The Facts of the Franck's case

A veterinarian commissioned Franck's Compounding Lab, a Florida pharmacy, to compound an injectable solution of a prescription drug, Biodyl, which is not commericially available in the United States.  The Biodyl was injected into horses on the Venezuelan Polo Team in 2009.  After injected with the Biodyl, 21 horses died; five horses who did not receive the injection lived.  The Florida Board of Pharmacy investigated and determined that a mathematical error--the misplacement of a decimal point-had made the solution of Biodyl deadly.  The board believed that the mathematical error had nothing to do with preparing the compound from bulk materials. Although the Board fined and reprimanded Franck's, it allowed Franck's to continue its drug compounding business, which is approximately 40% of Franck's total business revenues.

After the Florida Board of Pharmacy closed its case, the Federal Drug Administration (FDA) began investigating Franck's.  The FDA sent Franck's a "Form 483" notice containing five alleged violations-none of these involved claims of bulk compounding of animal drugs. A Form 483 notification is used for "Factory Inspections" to communicate "inspectional observations."  The Form 483 notice requires a response.  Franck's responded, arguing it had not violated federal law and asserting that compounding is regulated by the states rather than by the FDA or federal government.  In April 2010, the FDA filed a civil complaint in federal district court and requested a permanent injunction prohibiting Franck's from compounding animal medications.  See Memorandum of Law in Support of Plaintiff's Preliminary Injunction  On September 12, 2011, United States District Court Judge Timothy J. Corrigan issued an 80-page opinion, deciding in favor of Franck's, granting its motion for summary judgment and denying the FDA's request for an injunction.

The FDA appealed the district court's decision to the Eleventh Circuit Court of Appeals.  The Department of Justice (DOJ), who represents the FDA, has filed its brief in case number 11-15350.  Franck's has filed its response brief.  DOJ's reply to Franck's brief is due now due on May 1, 2012, after they received an extension of time to file.

What Is Considered a Compounded Drug?

When your child does not like the taste of the antibiotic the doctor prescribes and the pharmacist adds a flavor to the medication, the result is a compounded drug.  When a commercial drug is available only in tablet form for your pet, but a liquid version of the medication is needed, prepared and provided to you for your animal, the result is a compounded drug.

Compound preparations for both humans and animals have existed for years.  See United States v. Bader, slip opinion, *2-3, n.1 (Colo. July 23, 2009)  Compound preparations accounts for some 30 million prescriptions a year in the United States and are a huge money-making business.  Compounding is the only source for some medications.  Today, compounding of drugs is “a traditional component of the practice of pharmacy, and is taught as part of the standard curriculum at most pharmacy schools.” Thompson v. W. States Med. Ctr., 535 U.S. 357, 361 (2002)(internal citations omitted).

Despite the long history and tradition of compound drugs, the Federal Drug Administration (FDA) does not have a formal definition of compounded drugs in its regulations.  Instead, Congress defined what is not compounding in the Food and Drug Administration Modernization Act of 1997, which amended  21 U.S.C. § 353A, as follows:

``(f) Definition.--As used in this section, the term `compounding' does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling.''.

Case law defines compounding as "a process by which a pharmacist combines, mixes, or alters ingredients to create a medication tailored to the needs of an individual human or animal patient." United States v.Francks, Case No. 5:10-cv-147-Oc-32TBS, slip op., at *9 (M.D. Fla. 2011)(citing Thompson v. W. States Med. Ctr., 535 U.S. 357, 360-61 (2002); Med. Ctr. Pharm.v. Mukasey, 536 F.3d 383, 387 (5th Cir. 2008)).  See also Compounding Troubles, Trends Magazine (February 2012).  Another way of defining compounded drugs is that they are a customized preparation of a medicine in a way that is not available from major drug makers.  Compounded drugs are not the same thing as generic drugs. Generic drugs are approved by the Federal Drug Administration: compounded drugs are not.

The ability to customize preparation of a medicine that is not available from major drug makers is necessary for obvious reasons.  The issue is when does this customize preparation of a medicine cross over from mere compounding and become manufacturing of a drug.  This area of law is opaque and fluctuating and in much need of more developed laws, rules, regulations and especially guidance to those who prescribe and prepare compound drugs.