FDA WARNS DRUG COMPOUNDING FIRM FOR OPERATING AS A DRUGMAKER
The FDA has issued a warning letter to Lincare and its subsidiary, Reliant Pharmacy Services, informing them that their practice of manufacturing compounded drug products is in violation of the Compliance Policy Guide (CPG) of the Federal Food, Drug, and Cosmetic Act (FDCA).
Based on an inspection of a Lincare facility in Southaven, Miss., the FDA determined that the company's practice "goes well beyond the scope of traditional pharmacy compounding and instead more closely resembles a drug manufacturing operation."
In the warning letter to Lincare, the FDA asked the company to notify the agency in writing of the specific steps the company is taking to correct the violations. Officials from Lincare could not be reached for comment.
According to the CPG, the FDA is greatly concerned about veterinarians and pharmacies that are engaged in manufacturing and distributing unapproved new animal drugs in a manner that is outside the bounds of traditional pharmacy practice and that violate the FDCA.
The FDA pointed to compounding that is intended to circumvent the drug approval process as particularly worrisome, since it could lead to the mass marketing of products that have been produced with little or no quality control or manufacturing standards to ensure the purity, potency and stability of the product.
To view the Lincare warning letter, go to http://www.fda.gov/foi/warning_letters/g5123d.htm (http://www.fda.gov/foi/warning_letters/g5123d.htm).