FDA warns compounders, veterinarians
The Food and Drug Administration has issued at least five warning letters to pharmacies compounding human and/or animal drugs since issuing a Compliance Policy Guide clarifying the department's stance on drug compounding. The FDA has also warned two veterinary practices about extralabel drug use and illegal drug residues in food animals.
The compounding warning letters allege that the pharmacies have failed to comply with the Food, Drug, and Cosmetic Act, which limits drug compounding to situations in which a product is medically necessary for treatment and is prescribed as part of a valid veterinarian-client-patient relationship for a specific patient. The CPG, available at www.fda.gov, and an article in the Dec. 1, 2003, issue of JAVMA on page 1558, or online at www.avma.org/onlnews/JAVMA/dec03/031201l.asp, describe in greater detail the compounding oversight and circumstances in which the FDA is likely to exercise discretionary authority and not prosecute those who are acting outside the regulations.
The letters require the pharmacies to take corrective actions and cover a range of alleged infractions. Those infractions include:
- Compounding drugs for use in animals where an approved drug is available
- Compounding outside a valid veterinarian-client-patient relationship
- Manufacturing commercial-sized lots of drugs in anticipation of receiving prescriptions
- Failing to comply with FDA current good manufacturing practices
- Compounding from bulk drugs
- Using compounded drugs, made from bulk ingredients, in situations where the health of the animal is not threatened
- Compounding from bulk drugs that have been removed from the market for human use for safety reasons
- Labeling drugs inadequately
At least two warning letters have been issued to veterinary practices since December for illegal extralabel drug use, and illegal residues in food animals.
One letter warned a veterinary hospital about prescribing, compounding, and dispensing gentamicin and gentamicin combined with other antimicrobials for the treatment of bacterial infections in dairy cows, with labeling specifying a 30-day withdrawl time. Gentamicin is not FDA-approved for use in cows, and extralabel use of the drug must comply with FDA regulations, according to the warning letter. The letter noted that the specified withdrawal time was not supported by science. According to the letter, there is no scientifically established withdrawal time for the use of gentamicin in cattle; however, the Food Animal Residue Avoidance Bank advises that a minimum preslaughter withdrawal period of 18 months or more be established.
Another letter warned a veterinary practice about the sale of prescription drugs for extralabel use without a valid veterinarian-client-patient relationship.