In 2009 a president of a Venezuelan Banking Association sent his team of polo horses to compete in the 2009 U.S. Open Polo Championships. While in the US, a veterinarian prescribed a supplement for the horses to prevent rhabdomyolysis (more info. here). The prescription contained an error, far too high of a dose (oral sources indicate the pharmacist called the veterinarian to verify the high dose and was told it was correct), the pharmacy compounded the prescription as stated and 21 horses died. (More details) The both the FDA and the Florida State Board of pharmacy investigated the compounding pharmacy, Franck's Lab, Inc., which had been compounding veterinarian medication for nearly 25 years. The Florida Board was content with its investigation, but the FDA continued to investigate the pharmacy, including bringing the lawsuit US vs. Franck's Lab, Inc. against the pharmacy and all compounding pharmacies in general.
Results:
On September 13th, Judge Timothy Corrigan of the US District Court for the Middle District of Florida has issued his ruling:
- The FDA does not have authority over compounded medications dispensed by a licensed pharmacy so long as the pharmacy’s activities are not manufacturing. That authority rests with individual state Boards of Pharmacy.
- Congress did not give FDA jurisdictional authority, when it enacted the Food, Drug and Cosmetics Act (FDCA) in 1938, to take enforcement action against a pharmacy that is engaged in traditional compounding practice.
- The FDA cannot use its Compliance Policy Guidelines (CPG) for veterinary compounding issued in 2003 as the basis for enforcement action.
- The regulations enacted by the FDA based on the 1994 Animal Medicinal Drug Use Clarification Act (AMDUCA) are in error. This legislation did not give FDA authority to prohibit the use of bulk active pharmaceutical ingredients APS) in veterinary compounding.
- The size and scope of a compounding pharmacy does not mean the pharmacy is a manufacturer.
- The use of bulk APIs in compounding for humans and the prohibition of bulk APIs for compounding for non-food producing animals is an illogical position for the FDA to take and contraindicated by its own actions over the past 50+ years.
