In the past six (6) months, FDA has issued two (2) Alerts (here and here), for patients and caregivers to not use sterile products manufactured by the two companies cited in the alerts. One company compounds product for human patients, and the other for veterinarians and animals (pet owners, beware). In that same 6-month period, four (4) Warning Letters were issued to four (4) other 503B outsourcing facilities.
Compounding is a necessary and important component of our health care delivery system which provides needed medications to patients with specific needs that cannot be otherwise met by traditional pharmacy practice. 503B outsourcing facilities operate much more like a pharmaceutical manufacturing facility than pharmacy compounders under 503A. 503B outsourcing facilities must comply with cGMPs as do commercial scale drug manufacturers. The stringent requirements are especially important for sterile products including those intended for parenteral and ophthalmic administration, among others dosage forms.
It is a fact that commercial manufacturers also run afoul of cGMPs and are the subject of FDA alerts, warning letters, drug recalls, and are cited in FDA 483 inspection reports. This post is not to single out outsourcing facilities, but just to provide some color to the difficulties that outsourcing facilities face. This is most starkly illustrated by the meningitis outbreak that started in September of 2012, due to shoddy practices at the New England Compounding Center, which points out the danger that can occur when parenteral products become contaminated.
As a pharmacist who in another life worked part-time in a small community pharmacy that prepared mostly non-sterile compounded prescriptions, I used to shudder when we were called upon to prepare a sterile product. Luckily, we never had a problem with a prepared sterile product, but the level of worry never lessened.
Take heart that the FDA and States are watching over the industry, and the industry is trying hard to assure compliance, but failures do occur in any setting, whether it be an FDA-registered manufacturing site or an FDA-registered outsourcing facility or a 503A compounding pharmacy. It is a tough business and requires the utmost continuous and unflagging care and diligence to assure the safety of its products and long-term success.
