Ensure Compliance

FDA 503B Compliance

In 2013 the FDA instituted the Drug Quality and Security Act which created section 503B of the Federal Food, Drug and Cosmetic (FD&C) Act. Under section 503B compounding facilities can choose to register with the FDA as an outsourcing facility. If a facility is registered with the FDA as an outsourcing facility to produce sterile…

Specialty Pharmacy Solutions

Applying Specialty Pharmacy Regulations When Working with Partners or Contracted Organizations

Partner models consist of a healthcare institution operating a specialty pharmacy in partnership or in contract with another entity to offer the full range of services required for an accredited specialty pharmacy. Accreditation standards are a valuable resource to healthcare pharmacy leaders to ensure that all internal and partner specific regulatory components are in place.…

Specialty Drugs & Pharmacies

Why are Specialty Drugs and Specialty Pharmacies “Special”?

Specialty drugs are distinguished by two main characteristics: cost and complexity. Specialty drugs are expensive because of their delicate nature such as limited shelf life, need for climate-controlled shipping and meticulous storage. Specialty drugs are complex because they require special handling and services, inventory management and intense administration. They also need a high level of…