cGMP

cGMP Regulations

Our commitment to patient safety combines utilization of the highest quality materials available, cutting edge technology, and quality assurance process controls that provide the right drug, right concentration, right route of administration for the right patient every time. Since 2009, Empower Pharmacy has become a national leader in sterile compounding through our commitment to developing quality processes that ensure the highest level of safety for patients.

Empower Pharmacy is designed and operated to meet cGMP standards. Furthermore, Empower Pharmacy adheres to the guidance provided by under section 503B of The Drug Quality and Security Act. We are regularly inspected by the State Boards of Pharmacy, DEA, and FDA to assure compliance. The key to providing safe, sterile compounded products resides in using the principles of aseptic technique throughout the compounding process. This allows us to maintain the highest degree of product integrity and compliance with state and federal regulations.

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.

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.