Compounders receive FDA warning letters
Washington-The Food and Drug Administration (FDA) has issued a handful of warning letters to compounding pharmacies working with human and/or animal drugs and at least two written warnings to veterinary practices.
Washington-The Food and Drug Administration (FDA) has issued a handful of warning letters to compounding pharmacies working with human and/or animal drugs and at least two written warnings to veterinary practices.
The letters follow FDA's recent release of a compliance policy guide, which clarifies the regulatory agency's stance on drug compounding.
While the veterinary practices have been warned about extra-label drug use and illegal drug residues in food animals, letters to pharmacies allege a failure to comply with the Food, Drug and Cosmetic Act, which limits drug compounding to situations in which a product is medically necessary and prescribed as part of a valid veterinarian-client-patient relationship.
According to the American Veterinary Medical Association (AVMA), the letters require the pharmacies take corrective actions for a number of alleged violations, including:
- 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 good manufacturing practices.
- Compounding from bulk drugs
- Using compounded drugs in situations where the health of a patient is not threatened.
- Compounding from bulk drugs that have been removed from the market for human use for safety reasons.
- Labeling drugs inadequately
Of the letters sent to veterinarians, one warns the practice about prescribing, compounding and dispensing gentamicin and gentamicin combined with other antimicrobials to treat bacterial infections in dairy cows, with labeling specifying a 30-day withdrawal time. The drug is not FDA-approved for use in cows, and its extra-label use must comply with the agency's regulations.
The second letter to a veterinary practice warned it about the sale of prescription drugs for extra-label use without a valid veterinarian-client-patient relationship, the AVMA reports.
