cGMP refers to the Current Good Manufacturing Practices enforced by the US Food and Drug Administration (FDA). cGMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to cGMP regulations assures the identity, strength, quality and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations and maintaining validated testing methods. This formal system of controls, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures and errors.
Drug Quality and Security Act
The Drug Quality and Security Act (DQSA) became law on November 27, 2013. The 80-page Act has direct consequences for compounding pharmacies and providers that use their services. The DQSA updated the Section 503A exemption. This exemption now applies only to small compounding pharmacies that produce medications in limited quantities, allowing them to continue their operations without having to use the most advanced quality and manufacturing techniques. State boards of pharmacy will continue to provide primary oversight of these pharmacies, and each pharmacy will only be allowed to have a small percentage of their medications shipped out-of-state, assuming valid licenses in those states. In addition, the prescriptions will need to be patient-specific for each compound.
DQSA also introduced a 503B exemption (designating Outsourcing Facilities) for larger sterile compounding pharmacies that requires the use of advanced manufacturing standards and imposes federal oversight.
All Outsourcing Facilities must comply with cGMP. These principles are designed to eliminate contamination of compounded medications, deviations from protocols or incorrect ingredients as well as other safety and quality issues. Under these requirements, a sample of each medication must be tested for the sterility and integrity of ingredients. Preparing compounded medications in a sophisticated, state-of-the-art cleanroom is also mandatory to adhere to cGMPs. Amongst other requirements, registered Outsourcing Facilities must:
- Comply with cGMP requirements
- Agree to maintain stringent reporting systems
- Submit to unscheduled on-site inspections of their facilities
- Adhere to FDA regulations regarding the bulk drug substances used to compound
- Implement an adverse event reporting system
As a result, providers that use compounded and sterile medications can now easily identify a pharmacy partner that meets high standards around quality control and patient safety via the 503B Outsourcing Facility designation. While medications from pharmacies that do not register as an Outsourcing Facility may be less expensive, these facilities do not provide the same quality and safety assurance.