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.