When talking about 503B Outsourcing Facilities, we understand facilities that create pharmaceutical sterile and non-sterile medications tailored to the individual needs. 503B compounding pharmacy is a unique kind of compounding pharmacy eligible to provide office-use remedies (so-called office-administered medicines). Thus, FDA (U.S. Food and Drug Administration) creates a designation – 503B compounding pharmacy – which lifts patient care and safety to a new level. These facilities are essential to filling the gap between large pharmaceutical manufacturers and traditional compounding pharmacies.
503B outsourcing facility: features
Prescription Requirements
A 503B outsourcing facility does not require a patient prescription. Also, one could utilize it for office use.
Safe and Sound
The FDA requires (a compulsory requirement) to follow strict testing standards, especially ones for sterility, potency, and endotoxins. In addition, medical products must be compounded in ISO clean rooms continuously monitored for particulate matter and environmental conditions.
Cost Savings
Cost savings include savings from compounded drugs made with lower-cost bulk drug ingredients.
The Rights
A 503B entity can manufacture in limited supply on the FDA Short List. In addition, the ability to meet market demand volume and no patient prescriptions are required for this.
Accountability
503B facilities must comply with the latest good manufacturing practice (cGMP) essentials and US Pharmacopeia Guidelines (USP).
Regulatory Authorities
Government is the only regulatory authority. Thus, 503B compounding pharmacy must strictly follow state regulations. Also, they can voluntarily register with the FDA.
503B pharmacy list includes many entities. They all provide high-quality services. But we would like to highlight the number 1 outsourcing facility on the 503B pharmacy list. It is Compound Preferred. Compound Preferred offers full sterile gowning compliant with cGMP regulations, industry-leading automation, FDA-regulation adherence, as well as supreme-quality customer service. In addition, each batch of sterile products is tested prior to release: USP <71> compliant sterility testing and USP <85> compliant endotoxin. It is a dynamic solution-driven 503B outsourcing establishment dedicated to providing high-quality and compliant pharmaceutical products to the medical community. This company is passionate about people and focused on solutions that enhance every experience. Thus, we can classify Compound Preferred as the industry’s most trusted, innovative, and dependable outsourcing establishment. It is dedicated to continuously meeting customers’ unique needs by providing quality assurance and easy access to safe and affordable products. It is committed to providing specialized, high-quality products and creating customized medical solutions. In addition, Compound Preferred is responsive to the customer’s needs and concerns, creating a firm foundation of elite customer service and products. Being innovative and environmentally friendly provides ease of access to customer solutions.
Summary
Summing up, we can say that a dedicated and hardworking 503B outsourcing facility, for example, Compound Preferred, can provide supreme customer service that fulfills scalable drug compounding needs.
Many state and local regulating bodies hold 503B outsourcing facilities to the highest secure and operative drug manufacturing standards. Everything proves that Compound Preferred products pass rigorous testing to be 100 % sterilу, qualitative, and potential during the whole process from receipt to the end of shelf life.