Battles over compounding from bulk drugs move forward

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Animal drug compounding from bulk drug substances—unapproved active pharmaceutical ingredients—has become a heated issue since the Food and Drug Administration revised its Compliance Policy Guide in July 2003. The FDA has since aggressively enforced the drug compounding laws, and several suits involving pharmacies were filed in the past few years. In addition, the FDA has issued a warning letter to a pharmacy that targets how veterinarians might unknowingly play an illegal role in drug compounding.

Compounding is the manipulation of a drug, other than in accordance with the FDA-approved label, to make a different formulation of the drug to meet the needs of a specific patient.

In June 2004, the AVMA requested that the FDA amend its policy on drug compounding for animals. The Association believes veterinarians should have the discretion to compound bulk, or raw, pharmaceutical ingredients to produce a medically necessary product that is otherwise unavailable for a specific nonfood animal patient.

After receiving letters similar to the AVMA's and numerous others from veterinarians, compounding pharmacists, and associations expressing concern over the CPG, the FDA Center for Veterinary Medicine announced it would again revise the guidelines. The announcement was made in September 2004 and the revisions were to be released for comment later that fall. An FDA spokesperson confirmed the revisions still have not been released.  

Court suits progress

While the FDA works to revise the CPG, several suits involving drug compounding and pharmacies are playing out in the courts.

In August 2004, the Kentucky pharmacy BET Pharm LLC was found by the FDA to be in violation of the federal Food, Drug and Cosmetic Act for illegally compounding drugs (see JAVMA, Oct. 1, 2004). In response to the claim, the International Academy of Compounding Pharmacists filed an initial friend-of-the-court brief on behalf of BET in October. The FDA responded to the brief in November and, in December, the IACP filed a reply brief.

In March 2005, the Kentucky federal district court presiding over the case issued a decision on the motion to dismiss that rejected BET and IACP's claim that compounded medications are not subject to the provisions of the FDCA.

In a separate suit, 10 compounding pharmacies filed a complaint in a Texas court in September 2004 against the FDA (see JAVMA, Dec. 1, 2004). The pharmacies stated that the FDA did not have jurisdiction to regulate compounding pharmacies, and that it is not illegal to compound drugs from bulk ingredients for nonfood animals on a veterinarian's prescription when there is not an FDA-approved drug available to fill the medical need.

The FDA petitioned the court in December to dismiss the pharmacies' complaint.

In March, the IACP filed a friend-of-the-court brief in support of the pharmacies. The brief stated that compounded medications are not "new drugs" and urged the court to deny the FDA's motion to dismiss. Several additional groups filed friend-of-the-courts briefs, including the American Pharmacists Association, Association of American Physicians and Surgeons, and the Texas Pharmacy Association.

Next, a coalition of respiratory associations filed a friend-of-the-court brief in support of FDA's motion to dismiss. The brief addressed the question whether the "new drug" approval provisions of the FDCA can be applied to human drugs that are compounded by pharmacies.

In May, the Texas district court denied the FDA's motion to dismiss. 

Veterinarians' responsibility

Since pharmacies are selling these compounded drugs, veterinarians should be aware that the FDA objects to the pharmacies compounding for third parties who resell to individual patients, as opposed to compounding for individual patients.

The FDA demonstrated its disapproval when it issued a warning letter to a pharmacy located in Omaha, Neb., following an inspection that turned up violations to the CPG. One of the violations, the letter stated, was that a substantial number of the pharmacy's compounded veterinary drugs appeared to be compounded outside the context of a valid veterinarian-client-patient relationship for administration by an end user. Instead, they appeared to be sold to veterinarians for use as office stock in their professional practice or for subsequent general distribution.

Compounding regulations can also vary from state to state. Veterinarians are encouraged to consult their own state's regulations along with the FDA's CPG.

For more information, visit the compounding section of the AVMA's Web site. The site includes compounding rules, definitions, pharmacology basics, answers to frequently asked questions, and the AVMA's position statements.