The Drug Quality and Security Act adds a new section 503(b) to the FD&C Act. Under section 503(b), a compounder can register with the FDA as an outsourcing facility. Drug products compounded in a registered outsourcing facility can qualify for exemptions from the FDA approval requirements in section 505 of the FD&C Act and the requirement to label drug products with adequate directions for use under section 502(f)(1) if the requirements in section 503(b) are met. 503B Outsourcing facilities will be inspected by FDA and must comply with other provisions of the FD&C Act, including cGMP requirements under section 501(a).
21 CFR part 211, “Current Good Manufacturing Practice for Finished Pharmaceuticals,” sets out the requirements applicable to the design of facilities used in the manufacture of drug products. Certain elements of facility design are considered critical to ensuring the quality of compounded sterile drug products. Empower Pharmacy’s facilities were designed and constructed from the ground up with cGMP in mind. Our state-of-the-art facility built in 2016 includes the following features:
- 15,000 square foot building designed and operated with facility layout, room separation, and process flow considered in a manner to prevent the influx of contamination from adjacent areas and rooms of lower air quality.
- Class 100 ISO 5 Lyophilization Suite. Empower is one of the only outsourcing facilities in the nation with such a room.
- Smoke studies of all our clean rooms and hoods are conducted under dynamic conditions to qualify them for use.
- Fully automated sterile processing line capable of cleaning, sterilizing, filling, stoppering, and capping up to 60 vials per minute with no human intervention.
- Steris Finn-Aqua BPS double door pit mounted steam sterilizer.
- Steris Finn-Aqua Pure Steam Generator creates pure pharmaceutical grade steam used for sterilization and cleanroom humidification.
- Steris Reliance Pharmaceutical Grade Washer that uses TOC monitoring, HEPA drying, purified water, and validated alkaline/acidic detergents to clean equipment and parts involved in the manufacturing process.
- Sterile and non-sterile hazardous drug compounding suites built to meet the new USP <800> requirements.
- Biannual certifications of cleanrooms and all HEPA filters.
- Daily viable air testing is performed in all areas where aseptic compounding occurs.
- Automated environmental control systems include built-in alarms to detect excursions. Real time monitoring of pressure differentials, humidity, particulates, and temperatures.
- 35 foot ceiling shipping/receiving warehouse with controlled temperature and humidity for storage utilizing FedEx, UPS and USPS systems for shipments.