The FDA has implemented a new law concerning compounding pharmacies that is designed to protect consumers from dangerous and unsafe compounded drugs. This comes as welcome news in light of the tragic fungal meningitis outbreak from contaminated steroids manufactured by New England Compounding Pharmacy. Over the past year, state and federal inspections of compounding pharmacies such as Specialty Compounding and Medaus Pharmacy revealed inadequate quality control practices and sterility concerns.
FDA regulations applicable to conventional manufacturers require compliance with federal quality standards, accurate labeling, and FDA approval before distributing and marketing new drugs. Compounding pharmacies are not subject to the same standards. The Drug Quality and Security Act incentivizes compounding pharmacies to adopt more rigorous and comprehensive quality and safety standards.
The new law enables compounders to register as “outsourcing facilities,” meaning they will be subjected to certain FDA requirements. Outsourcing facilities will be required to:
- Comply with current good manufacturing practices;
- Submit to risk-based FDA inspections; and
- Provide the FDA with certain information about compounded products and adverse events
Although some compounding manufacturers will continue to be exempt from these requirements, the FDA hopes the registration program will encourage hospitals and doctors to purchase drugs from these outsourcing facilities by ensuring safe practices and quality control. If compounding pharmacies choose not to register as outsourcing facilities, they will be regulated as conventional manufacturers if they fail to meet certain requirements under the new law.
The FDA will continue to work with state authorities in the oversight of compounding facilities and other pharmacies to ensure compliance with the new law.
Andrews Thornton Higgins Razmara encourages patients and loved ones who have been harmed by unsafe compounded drugs to contact us for a free case evaluation at www.andrewsthornton.com or toll free at 1-800-644-1734.