Veterinary Compounding Pharmacy Resumes Operations Despite FDA’s Attempt to Obtain a Preliminary Injunction

September 2, 2010

By William T. Koustas

Franck’s Lab, Inc. (“Defendant”), an Ocala, Florida veterinary compounding pharmacy, resumed compounding after a federal judge in the United States District Court for the Middle District of Florida denied the Government’s (“Plaintiff”) request for a preliminary injunction on August 19, 2010 that would have prohibited such activity.  The Defendant had previously admitted that it mistakenly compounded a vitamin supplement that was injected into 21 polo horses during the U.S. Open Polo Championships in April 2009, causing their deaths. 

In its Motion for Preliminary Injunction, the Plaintiff argued that regulations regarding the compounding of veterinary drugs permits such activity only “if such drugs are compounded from ‘approved animal or human drugs’ and state that ‘[n]othing in this part shall be construed as permitting compounding from bulk drugs.’”  U.S.A. v. Franck’s Lab, Inc., et al., United States District Court for the Middle District of Florida, Ocala Division, Memorandum in Support of Plaintiff’s Motion for Preliminary Injunction, July 2, 2010 (“Motion”) at 14; 21 C.F.R. § 530.13.  The Plaintiff noted that FDA issued a compliance policy guidance in 2003 regarding compounding in which it purportedly clarified its interpretation of the Animal Medicinal Drug Use Clarification Act.  Motion at 15.  In this guidance, FDA stated its view that compounding veterinary medicines is only acceptable as long as the compounding entity is not attempting to “intentionally circumvent the drug approval process,” and “compounding from bulk drug substances [as the Defendant did] or unapproved drugs renders the compounded drugs unsafe as a matter of law, and thus adulterated in violation of 21 U.S.C. § 351(a)(5).”  Id.  Therefore, the Plaintiff argues, the veterinary drugs the Defendant compounds from bulk drugs are new animal drugs as defined in 21 U.S.C. § 321(v) and require proper regulatory approval before they may be sold in interstate commerce.  Motion at 17.  The Plaintiff noted that the Defendant voluntarily agreed to temporarily stop compounding animal drugs as this litigation proceeded, but the Plaintiff sought this preliminary injunction anyway as such a suspension could be withdrawn at any time with 48 hours notice.  Motion at 2.

However, in its Response to Plaintiff’s Motion for Preliminary Injunction, the Defendant essentially argued that FDA does not have the authority to ban the compounding of veterinary drugs from bulk ingredients.  U.S.A. v. Franck’s Lab, Inc., et al., United States District Court for the Middle District of Florida, Ocala Division, Response to Plaintiff’s Motion for Preliminary Injunction, August 6, 2010 (“Response”) at 1.  The Defendant asserts that the “use of bulk ingredients to compound commercially unavailable preparations is a core part of the traditional pharmacy practice,” which is traditionally regulated by the states.  Response at 2.  Though the Defendant agrees that FDA has the authority to regulate the manufacturing of veterinary drugs “if it occurs in the guise of compounding,” such authority “does not permit FDA to override state law and impose a blanket ban on traditional pharmacy compounding practices.”  Response at 5-6.  The Defendant further notes that the legislative history of the Federal Food, Drug, and  Cosmetic Act (“FDCA”) seems to demonstrate that Congress intentionally left the regulation of compounding to the states as part of the practice of pharmacy while regulating the manufacturing of drugs because it was not generally regulated by the states.  Response at 7.  Additionally, the Defendant claims that even if the FDCA would allow FDA to regulate the compounding of veterinary drugs, it would need to do so by the promulgation of regulations through notice and comment rulemaking procedures rather than by the use of non-binding guidance documents.  Response at 11.

While the judge denied the Plaintiffs Motion for Preliminary Injunction, he also denied the Defendant’s Motion to Dismiss.  In issuing the denials, the judge did not write an opinion explaining his decision.  The Court is still considering the Plaintiff’s request to permanently enjoin the Defendant from compounding veterinary drugs from bulk drugs.