thompson Supreme Court decision. The CPG sets forth a list of factors that FDA considers in determining whether to take enforcement action when the scope and nature of a pharmacy’s activities raise the kind of concerns ordinarily associated with drug manufacturing. For example, FDA would consider enforcement action against pharmacists who compound medications that are commercially available in the marketplace or those that use bulk ingredients that are not components of FDA approved drugs or those pharmacists who use commercial scale manufacturing or testing equipment.

Recommendations

Here is what I propose. The tier proposal is a good start. Yet, what really needs to happen is communication on all levels. By that I mean communication with state and federal government agencies as well as communication between industry and the FDA as well as state pharmacies. Finally, the nature of pharmacy compounding has markedly changed from small to large scale manufacture. So, the time is ripe for Congress to address this issue legislatively.

Stay tuned for more on pharmacy compounding specific to veterinary products.