posted November 15, 2006
Given the recent Texas court decision on drug compounding, have the rules on drug compounding changed?
director of the AVMA
The court decision was in the case of Medical Center Pharmacy et al vs. Gonzalez et al in the U.S. District Court for the Western District of Texas, Midland-Odessa Division. Several pharmacies filed the case, which challenged the FDA's approach to regulating compounded drugs.
The court decision differentiated between compounding from "legal" bulk ingredients and compounding from "illegal" bulk ingredients. The decision stated that compounding drugs for nonfood animals is legal when using "legal" bulk ingredients but illegal when using "illegal" bulk ingredients. To my knowledge, there are no such legally defined categories of ingredients—making implementation problematic or, at least, unclear.
While the decision is noteworthy and something to monitor, I would encourage veterinarians to take a wait-and-see attitude. I understand that the decision affects only the court's jurisdiction inside Texas. We can anticipate that the FDA will continue to follow its existing policies and procedures in other regions.
I also believe we can continue to expect the FDA to act against illegal manufacturing occurring under the guise of compounding. So, beware of any products for sale as compounded, cheaper versions of FDA-approved, commercially marketed drugs.
At press time, the FDA had not announced a strategy in the Texas case. Clearly, the FDA disagrees with the court decision. Spokeswoman Susan Cruzan said the FDA will consider all options, including seeking an appeal (see JAVMA, page 1228, Oct. 15, 2006).
Will this case affect the FDA Compliance Policy Guide?
Until closure of the case, the FDA is unlikely to release long-awaited updates to its Compliance Policy Guide—which the AVMA hoped would clarify the FDA's regulatory discretion regarding compounding.
Remember, compounding from FDA-approved drugs continues to be legal as long as veterinarians comply with regulations for extralabel use under the Animal Medicinal Drug Use Clarification Act. And recall that the use of compounded drugs in food animals has accompanying food safety concerns that preclude the drugs' use unless information exists to ensure avoidance of illegal tissue residues.